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Tableting

Tableting is the core process in pharmaceutical manufacturing that involves compressing powdered or granulated mixtures of active pharmaceutical ingredients (APIs) and excipients into compact, solid dosage forms known as tablets, which provide a stable and convenient means for oral drug administration.^[1] This method ensures precise dosing, uniform drug distribution, and enhanced bioavailability compared to liquid or powder forms.^[2] The tableting process encompasses several critical stages to produce high-quality tablets, beginning with pre-formulation studies that evaluate the physical and chemical properties of APIs and excipients, followed by blending to achieve homogeneity.^[2] Granulation may then be employed to improve powder flowability and compressibility, with compression occurring in specialized tablet presses that apply high pressure to form the final shape.^[3] Optional coating steps protect the tablet, control release rates, or mask taste, after which rigorous quality control tests assess attributes like hardness, dissolution, and content uniformity to ensure compliance with regulatory standards.^[1] Three primary methods dominate tablet production: direct compression, wet granulation, and dry granulation, each selected based on the material properties and formulation requirements.^[4] Direct compression blends powders directly before pressing, offering efficiency and cost savings for free-flowing materials but limited by poor compressibility in some APIs.^[1] Wet granulation involves adding a liquid binder to form granules that are dried and milled, enhancing uniformity and suitable for moisture-tolerant substances, though it requires multiple steps and drying equipment.^[4] Dry granulation compacts powders into dense slugs or ribbons for milling into granules, avoiding moisture exposure and ideal for heat- or moisture-sensitive drugs, but it demands materials with inherent binding capacity.^[4] Challenges in tableting include managing powder flow issues, preventing segregation during blending, and mitigating compression defects such as capping or sticking, which can compromise tablet integrity and drug release.^[1] Advances in continuous manufacturing and high-shear equipment have improved efficiency and scalability, making tableting indispensable for producing billions of tablets annually to meet global healthcare demands.^[5]

Overview

Introduction

Tableting is the process of compressing powdered or granulated materials into compact, solid dosage forms known as tablets, primarily used to deliver active substances in a controlled and uniform manner.^[2] This mechanical technique transforms loose powders into durable, portable units that facilitate accurate dosing and protect the active components from environmental degradation.^[6] While most prevalent in the pharmaceutical industry for oral drug delivery, tableting also finds applications in nutraceuticals for supplements like vitamins, in confectionery for compressed candies, and in various industrial sectors for forming technical compacts such as catalysts or cleaners.^[7]^[8]^[9] The overall tableting process encompasses several key stages: formulation to select and mix ingredients, preparation involving steps like blending and granulation to achieve suitable powder properties, compression to shape the material under pressure, and finishing through coating or packaging to enhance functionality and stability.^[3] Core steps such as granulation for improving flowability and compression for densification are integral to producing consistent tablets.^[4] Tablets offer significant advantages in pharmaceutical manufacturing, including precise dosing that minimizes variability, enhanced chemical and physical stability for extended shelf life, ease of administration for patient compliance, and scalability for high-volume production.^[10]^[11] However, challenges persist in ensuring content uniformity across batches to meet regulatory standards and optimizing bioavailability, particularly for poorly soluble drugs where formulation can impact absorption rates.^[12]^[13]

History

The origins of tableting trace back to the 19th century, when manual pill presses were developed to produce compressed forms of herbal remedies and early medicinal extracts, enabling more precise dosing than traditional methods like hand-rolling.^[14] In 1843, British inventor William Brockedon patented the first mechanical device for compressing powders into tablets, known as the Brockedon press, which used a die and punch struck by a hammer to form uniform shapes without binders, marking the birth of modern compressed tablets.^[15] This single-punch machine laid the foundation for mechanized production, initially applied to lozenges and pills from natural sources like opium extracts.^[16] By the late 19th century, innovations advanced toward higher throughput, with an employee of the American pharmaceutical company John Wyeth & Brother, Henry Bower, developing the first rotary tablet press in 1872, which rotated multiple dies to produce tablets continuously and revolutionized mass production for pharmaceuticals.^[17] German engineering firm Fette Compacting, founded in 1908, contributed further in the early 20th century by developing specialized presses, including its first in-house model, the Perfecta, in 1948, which supported post-war industrial scaling.^[18] The 1920s saw a pivotal shift toward pharmaceutical applications, driven by the standardization of pharmaceutical ingredients through the United States Pharmacopeia (USP), which established reference standards for active substances like vitamins to ensure consistency in tablet formulations.^[19] World War II accelerated this evolution, as demand surged for mass-produced vitamin tablets to address nutritional deficiencies in troops and civilians, spurring investments in efficient compression technologies.^[20] From the 1970s onward, tableting entered an era of automation, with the introduction of computer-controlled presses that optimized force, speed, and quality monitoring, enabling higher output rates and reduced variability.^[21] Key regulatory milestones included the U.S. Food and Drug Administration's (FDA) 1978 Current Good Manufacturing Practice (CGMP) guidelines, which formalized standards for pharmaceutical production processes, including tableting, to enhance safety and uniformity.^[22] The 1980s marked the rise of direct compression techniques, facilitated by co-processed excipients that eliminated granulation steps, streamlining manufacturing and improving efficiency for heat-sensitive drugs.^[23] In the 2000s, the integration of Process Analytical Technology (PAT), as outlined in the FDA's 2004 guidance, introduced real-time monitoring tools like near-infrared spectroscopy during compression, allowing for immediate quality adjustments and continuous manufacturing paradigms.^[24] In the 2010s and 2020s, advancements continued with the adoption of continuous manufacturing processes, supported by FDA guidance in 2023, and the integration of artificial intelligence for predictive maintenance and optimization in tablet presses. Emerging technologies, such as 3D printing for personalized tablet production, have further expanded tableting capabilities as of 2025.^[25]^[26]

Formulation

Active Ingredients and Excipients

Active pharmaceutical ingredients (APIs) represent the biologically active components in tablet formulations, delivering the intended therapeutic effect. Selection of an appropriate API is guided by key physicochemical properties, including solubility, stability, and bioavailability, which directly influence the drug's absorption and efficacy in oral solid dosage forms. Solubility determines the rate and extent of dissolution in gastrointestinal fluids, while stability ensures the API withstands manufacturing stresses and storage conditions without degradation. Bioavailability, the fraction of the administered dose reaching systemic circulation, is particularly critical for achieving predictable pharmacological responses.^[27]^[28] The Biopharmaceutics Classification System (BCS) provides a framework for API selection by categorizing drugs into four classes based on aqueous solubility and intestinal permeability. BCS Class I APIs exhibit high solubility (dissolving the highest therapeutic dose in ≤250 mL of aqueous media across pH 1.2–6.8 at 37°C) and high permeability (≥85% bioavailability), enabling rapid absorption suitable for immediate-release tablets. In contrast, Class II APIs, with low solubility but high permeability, often require formulation strategies like particle size reduction or solid dispersions to enhance dissolution and bioavailability, as poor solubility can limit absorption for over 40% of new chemical entities. Class III and IV APIs face additional challenges with low permeability or combined low solubility and permeability, necessitating excipient optimization to improve overall performance.^[29]^[28]^[27] Excipients, defined as inactive substances incorporated into tablets, serve essential roles in manufacturing, stability, and drug delivery without contributing to therapeutic activity. They are classified by function: diluents (e.g., lactose or microcrystalline cellulose) add bulk to low-dose formulations and improve powder flow; binders (e.g., polyvinylpyrrolidone or PVP) enhance particle adhesion during wet granulation; disintegrants (e.g., starch) promote rapid tablet breakup upon ingestion; lubricants (e.g., magnesium stearate) minimize friction between powder and die walls during compression; and glidants (e.g., colloidal silicon dioxide) reduce interparticle cohesion to facilitate uniform flow. These categories ensure processability and product quality, with excipients comprising the majority of tablet mass when API loads are low.^[30]^[30]^[30] Formulation design targets specific drug release profiles—immediate, sustained, or controlled—to optimize therapeutic outcomes, such as rapid onset for pain relief or prolonged exposure for chronic conditions. Immediate-release profiles achieve quick disintegration and dissolution for fast bioavailability, while sustained and controlled release use polymers to modulate API elution, maintaining steady plasma levels and reducing dosing frequency. Compatibility testing between APIs and excipients is vital to identify potential interactions, such as chemical degradation or altered release kinetics, ensuring formulation stability. API content typically ranges from 1–50% w/w, depending on potency and dosage form, with higher loads challenging direct compression processes. Quality by Design (QbD) principles systematically define critical quality attributes (e.g., dissolution rate) and material attributes to develop robust formulations that minimize variability and enhance manufacturability.^[31]^[31]^[30] Challenges in excipient selection include patient-specific sensitivities, such as lactose intolerance, which affects approximately 65% of the world's adult population and varies by ethnicity (e.g., 5-15% in people of Northern European descent and up to 90% in many Asian and African populations), where even small amounts (e.g., 100–500 mg per tablet) may cause gastrointestinal discomfort.^[32] Regulatory compliance mandates adherence to United States Pharmacopeia (USP) standards, which specify purity, particle size, and microbial limits for excipients like lactose to ensure safety and consistency across formulations. The formulated blend of APIs and excipients undergoes uniform mixing to achieve content uniformity before further processing.^[33]^[34]

Types of Tablets

Tablets in pharmaceutics are classified based on several criteria, including their physical design, drug release mechanisms, intended route of administration, and specialized functionalities to meet specific therapeutic needs.^[35]^[36]

Classification by Shape and Size

Tablets vary in shape and size to facilitate handling, swallowing, and administration. Common shapes include round tablets, which are the most prevalent for ease of production and ingestion; oval or elliptical forms, which aid swallowing for larger doses; and caplets, which mimic capsule shapes for smoother passage through the esophagus. Specialized shapes encompass bullet-shaped or ovoid designs for vaginal tablets to ensure proper insertion and retention, and small, flat forms for sublingual use to promote rapid dissolution. Effervescent tablets are typically larger and porous to enhance dissolution in water, while chewable tablets are often flavored and textured for mastication.^[37]^[35]

