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Magnesium trisilicate
منیزیم تریسیلیکات
1Nonproprietary names
- BPMagnesium Trisilicate
- Ph. Eur.Magnesium Trisilicate
- USP–NFMagnesium Trisilicate
2Synonyms and trade names
Magnesium mesotrisilicate; hydrated magnesium trisilicate; magnesii trisilicas; silicic acid, magnesium salt (1:2), hydrate
3Chemical name and CAS Registry Number
Magnesium trisilicate (hydrated) · [14987-04-3]
UNII FML8G1U0Y3 · PubChem CID 5311266
4Empirical formula and molecular weight
2MgO·3SiO2·xH2O · 260.86 (anhydrous)
5Functional category
Glidant, Adsorbent
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used in oral pharmaceutical products and foods as a glidant and adsorbent. It is used more widely as an active ingredient, an antacid, often combined with aluminium hydroxide.
7Description
A white, odourless, tasteless, fine powder, free from grittiness.
8Typical properties
- Loss on ignition
- 17–34% w/w
- Solubility
- practically insoluble in water and ethanol; readily decomposed by mineral acids
- Hygroscopicity
- slightly hygroscopic
- Acid-neutralising behaviour
- neutralises acid slowly, forming gelatinous hydrated silica
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Decomposed by acids. It adsorbs many drugs and can reduce the absorption of, for example, tetracyclines, nitrofurantoin and some antimuscarinics; it also binds preservatives such as parabens, reducing their efficacy.
11Method of manufacture
Prepared by precipitation from solutions of sodium silicate and a soluble magnesium salt, such as magnesium sulfate, followed by washing and drying.
12Safety
Regarded as non-toxic at excipient levels. Prolonged ingestion of large antacid doses has caused silica-containing kidney stones, and magnesium may accumulate in renal impairment. Large doses can be laxative.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid generating dust; eye protection, gloves and a dust mask are recommended.
14Regulatory status
Described in the Ph. Eur. and USP–NF and used in non-parenteral (oral) medicines licensed in Europe.
15Related substances
Magnesium silicate; magnesium aluminium silicate; aluminium hydroxide; talc.
16Comments
Its strong adsorptive capacity is an advantage as a glidant but a risk for low-dose drugs and preserved liquids; check drug assay, preservative efficacy and dissolution when it is included in a formulation.