Journal of Pharmaceutical Analysis and Drug Research ISSN: 3108-0839 (Online)

Authors: Dr. Kavita R. Mehra, Mr. Anil P. Gupta

Abstract: Dissolution testing serves as a cornerstone in pharmaceutical quality control and drug development by providing predictive information about drug bioavailability. By evaluating the rate and extent at which a drug dissolves in a specific medium, dissolution studies inform formulation optimization, quality assurance, and regulatory compliance. This paper reviews the principles of dissolution testing, including apparatus selection, media composition, and sampling strategies. Correlations between in vitro dissolution data and in vivo pharmacokinetic profiles are discussed, highlighting biopharmaceutics classification system (BCS)-based approaches. Tables summarizing apparatus types, validation parameters, and key dissolution profiles are included. The impact of dissolution rate on bioavailability, challenges in method standardization, and regulatory expectations from ICH and USP guidelines are analyzed. The study emphasizes dissolution testing as an essential predictive tool for ensuring consistent therapeutic efficacy and safety in oral drug products.

Keywords: Dissolution Testing, Bioavailability, In Vitro–In Vivo Correlation, Drug Release, BCS Classification, Quality Control, Regulatory Guidelines