Classification by Release Profile

The release profile determines how quickly or slowly the active pharmaceutical ingredient (API) is made available to the body. Immediate-release tablets disintegrate rapidly in the gastrointestinal tract to provide quick onset of action, suitable for acute conditions. Extended-release tablets employ matrix systems or osmotic pumps to sustain drug delivery over several hours, reducing dosing frequency and maintaining steady plasma levels; for instance, metformin extended-release formulations manage type 2 diabetes by prolonging glycemic control throughout the day. Delayed-release tablets feature protective coatings that prevent dissolution in the stomach, releasing the drug in the intestines to shield sensitive APIs from gastric acid or target specific absorption sites.^[36]^[35]^[38]

Classification by Route of Administration and Application

Most tablets are designed for oral administration, but variations cater to alternative routes for targeted delivery. Oral ingestion tablets, including standard compressed forms, are swallowed whole for systemic or local gastrointestinal effects, such as antacids for acid neutralization. Sublingual tablets, placed under the tongue, enable rapid absorption through the oral mucosa, bypassing first-pass metabolism; nitroglycerin exemplifies this for acute angina relief. Buccal tablets adhere to the cheek lining for prolonged mucosal absorption, often used for hormones or analgesics. Vaginal tablets dissolve locally for infections or contraception, while implantable tablets, inserted subcutaneously, provide long-term release over months for conditions like hormone therapy. Rectal tablets offer an alternative for patients unable to swallow, with absorption via the rectal mucosa.^[37]^[36]^[35]

Specialized Types

Specialized tablets address unique formulation challenges or patient needs. Multilayer tablets separate incompatible APIs into distinct layers, allowing sequential or combined release for combination therapies. Orally disintegrating tablets (ODTs) use superdisintegrants to dissolve in the mouth within seconds without water, improving compliance in pediatrics or geriatrics. Effervescent tablets react with water to produce carbon dioxide, aiding dispersion and absorption for vitamins or analgesics like aspirin in soluble form. Dispersible tablets break down in small volumes of liquid for easier ingestion, particularly for antimalarials. Film-coated tablets provide a thin protective layer for taste masking and stability, while sugar-coated variants offer similar benefits with a thicker, decorative shell, though less common due to processing time.^[35]^[36]^[37]

Pre-Compression Processes

Particle Sizing

Particle sizing is a critical pre-compression step in tableting that reduces the size of active pharmaceutical ingredients (APIs) and excipients to enhance powder flowability, compressibility, and content uniformity in the final tablet. By increasing the surface area of particles, this process improves dissolution rates and bioavailability while promoting better packing density to minimize segregation during subsequent handling and processing. Optimal particle sizes typically range from 50 to 500 μm, as finer particles can lead to cohesive powders with poor flow, whereas coarser ones may cause uneven die filling.^[39]^[40]^[41] The primary methods for particle sizing involve milling techniques such as hammer milling for moderate size reduction, ball milling for finer grinding, and jet milling for achieving sub-micron particles without contamination. These are often followed by sieving to separate and classify particles, using vibratory sieves for general fractionation or air-jet sieves for handling fine, cohesive materials. Milling breaks down agglomerates and exposes new crystal surfaces, which can alter surface energy and influence downstream tableting properties.^[39]^[41]^[42] Equipment commonly used includes oscillating granulators and Fitz mills for coarse to intermediate sizing of heat-sensitive materials, producing particles in the 100-500 μm range through impact and shear forces. For precise analysis of particle size distribution (PSD), laser diffraction instruments are employed, compliant with standards like USP <429>, enabling real-time or off-line measurements. These tools ensure the PSD meets specifications critical for uniform tablet weight and drug content.^[40]^[43]^[44] Key parameters in particle sizing include D10, D50, and D90, which represent the particle diameters below which 10%, 50%, and 90% of the sample lies by volume, respectively; the span, calculated as (D90 - D10)/D50, quantifies distribution uniformity, with narrower spans indicating better consistency for tableting. A span below 1.5 is often targeted to ensure reproducible flow and compaction.^[40] Challenges in particle sizing include over-milling, which generates excessive dust, increases interparticle cohesion, and impairs flow properties due to elevated surface energy. Additionally, milling can disrupt API polymorphs, potentially leading to phase transitions that compromise drug stability and efficacy, necessitating controlled conditions to preserve the desired crystalline form. Sized particles are subsequently fed into powder blending for uniform mixture preparation.^[39]^[42]^[45]

Powder Blending

Powder blending is a critical pre-compression process in tableting that involves the homogeneous mixing of active pharmaceutical ingredients (APIs), excipients, and lubricants to achieve content uniformity in the final dosage form.^[46] The primary goal is to ensure a uniform distribution of the API throughout the blend, meeting regulatory standards such as those outlined in USP <905> Uniformity of Dosage Units, where blend uniformity is often targeted with a relative standard deviation (RSD) of less than 6% for low-dose drugs to prevent variations in potency.^[47]^[46] This step typically uses sized powders as input to facilitate effective mixing and minimize segregation risks.^[48] Common techniques for powder blending include geometric or tumble mixing, high-shear mixing, and diffusion-based mixing, each suited to different powder properties. Geometric mixing employs equipment like V-blenders or double-cone blenders, where the tumbling action splits and recombines powder layers to promote uniformity without excessive shear, ideal for fragile or shear-sensitive blends.^[49]^[50] High-shear methods, such as ribbon or planetary mixers, use agitators to create intense mixing forces, effectively handling cohesive or poorly flowing powders but requiring careful control to avoid over-mixing.^[50] Diffusion mixing, often achieved in tumble blenders at low speeds, relies on random particle movement for gentle blending of heat- or moisture-sensitive materials.^[49] Key parameters influencing blend quality include blend time, mixing speed, and the order of ingredient addition. Typical blend times range from 5 to 20 minutes, depending on equipment and powder characteristics, to achieve homogeneity without inducing segregation or over-lubrication.^[51] Mixing speeds are optimized to balance uniformity and powder integrity, while lubricants like magnesium stearate are added last to prevent coating of particles that could impair tablet compressibility.^[52]^[53] Segregation risks, such as sifting or fluidization during blending or transfer, can lead to API-rich or API-poor regions, compromising content uniformity. These risks are mitigated by controlling particle size and shape to reduce density or size differences between components, as blends with uniform particle properties exhibit lower segregation tendencies.^[46] In-process monitoring using near-infrared (NIR) spectroscopy enables real-time assessment of blend uniformity, allowing adjustments to prevent segregation and ensure compliance with RSD limits.^[54]^[55] Blends prepared for direct compression demand stricter moisture control compared to those for granulation feeds, as direct methods lack subsequent drying steps and are more sensitive to moisture-induced sticking or flow issues.^[56] This lower moisture tolerance enhances stability for sensitive APIs but requires precise environmental controls during blending.^[56]

Granulation

Granulation is an essential pre-compression process in pharmaceutical tableting that aggregates fine powder particles into larger, free-flowing granules to enhance bulk density, reduce dust generation, improve powder flowability and compressibility, and ultimately contribute to stronger, more uniform tablets.^[57] This step is particularly crucial for formulations where direct compression is challenging due to poor powder properties, starting from the blended powders of active pharmaceutical ingredients (APIs) and excipients.^[57] Wet granulation, the most widely adopted technique, involves adding a liquid binder solution to the powder blend to form a wet mass that is subsequently processed into granules. The process typically includes steps such as initial mixing of the dry powders, addition of the binder solution during wet massing, kneading to achieve uniform distribution and agglomeration, extrusion through a screen or die to shape the wet mass, and spheronization for producing spherical granules when needed for controlled-release applications.^[57]^[58] Common binders include hydroxypropyl methylcellulose (HPMC), which provides strong adhesion at concentrations of 2-5% w/w, and gelatin, often used in aqueous solutions for its excellent binding properties in wet massing.^[59] The endpoint of wet granulation is determined by monitoring parameters such as impeller power consumption, which increases as the wet mass becomes denser, or moisture content to ensure optimal granule size (typically 0.2-2 mm) and avoid over-wetting.^[60]^[57] Equipment for wet granulation includes high-shear mixers, such as the Diosna series, which facilitate rapid binder distribution and kneading through high-speed impellers and choppers, and fluid bed granulators that enable top- or bottom-spray addition of binder for gentle agglomeration.^[61]^[57] Dry granulation is employed for moisture- or heat-sensitive APIs, relying on mechanical compaction without liquids to densify the powder. Key methods include slugging, where the powder blend is compressed into oversized tablets (slugs) using a heavy-duty press and then milled into granules, and roller compaction, which forces the powder between counter-rotating rolls to form a solid ribbon that is milled subsequently.^[57]^[62] These techniques are followed by size reduction to achieve uniform granules suitable for tableting. Wet granulation offers advantages such as superior content uniformity and robust granule strength due to the intimate mixing with binders, making it ideal for poorly compressible powders, but it is more complex, time-intensive, and unsuitable for sensitive materials owing to liquid exposure.^[57] In contrast, dry granulation provides a simpler process without drying requirements, preserving stability for heat-labile or moisture-sensitive drugs, though it may yield granules with variable density and limited applicability to highly compressible formulations.^[57]^[62]

