สำนักงานราชบัณฑิตยสภา

สมพล ประคองพันธ์ 135 วารสารราชบัณฑิตยสภา ปีที่ ๔๐ ฉบับที่ ๑ ม.ค.-มี.ค. ๒๕๕๘ Abstract Dissolution Testing for Generic Drugs Sompol Prakongpan Associate Fellow of the Academy of Science, The Royal Society, Thailand Dissolution rate of a pharmaceutical product is an important factor for in vivo performance of the drug. The active pharmaceutical ingredient (API) has to be dissolved/released from oral product in the gastrointestinal tract in order to be absorbed. Dissolution testing has been successfully used in various stages of product life cycle including product development, drug registration, formulation development, manufacturing process, quality control and drug shelf-life. Dissolution testing also used in scale up and post approval changes (variations) of a product. In certain cases it can be used as surrogate for bioequivalence testing. This article review the guidelines and applications of dissolution testing for oral solid dosage generics. Keywords : dissolution, dissolution testing, bioavailability, bioequivalence, biopharmaceutic classification system, variations