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Magnesium silicate
منیزیم سیلیکات
1Nonproprietary names
- JPMagnesium Silicate
- USP–NFMagnesium Silicate
2Synonyms and trade names
Synthetic magnesium silicate; hydrated magnesium silicate; magnesium silicate hydrate; E553a
3Chemical name and CAS Registry Number
Magnesium silicate (variable composition) · [1343-88-0]
4Empirical formula and molecular weight
MgO·xSiO2·yH2O (variable)
5Functional category
Glidant
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used in oral pharmaceutical products and foods as a glidant and anticaking agent, and as an adsorbent. Therapeutically it has been used as an antacid. It has also been used as a filter aid and in chromatography.
7Description
A fine, white, odourless and tasteless powder, free from grittiness. It is a synthetic compound of magnesium oxide and silicon dioxide with varying amounts of water.
8Typical properties
- pH
- 7.0–10.8 (10% w/v aqueous slurry)
- Solubility
- practically insoluble in water and ethanol; decomposed by mineral acids
- Hygroscopicity
- slightly hygroscopic
- Surface
- porous, with a high specific surface area and good adsorptive capacity
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Decomposed by acids. Because of its adsorptive capacity it may bind drugs and preservatives, and magnesium ions may chelate drugs such as tetracyclines, so drug release and availability should be checked.
11Method of manufacture
Made by precipitation from an aqueous solution of sodium silicate with a soluble magnesium salt, followed by washing, drying and milling.
12Safety
Regarded as non-toxic and non-irritant at excipient levels. Long-term ingestion of large amounts of magnesium silicates (as antacids) has been associated with silica kidney stones. Inhalation of the dust should be avoided.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid generating dust; eye protection, gloves and a dust mask are recommended.
14Regulatory status
GRAS listed as an anticaking agent. Accepted as a food additive in Europe (E553a).
15Related substances
Magnesium trisilicate; magnesium aluminium silicate; calcium silicate; talc.
16Comments
Composition (the MgO to SiO2 ratio and water content) varies between products, which affects adsorption and flow properties; the supplier's specification should be checked against the intended use.