Drying

Drying is an essential step following wet granulation in pharmaceutical tableting, aimed at removing excess moisture from the granules to achieve a final moisture content typically below 2 wt.% while preserving the integrity of the active pharmaceutical ingredient (API) and excipients. This low moisture level is critical to prevent microbial growth, as free water can serve as a breeding ground for contaminants, and to mitigate API instability, such as hydrolysis or degradation, which could compromise tablet efficacy and shelf life. Excess moisture can also lead to poor granule flowability, sticking during compression, and reduced tablet hardness. The loss on drying (LOD) test is routinely employed to quantify moisture content by measuring the weight loss of a sample after heating under controlled conditions, typically at 105°C until constant weight is achieved, providing a reliable indicator of drying endpoint and product quality. Several drying methods are utilized depending on the scale, material sensitivity, and production needs. Tray drying, a batch-oriented, low-technology approach, involves spreading wet granules evenly on perforated trays within an oven where hot air circulates to evaporate moisture; it is simple and cost-effective but time-consuming, often requiring 4-24 hours per batch. Fluid bed drying, in contrast, offers a more efficient, semi-continuous process by suspending granules in a stream of heated air, promoting uniform heat and mass transfer through fluidization, which significantly reduces drying time to 30-90 minutes compared to tray methods. For heat-sensitive APIs, vacuum drying is preferred, as it lowers the boiling point of water under reduced pressure, enabling moisture removal at temperatures as low as 30-50°C without thermal degradation, often integrated into single-pot processors for seamless granulation-to-drying transitions. Key process parameters must be optimized to ensure effective drying without compromising granule properties. In fluid bed systems, inlet air temperature is typically maintained between 40-80°C to balance evaporation rate and material stability, while airflow rates of 0.8-1.6 m/s ensure proper fluidization and prevent channeling. The drying endpoint is determined using techniques such as Karl Fischer titration for precise water content measurement or near-infrared (NIR) spectroscopy for real-time, non-destructive monitoring of moisture levels, allowing adjustments to avoid under- or over-drying. Challenges in drying include over-drying, which can render granules brittle and friable, leading to excessive fines and weak tablets during compression, and case hardening, where rapid surface drying due to inadequate fluidization traps internal moisture, resulting in uneven granule structure and potential API migration. To address energy efficiency and processing speed, microwave-assisted drying has emerged as a promising technology for pharmaceutical granules. This method uses electromagnetic waves to generate volumetric heat within the granules, accelerating moisture evaporation up to 10 times faster than conventional hot air drying while minimizing exposure to high temperatures and reducing overall energy use by up to 50%. It is particularly advantageous in continuous manufacturing lines but requires careful control to prevent hotspots and ensure uniform drying.

Tablet Compression

Compression Mechanism

The compression mechanism in tableting transforms loose powders or granules into coherent compacts through a series of physical stages, beginning with die filling, where the prepared material is gravity-fed or metered into the die cavity to achieve uniform initial volume.^[63] This is followed by consolidation under applied pressure, which reduces porosity by particle rearrangement and deformation, accompanied by air expulsion to prevent entrapment that could lead to defects.^[64] The process culminates in elastic recovery during decompression, where the compact partially rebounds due to stored energy, potentially affecting final dimensions and integrity.^[65] Compressibility during these stages is often quantified using the Heckel equation, expressed as \ln\left(\frac{1}{\epsilon}\right) = KP + C, where \epsilon is the porosity of the compact, P is the applied pressure, K is a constant inversely related to the material's yield pressure (indicating deformation ease), and C accounts for initial repacking.^[66] This logarithmic relationship models the densification phase, with higher K values signifying greater plasticity and better bonding potential.^[67] Typical applied pressures range from 50 to 500 MPa, sufficient to overcome interparticle friction and achieve densities of 0.8–1.2 g/cm³, depending on the material.^[68] Punch displacement controls the volume reduction, while dwell time—the duration at maximum pressure—influences viscoelastic relaxation and final density, with longer times (e.g., >50 ms) promoting more uniform consolidation in rate-sensitive materials.^[69] Material behavior under compression varies between plastic deformation, where particles flow and form intimate contacts for strong van der Waals bonds (common in excipients like microcrystalline cellulose), and brittle deformation, involving fragmentation that exposes new surfaces for bonding but risks uneven stress distribution (typical in crystalline actives like mannitol).^[70] Viscoelastic recovery, a time-dependent elastic rebound, can exceed 5–10% in poorly consolidating formulations, leading to capping (partial top separation) or lamination (horizontal splitting) if interparticulate bonds fail to withstand radial and axial stresses during ejection.^[65] These defects arise from mismatched deformation rates, where rapid decompression amplifies recovery forces beyond the compact's tensile strength (often <5 MPa).^[71] Key factors influencing compactibility—the ability to form strong tablets—and hardness include granule size, with finer particles (50–200 µm) enhancing packing density but increasing air entrapment risk; moisture content, where 1–5% optimal levels plasticize particles for better bonding without softening; and lubricant levels, such as 0.5–2% magnesium stearate, which reduce friction but at higher concentrations (>1%) coat surfaces and diminish hardness by up to 30%.^[72]^[73] Larger granules (>500 µm) may reduce compactibility due to poor flow and rearrangement, while excess moisture (>6%) promotes stickiness and weakens bonds.^[74] To prevent defects, a pre-compression force (typically 10–50 MPa) is applied briefly before main compression to expel entrapped air, reducing porosity by 20–40% and minimizing recovery-induced stresses.^[64] Optimized tooling design, including tapered dies and punch face radii (e.g., 0.5–1 mm), distributes radial pressures evenly, lowering lamination risk by 50% in sensitive formulations through improved stress gradients.^[75]

Tablet Presses

Tablet presses are essential machinery in pharmaceutical manufacturing used to compress powder or granule formulations into tablets through controlled application of force. These devices vary in design to accommodate different production scales, from research and development to high-volume commercial output, ensuring uniformity in tablet weight, size, and hardness. The primary types include single-punch presses, rotary presses, and compaction simulators, each suited to specific operational needs based on throughput and precision requirements.^[76] Single-punch, also known as eccentric, presses operate with a single die and punch set, producing one tablet per cycle through a vertical reciprocating motion driven by an eccentric cam. These machines are ideal for small-batch production or laboratory settings, with typical outputs ranging from 1,000 to 5,000 tablets per hour, making them suitable for formulation development where frequent adjustments are needed. In contrast, rotary presses feature a rotating turret holding multiple dies and punches—often 20 to 45 stations—enabling simultaneous compression at multiple points for high-speed production, achieving rates up to 1,000,000 tablets per hour depending on the model and configuration. Compaction simulators, essentially instrumented single-station devices, replicate the dynamics of rotary presses for research purposes, allowing precise simulation of compression profiles without large-scale equipment.^[77]^[78]^[79] Key components of tablet presses include the hopper for material storage, dies that form the tablet shape, upper and lower punches for compression, and in rotary models, the turret that rotates to cycle stations through filling, compression, and ejection phases. The feeding system, often equipped with force feeders using paddles or impellers, ensures uniform die filling by overcoming powder flow variations and air entrapment. Cam tracks guide punch movements, while compression rollers apply the necessary force, typically monitored via instrumentation such as strain gauges for force-displacement profiles to optimize compression physics and detect anomalies like capping or sticking.^[80]^[81]^[82] Tablet presses operate across scales: laboratory versions handle small batches for R&D, often with manual or semi-automated features, while production-scale rotary presses comply with Good Manufacturing Practices (GMP), incorporating clean-in-place (CIP) systems for efficient sanitation between batches to prevent cross-contamination. Advancements include servo-driven presses, which use programmable motors for precise control of punch speed and dwell time, improving tablet quality consistency over traditional mechanical drives. Integration with Process Analytical Technology (PAT) enables real-time monitoring and adjustments, such as automated weight control, enhancing efficiency in continuous manufacturing environments.^[69]^[83]^[84]

Specific Equipment Examples

Fette Compacting, founded in 1908 in Germany, has been a pivotal player in the development of tablet compression equipment, particularly through its introduction of high-speed rotary presses starting in the 1970s with the P2000 model, which marked the beginning of modern high-output tableting technology.^[18]^[85] The company's P series represents a cornerstone of standardized production presses, designed for versatility in pharmaceutical manufacturing; for instance, the P 1200 model typically features 24 to 30 stations and achieves outputs ranging from 45,000 to 216,000 tablets per hour, depending on configuration and material properties.^[86]^[87] Key features of the P series include exchangeable turret systems that facilitate quick tooling changes and reduce downtime, integrated force monitoring to detect and prevent overload conditions during compression, and seamless integration with downstream dedusting units for continuous operation.^[88]^[89] Fette's equipment played a significant role in the post-World War II pharmaceutical expansion, with its first in-house tableting machine, the Hanseaten Perfecta, launched in 1948 to meet growing demands for efficient solid dosage production amid the industry's recovery and boom.^[90] In contemporary applications, Fette presses incorporate in-process controls (IPC) such as real-time weight and hardness monitoring, enhancing compliance with regulatory standards and enabling upgrades for continuous manufacturing lines.^[91] Beyond Fette, other notable manufacturers provide specialized equipment tailored to diverse production needs. Manesty, a UK-based company now part of Syntegon, is renowned for its single-rotary presses, such as the Unipress series, which support small-batch and R&D applications with outputs up to 202,500 tablets per hour across 27 stations, emphasizing simplicity and pre-compression for consistent tablet quality.^[92]^[93] Korsch AG, another German firm, excels in modular designs, exemplified by the XL 400 series, which allows flexible reconfiguration for multi-layer tablets and various formats on a single machine, accommodating up to 338,400 tablets per hour for single-layer tablets in high-volume setups.^[94]^[95] In comparisons within the industry, Fette presses are often favored for their superior reliability and precision in demanding pharmaceutical environments, attributed to robust engineering and low maintenance needs, though they command higher upfront costs—typically 20-50% more than generic or entry-level rotary presses from lesser-known suppliers—making them a preferred choice for large-scale, regulated production over more economical alternatives suited to generics manufacturing.^[96]^[97]

