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Magnesium trisilicate

Magnesium trisilicate is a synthetic or purified inorganic compound consisting of magnesium oxide and silicon dioxide in varying proportions of water, with the approximate formula 2MgO · 3SiO₂ · xH₂O, where x typically ranges from 1 to 2. It is primarily utilized as an antacid for the symptomatic relief of heartburn, indigestion, acid reflux, peptic ulcers, bloating, colic, and flatulence, often in combination with other agents like aluminum hydroxide or simethicone. According to the United States Pharmacopeia (USP), it must contain not less than 20.0% magnesium oxide (MgO) and 45.0% silicon dioxide (SiO₂) on an ignited basis, ensuring its efficacy and consistency in medicinal applications.^[1]^[2] Physically, magnesium trisilicate presents as a fine, white, odorless, and tasteless powder that is insoluble in water and dilute acids but slowly decomposes in strong acids to form a colloidal solution of silica. Its molecular weight varies with hydration but is approximately 260.86 g/mol for the anhydrous form (Mg₂Si₃O₈), rising to around 278.88 g/mol for the monohydrate (H₂Mg₂O₉Si₃). In therapeutic use, it neutralizes excess gastric acid to raise stomach pH and reacts with hydrochloric acid to produce a gelatinous layer of silicon dioxide that coats and protects ulcerated mucosa, promoting healing. Absorption is minimal, with about 5% of the magnesium component entering the bloodstream and being excreted primarily via urine, though it may cause loose stools or diarrhea in sensitive individuals.^[1]^[3] Beyond medicine, magnesium trisilicate functions as a glidant and lubricant in pharmaceutical tablet manufacturing to improve powder flow and prevent sticking. It is also approved as a food additive under the European Union designation E553a(ii), serving as an anti-caking agent in powdered foods, a glazing agent, and an adsorbent to remove fatty acids from used frying oils in fast-food applications. The European Food Safety Authority (EFSA) has evaluated it as safe for these uses at typical intake levels, with no significant toxicity concerns when consumed within authorized limits. Additionally, it finds application in cosmetics as a bulking agent and absorbent, and in industrial settings for filtration and clarification processes.^[4]

Chemistry

Chemical formula and structure

Magnesium trisilicate is an inorganic compound with the empirical formula Mg₂Si₃O₈ in its anhydrous form. It commonly occurs as a hydrated silicate, denoted as 2MgO·3SiO₂·xH₂O, where x represents the variable degree of hydration, often ranging from 2 to 5 or more (corresponding to 17.0%–34.0% loss on ignition) depending on preparation conditions.^[2] The compound is identified by CAS number 14987-04-3 and is known by its common name, magnesium trisilicate. Its systematic IUPAC name is dimagnesium(2+) spiro[3.3]trisiloxane-2,2,6,6-tetrakis(olate) hydrate, reflecting a representation of its core siloxane units coordinated with magnesium cations.^[3]^[5] In terms of structure, magnesium trisilicate consists of a framework of corner-sharing SiO₄ tetrahedra forming silicate chains or sheets, with Mg²⁺ ions occupying octahedral sites within the lattice, akin to the ribbon-layered arrangement in the mineral sepiolite (a natural hydrated magnesium silicate). This configuration imparts a fibrous or platy morphology in crystalline variants.^[6]^[7] Magnesium trisilicate exists in both amorphous and crystalline polymorphs, with the synthetic form used commercially typically being amorphous or microcrystalline to optimize surface area and reactivity, while natural occurrences like sepiolite exhibit a well-defined orthorhombic crystal structure.^[6]^[8]

