The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing

Results in Pharma Sciences
Mubarak Nasser Al AmeriAtholl Johnston

Abstract

Dissolution is the amount of substance that goes into solution per unit time under standardised conditions of liquid/solid interface, solvent composition and temperature. Dissolution is one of the most important tools to predict the in-vivo bioavailability and in some cases to determine bioequivalence and assure interchangeability. To compare the differences in dissolution behaviour of solid dosage forms between innovators (reference products) and their generic counterparts (tested products). Four replicates for each batch of 37 tested medicines was carried out using A PT-DT70 dissolution tester from Pharma Test. A total of 13 branded medicines and 24 generic counterparts were obtained locally and internationally to detect any differences in their dissolution behaviour. They were tested according to the British Pharmacopeia, European Pharmacopeia and the US Pharmacopeia with the rate of dissolution determined by ultra-violet Spectrophotometery. Most tested medicines complied with the pharmacopoeial specifications and achieved 85% dissolution in 60 min. However, some generic medicines showed significant differences in dissolution rate at 60 and 120 min. Many generic medicines showed a slower dissolution rate than their branded c...Continue Reading

Citations

Sep 11, 2019·European Heart Journal. Cardiovascular Pharmacotherapy·Juan Tamargo, Giuseppe Rosano
Sep 3, 2019·Frontiers in Pharmacology·Ensieh IzadiLong Chiau Ming
Dec 2, 2017·The Journal of Pharmacy and Pharmacology·Chan JinZhonggui He

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