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Excipient monograph · مونوگراف ماده جانبی
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Attapulgite
آتاپولژیت
1Synonyms and trade names
Activated attapulgite; colloidal activated attapulgite; Attagel; palygorskite; Pharmasorb
2Chemical name and CAS Registry Number
Hydrated magnesium aluminium silicate clay (palygorskite) · [12174-11-7]
3Empirical formula and molecular weight
approximately (Mg,Al)5Si8O20(OH)2(OH2)4·4H2O
4Functional category
Adsorbent
Typical concentrations: — · Dosage forms: Solid, Liquid
5Applications in pharmaceutical formulation
Used as a suspending, thickening and thixotropic agent in oral and topical suspensions and as an adsorbent. Heat-activated attapulgite was formerly widely used as an antidiarrhoeal active ingredient. Colloidal grades are used as rheology modifiers in pharmaceutical, cosmetic and industrial products.
6Description
A cream to buff-coloured, very fine, odourless powder with a slightly earthy taste. It is a naturally occurring clay mineral (palygorskite) with a chain-type structure that forms elongated, needle-shaped particles.
7Typical properties
- Particle shape
- acicular (needle-like) crystals that form a lattice-like network in water
- Solubility
- practically insoluble in water and organic solvents; disperses in water without the marked swelling seen with bentonite
- Adsorptive capacity
- high, and increased by thermal activation
- Electrolyte tolerance
- dispersions retain viscosity in the presence of electrolytes better than swelling smectite clays
8Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
9Incompatibilities
Because of its high adsorptive capacity it can bind drugs, preservatives and flavours given at the same time, reducing their availability or activity.
10Method of manufacture
Mined from natural deposits, then dried, milled and classified. Activated grades are produced by controlled heating, which removes water and increases adsorptive capacity; colloidal grades are processed to a very fine particle size.
11Safety
Not absorbed from the gastrointestinal tract and regarded as of low toxicity orally. Long-term inhalation of clay dusts, which may contain crystalline silica, should be avoided.
12Handling precautions
Observe normal precautions for the quantity handled. Avoid dust generation and use a suitable dust mask and eye protection.
13Regulatory status
In the USA, attapulgite was removed from the over-the-counter antidiarrhoeal monograph in 2003 because of insufficient evidence of effectiveness, but it remains in use as an excipient and in some markets as an active ingredient.
14Related substances
Bentonite; kaolin; magnesium aluminium silicate; sepiolite.
15Comments
Unlike swelling clays such as bentonite, attapulgite builds viscosity through a network of interlocking needles rather than through swelling, so its suspensions are less sensitive to electrolytes. Its adsorptive capacity should be considered whenever it is co-formulated with low-dose drugs.