Physical and chemical properties

Magnesium trisilicate is a fine, white or almost white powder that is odorless, tasteless, and free from grittiness.^[9] It has a true density of approximately 2.7 g/cm³ and decomposes above 1000 °C, indicating significant thermal stability.^[9]^[10] For pharmaceutical applications, the particle size is typically in the range of 1 to 50 μm to ensure uniformity and efficacy.^[11] The compound is practically insoluble in water (with a solubility of about 0.268 g/L at 30°C) and in ethanol (96%).^[10]^[9] It exhibits low solubility in neutral and alkaline conditions, owing to its silicate framework that resists dissolution in such media.^[9] Chemically, magnesium trisilicate possesses basic properties attributable to its magnesium oxide content, allowing it to neutralize acids.^[1] It reacts with mineral acids, such as hydrochloric acid, to form magnesium salts and silicic acid, often precipitating colloidal silica that can create a protective gel layer.^[1] Under normal conditions, it is resistant to hydrolysis and remains stable when stored in a cool, dry place in a well-closed container, though it decomposes in concentrated alkali to form magnesium hydroxide.^[9]

Production

Synthesis

Magnesium trisilicate is primarily synthesized on a laboratory scale through a precipitation reaction involving a soluble magnesium salt, such as magnesium chloride (MgCl₂), magnesium sulfate (MgSO₄), or magnesium nitrate (Mg(NO₃)₂), and sodium silicate (Na₂SiO₃, also known as water glass).^[12]^[13] The reaction occurs in an aqueous medium under controlled conditions to form the precipitate, typically maintaining a silicon-to-magnesium molar ratio of approximately 3:2 to yield the desired Mg₂Si₃O₈ composition.^[13] This represents the formation of anhydrous magnesium trisilicate, though hydrated variants (e.g., Mg₂Si₃O₈·xH₂O, where x typically varies from 1 to 5) are common due to the aqueous environment and can be obtained by adjusting drying conditions.^[14] The precipitation is conducted at a pH of 9–10, often achieved by the alkalinity of the sodium silicate solution, and at temperatures between 50°C and 80°C to promote gelation and particle formation while minimizing impurities like magnesium hydroxide.^[13]^[15] The reactants are typically added slowly, such as via a reverse strike method where the magnesium salt is introduced into the silicate solution, followed by aging for 1–4 hours to allow complete precipitation.^[16] Alternative laboratory methods include hydrothermal synthesis for producing more crystalline forms of magnesium trisilicate. In this approach, magnesium and silicate precursors are reacted under elevated pressure and temperature (120–200°C for 24–48 hours), often using templates like activated carbon to create hierarchical porous structures.^[13] Another variation is co-precipitation with alumina, where aluminum salts are added alongside magnesium and silicate sources to form combined antacid materials, such as aluminum hydroxide-magnesium trisilicate composites, under similar alkaline precipitation conditions.^[17] Following precipitation, the product undergoes purification by filtration to separate the solid from the alkaline mother liquor, thorough washing with water to remove sodium ions and other soluble impurities, and drying (e.g., via spray drying or calcination at around 450°C) to yield a fine, white powder.^[12]^[13] This process ensures high purity, with the final material exhibiting properties suitable for further applications like pharmaceutical formulations.^[16]

Commercial manufacturing

Magnesium trisilicate is commercially manufactured through a precipitation reaction involving soluble magnesium salts and silicates, primarily magnesium sulfate (MgSO₄) and sodium silicate (Na₂SiO₃), which are derived from natural sources such as seawater brines for magnesium compounds and silica sand for silicates.^[18]^[6] In the industrial process, a solution of magnesium sulfate is gradually added to sodium silicate in a stirred reactor maintained at 50–60°C, resulting in the immediate precipitation of magnesium trisilicate as a gelatinous solid. The resulting slurry is filtered to separate the precipitate, which is then thoroughly washed with water to remove residual sodium sulfate and other soluble impurities. The washed cake undergoes drying, typically via spray drying or flash drying methods, to yield a fine, free-flowing white powder; this drying step is energy-intensive due to the high water content of the hydrate (up to 34%) and requires careful control to prevent agglomeration.^[15]^[19]^[12] Global production is concentrated among pharmaceutical and chemical manufacturers in Asia, Europe, and North America, with key players including Paul Lohmann GmbH KG in Germany, Jai Radhe Sales and Octavius Pharma Pvt. Ltd. in India, and Spectrum Chemical Mfg. Corp. in the United States; annual output supports demand in antacid formulations and industrial applications, though specific tonnage figures are not publicly detailed.^[20]^[21]^[22] For pharmaceutical-grade material, production adheres to United States Pharmacopeia (USP)/National Formulary (NF) standards, requiring not less than 20.0% magnesium oxide (MgO) and 45.0% silicon dioxide (SiO₂) on the ignited basis, a SiO₂:MgO ratio between 2.0 and 2.5, loss on ignition of 17.0–34.0%, acid-consuming capacity of 140–160 mL of 0.1 N HCl per gram, heavy metals not exceeding 40 ppm, and microbial limits such as total aerobic microbial count below 1000 CFU/g and absence of specified pathogens like Escherichia coli. Quality control also involves testing for lead (≤10 ppm) and arsenic (≤3 ppm) to ensure safety for oral use.^[2]^[23]^[24]