Post-Compression Processes

Dedusting

Dedusting is an essential post-compression process in pharmaceutical tableting, aimed at removing excess powder fines from the surfaces of compressed tablets and punch faces to ensure cleanliness, prevent contamination, and maintain product quality. This step eliminates dust generated during compression, which can otherwise lead to equipment malfunctions, packaging issues, and reduced patient confidence in tablet appearance. Integrated directly after the compression stage, dedusting helps sustain high production yields by minimizing tablet loss due to dust-related defects.^[98]^[99] Common methods for dedusting include vibratory techniques, which use mechanical shaking or electromagnetic vibration to dislodge loose particles from tablets; air aspiration systems, employing vacuum suction or compressed air jets to capture and remove fines; and rotary dedusters, where tablets are elevated through spiral paths for agitation and cleaning. These approaches are often combined, such as vibratory systems enhanced with air-jet assistance and extraction curtains, to achieve efficient dust removal without compromising tablet integrity. For instance, rotary methods leverage height gain—optimal up to 30 inches—to improve dedusting performance progressively.^[98]^[99]^[100] Equipment for dedusting is typically installed inline with tablet presses, featuring units like segmented spiral dedusters made from polymer or stainless steel for quick changeovers and compatibility with various tablet sizes. These systems include adjustable speeds to synchronize with production rates, often reaching capacities of up to 800,000 tablets per hour, and may incorporate additional functions such as elevation, polishing, or metal detection. Dust collection occurs via integrated vacuum ports and circumferential channels, ensuring captured particles are contained effectively.^[98]^[100]^[99] Challenges in dedusting include the risk of damaging friable tablets through excessive vibration or air pressure, buildup of static electricity that can attract dust, and the need for validation to confirm dust capture efficiency and process consistency. To mitigate these, equipment designs incorporate adjustable parameters and materials that reduce static, while validation protocols assess performance metrics like weight variation improvements exceeding 40%. From a GMP perspective, dedusting systems must feature dust-tight enclosures, HEPA-filtered exhausts, and wash-in-place capabilities to comply with cGMP standards, OSHA occupational safety requirements for dust exposure limits (e.g., 15 mg/m³ total dust over 8 hours), and environmental regulations for emission control. Proper documentation of cleaning and maintenance is required for audits to prevent cross-contamination and ensure operator safety.^[98]^[99]^[100]^[101]

Tablet Testing

Tablet testing encompasses a series of in-process and final quality assessments to ensure tablets meet pharmacopeial standards for uniformity, mechanical integrity, drug release, potency, appearance, and stability. These tests are critical for verifying compliance with regulatory requirements, such as those outlined in the United States Pharmacopeia (USP) and International Council for Harmonisation (ICH) guidelines, to guarantee product safety and efficacy. In-process testing occurs during manufacturing to monitor critical quality attributes in real time, while final testing evaluates completed batches for release and shelf-life determination.^[102]^[103] In-process tests include weight variation, which assesses dosage uniformity by weighing individual tablets and comparing to the average; per USP <905>, limits range from ±10% for tablets weighing 80 mg or less to ±5% for those exceeding 250 mg, ensuring consistent drug content across units. Thickness and hardness are measured to evaluate compressibility and durability, with tensile strength typically targeted above 2 MPa to withstand handling and packaging without breakage. Friability testing, conducted using a Roche friabilator per USP <1216>, involves rotating 10-20 dedusted tablets at 25 rpm for 4 minutes (100 rotations) and requires weight loss below 1% for uncoated tablets to confirm resistance to abrasion.^[104]^[105]^[106] Final tests focus on performance and content. Dissolution testing, using USP Apparatus 1 (basket) or 2 (paddle) per USP <711>, simulates gastrointestinal release; for immediate-release tablets, a common specification is at least 80% (Q=80%) of the active pharmaceutical ingredient (API) dissolved within 30 minutes in specified media like 0.1 N HCl or pH 6.8 buffer. Content uniformity, also under USP <905>, ensures the API distribution meets an acceptance value of ≤15 through either weight variation or individual assays, preventing dose inconsistencies. Assay determination of API potency typically employs high-performance liquid chromatography (HPLC) as specified in USP monographs, verifying content between 90% and 110% of the labeled amount to confirm manufacturing accuracy.^[102]^[104]^[107] Appearance inspection involves visual examination for defects such as picking (surface material adhesion loss), mottling (uneven color), or chipping, which can indicate formulation or processing issues; automated vision systems enhance this by using high-speed cameras and image analysis to detect anomalies like cracks or foreign particles at rates exceeding hundreds of tablets per minute. Stability testing follows ICH Q1A(R2) guidelines, subjecting tablets to accelerated conditions of 40°C and 75% relative humidity for at least 6 months to predict shelf life through periodic assays for degradation products, dissolution, and physical changes.^[108]^[103] Non-destructive methods like near-infrared (NIR) spectroscopy provide real-time monitoring of blend uniformity during compression, analyzing powder spectra in the tablet press feed frame to detect API concentration variations without sampling disruption, as validated in process analytical technology (PAT) applications.^[109]

Coating

Tablet coating involves the application of a thin layer of material onto the surface of compressed tablets to enhance their functionality, stability, and patient acceptability. This process typically occurs after dedusting to ensure a clean substrate. Common types include film coating, which applies a thin polymer layer (20–100 μm thick) using aqueous or solvent-based suspensions for purposes such as taste-masking with hydroxypropyl methylcellulose (HPMC); sugar coating, a multi-step aesthetic process involving multiple layers of sucrose syrup that increases tablet weight by 30–50%; and enteric coating, which employs pH-sensitive polymers like Eudragit L 30 D-55 to protect acid-labile drugs by dissolving only at pH >5.5 in the intestines.^[110]^[111]^[110] The primary processes for tablet coating are pan coating and fluid bed coating. In pan coating, a batch process, tablets tumble in a rotating perforated drum while a coating suspension is sprayed onto the bed and dried with hot air, allowing for controlled application in standard or side-vented pans. Fluid bed coating, often using a bottom-spray Wurster configuration, suspends tablets in an upward airflow column for uniform spraying and drying, promoting better coating efficiency and reduced processing time compared to pan methods. Key parameters include spray rate (typically 10–100 g/min to optimize droplet size and uniformity), inlet air temperature (40–80°C for drying), and target weight gain of 2–5% for film coatings to achieve adequate coverage without excessive buildup.^[111]^[111]^[110] Equipment for these processes commonly features perforated drum coaters, such as the Accela-Cota or Glatt systems, which include spray nozzles positioned at the top or bottom of the drum, exhaust systems for solvent removal, and automated controls for parameters like rotation speed (4–15 rpm) and airflow. Auto-polishing attachments can be integrated post-coating to enhance surface gloss by gentle tumbling with polishing agents. The shift from organic solvent-based to aqueous systems in modern equipment reduces volatile organic compound (VOC) emissions, improving environmental safety while maintaining coating integrity.^[110]^[110]^[111] Coating serves multiple functions, including acting as a moisture barrier to protect hygroscopic drugs, improving swallowability by smoothing rough edges, and enabling controlled release modifications such as sustained release with ethylcellulose or enteric protection with Eudragit polymers. For instance, HPMC-based films mask bitter tastes in pediatric formulations, enhancing compliance.^[111]^[111]^[110] Challenges in tablet coating include defects like the orange-peel effect, a rough surface resulting from rapid drying of sprayed droplets leading to uneven film formation, and bridging, where the coating fills tablet embossings or logos, potentially altering drug release profiles. These issues can be mitigated by optimizing spray rates and air temperatures, though aqueous systems may prolong drying times compared to solvents.^[111]^[111]

Tablet Properties and Quality

Physical Characteristics

Physical characteristics of compressed tablets encompass measurable attributes that ensure their functionality, stability, and patient acceptability in pharmaceutical applications. These properties are primarily determined during the compression process and influence subsequent handling, dissolution, and bioavailability. Key attributes include dimensions, mechanical strength, appearance, and density, each optimized based on formulation and tooling design to meet regulatory standards. Tablet dimensions typically include a diameter ranging from 5 to 20 mm and a thickness of 2 to 8 mm, with individual tablet weights varying between 50 and 1000 mg depending on the dose and excipient composition.^[112]^[113] These parameters are directly influenced by the die and punch design used in the tablet press, where the die cavity sets the diameter and the fill depth controls the thickness and weight.^[114] Mechanical properties assess the tablet's ability to withstand handling and transportation without degradation. Hardness, measured in kiloponds (kp) using devices like the Monsanto tester, generally falls within 4 to 10 kp for conventional tablets, providing sufficient durability while allowing for disintegration. Friability quantifies resistance to abrasion, with acceptable weight loss limited to less than 1.0% for uncoated tablets after mechanical stress simulation.^[115] Tensile strength (σ), a more precise indicator of internal bonding, is calculated using the formula:

\sigma = \frac{2P}{\pi D T}

where P is the applied load at failure, D is the tablet diameter, and T is the thickness; this diametral compression-derived value helps correlate mechanical integrity across different tablet geometries.^[116] Appearance properties contribute to product identification and aesthetic appeal, including uniform color distribution achieved through even pigment dispersion, smooth or textured surface finishes depending on punch face design, and well-defined edges that prevent chipping.^[30] Density characteristics reflect the compaction efficiency and porosity of the tablet. Bulk and tapped densities of the pre-compression powder blend inform flowability, with Carr's index—calculated as \frac{\text{tapped density} - \text{bulk density}}{\text{tapped density}} \times 100—ideally below 20% for optimal filling.^[117] True density, determined via helium pycnometry, excludes void spaces and typically yields values around 1.2–1.5 g/cm³ for pharmaceutical excipients, enabling porosity calculations.^[118] Tablet porosity often ranges from 10% to 20%, decreasing with higher compression forces that consolidate particles and reduce intergranular voids.^[119] Variations in these properties arise between core (uncoated) and coated tablets, where coatings add 50–200 µm thickness and alter surface texture and density without significantly impacting core dimensions or mechanical strength. Compression force adjustments during production can modulate porosity and thus mechanical attributes, balancing robustness against rapid drug release.^[30]

