Investigating the dissolution profiles of amoxicillin, metronidazole, and zidovudine formulations used in Trinidad and Tobago, West Indies.
Trinidad and Tobago is a twin-island Republic in the Caribbean and like many developing countries, it has included generic drugs on the national drug formulary to decrease the financial burden of pharmaceutical medications. However, to ensure that medications received by patients are beneficial, generic drugs need to be interchangeable with the innovator which has demonstrated safety, efficacy, and quality. The objective of the study was to compare the dissolution profiles and weight variations for different formulations of amoxicillin, metronidazole, and zidovudine that are on the national drug formulary and marketed in Trinidad and Tobago. All the products investigated are categorized as class 1 drugs according to the Biopharmaceutics Classification System (BCS) and the dissolution profiles were assessed according to the World Health Organization (WHO) criteria for interchangeability between products. The similarity factor, f 2, was used to determine sameness between the products. No generic formulation was found to be similar to Amoxil® 500-mg capsules. The two generic products for metronidazole 200-mg tablets demonstrated more than 85% drug release within 15 min in all three of the buffers; however, their 400-mg counterparts did not fulfill this requirement. The zidovudine 300-mg tablet complied with the requirements in buffer pH 4.5 and simulated gastric fluid (SGF) but not for simulated intestinal fluid (SIF). Some Class 1 pharmaceutical formulations may possess the same active ingredient and amount of drug but may show significant differences to in vitro equivalence requirements. Nevertheless, the dissolution process is suitable to detect these variations.
Faculty of Medical Sciences, Pharmacology Unit, University of the West Indies, St. Augustine, Trinidad and Tobago.
Arlene Villarroel
AV
Stuart
Jieyu
J
Zuo
Raimar
R
Löbenberg
D000658:Amoxicillin / Q000737:chemistry* / Q000592:standards*; D000900:Anti-Bacterial Agents / Q000737:chemistry* / Q000592:standards*; D019380:Anti-HIV Agents / Q000737:chemistry* / Q000592:standards*; D000994:Antitrichomonal Agents / Q000737:chemistry* / Q000592:standards*; D002214:Capsules / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D065546:Drug Liberation; D016568:Drugs, Generic / Q000737:chemistry* / Q000592:standards*; D008795:Metronidazole / Q000737:chemistry* / Q000592:standards*; D012995:Solubility; D013607:Tablets / Q000032:analysis; D014300:Trinidad and Tobago; D015215:Zidovudine / Q000737:chemistry* / Q000592:standards*
D000900:Anti-Bacterial Agents; D019380:Anti-HIV Agents; D000994:Antitrichomonal Agents; D002214:Capsules; D016568:Drugs, Generic; D013607:Tablets; D008795:Metronidazole; D015215:Zidovudine; D000658:Amoxicillin