Applications

Medical uses

Magnesium trisilicate is primarily indicated for the relief of heartburn, indigestion, acid reflux, and symptoms associated with peptic ulcers through its action as a non-systemic antacid that neutralizes excess gastric acid.^[1]^[25] It is commonly used to manage mild intermittent gastroesophageal reflux disease (GERD), non-ulcer dyspepsia, and related hyperacidity conditions, providing symptomatic relief without significant systemic absorption.^[25] Clinical applications extend to stress gastritis and, in combination formulations, to alleviate bloating, colic, and flatulence. Prolonged or high-dose use during pregnancy is not recommended due to potential fetal risks, such as nephrolithiasis.^[26]^[27]^[28] Available in various over-the-counter formulations, magnesium trisilicate is most often found as chewable tablets or oral suspensions, frequently combined with aluminum hydroxide to balance neutralizing effects and minimize side effects like diarrhea.^[1]^[29] Products such as Gaviscon incorporate it alongside alginic acid and aluminum hydroxide for enhanced protection against reflux.^[30] Typical dosing for adults involves 1 to 2 chewable tablets or 10–20 mL of suspension, taken up to 4 times daily after meals and at bedtime, with a maximum of 8 tablets or equivalent per day to avoid overuse.^[29]^[31] Dosing should be adjusted for children over 12 years and taken while upright to optimize efficacy.^[32] Introduced in the mid-20th century, magnesium trisilicate emerged as a preferred alternative to systemic antacids like sodium bicarbonate due to its localized action in the gastrointestinal tract.^[33] Early clinical evaluations in the 1950s confirmed its role in controlling gastric hyperacidity and peptic ulcer pain.^[34] Efficacy studies, including randomized trials, demonstrate its ability to reduce postprandial esophageal acidity and provide relief from heartburn symptoms, with effects lasting 1–2 hours, though onset may be gradual compared to faster-reacting agents.^[35]

Industrial and food uses

Magnesium trisilicate, designated as food additive E553a(ii) in the European Union, functions primarily as an anti-caking agent, stabilizer, and carrier in various food products. It is authorized for use in 28 food categories under Regulation (EC) No 1333/2008, at quantum satis or up to 10,000 mg/kg.^[36] In the United States, it holds Generally Recognized as Safe (GRAS) status for similar applications, allowing its incorporation in edible oils and powdered mixes to prevent clumping and improve flowability.^[6] Representative examples include its addition to fast food seasonings and chewing gum bases, where it absorbs excess fatty acids and filters impurities from used frying oils, extending shelf life without altering flavor.^[37] In industrial applications, magnesium trisilicate serves as a versatile filler and extender in manufacturing processes. It is incorporated into rubber and plastics to enhance mechanical strength, tensile properties, and cost efficiency, often replacing more expensive synthetic alternatives due to its inert nature and low toxicity at operational concentrations.^[38] Similarly, in ceramics production, it acts as a filler to improve durability and thermal stability, contributing to the structural integrity of finished products.^[39] As an adsorbent, it is employed in oil refining to clarify and purify fats and oils by removing colorants, odors, and degradation byproducts, leveraging its high surface area for effective filtration without introducing contaminants.^[40] Additionally, magnesium trisilicate finds use as a mild abrasive in polishing formulations, such as dental pastes and surface cleaners, where its fine particle size enables gentle cleaning and polishing action while minimizing surface damage. It is authorized at quantum satis or up to specified levels (e.g., 10,000 mg/kg) in relevant food categories under EU regulations. Its advantages include chemical inertness, which prevents reactions with other ingredients, and environmental considerations during disposal, where industrial waste containing it must be managed to avoid release into waterways, in line with standard hazardous material protocols.^[41] These properties make it a cost-effective choice over synthetic adsorbents in both sectors.

