Magnesium Trisilicate

Basic Information

Name: Magnesium Trisilicate

CAS No: Magnesium trisilicate [14987-04-3]

Functional Categories

Anticaking agent Glidant Therapeutic agent

1. Nonproprietary Names

BP: Magnesium Trisilicate PhEur: Magnesium Trisilicate USP: Magnesium Trisilicate

2. Synonyms

E553a; magnesii trisilicas; magnesium mesotrisilicate; silicic acid, magnesium salt (1 : 2), hydrate.

3. Chemical Name & CAS Registry

Magnesium trisilicate [14987-04-3]

4. Empirical Formula & Molecular Weight

Mg2Si3O8xH2O 260.86 (anhydrous)

5. Structural Formula

See Section 4.

6. Applications

Magnesium trisilicate is used in oral pharmaceutical formulations and food products as a glidant. It is also used therapeutically as an antacid, and also for the treatment of ciprofloxacin overdose or toxicity.(1

7. Description

The USP 32 describes magnesium trisilicate as a compound of magnesium oxide and silicon dioxide with varying proportions of water. It contains not less than 20.0% of magnesium oxide and not less than 45.0% of silicon dioxide. The PhEur 6.0 similarly describes magnesium trisilicate as having a variable composition corresponding to the approximate formula Mg2Si3O8xH2O. It contains not less than 29.0% of magnesium oxide and not less than the equivalent of 65.0% of silicon dioxide, both calculated with reference to the ignited substance. Magnesium trisilicate occurs as an odorless and tasteless, fine, white-colored powder that is free from grittiness.

8. Pharmacopeial Specifications

See Table I.

9. Typical Properties

Moisture content Magnesium trisilicate is slightly hygroscopic. At relative humidities of 15–65%, the equilibrium moisture content at 258C is 17–23% w/w; at relative humidities of 75–95%, the equilibrium moisture content is 24–30% w/w. NIR spectra see Figure 1. Solubility Practically insoluble in diethyl ether, ethanol (95%) and water.

10. Stability & Storage

Magnesium trisilicate is stable if stored in a well-closed container in a cool, dry place

11. Incompatibilities

Magnesium trisilicate, when taken with drugs such as mebeverine hydrochloride,(2) proguanil,(3) norfloxacin,(4) sucralfate, and tetracycline, may cause a reduction in bioavailability via binding or chelation. The dissolution rate of folic acid,(5) erythromycin stearate,(6) paracetamol, and chloroquine phosphate(7) may be retarded by adsorption onto magnesium trisilicate. Antimicrobial preservatives, such as the parabens, may be inactivated by the addition of magnesium trisilicate.(8) Magnesium trisilicate is also readily decomposed by mineral acids.

12. Method of Manufacture

Magnesium trisilicate may be prepared from sodium silicate and magnesium sulfate. It also occurs in nature as the minerals meerschaum, parasepiolite, and sepiolite.

13. Safety

Magnesium trisilicate is used in oral pharmaceutical formulations and is generally regarded as an essentially nontoxic and nonirritant material. When administered orally, magnesium trisilicate is neutralized in the stomach to form magnesium chloride and silicon dioxide; some magnesium may be absorbed. Caution should be used when concentrations greater than 50 mEq of magnesium are given daily to persons with impaired renal function, owing to the risk of hypermagnesemia. Therapeutically, up to about 2 g of magnesium trisilicate may be taken daily as an antacid. Reported adverse effects include the potential for osmotic diarrhea in the elderly using antacids containing magnesium trisilicate;(9) and the potential for the formation of bladder and renal calculi following the long-term use of magnesium trisilicate as an antacid.(10,11)

14. Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection is recommended.

15. Regulatory Status

GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Database (oral tablets). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

16. Related Substances

Calcium silicate; magnesium aluminum silicate; magnesium silicate; magnesium trisilicate anhydrous; talc. Magnesium trisilicate anhydrous Empirical formula Mg2Si3O8 Molecular weight 260.86 CAS number [14987-04-3]

17. Comments

Magnesium trisilicate is regarded as a type of magnesium silicate. The European food additive code E553a has been applied to both. The EINECS number for magnesium trisilicate is 239-076-7. The PubChem Compound ID (CID) for magnesium trisilicate is 5311266