Catatan

Pharmaceutical dissolution testing has developed into an essential tool in pharmaceutical research, formulation development, quality control, and the evaluation of drug bioavailability and bioequivalence. This literature review discusses the fundamental principles and applications of pharmaceutical dissolution testing based on the book Pharmaceutical Dissolution Testing, edited by Jennifer Dressman and Johannes Krämer. The discussion covers the historical development of dissolution testing, official compendial apparatus, instrument qualification, potential sources of testing errors, gastrointestinal physiology, and hydrodynamic factors influencing drug dissolution. Furthermore, it examines biopharmaceutical and regulatory approaches, including the Biopharmaceutical Classification System (BCS), biowaiver requirements, dissolution profile comparison using the similarity factor (f₂), and the application of biorelevant dissolution media such as FaSSIF and FeSSIF. These aspects demonstrate the importance of appropriate dissolution methods in evaluating drug release characteristics and predicting in vivo drug performance. In conclusion, pharmaceutical dissolution testing plays a significant role in ensuring the quality, consistency, safety, and efficacy of pharmaceutical products, while supporting the development of reliable drug formulations and regulatory decision-making.