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Magnesium aluminum silicate
ویگوم
1Nonproprietary names
- BPAluminium Magnesium Silicate
- Ph. Eur.Aluminium Magnesium Silicate
- USP–NFMagnesium Aluminum Silicate
2Synonyms and trade names
Aluminium magnesium silicate; magnesium aluminium silicate; colloidal magnesium aluminium silicate; aluminii magnesii silicas; smectite clay; Veegum; Magnabite
3Chemical name and CAS Registry Number
Aluminium magnesium silicate (a purified blend of colloidal montmorillonite and saponite clays) · [1327-43-1]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Gelling agent, viscosity modifier, Adsorbent
Typical concentrations: — · Dosage forms: Liquid, Semi-solid
6Applications in pharmaceutical formulation
Used as a suspending agent, emulsion stabiliser, viscosity-increasing agent and adsorbent in oral and topical preparations, and as a binder and disintegrant in tablets. Typical concentrations: adsorbent 10–50%; emulsion stabiliser 1–5% (oral) or 2–5% (topical); suspending agent 0.5–2.5% (oral) or 1–10% (topical); tablet binder or disintegrant 2–10%; viscosity-increasing agent 2–10%.
7Description
Off-white to creamy white, odourless, tasteless, soft, slippery small flakes or a fine powder. The particles are thin platelets that swell in water to form colloidal dispersions.
8Typical properties
- pH
- 9.0–10.0 (5% w/v aqueous dispersion)
- Moisture content
- not more than 8% w/w
- Viscosity
- grade-dependent; 5% w/v dispersions range from low to high viscosity and are thixotropic
- Solubility
- practically insoluble in water, ethanol and organic solvents; swells in water
9Stability and storage conditions
Stable indefinitely when stored dry. Aqueous dispersions are stable over a wide pH range (about 3.5–11) and their viscosity rises on standing or with heating; they may need a preservative. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Strongly acidic conditions (below pH 3.5) reduce the viscosity of dispersions. Being anionic, it can be flocculated by cationic materials and electrolytes, and it may adsorb some drugs (for example certain antibiotics and amines), reducing their availability.
11Method of manufacture
Obtained from naturally occurring smectite clays, which are blended, dispersed in water to remove grit, then dried and milled or flaked.
12Safety
Not absorbed after oral administration and regarded as non-toxic and non-irritant at excipient levels. 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
Included in the FDA Inactive Ingredient Database (oral suspensions and tablets; rectal and topical preparations) and in non-parenteral medicines licensed in Europe.
15Related substances
Attapulgite; bentonite; hectorite; kaolin; magnesium trisilicate; talc.
16Comments
Dispersions are best prepared by adding the powder slowly to water with vigorous stirring; hydration is faster in warm water. It is often combined with xanthan gum or carboxymethylcellulose sodium, which gives synergistic viscosity and better suspension stability.