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Carboxymethylcellulose calcium
کربوکسی متیل سلولز کلسیم
1Nonproprietary names
- BPCarmellose Calcium
- JPCarmellose Calcium
- Ph. Eur.Carmellose Calcium
- USP–NFCarboxymethylcellulose Calcium
2Synonyms and trade names
Calcium carboxymethylcellulose; calcium CMC; carmellosum calcicum; cellulose, carboxymethyl ether, calcium salt; ECG 505
3Chemical name and CAS Registry Number
Cellulose, carboxymethyl ether, calcium salt · [9050-04-8]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Disintegrant
Typical concentrations: 1–15% · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used in oral and topical products mainly for its water-absorbing and swelling properties: as a tablet disintegrant and binder, and as a suspending or viscosity-increasing agent. In tablets it is typically used at about 1–15% w/w.
7Description
A white to yellowish-white, hygroscopic, odourless fine powder.
8Typical properties
- pH
- ≈ 4.5–6.0 (1% w/v aqueous dispersion)
- Solubility
- practically insoluble in water, ethanol, acetone and ether; swells in water to form a suspension; slightly soluble in dilute sodium hydroxide
- Hygroscopicity
- hygroscopic
9Stability and storage conditions
Stable but hygroscopic. Store in a well-closed container in a cool, dry place.
10Incompatibilities
As with carboxymethylcellulose sodium, it is incompatible with strongly acidic solutions and with soluble salts of iron and some other metals such as aluminium, mercury and zinc.
11Method of manufacture
Cellulose is carboxymethylated with chloroacetic acid in the presence of sodium hydroxide; the sodium salt is converted to the acid form and then to the calcium salt, for example with calcium carbonate.
12Safety
Used in oral pharmaceuticals and regarded as non-toxic and non-irritant; it is not absorbed. Very large oral amounts may have a laxative effect.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid inhaling the dust; eye protection and gloves are recommended.
14Regulatory status
Included in the FDA Inactive Ingredient Database (oral capsules and tablets) and in non-parenteral medicines licensed in Europe.
15Related substances
Carboxymethylcellulose sodium; croscarmellose sodium; sodium starch glycolate.
16Comments
Unlike the sodium salt, the calcium salt is insoluble in water; it swells instead of dissolving, which is why it works as a disintegrant rather than a thickener. It is used particularly widely in Japan.