PharmaVault
گنجینه اطلاعات داروسازی
The Pharmaceutical Information Vault
Excipient monograph · مونوگراف ماده جانبی
pharmavault.ir
Calcium silicate
کلسیم سیلیکات
1Nonproprietary names
- USP–NFCalcium Silicate
2Synonyms and trade names
Calcium hydrosilicate; calcium metasilicate; calcium monosilicate; Micro-Cel; silicic acid, calcium salt; E552
3Chemical name and CAS Registry Number
Hydrated calcium silicate of variable composition · [1344-95-2]
4Empirical formula and molecular weight
CaSiO3 (nominal; commercial material is hydrated and variable) · 116.16 (CaSiO3)
5Functional category
Glidant, Adsorbent
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used as an anticaking agent and glidant in powders, and as an adsorbent that converts liquids or oily drugs into free-flowing powders for tableting (for example liquisolid systems). Porous grades of low density have been used in floating, gastroretentive dosage forms. It is also used in foods and cosmetics.
7Description
A white to off-white, free-flowing, very fine powder of low bulk density and high specific surface area.
8Typical properties
- Solubility
- practically insoluble in water; decomposed by mineral acids with formation of a silica gel
- Liquid absorption
- very high; porous grades can take up several times their own weight of water or oil and remain free-flowing
- Bulk density
- low; fluffy, high-surface-area powder
- pH
- alkaline (aqueous slurry)
9Stability and storage conditions
Stable. Store in a well-closed container in a dry place.
10Incompatibilities
Decomposed by strong acids. Its alkaline surface may degrade alkali-sensitive drugs, and its large surface area can adsorb drugs and preservatives.
11Method of manufacture
Produced by hydrothermal reaction of lime (calcium oxide or hydroxide) with a reactive silica such as diatomaceous earth, or by precipitation from solutions of sodium silicate and a calcium salt.
12Safety
Regarded as non-toxic when taken orally at the levels used. As with other fine silicates, inhalation of the dust should be avoided.
13Handling precautions
Observe normal precautions for the quantity handled. Use with adequate ventilation and wear eye protection and a dust mask.
14Regulatory status
GRAS listed. Accepted as a food additive in Europe (E552).
15Related substances
Magnesium silicate; magnesium aluminium silicate; silicon dioxide, colloidal.
16Comments
Its capacity to hold liquids while staying free-flowing distinguishes it from most other glidants and makes it useful for loading oily drugs or lipid formulations into tablets and capsules.