Quality Control Measures

Quality control measures in tableting encompass systematic approaches to ensure the reliability, consistency, and compliance of the manufacturing process, safeguarding product quality from raw material blending through compression.^[120] Central to these measures is process validation, which verifies that the tableting process consistently produces tablets meeting predefined quality attributes. This involves three key stages: Installation Qualification (IQ) to confirm equipment installation meets specifications, Operational Qualification (OQ) to demonstrate equipment functions within operational parameters, and Performance Qualification (PQ) to prove the process yields consistent results under routine conditions, as outlined in FDA regulations under 21 CFR Part 211.^[121] Scale-up from laboratory to production scales requires additional validation to address variations in equipment and process parameters, ensuring reproducibility while mitigating risks associated with larger volumes.^[120] Risk management tools are integral to identifying and controlling potential failures in tableting operations. Failure Mode and Effects Analysis (FMEA) is widely applied to assess critical parameters, such as blend uniformity, by evaluating failure modes, their severity, occurrence, and detectability to prioritize mitigation strategies.^[122] Corrective and Preventive Actions (CAPA) systems address deviations by investigating root causes and implementing solutions to prevent recurrence, forming a core component of pharmaceutical quality systems.^[24] These tools align with international standards like ICH Q9, promoting proactive oversight to minimize variability in powder flow, compression force, and tablet integrity.^[122] Regulatory compliance under current Good Manufacturing Practices (cGMP) mandates comprehensive documentation and traceability in tableting. The FDA's 21 CFR Part 211 requires detailed batch records to record all process steps, materials, and controls, enabling traceability and facilitating audits.^[121] Audit trails, particularly in electronic systems, provide secure, time-stamped records of data changes to ensure integrity and prevent unauthorized alterations, as emphasized in FDA guidance on data compliance.^[123] WHO guidelines reinforce these requirements, advocating for validation master plans and ongoing process monitoring to align with global standards for pharmaceutical quality assurance.^[124] Advanced methodologies enhance quality control efficiency in tableting. Six Sigma methodologies target defect reduction to near-zero levels (3.4 defects per million opportunities) by applying data-driven tools like DMAIC (Define, Measure, Analyze, Improve, Control) to optimize processes such as granulation and compression.^[125] Process Analytical Technology (PAT), endorsed by the FDA, enables real-time monitoring of critical quality attributes using tools like near-infrared spectroscopy for blend uniformity, supporting Real-Time Release Testing (RTRT) to approve batches based on process data rather than end-product testing.^[24] Addressing common issues is vital for maintaining tableting integrity. Cleaning validation protocols prevent cross-contamination by verifying that cleaning procedures remove residues to acceptable limits, typically below 10 ppm for prior actives, through swab and rinse sampling as per FDA and WHO standards.^[126] ^[124] Stability programs monitor tablet degradation under various conditions (e.g., temperature, humidity) over time, using accelerated and long-term studies to establish shelf-life and storage recommendations, in line with ICH Q1 guidelines integrated into FDA and WHO frameworks.^[123]

Packaging and Storage

Packaging Methods

Primary packaging for pharmaceutical tablets directly encloses the product to shield it from environmental contaminants like moisture, oxygen, and light, while facilitating unit-dose administration and tamper-evidence. Common formats include blister packs, bottles, and strips, each tailored to specific product stability needs and regulatory requirements. These methods ensure that stable tablets, post-compression and testing, remain protected during distribution.^[127] Blister packs, the most prevalent primary packaging for oral solids, feature a thermoformed plastic cavity—typically polyvinyl chloride (PVC) or polyvinylidene chloride (PVDC)—sealed with aluminum foil lidding to provide a barrier against moisture and oxygen ingress. This unit-dose design enhances patient compliance by allowing easy dispensing of individual tablets. Strip packs, a variant, employ two flexible layers (often foil or plastic laminates) heat-sealed around the tablets without pre-formed cavities, offering similar protection but in a continuous strip format suitable for higher-volume production. Bottles, commonly constructed from high-density polyethylene (HDPE), accommodate bulk tablets and incorporate cotton plugs or silica gel desiccants to control internal humidity.^[128]^[129]^[127] Secondary packaging, such as folding cartons or boxes, encases primary containers to add labeling, branding, and further mechanical protection during shipping and storage. These often include child-resistant features, like push-and-turn closures or restricted-access flaps, mandated by the Consumer Product Safety Commission (CPSC) under the Poison Prevention Packaging Act (PPPA) for most oral prescription drugs to prevent accidental pediatric access.^[130]^[131] Packaging processes are highly automated to maintain efficiency and sterility, integrating directly with tablet compression lines via conveyor systems for seamless transfer. Counting and filling machines precisely tally tablets into primary containers using vibratory or auger mechanisms, followed by sealing via heat, induction, or ultrasonic methods to ensure airtight integrity. For oxygen-sensitive formulations, nitrogen flushing displaces air during filling, reducing oxidation risk before capping or lidding.^[132]^[133] Material selection prioritizes barrier performance to match tablet sensitivity; for instance, packaging with low moisture-vapor transmission rates (MVTR), such as less than 0.1 g/m²/day, is essential for hygroscopic products to prevent degradation.^[134] Light-protective options like amber glass bottles block ultraviolet and visible light transmission, complying with United States Pharmacopeia (USP) standards for photosensitive drugs.^[135] Modern automation incorporates serialization—applying unique identifiers like 2D barcodes to each package unit—for compliance with the Drug Supply Chain Security Act (DSCSA), enabling electronic track-and-trace to combat counterfeiting and ensure supply chain integrity. Vision systems verify codes during inline printing and inspection, with data integration into enterprise systems for regulatory reporting.^[136]^[132]

Stability and Storage

Tablet stability encompasses chemical, physical, and microbial aspects, each critical to ensuring the product's quality over its shelf life. Chemical stability focuses on the integrity of the active pharmaceutical ingredient (API), where degradation such as hydrolysis can occur when water molecules interact with the drug, leading to breakdown products that may reduce efficacy or produce impurities.^[137]^[138] Physical stability involves maintaining attributes like appearance and hardness, with discoloration often resulting from interactions between excipients such as amines and lactose, causing browning over time.^[139]^[140] Microbial stability prevents contamination and growth, particularly in formulations with sufficient water activity, though low-moisture tablets like those in solid oral dosage forms generally exhibit high resistance to microbial proliferation under controlled conditions.^[141]^[142] These stability types are evaluated across ICH Q1A-defined climatic zones I-IV, which classify global regions based on temperature and humidity: Zone I (temperate, e.g., 21°C/45% RH), Zone II (subtropical/Mediterranean, 25°C/60% RH), Zone III (hot/dry, 30°C/35% RH), and Zone IV (hot/humid, subdivided into IVa at 30°C/65% RH and IVb at 30°C/75% RH).^[143]^[144] Stability testing protocols under ICH Q1A(R2) include long-term studies at 25°C/60% RH for 12-36 months to simulate real-world conditions, and accelerated tests at 40°C/75% RH for 6 months to predict shelf life using kinetic models.^[145] Predictive kinetics often employ the Arrhenius equation, which relates reaction rate constant k to temperature via:

k = A e^{-\frac{E_a}{RT}}

where A is the pre-exponential factor, E_a is activation energy, R is the gas constant, and T is absolute temperature; this allows extrapolation of degradation rates from accelerated data to ambient storage.^[145] Intermediate testing at 30°C/65% RH may be conducted if significant changes occur in accelerated conditions, with at least three batches tested to establish shelf life.^[145] Recommended storage conditions for tablets emphasize a cool, dry environment below 25°C and 60% relative humidity to minimize degradation, with excursions permitted up to 30°C but avoiding direct sunlight or heat sources.^[146]^[147] Labels must include expiry dates based on stability data, typically indicating "store in a cool, dry place" to maintain potency.^[148] Common degradation causes in stored tablets include moisture ingress, which promotes hydrolysis and microbial growth, and light exposure, which can induce photodegradation leading to discoloration or potency loss.^[149]^[150] Mitigation strategies involve using desiccants in packaging to absorb excess humidity and opaque materials to block light, thereby extending shelf life without altering the formulation.^[151]^[152] Post-market stability monitoring requires ongoing studies for reformulated products to verify continued compliance with initial data, with any detected instability triggering regulatory actions such as recalls to protect public health.^[153]^[154] If instability is identified through surveillance, manufacturers must initiate recall procedures, classifying them by risk level (e.g., Class I for serious health hazards) and coordinating with agencies like the FDA.^[154]

