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Magnesium trisilicate | CAS No: 14987-04-3 | GMP-certified suppliers
A medication that supports relief of peptic ulcers, indigestion, and heartburn for reliable gastrointestinal care across key North American markets.
Therapeutic categories
Primary indications
- For the treatment of peptic ulcers
- Relieving indigestion and heartburn
Product Snapshot
- Magnesium trisilicate is an oral small‑molecule antacid available in solid and liquid formulations, with limited topical use
- It is used for managing peptic ulcer symptoms as well as indigestion and heartburn
- It is approved in major North American markets, including the US and Canada
Clinical Overview
The compound reacts with hydrochloric acid in the stomach to elevate intragastric pH, decreasing acidity and reducing pepsin activity. During this reaction, colloidal silicon dioxide is generated, forming a gelatinous precipitate that can adhere to ulcerated or irritated mucosa. This physical barrier limits further exposure to acid and digestive enzymes. The antacid effect is gradual compared with soluble magnesium salts due to its lower reactivity and partial insolubility.
Systemic absorption of magnesium trisilicate is minimal, and pharmacokinetics are largely governed by local gastrointestinal processes. Small amounts of magnesium ions released during neutralisation may be absorbed and are primarily eliminated renally. Unreacted silicate is excreted in feces. Meaningful plasma concentrations are not expected at therapeutic doses.
Safety considerations relate mainly to magnesium load and potential interactions. Excessive intake or impaired renal function may lead to magnesium accumulation, presenting as hypermagnesemia with neuromuscular or cardiac manifestations in severe cases. Silicate deposition has not been clinically significant at standard antacid doses. Gastrointestinal effects such as mild laxation may occur due to magnesium ion activity. Interaction with concurrent oral medications is possible through alteration of gastric pH or adsorption, and spacing administration is commonly practiced in clinical settings.
Magnesium trisilicate is incorporated in various over‑the‑counter antacid preparations and combination gastrointestinal products in multiple global markets, often alongside aluminum hydroxide or simethicone.
For API procurement, quality assessment should focus on compliance with relevant pharmacopoeial monographs, particle size distribution, silicate composition consistency, and control of elemental impurities. Verification of insoluble matter and reactivity characteristics is important to ensure predictable antacid performance in finished dosage forms.
Identification & chemistry
| Generic name | Magnesium trisilicate |
|---|---|
| Molecule type | Small molecule |
| CAS | 14987-04-3 |
| UNII | FML8G1U0Y3 |
| DrugBank ID | DB09281 |
Pharmacology
| Summary | Magnesium trisilicate acts as an antacid that neutralizes gastric acid, increasing gastric pH. Its reaction with gastric contents produces gelatinous silicon dioxide, which forms a protective colloidal coating over ulcerated or irritated mucosa. These actions reduce acid-related irritation and support mucosal healing in peptic and dyspeptic conditions. |
|---|---|
| Mechanism of action | The gelatinous silicon dioxide, formed by the reaction of magnesium trisilicate with gastric contents is said to protect ulcerated mucosal surfaces and favor healing. |
| Pharmacodynamics | Magnesium trisilicate works by increasing the pH of gastric juice via a neutralisation reaction. It also precipitates colloidal silica, which can coat gastrointestinal mucosa conferring further protection. |
ADME / PK
| Absorption | The hydrated silicon dioxide formed in the stomach and passes into the intestinal track where, silica can be partly absorbed. |
|---|---|
| Half-life | 16-20 hours |
| Protein binding | 33% |
| Route of elimination | Excreted in the urine. |
| Volume of distribution | The hydrated silicon dioxide formed in the stomach and passes into the intestinal track. |
| Clearance | Maximum magnesium clearance is directly proportional to creatinine clearance. |
Formulation & handling
- Oral formulations rely on the insoluble, inorganic nature of this antacid material, requiring suspension or chewable formats to ensure uniform dispersion and acceptable mouthfeel.
- The silicate matrix is stable and moisture tolerant, but powders and suspensions benefit from controlled particle size to maintain consistent neutralization capacity and prevent sedimentation.
- Topical stick preparations require homogeneous dispersion of the solid mineral phase to avoid grittiness and ensure consistent application.
