Journal
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY
Volume 27, Issue 4, Pages 425-434Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/10837450.2022.2073370
Keywords
Rosuvastatin calcium; statin drugs; tribasic calcium phosphate; direct compression; chemical stabilization
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Reliable and stable tablet formulations for rosuvastatin calcium have been developed, providing good mechanical properties, rapid disintegration, and dissolution rate, as well as satisfactory chemical stability.
Reliable and stable tablet formulations for rosuvastatin calcium (RSC) in four strengths: 5 mg, 10 mg, 20 mg, and 40 mg have been developed. Rosuvastatin is a cholesterol-lowering statin drug and is known to be unstable during storage. The possibility of its stabilization with inorganic salts of multivalent metals has already been reported in the literature. In the present study, a special grade of tribasic calcium phosphate excipient was used to chemically stabilize RSC in a directly compressible immediate release tablet formulation. The developed tablets exhibited good mechanical properties (breaking force ranging from 177 N to 250 N depending on tablet strength), rapid disintegration (less than three minutes) and fast dissolution rate (85% of the drug substance dissolved within 15 minutes) as well as satisfactory chemical stability during storage under stress conditions (50 degrees C/80% RH), even compared to the reference commercial product.
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