References

[1]
Tablet Manufacture - an overview | ScienceDirect Topics
The ability of a powder to form a tablet of adequate mechanical strength is termed as tabletting. It is important that a tablet remain intact during its ...
[2]
Tablet Manufacturing Process: An Overview | Pharmaguideline
Jan 25, 2024 · Tablet manufacturing involves blending powders, pre-formulation, formulation, compression, coating, and then final testing and packaging.<|control11|><|separator|>
[3]
The Complete Guide to Tablet Manufacturing Processes
Tablet manufacturing includes formulation, quality check, granulation, compression, coating, and packaging, from raw powder to oral solid dosage forms.Basics of Tablet Manufacturing · Key Steps in Tablet... · Leading Pharmaceutical...
[4]
How Tablets Are Manufactured | Thomas Processing
Tablets are made using wet granulation, dry granulation, or direct compression. Wet granulation uses a binder, dry granulation compacts and breaks down, and ...
[5]
Continuous Tableting and the Road to Global Adoption - GMP Journal
Mar 4, 2024 · Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets.
[6]
Moisture Behavior of Pharmaceutical Powder during the Tableting ...
Tableting is the mechanical process adopted by the pharmaceutical industry to produce medicinal tablets. It involves direct compression of a powder mixture ...
[7]
Tablet Tooling Nutraceutical Products | Natoli Blog
Manufacturers use tablet presses to produce a variety of products, such as pharmaceuticals, nutraceuticals, veterinary products, confectionary products, ...Missing: applications | Show results with:applications
[8]
Types of Tablets in Pharmacy: Advantages, Forms & Innovations
Aug 1, 2025 · ✓ Advantages of Tablets · Accurate dosage and easy identification · Long shelf-life and chemical stability · Convenient packaging and transport.
[9]
A review of emerging technologies enabling improved solid oral ...
Tablets are the most widely utilized solid oral dosage forms because of the advantages of self-administration, stability, ease of handling, transportation ...<|control11|><|separator|>
[10]
What are some general challenges when developing oral solid ...
Jun 1, 2024 · Some common challenges include formulating the drug to ensure stability and bioavailability, selecting appropriate excipients to enhance drug ...
[11]
Overcoming Challenges in Early Phase Drug Product Development
May 6, 2025 · Poor solubility of active pharmaceutical ingredients (APIs) can limit bioavailability ... uniformity can present challenges due to the ...
[12]
The history of compounds, extraction and tablet compression
Jun 6, 2016 · A look back at the history of tablets shows how this delivery form came to dominate current pharmaceutical and supplement markets.
[13]
Tools of the Trade | RPS - Royal Pharmaceutical Society
Fact: The first tablet making device was patented by William Brockedon in 1843, who is credited as the inventor of the compressed tablet. Called a single tablet ...
[14]
Brockedon's metal pill die with three boxes of pills, 1843.
William Brockedon invented this machine for producing pills in 1843. Powder was poured into a tube, and then compressed with a mallet until solid.Missing: Thomas | Show results with:Thomas
[15]
About Fette Compacting
Fette Compacting is the international market leader in the area of tablet presses in the pharmaceutical industry. Fette Compacting is based in Schwarzenbek ...Missing: 1917 | Show results with:1917
[16]
[PDF] On January 6, 1817 at a meeting of the New York County Medical ...
The 1920's marked the advent of the USP Reference Standards program with standards for Vitamin A and D content in cod liver oil. During the period 1900 and ...
[17]
Vitamins Come to Dinner | Science History Institute
Jun 7, 2012 · Neither medicine nor food, the vitamin pill was born in the early 20th century and came of age during World War II. Now, vitamins are here ...
[18]
The Development History Of Tablet Press - Rich Packing Machinery
Dec 10, 2021 · The tablet press first appeared earlier in Europe and the United States, and by 2021 it has more than a hundred years of history.
[19]
Milestones in US Food and Drug Law - FDA
Jan 30, 2023 · 1970-1979: FDA Milestones ; 1972. Over-the-Counter Drug Review begun to enhance the safety, effectiveness and appropriate labeling of drugs sold ...
[20]
A review on co-processed excipients used in direct compression of ...
1. Introduction. The pharmaceutical industry first started to use co-processed excipients from the late 1980s, with early examples. including co-processed ...
[21]
[PDF] FDA Guidance for Industry PAT – A Framework for Innovative ...
This FDA guidance provides a framework for innovative pharmaceutical development, manufacturing, and quality assurance, representing the FDA's current thinking.
[22]
[PDF] M9 Biopharmaceutics Classification System- Based Biowaivers - FDA
BCS-based biowaivers are applicable to drug products where the drug substance or substances exhibit high solubility and, either high permeability (BCS Class I) ...
[23]
Drug Solubility: Importance and Enhancement Techniques - PMC
Especially for class II (low solubility and high permeability) substances according to the BCS, the bioavailability may be enhanced by increasing the solubility ...
[24]
[PDF] BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED ... - ICH
Nov 20, 2019 · By definition, BCS Class I drugs are highly absorbed, and have neither solubility nor permeability limited absorption.
[25]
Understanding Pharmaceutical Quality by Design - PMC - NIH
Among 42 functional excipient categories listed in USP/NF (24), commonly used excipients include binders, disintegrants, fillers (diluents), lubricants, ...
[26]
Controlled Drug Delivery Systems: Current Status and Future ...
Abstract. The drug delivery system enables the release of the active pharmaceutical ingredient to achieve a desired therapeutic response.
[27]
Development and Evaluation of Lactose-Free Single-Unit and ... - NIH
Recently, an increasing number of patients have reported suffering from lactose intolerance, and therefore, they try to avoid products, including medicines, ...
[28]
Exploring the Versatility of Pharmaceutical Lactose - From Origins to ...
Jul 12, 2025 · Lactose must adhere to pharmacopoeial standards, which define its purity, particle size, and other critical parameters. Different pharmacopoeias ...
[29]
[PDF] Excipients: A Blind Spot in Ensuring Medicine Quality and Supply ...
USP supports the adoption and use of a risk-benefit based regulatory approach for excipients, which will identify excipients that are vulnerable to quality and ...Missing: tablets lactose intolerance
[30]
A Brief Overview on Tablet and It's Types - ResearchGate
Oct 27, 2020 · The most commonly used pharmaceutical solid dosage forms today include granules, pellets, tablets and capsules. Tablets may be defined as solid ...
[31]
[PDF] TABLET - World Journal of Pharmaceutical and Life Sciences
May 27, 2020 · Mainly the tablets are classified into two classes- a) Compressed Tablets b) Molded Tablets. Fig. 1: Types of tablets. Review Article. ISSN ...
[32]
None
### Classification of Different Types of Tablets
[33]
Long-Acting Metformin Vs. Metformin Immediate Release in Patients ...
May 17, 2021 · Our systematic review indicates that metformin XR and IR formulations have similar effectiveness and safety, but that metformin XR is associated with improved ...
[34]
Particle Engineering in Pharmaceutical Solids Processing - NIH
This review will consider the role played by surface energy in pharmaceutical particle processing operations.
[35]
Challenges Of Particle Characterisation - Pharmaceutical Technology
Apr 1, 2011 · Particle size is a potentially important variable in pharmaceutical production and efficacy. In solid or suspension delivery systems, ...Missing: "review | Show results with:"review
[36]
Pharmaceutical Milling and Sieving Technologies: Complete Guide
It reduces particle size of drug substances and excipients. Milling techniques range from conventional methods to advanced technologies.
[37]
https://www.ijrrr.com/papers15-1/paper3-Discussion%20and%20Ingredients%20of%20Different%20Types%20of%20Tablets-%20A%20Comprehensive%20Review.pdf
[38]
https://pmc.ncbi.nlm.nih.gov/articles/PMC8165304/
[39]
Oscillating Granulator | Particle Size Reduction - United Pharmatek
The Oscillating Granulator is a popular granulating machine used for size reduction or forming the required granule sizes from moist powder material.
[40]
https://www.pharmtech.com/view/challenges-particle-characterisation
[41]
Blend Segregation in Tablets Manufacturing and Its Effect on Drug ...
Nov 11, 2021 · This review presents the most relevant powder segregation mechanisms in tablet manufacturing and summarizes the currently available, up-to-date research.
[42]
[PDF] 〈905〉 UNIFORMITY OF DOSAGE UNITS - US Pharmacopeia (USP)
Dec 1, 2011 · Select not fewer than 30 dosage individual contents of the units are replaced with the indi- units, and proceed as follows for the dosage form ...
[43]
"A MECHANISTIC STUDY OF FLOW AND COMPRESSION ...
Jun 23, 2014 · The drug substance is mixed with excipients and the resulting powder blend is compressed into tablets. For a pharmaceutical powder to be ...
[44]
Blending Trace Ingredients - Pharmaceutical Technology
Macro blending is achieved by rotating the shaped vessel, allowing the material bed to fall away from the vessel's walls. Tumble blender vessel shapes are ...Missing: tableting | Show results with:tableting
[45]
The Ultimate Guide to Pharmaceutical Blenders - SED Pharma
V-type mixers: Suitable for gentle, efficient mixing of various dry powders and granules. Ribbon mixers: Designed for uniform mixing of dry materials or ...
[46]
Using density changes to monitor blending with magnesium stearate ...
Mar 15, 2025 · The effect of shear was investigated by variation of blending times (5 – 20 min) in a diffusion blender. THz-TDS measurements of the powder ...
[47]
Mixing order of glidant and lubricant – Influence on powder and ...
May 16, 2011 · Mixing order 1 resulted in improved powder flow properties, low weight variability, higher average tablet weight and slow drug release rates.
[48]
Mixing order of glidant and lubricant – Influence on powder ... - NIH
This study highlighted the importance of strain and excipient mixing order (for CS and MgSt) on blend and tablet and powder properties.
[49]
Analyzing Content Uniformity - Pharmaceutical Technology
Feb 2, 2018 · New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.
[50]
Underpinning mechanistic understanding of the segregation ...
Nov 1, 2020 · The employed NIR-based segregation tester proved to be a useful small-scale predictive tool to evaluate and rank the segregation risk of the studied ...
[51]
A review of co-processed directly compressible excipients.
Direct compression is more suitable for moisture and heat sensitive APIs, since it eliminates wetting and drying steps and increases the stability of active ...
[52]
Granulation techniques and technologies: recent progresses - NIH