Regulatory status
| Lifecycle | Patent‑expiry information for this API was not provided, so its lifecycle status cannot be specified. In Canada and the US, market maturity will depend on whether key patents have already lapsed (supporting generic competition) or remain in force (supporting a more protected market). |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Magnesium trisilicate is an established antacid with no active patent protection, so supply is typically supported by multiple manufacturers rather than a single originator. Branded and generic products have long been available in the US and Canada, indicating broad commercial maturity. The absence of exclusivities suggests that generic competition is already well‑established. |
|---|
Safety
| Toxicity | Adequate doses of magnesium trisilicate may cause diarrhea due to the action of soluble magnesium salts in the enteric tract. Approx 5% of the magnesium is absorbed. |
|---|
- High oral doses can produce osmotic diarrhea attributable to soluble magnesium salts formed in the GI tract
- Systemic exposure is limited
- Approximately 5% of elemental magnesium is absorbed, but accumulation may occur in severe renal impairment
Written Confirmation
When an API is imported into the European Union from elsewhere in the world, it should be accompanied by a “written confirmation” (WC). A written confirmation is a document set up by the health authorities of the country where the API was manufactured. After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide a WC. These inspections will also have to regularly take place in the future.
Magnesium Trisilicate is a type of Magnesium Salts
Magnesium salts are a crucial subcategory of active pharmaceutical ingredients (APIs) widely used in the pharmaceutical industry. These salts are compounds formed by combining magnesium with other chemical elements or groups. Magnesium salts are highly valued for their therapeutic properties and play a significant role in various medical applications.
One of the most well-known magnesium salts is magnesium oxide, which is commonly used as a supplement to treat magnesium deficiency in the body. This salt is known for its high bioavailability, making it an effective option for oral administration.
Another important magnesium salt is magnesium sulfate, which finds extensive use in both pharmaceutical and medical settings. It is often utilized in the treatment of conditions such as eclampsia, pre-eclampsia, and magnesium deficiency in pregnant women. Magnesium sulfate can be administered intravenously or orally, depending on the specific medical requirements.
Furthermore, magnesium citrate, a salt formed by combining magnesium with citric acid, is renowned for its laxative properties. It is frequently employed in the formulation of bowel preparations to facilitate bowel movements before medical procedures or surgeries.
The versatility of magnesium salts extends beyond medical applications. They are also utilized in the manufacturing of antacids, laxatives, and various over-the-counter products.
In conclusion, magnesium salts form a significant subcategory of pharmaceutical APIs, offering a wide range of therapeutic benefits. These salts, including magnesium oxide, magnesium sulfate, and magnesium citrate, play vital roles in treating magnesium deficiencies, supporting pregnancy-related conditions, and aiding bowel movements. Their extensive usage and efficacy make them indispensable components in the pharmaceutical industry.
Magnesium Trisilicate (Magnesium Salts), classified under Therapeutic Nutrients/Minerals/Electrolyte
Therapeutic Nutrients/Minerals/Electrolytes: A Comprehensive Technical DescriptionTherapeutic nutrients, minerals, and electrolytes are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to support and enhance overall health and well-being. These compounds play a crucial role in maintaining the body's physiological balance, aiding in various metabolic processes, and addressing specific deficiencies.
Therapeutic nutrients encompass a broad range of substances, including vitamins, minerals, and electrolytes. Vitamins are organic compounds required in small quantities for proper bodily functions and are essential for growth, development, and disease prevention. Minerals, on the other hand, are inorganic substances that support numerous physiological processes, such as bone formation, nerve function, and energy production.
Electrolytes are minerals that carry an electric charge when dissolved in bodily fluids, including sodium, potassium, calcium, magnesium, and chloride. They play a crucial role in maintaining proper hydration, nerve impulses, muscle contractions, and pH balance.
Pharmaceutical APIs in the Therapeutic Nutrients/Minerals/Electrolyte category are designed to address specific deficiencies or imbalances in the body. These APIs are often used in the formulation of dietary supplements, nutritional products, and therapeutic treatments. They are manufactured under stringent quality control guidelines to ensure purity, potency, and bioavailability.
Therapeutic nutrients/minerals/electrolytes APIs are available in various forms, including tablets, capsules, powders, and liquid formulations. They are formulated to meet specific dosage requirements and can be combined with other ingredients for targeted health benefits.
Overall, therapeutic nutrients, minerals, and electrolytes APIs are essential components in maintaining optimal health. Their use helps address deficiencies, support bodily functions, and promote overall well-being. Pharmaceutical companies and healthcare professionals rely on these high-quality APIs to develop effective and safe products that contribute to a healthier population.
Magnesium Trisilicate API manufacturers & distributors
Compare qualified Magnesium Trisilicate API suppliers worldwide. We currently have 4 companies offering Magnesium Trisilicate API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Taurus Chemicals | Producer | India | India | CoA, WC | 5 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Magnesium Trisilicate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Magnesium Trisilicate API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Magnesium Trisilicate API
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Technical
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