Comparative in Vitro Dissolution Studies of Selected Generic Essential Medicines in Tanzania

Abstract BACKGROUND: The use of generic drugs is steadily increasing internationally because of economic pressure on drug budgets. When principles and practice of Health Technologies Assessments (HTA) are well applied, generic drugs provide the opportunity for major savings in healthcare expenditure since they are usually substantially lower in price than the innovator brands. However, physicians, pharmaceutical personnel and the community in general are apprehensive regarding the quality of generic drugs. There are concerns about their pharmaceutical equivalence and if they can interchange between one generic and the other without affecting therapeutic outcomes. AIM:The objective of this study was to evaluate the biopharmaceutical equivalence of different brands of selected essential medicines by using comparative invitro dissolution profile technique. METHOD: Dissolution testing using three different dissolution media at various pH (1.2, 4.5, and 6.8) was used by employing dissolution testing apparatus II. Samples were withdrawn at specified time intervals and analyzed for the released drug content by UV/VIS spectrophotometer. Drug released at each time interval were calculated and data obtained were used for comparison against a reference product. RESULTS: In this study five medicines (Ibuprofen, Ciprofloxacin, Erythromycin, Furosemide, Griseofulvin) _ were tested to determine their equivalence to the innovator brand. After conducting comparative dissolution testing and analyzed the similarity (f2) factor all brands of Ibuprofen, erythromycin, and ciprofloxacin were confirmed to be equivalent to their innovator brands. While one brand of Griseofulvin and all the brands of furosemide showed marked difference from innovator brands. Hence the findings revealed that of all the tested samples 70% showed similarity with innovator brand while 30% was not similar and cannot used interchangeably. CONCLUSION: The finding indicated that three is a need for continuous market surveillance to ensure that the quality of drug in the market always complies with specifications. But also, to sensitize manufactures to evaluate and improve the pharmaceutical characteristics of their formulation. There is need for careful evaluation of the various generics manufactured worldwide, to ensure the compliance to official standards.