Granulation process can be divided into two types: wet granulation that utilize a liquid in the process and dry granulation that requires no liquid. The type of ...
[53]
Extrusion–spheronization a promising pelletization technique
The wet granulation process plays an important role in extrusion–spheronization. ... During the kneading stage, net growth is diminished until a steady state is ...
[54]
Hydroxypropyl Methylcellulose—A Key Excipient in Pharmaceutical ...
The lower viscosity grades of HPMC serve as both a binder and a disintegrant in tablets, pills, and granulations, whereas higher viscosity grades function ...
[55]
Power consumption profiles in high-shear wet granulation. I - PubMed
Wet granulation processes frequently rely on the device power consumption profile to monitor the process endpoint. This work shows how the observed power ...Missing: gelatin HPMC determination moisture
[56]
Experience with the Diosna mini-granulator and assessment of ...
One of the methods commonly employed for the preparation of such intermediates is wet granulation in a high-shear mixer [2]. ... The Diosna mini-granulator ...<|separator|>
[57]
Comprehensive review on modern techniques of granulation in ...
This comprehensive review explores modern granulation techniques in pharmaceutical dosage forms along with conventional methods, focusing on dry granulation ...
[58]
Development of predictive tools to assess capping tendency of tablet ...
It is generally accepted that the tablet compaction process can be partitioned in four distinct stages: (i) die filling and particle rearrangement, (ii) ...Missing: expulsion | Show results with:expulsion
[59]
Air entrapment during tablet compression - Diagnosis, impact on ...
Aug 10, 2025 · Air entrapment during powder compression, a phenomenon that can cause tablet defects upon decompression and ejection, was diagnosed for celecoxib powder.
[60]
Estimation of elastic recovery, work of decompression and Young's ...
Capping and lamination occur when the bonds within a tablet cannot withstand the elastic recovery during decompression. To estimate tablet recovery, ...Missing: viscoelastic | Show results with:viscoelastic
[61]
A tabletability change classification system in supporting the ... - NIH
In this paper, the material library approach was used to uncover the pattern of tabletability change and related risk for tablet formulation design.
[62]
Compaction equations: a comparison of the Heckel and Kawakita ...
A compaction equation relates some measure of the state of consolidation of a powder, such as porosity, volume (or relative volume) density, or void ratio.
[63]
Influences of variations of the amount of compressed material on ...
The minimum of the in-die thickness was adjusted to cover the range from approximative 50 to 1000 MPa for the compression pressure in 10 factor levels. At every ...
[64]
Scaling Tableting Processes from Compaction Simulator to Rotary ...
Mar 31, 2020 · It is visible that the distance between punches reduces over dwell time in CS experiments. This behavior is more pronounced with higher ...<|separator|>
[65]
Physical Processes of Tableting - Journal of Pharmaceutical Sciences
Furthermore, plastic deformation tends to increase the number of dislocations in a crystal; a hard crystal may first become softer and, if sufficiently "worked ...
[66]
Deformation properties of pharmaceutical excipients determined ...
Our results showed that plasticity and elasticity may be considered independent deformation properties as highly plastic materials (microcrystalline cellulose, ...
[67]
Effects of moisture content and compression pressure of various ...
Apr 1, 2017 · Moisture content of granules and compression pressure influence on the physical properties of tablet. · Their mutual interactions have an effect ...Missing: compactibility | Show results with:compactibility
[68]
The Effect of Lubricants on Powder Flowability for Pharmaceutical ...
It is generally accepted that magnesium stearate has more negative effects on the hardness of the tablets with more deformable materials than brittle ones (1).
[69]
(PDF) Affect of granule sizes, types and concentrations of lubricants ...
Aug 6, 2025 · Several factors have been found to affect the hardness of tablets; these include lubricant type and concentration, particle size and density ...
[70]
Solving Sticking and Picking Through Tablet Design
Apr 1, 2019 · A tooling vendor should be able to explain the unique properties and advantages of the tool steels and coatings available for a formulation. A ...
[71]
The Different Types Of Tablet Press | Types of Pill Presses
Also known as a single punch or eccentric press. This is the simplest of all types of tablet making machine. It uses a single tooling station that has a die and ...
[72]
When To Choose Single Punch Tablet Presses Vs Rotary Tablet ...
May 26, 2025 · If your needs are below 5,000 tablets per hour or you require frequent formulation changes, the TDP 6 is likely the more suitable option. For ...
[73]
https://pmc.ncbi.nlm.nih.gov/articles/PMC3755167/
[74]
Why use a Compaction Simulator? - Korsch Tablet Presses
Jun 9, 2023 · Modern compaction simulators are highly instrumented single-station compression machines fitted with an upper punch, a lower punch, and a die ...
[75]
Rotary Tablet Compression Machine in the Pharmaceutical Industry
Components of a Rotary Tablet Compression Machine · 1. Hopper · 2. Feeding Mechanism · 3. Dies and Punches · 4. Turret · 5. Cam Tracks · 6. Compression Rollers · 7.
[76]
Tablet Compression - How it works
On some tablet presses, a force feeder is used which moves the powder over the top of the die to fill the die bores more efficiently. Metering, next the ...
[77]
Tableting: Advantages of Using an Instrumented R&D Tablet Press
Sep 19, 2019 · An instrumented R&D tablet press can help developers analyze these forces and better understand the material's behavior prior to scaling up for ...
[78]
Advanced Model Predictive Feedforward/Feedback Control of a ...
Servo presses, driven directly by servo motors, can realize the flexible control of press movement and have become the trend in the industry for future ...<|separator|>
[79]
Quality in real time - Process analytical technologies for continuous ...
Mar 20, 2022 · ... PAT technology and use case. Particularly in the area of R&D, a sensor is often used after the mixer before the powder reaches the tablet press.Missing: driven | Show results with:driven
[80]
[PDF] a clean solution - Fette Compacting
In 1970 Fette Compacting also launched the first high-speed tablet press, the P2000. ... Ferrer already owns two high-performance rotary presses of this type.
[81]
Tablet presses of the P series - Fette Compacting
The new p Series is based on a technology platform for all standard applications. It combines high-performance tableting with maximum flexibility and a modern ...Missing: history founded 1917
[82]
Fette P 1200 Used machines - Exapro
Used Fette 1200 rotary tablet press, 24 station, 80 Kn main compression, 80 Kn pre-compression, single sided, 16 mm max tablet diameter, 18 mm max depth of fill ...
[83]
[PDF] Fette Compacting Tablet Press - Thomasnet
Compacting Tablet Press is operating at peak efficiency and maintaining the consistently high level of performance that you would expect from Fette Compacting.
[84]
[PDF] tablet press P1200 / TSC - Amazon S3
WILHELM FETTE GMBH. Model: FETTE P 1200. Name plate: Behind the lower flap under the tabletchute. Operating voltage: 400 --- 460 V, 50/60 Hz, 3 Ph. Power ...
[85]
75 years - Fette Compacting tablet presses
Jun 21, 2023 · In 1948, Fette Compacting presents the first tableting machine developed in-house under the name Hanseaten Perfecta.
[86]
i Series tablet presses - Fette Compacting
The i Series tablet presses feature innovation, SmartInterface, RFID login, and are compact, available in single/double rotary for single/double layer tablets.Missing: exchangeable force dedusters
[87]
TPR tablet presses from Syntegon: a long history of successful ...
Oct 4, 2024 · It was the first fully operational machine in the world capable of compressing tablets at a rate of 10,000 per minute. From then on, Manesty ...
[88]
Manesty Unipress Diamond 27 Station Rotary Tablet Press
2703 – Manesty Unipress Diamond 27 station, single sided rotary tablet press, output variable up to 202500 tablets per hour, maximum tablet diameter 16.0 mm ...
[89]
XL 400 4 MFP - Most Flexible Tablet Press in the World
The XL 400 4 MFP offers an innovative and flexible design platform that permits the production of all tablet formats on a single tablet press.
[90]
Korsch AG: Korsch Tablet Presses | The Tableting Specialist
KORSCH develops and builds tablet presses with unparalleled competence in standard and special tableting process for Pharma, Food, Technical and Chemical ...KORSCH India · KORSCH Singapore · KORSCH Korea · KORSCH AmericaMissing: modular designs
[91]
Top 8 Tablet Press Manufacturers - SED Pharma
Fette Compacting is known for its rotary tablet presses, single punch presses, and lab-scale tablet presses. Their quality, dependable equipment is popular ...
[92]
Top Tablet Compression Machines Companies & How to Compare ...
Oct 3, 2025 · Fette Compacting: Demonstrated consistent performance in a pilot with a leading generic pharma company, ensuring compliance with cGMP standards.
[93]
Addressing Dust Accumulation in Tablet Manufacturing
Mar 4, 2016 · Dedusting equipment and techniques address problems associated with tablet manufacturing dust accumulation.
[94]
How Are Tablet Dedusters Used In Pharmaceutical Manufacturing?
Tablet dedusters are specialized pieces of equipment in pharmaceutical manufacturing used to clean tablets after they are pressed but before packaging or ...
[95]
Tablet Dedusters - SaintyCo
What is Tablet Deduster? Tablet Dedusters are machines you can use to remove dust from the surfaces of tablets in the pharmaceutical industry.Missing: methods challenges
[96]
[PDF] Evaluation of Exposures to Dust and Noise at a Pharmaceutical ...
The OSHA PEL for airborne total dust is 15 milligrams per cubic meter (mg/m3) over an 8-hour TWA. Total dust means particles of various sizes and composition. ...Missing: yield GMP
[97]
[PDF] 〈711〉 DISSOLUTION - US Pharmacopeia (USP)
Test. Performance Verification Test, Apparatus 1 and 2—. Test USP Prednisone Tablets RS according to the operating conditions specified. The apparatus is ...
[98]
[PDF] Q1A(R2) Guideline - ICH
The purpose of the stability study is to establish, based on testing a minimum of three batches of the drug substance and evaluating the stability information.
[99]
[PDF] 〈905〉 UNIFORMITY OF DOSAGE UNITS - US Pharmacopeia (USP)
Aug 1, 2023 · The term “uniformity of dosage unit” is defined as the degree of uniformity in the amount of the drug substance among dosage units.
[100]
Intro to USP <1062> — What is Tabletability? - Natoli Engineering
A target mechanical strength of 1 to 2MPa is a representative value for a robust tablet that will withstand handling, friability and coating operations. It's ...
[101]