Pharmacology and health effects

Mechanism of action

Magnesium trisilicate functions as an antacid by neutralizing excess hydrochloric acid (HCl) in the gastric environment, thereby elevating the pH of stomach contents and alleviating symptoms of acid-related disorders. The compound reacts with HCl to produce magnesium chloride (MgCl₂), a soluble salt, and silicic acid (H₄SiO₄ or related hydrated forms such as H₂SiO₃), which is non-irritating to the gastrointestinal mucosa.^[6] This silicic acid also partially adsorbs pepsin, an enzyme that can exacerbate mucosal damage in acidic conditions.^[42] The approximate reaction for the anhydrous form of magnesium trisilicate is:

\mathrm{(MgO)_2 \cdot 3SiO_2 + 4HCl \rightarrow 2MgCl_2 + 2H_2O + 3SiO_2}

This process results in the precipitation of colloidal silica, forming a gelatinous layer that provides a protective coating on the gastric mucosa, shielding it from further acid erosion and promoting healing.^[1] Due to its relative insolubility in water, magnesium trisilicate exhibits minimal systemic absorption, with the majority of the compound and its reaction products remaining in the gastrointestinal tract; this limits potential electrolyte imbalances associated with magnesium overload.^[1] Pharmacokinetically, the onset of neutralizing action is gradual, with less than 30% reaction occurring within the first 15 minutes in simulated gastric acid, leading to symptomatic relief typically beginning within 15-30 minutes.^[43] The duration of action typically lasts 30-60 minutes, after which the unabsorbed material is primarily excreted in the feces, with approximately 5% of the magnesium absorbed and subsequently excreted via urine.^[14]^[1]

Safety, side effects, and toxicity

Magnesium trisilicate is generally well-tolerated when used as directed, but common side effects primarily involve the gastrointestinal tract. These include diarrhea, which arises from the laxative effect of soluble magnesium salts released in the digestive system, as well as stomach cramps, belching, and nausea.^[44]^[45]^[14] Constipation may occur in formulations combined with aluminum compounds, though it is less common with magnesium trisilicate alone. Rare allergic reactions, such as skin rash, itching, hives, or swelling of the face, lips, tongue, or throat, have been reported and require immediate medical attention.^[46]^[32] Contraindications include severe renal impairment, where the risk of hypermagnesemia increases due to reduced magnesium excretion, potentially leading to symptoms like muscle weakness, hypotension, and cardiac arrhythmias.^[47]^[43] It is also contraindicated in patients with hypophosphatemia, gastrointestinal obstruction, or those on sodium-restricted diets, as some formulations may contain sodium bicarbonate. Use in children under 12 years is not recommended without medical advice, due to limited safety data and potential for electrolyte imbalances.^[31]^[32] Acute oral toxicity is low, with an LD50 greater than 5,000 mg/kg in rats, indicating minimal risk from accidental ingestion in therapeutic doses.^[48] Overdose may cause hypermagnesemia, presenting with nausea, vomiting, respiratory depression, hypotension, and bradycardia; management involves supportive care, including hydration to promote renal excretion and monitoring of serum electrolytes and magnesium levels.^[49]^[50] Chronic inhalation of respirable dust in industrial settings may cause respiratory irritation, though this is not a concern in typical medical or food applications.^[41] Magnesium trisilicate holds Generally Recognized as Safe (GRAS) status from the FDA for use as a direct food additive and is listed in the FDA Inactive Ingredients Database for oral pharmaceutical formulations.^[6] The European Food Safety Authority has similarly affirmed the safety of magnesium silicates, including trisilicate forms, for food use up to specified levels without adverse effects.^[36]

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