Magnesium aluminum silicate

Product Name

Cat.No.

PE0365

Particle Size

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Price

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Product Details

cid3

49,150

Category

Adsorbent; Binder; Disintegrant; Emulsifier; Stabilizer; Suspending Agents; Stabilizer; Viscosity regulator

Grade

Pharmceutical Excipients

Description

Magnesium aluminum silicate occurs as off-white to creamy white, odorless, tasteless, soft, slippery small flakes, or as a fine, micronized powder. Flakes vary in shape and size from about 0.3~0.4 mm to 1.0~2.0 mm and about 25-240 mm thick. Many flakes are perforated by scattered circular holes 20-120 mm in diameter.

UNII

6M3P64V0NC

Chemical Name

Aluminum magnesium silicate

CAS Number

12511-31-8

Synonyms

Aluminium Magnesium Silicate(BP); Aluminii magnesii silicas(PhEur)

Administration route

Oral; Topical; Rectal; Vaginal

Dosage Form

Oral granules, solutions, suspensions, tablets, rectal preparations, topical preparations

Stability and Storage Conditions

Magnesium aluminum silicate is stable for a long time in a dry environment. It is stable in a wide pH range, has a certain alkali exchange capacity, can adsorb certain organic substances, and is compatible with organic solvents. Magnesium aluminum silicate should be stored in airtight, dry and cool environment.

Commonly used amount and the maximum amount

The maximum dosage in marketed oral preparations is 60%; the maximum dosage in marketed external preparations is 3.0%; the maximum dosage in marketed rectal preparations is 60%; the maximum dosage in marketed vaginal preparations is 5.39%.

Source and Preparation

Magnesium aluminum silicate can be obtained from silicate ore containing montmorillonite, which has a high magnesium content, and the ore is mixed with water to form a slurry to separate impurities and separate the colloidal part. The refined colloidal solution is dried with a drum dryer to form small flakes, and then micronized to form powder grades with different particle sizes.

Applications

It can be used as adsorbent; stabilizer, suspending agent; disintegrating agent for tablets and capsules; binder for tablets; thickener. Magnesium aluminum silicate has been used in tablets, ointments and creams for many years. It is used alone or in combination with other suspending agents as a suspending agent or stabilizer in oral or external preparations. After its aqueous dispersion is mixed with other suspending agents such as xanthan gum, the viscosity increases significantly due to synergistic effect. See heading Xanthan gum. Magnesium aluminum silicate is used as a binder and disintegrant in regular tablets and sustained release tablets.

Safety

Magnesium aluminum silicate is used as an auxiliary material for preparations, and is generally considered non-toxic and non-irritating. Mice and dogs in the subacute toxicity experiment were fed magnesium aluminum silicate at 10% of their daily diet for 90 days, and the results of anatomical and histopathological examinations were negative. LD50 (rat, oral): >16g/kg.

Incompatibilities

Magnesium aluminum silicate has incompatibility due to its extremely low inertness. However, it is not suitable for acidic solutions with a pH lower than 3.5. Magnesium aluminum silicate, like other clays, can adsorb drugs. If the drug is tightly bound or difficult to desorb, it will reduce the bioavailability of the drug. Such as amphetamine, tolbutamide, warfarin sodium, diazepam.

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