[PDF] 〈1216〉 TABLET FRIABILITY - US Pharmacopeia (USP)
Aug 1, 2023 · This chapter provides guidelines for the friability determination of compressed, uncoated tablets. The test procedure presented in this chapter ...
[102]
HPLC Method Development and Validation for Pharmaceutical ...
This article presents a simple and systematic approach to HPLC method development, beginning with sample preparation and finishing with practical analytical ...
[103]
Vision system checks pharmaceutical products - Machine Vision ...
The primary purpose of the inspection is to identify small particles or half tablets that might be present and to determine whether the tablets are of the ...
[104]
Development of an In-Line Near-Infrared Method for Blend Content ...
The study developed an in-line near-infrared (NIR) method for determining content uniformity of blends in a tablet feed frame, validated for monitoring blend ...
[105]
Pharmaceutical Coating and Its Different Approaches, a Review - PMC
Aug 15, 2022 · Common forms of tablet coating are FC and SC. The coating helps maintain the physical and chemical integrity of the active ingredient; meanwhile ...
[106]
Pharmaceutical Application of Tablet Film Coating - PMC - NIH
Sep 8, 2020 · Among three types of tablet-coating processes (sugar coating, film coating, and press coating), film coating is the most widely used approach ...
[107]
Impact of Tablet Size and Shape on the Swallowability in Older Adults
Mar 23, 2023 · Each participant swallowed four coated placebo tablets differing in weight (250 to 1000 mg) and shape (oval, round, oblong) in a blinded manner on three study ...
[108]
[PDF] Size, Shape, and Other Physical Attributes of Generic Tablets ... - FDA
This guidance revises the guidance of the same name issued in June 2015 to clarify that the largest dimension of a tablet should not exceed 22 mm and that ...
[109]
Tablet Weight - an overview | ScienceDirect Topics
Granulation technology may also be used to improve API content uniformity for low dose formulation (eg, the drug loading is <5% w/w). For API that has ...
[110]
[PDF] 1216 TABLET FRIABILITY This chapter provides guidelines for the ...
Nov 22, 2016 · This chapter provides guidelines for the friability determination of compressed, uncoated tablets. The test procedure presented in this chapter ...
[111]
Investigations into the tensile failure of doubly-convex cylindrical ...
This equation converts into the standard Brazilian equation (σt = 2P/πDW) when W equals T, i.e. is equally valid for flat cylindrical tablets. In practice, the ...Missing: formula | Show results with:formula
[112]
[PDF] 〈616〉 BULK DENSITY AND TAPPED DENSITY OF POWDERS
Aug 1, 2015 · Bulk density is the ratio of mass to volume of an untapped powder, including void volume. Tapped density is measured by mechanically tapping a ...Missing: helium pycnometry
[113]
A novel method for deriving true density of pharmaceutical solids ...
True density is commonly measured using helium pycnometry. However, most water-containing powders, for example, hydrates, amorphous drugs and excipients ...Missing: bulk tapped Carr's index
[114]
Characterisation of pore structures of pharmaceutical tablets: A review
This review presents the key properties of the pore structures in solid dosage forms and it discusses how to measure these properties.
[115]
[PDF] Process Validation: General Principles and Practices | FDA
pharmaceuticals are provided in 21 CFR parts 210 and 211. The CGMP regulations require that manufacturing processes be designed and controlled to assure ...
[116]
21 CFR Part 211 -- Current Good Manufacturing Practice for ... - eCFR
The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography ...
[117]
Quality Guidelines - ICH
This document is an annex to the main stability Guideline, and gives guidance on the basic testing protocol required to evaluate the light sensitivity and ...
[118]
[PDF] Data Integrity and Compliance With CGMP Guidance for Industry
For purposes of this guidance, validation is being used in a manner consistent with the above guidance documents. 7 For further discussion of such alternate ...
[119]
[PDF] Annex 3 - World Health Organization (WHO)
1.1 Validation is an essential part of good practices, including good manufacturing practices (GMP) (6) and good clinical practices (GCP). It is therefore an ...
[120]
Six Sigma in Pharmaceutical Industry – A Comprehensive Review
The analysis highlights the success of Six Sigma in reaching a nearly zero-defect rate (3.4 defects per million opportunities) and its role in sustainable ...
[121]
Validation of Cleaning Processes (7/93) - FDA
Aug 26, 2014 · GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES. Note: This document is reference material for investigators and other FDA personnel.Missing: stability | Show results with:stability
[122]
Pharmacy Packaging and Inserts - StatPearls - NCBI Bookshelf - NIH
Variations of pharmaceutical packaging include blister packs, alternative tamper-evident packaging, bottles, vials, ampules, intravenous bags, and calendar ...Missing: primary strips
[123]
20th Anniversary Special Feature: Two decades of packaging ...
Mar 1, 2008 · Traditionally, more than 50% of all medicines have been oral tablets or capsules, packed in blister packs (very common in Europe and Asia) or ...
[124]
Data Standards Manual (monographs) Package Type - FDA
Feb 22, 2016 · A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers ...Missing: tablet | Show results with:tablet
[125]
[PDF] Poison Prevention Packaging: A Guide for Healthcare Professionals
The PPPA requires special (child-resistant and adult-friendly) packaging of a wide range of hazardous household products including most oral prescription drugs.Missing: features | Show results with:features
[126]
[PDF] Guidance for Industry on Container Closure Systems for ... - FDA
Regulations issued under the PPPA establish performance standards and test methods that determine if a packaging system is child-resistant and adult-use ...
[127]
Meeting Challenges in Solid-Dose Packaging
Apr 2, 2022 · Innovations address supply-chain constraints, serialization, and new requirements for sustainable and patient-centric designs.
[128]
Interphex Showcases Packaging Innovations
Jun 2, 2007 · Exhibitors' products prevent counterfeiting, provide child resistance, protect product quality, and improve packaging-line efficiency.
[129]
Moisture Permeation of Pharmaceutical Packaging
Preventing moisture from permeating through the packaging is an important function of the container-closure system used for medicines.
[130]
How to determine the Protective Properties of Amber Glass ...
Jul 11, 2023 · The article provides proposed maximum allowed specific transmission values for colored glass containers. The comment deadline is 30 September ...
[131]
Drug Supply Chain Security Act (DSCSA) - FDA
Oct 16, 2025 · The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs.DSCSA Policies · FDA's implementation of... · Pharmacists: Utilize DSCSA...
[132]
[PDF] Q 1 A (R2) Stability Testing of new Drug Substances and Products
This guideline addresses climatic zones I and II. The principle has been established that stability information generated in any one of the three regions of the ...
[133]
Understanding the chemical basis of drug stability and degradation
Oct 9, 2010 · The main chemical reactions that affect the stability of a drug are oxidation and hydrolysis. Oxidation involves the removal of electrons ...
[134]
Discoloration of Tablets Containing Amines and Lactose
It has been noted by several workers that tablets of amine salts combined with lactose darken in color with aging, and this problem has been investigated.
[135]
A new method to determine discoloration kinetics of uncoated white ...
The evaluation of the CIELAB values from the stability data has shown that the discoloration of the white tablets means an intensification of yellowish or ...
[136]
Microbial Stability of Pharmaceutical and Cosmetic Products - PubMed
Oct 10, 2017 · This review gives a brief overview about microbial contamination in pharmaceutical products. We discuss the distribution and potential sources ...
[137]
Microbiological stability of tablets stored under tropical conditions
When the tablets were stored under more moderate conditions (31° C, 75% RH) they were not at risk of microbiological spoilage. Sodium methylhydroxybenzoate and ...
[138]
Climatic Zones for Stability Studies | Pharmaguideline
Oct 27, 2025 · Understanding Each Climatic Zone · Zone I – Temperate Climate · Zone II – Subtropical and Mediterranean · Zone III – Hot and Dry · Zone IVa – Hot ...
[139]
ICH Climatic Zones for Stability Testing
Dec 13, 2023 · WHAT ARE THE 4 TYPES OF ICH STABILITY ZONES? ; I, Temperate Zone, 21°C ; II, Mediterranean/Subtropical Zone, 25°C ; III, Hot/Dry Zone, 30°C ; IVa ...
[140]
None
### Summary of Key Sections on Stability Testing for Drug Products (ICH Q1A(R2))
[141]
Medication Storage Temperature Guidelines - What is Safe?
Aug 8, 2023 · In general, most medicines should be stored at 59 to 77 degrees F in a cool, dry place, away from sunlight. That temperature range is important.
[142]
Medication Storage Appropriateness in US Households - PMC - NIH
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not store in conditions where tablets are exposed to humid ...
[143]
[PDF] Guidance for Industry #5 - Drug Stability Guidelines - FDA
Mar 3, 1986 · They should be stored at 0°F or at some temperature chosen to reduce the chance of degradation, mold growth and chemical action. Storage of ...
[144]
Achieving Tablet Stability with Moisture Management - Colorcon
Mar 25, 2019 · To better manage moisture content, manufacturers should focus on reducing water activity within the formulation and retarding interaction with ...Moisture Management... · Building Moisture Protection... · The Role Of Film Coating In...
[145]
The Impact of Pharmaceutical Packaging on Shelf Life | Ascend
Pharmaceutical packaging protects drugs from light, moisture, air, and temperature, which can degrade medications, thus extending shelf life.
[146]
The Role of Moisture Control in Medical Packaging - Multisorb
Moisture control is critical because excess humidity can compromise product efficacy, safety, and stability, leading to degradation, contamination, and ...
[147]
Pharmaceutical Packaging Materials and Medication Safety: A Mini ...
It provides a good barrier against light, moisture, and oxygen, protecting the drugs from degradation. ... If transparent packaging is used in a light-exposed ...Missing: opaque | Show results with:opaque
[148]
Stability Lifecycle: An Application of ICH Q12 to Manage the ...
Jun 1, 2024 · Failing stability studies post-approval can also lead to product recalls or discontinuation. However, the stability knowledge of a product ...
[149]
How to Manage Pharmaceutical Product Recall and Adverse Events
Apr 30, 2025 · This article explores the mechanism of managing pharmaceutical product recalls, reporting adverse events, and effectively executing market actions.Missing: reformulations | Show results with:reformulations