2023
DOI: 10.52711/0975-4377.2023.00047
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A Review on Dissolution Method Development for Drug Products: Current Regulations and Prospects

Prashant Gupta,
Dipti H. Patel,
Nilesh Dhameliya
et al.

Abstract: Dissolution (in vitro release) testing has been the subject of intense scientific and regulatory interest over the past several decades. As an analytical methodology, in vitro dissolution testing measures drug release into the dissolution media. The U. S. Food and Drug Administration (USFDA) Dissolution Database was reviewed and screened regarding the type of dosage forms, apparatus type, agitation speed, media volume, and recommended time points for the dissolution profile. The dissolution method requires spe… Show more

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