Abstract
Dissolution tests evaluate the release of therapeutic agents in various dosage forms, acting as quality control tools to secure batch–batch equivalence and guides for formulation development and in vivo drug bioavailability prediction for pharmaceutical scientists. In this article, dissolution tests described in the Brazilian Pharmacopeia 6th ed. were systematically reviewed using the following descriptors: drug, dosage forms, apparatus, rotational speed, dissolution media, sampling time, quantitative procedure, and the value of Q . Test conditions were compared with those described in the United States Pharmacopeia (USP) dissolution database. In September, 2023, dissolution tests were required for 127 monographs, accounting for only 10% of those listed in the USP database. Paddles were used in 80 monographs (63.5%) at various rotation speeds. Basket apparatus was recommended for 47 products, including tablets, capsules, and gastro-resistant granules with variable speed ranges. The simulated gastric fluid was described in four monographs. Moreover, pH of the dissolution media for 29 products was adjusted in the physiological range of 2–7.5. Twenty-eight monographs are exclusively listed in the Brazilian Pharmacopeia. Among the 99 products listed in both compendiums, dissolution tests were only harmonized for 69 monographs.
Keywords:
Brazilian Pharmacopeia; Dissolution methods; Review; Solid dosage forms; USP dissolution database
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