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Calcium Carbonate - Pharmaceutical Excipients
Calcium Carbonate - Pharmaceutical Excipients
Calcium Carbonate - Pharmaceutical Excipients
Calcium Carbonate
1. Nonproprietary Names
BP: JP: PhEur: USP: Calcium Carbonate Precipitated Calcium Carbonate Calcium Carbonate Calcium Carbonate
2. Synonyms
Balcarb; Cal-Carb; calcii carbonas; calcii carbonas praecipitatus; calcium carbonate (1 : 1); Calopake; carbonic acid calcium salt (1 : 1); creta preparada; Destab; E170; MagGran CC; Pharma-Carb; precipitated calcium carbonate; precipitated carbonate of lime; precipitated chalk; Sturcal; Vicality; Vivapress; Witcarb.
5. Structural Formula
See Section 4.
6. Functional Category
Buffering agent; coating agent; colorant; opacifier; tablet binder; tablet and capsule diluent; therapeutic agent.
8. Description
Calcium carbonate occurs as an odorless and tasteless white powder or crystals.
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9. Pharmacopeial Specifications
See Table I. See also Section 18.
12. Incompatibilities
Incompatible with acids and ammonium salts (see also Sections 10 and 18).
14. Safety
Calcium carbonate is mainly used in oral pharmaceutical formulations and is generally regarded as a nontoxic material. However, calcium carbonate administered orally may cause constipation and flatulence. Consumption of large quantities (460 g daily) may also result in hypercalcemia
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or renal impairment.7 Therapeutically, oral doses of up to about 1.5 g are employed as an antacid. In the treatment of hyperphosphatemia in patients with chronic renal failure, oral daily doses of 2.517 g have been used. Calcium carbonate may interfere with the absorption of other drugs from the gastrointestinal tract if administered concomitantly. LD50 (rat, oral): 6.45 g/kg
18. Comments
Calcium carbonate is one of the materials that have been selected for harmonization by the Pharmacopeial Discussion Group. For further information see the General Information Chapter <1196> in the USP33NF28, the General Chapter 5.8 in PhEur 7.0, along with the 'State of Work' document on the PhEur EDQM website, and also the General Information Chapter 8 in the JP XV. When calcium carbonate is used in tablets containing aspirin and related substances, traces of iron may cause discoloration. This may be overcome by inclusion of a suitable chelating agent. Grades with reduced lead levels are commercially available for use in antacids and calcium supplements. Directly compressible grades containing only calcium carbonate are commercially available, such as MagGran CC (Magnesia GmbH). Barcroft CS90 (SPI Pharma) is a directly compressible grade containing 10% starch and Calci-Press MD (Particle Dynamics Inc.) is a directly compressible blend of calcium carbonate and maltodextrin. A specification for calcium carbonate is contained in the Food Chemicals Codex (FCC).8 The EINECS number for calcium carbonate is 207-439-9. The PubChem Compound ID (CID) for calcium carbonate includes 10112 and 516889.
1. Allen LV. Featured excipient: capsule and tablet diluents. Int J Pharm Compound 2000; 4(4): 306310, 324325. 2. Serra MD, Robles LV. Compaction of agglomerated mixtures of calcium carbonate and microcrystalline cellulose. Int J Pharm 2003; 258(12): 153164. (PubMed) 3. Gorecki DKJ et al. Dissolution rates in calcium carbonate tablets: a consideration in product selection. Can J Pharm 1989; 122: 484487, 508. 4. Bacher C et al. Improving the compaction properties of roller compacted calcium carbonate. Int J Pharm 2007; 342: 115123. (PubMed) 5. Bacher C et al. Compressibility and compactibility of granules produced by wet and dry granulation. Int J Pharm 2008; 358: 6974. (PubMed) 6. Carmargo IM et al. Abrasiveness evaluation of silica and calcium carbonate used in the production of dentifrices. J Cos Sci 2001; 52: 163167. (PubMed) 7. Orwoll ES. The milk-alkali syndrome: current concepts. Ann Intern Med 1982; 97: 242248. (PubMed) 8. Health and Safety Executive. EH40/2005: Workplace Exposure Limits. Sudbury: HSE Books, 2005 (updated 2007). http://0-www.hse.gov.uk.library.newcastle.edu.au/coshh /table1.pdf (accessed 2 December 2010). 9. Food Chemicals Codex, 7th edn. Bethesda, MD: United States Pharmacopeia, 2010: 133.
21. Author
NA Armstrong.
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