aluminium magnesium silicate(2:1:2)

Химические свойства

Almost white powder, granules or plates.

Использование

Aluminium magnesium silicate is used as an Antacid Raw material in a specific antacid formulations, Ceramics, Suspending Agent, Thickning agent etc.

Методы производства

Aluminium magnesium silicate is obtained from silicate ores of the montmorillonite group, which show high magnesium content. The ore is blended with water to form a slurry to remove impurities and separate out the colloidal fraction. The refined colloidal dispersion is drum-dried to form a small flake, which is then micro-atomized to form various powder grades.

Фармацевтические приложения

Aluminium magnesium silicate has been used for many years in the formulation of tablets, ointments, and creams. It is used in oral and topical formulations as a suspending and stabilizing agent either alone or in combination with other suspending agents. The viscosity of aqueous dispersions may be greatly increased by combination with other suspending agents, such as xanthan gum, owing to synergistic effects; see Xanthan Gum. In tablets, magnesium aluminum silicate is used as a binder and disintegrant in conventional or slow-release formulations.
Magnesium aluminum silicate may cause bioavailability problems with certain drugs.

Безопасность

Aluminium magnesium silicate is generally regarded as nontoxic and nonirritating at the levels employed as a pharmaceutical excipient. Subacute animal feeding studies in rats and dogs fed magnesium aluminum silicate at 10% of the diet, for 90 days, were negative, including autopsy and histopathological examinations.
LD50 (rat, oral): > 16 g/kg

хранилище

Magnesium aluminum silicate is stable indefinitely when stored under dry conditions. It is stable over a wide pH range, has baseexchange capacity, absorbs some organic substances, and is compatible with organic solvents.
Magnesium aluminum silicate should be stored in a well-closed container, in a cool, dry place.

Несовместимости

Owing to its inert nature, magnesium aluminum silicate has few incompatibilities but is generally unsuitable for acidic solutions below pH 3.5. Magnesium aluminum silicate, as with other clays,may adsorb some drugs. This can result in low bioavailability if the drug is tightly bound or slowly desorbed, e.g. amfetamine sulfate, tolbutamide, warfarin sodium, diazepam, and diclofenac sodium.

Регуляторный статус

Included in the FDA Inactive Ingredients Database (oral granules, solutions, suspensions and tablets; rectal; and topical preparations; vaginal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Nonmedicinal Ingredients.