Dissolution testing is used to evaluate the performance of pharmaceutical products. This study compared the dissolution profiles of seven immediate-release metformin 500-mg formulations, including two products with the trade name Glucophage, in simulated intestinal fluid (SIF) at pH 6.8 buffer without enzymes. Other characteristics investigated were absolute weight and drug content. These formulations were marketed in Trinidad and Tobago and are categorized as Class 3 drugs by the Biopharmaceutics Classification System (BCS). The paddle apparatus was used at 75 rpm in 900 mL of SIF at 37 ± 0.5 °C. Samples of 1.25 mL were removed at 10, 15, 20, 30, 45, and 60 min without replacement, of which 100 µL was diluted with fresh medium and then analyzed spectrophotometrically at 233 nm. Data were analyzed statistically using one-way analysis of variance and DDSolver Add-In to Excel. The weights were significantly different (p ≤ 0.05), and each of the formulations demonstrated drug content between 99% and 103%. Only one of the formulations showed <85% drug release in 15 min and a calculated f 2 value less than 50, which deviates from the acceptance criteria recommended by the World Health Organization (WHO).
Abstract. 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.
Background: Generic drugs are manufactured to be similar to their brand name counterparts. They are procured by healthcare organizations and governments to provide accessible and affordable medicines for patients worldwide. The objective of this study was to investigate the perception of patients regarding generic drugs. Methods: A non-randomized, crosssectional, convenient sample study design was employed. Patients were interviewed, at selected chronic disease clinics at health institutions in the North Central region of Trinidad, using a questionnaire to garner their perception of generic drugs. Results: While 30.43% of patients knew the names of their prescribed medicines, 74.75% did not know what a generic drug was. After patients were appropriately educated, both the single-item question on perception and the total perception domain demonstrated 'good', followed by 'excellent' general perception of generic drugs. Conclusion:The use of generic drugs can provide cost-effective, therapeutic benefits to the healthcare sector. Consequently, patient education on the advantages of generic drugs can improve their acceptance.
Objectives Unused/expired medicines that are improperly disposed of can enter soil and water supply and have negative implications for public health. This study aimed to assess patients’ knowledge and understanding of medication disposal practices and their willingness to participate in a medication takeback programme. Methods A self-administered questionnaire comprising of 26 questions based on demographics, knowledge, beliefs, practices and concerns was utilized in this study. The study was conducted over 12 weeks at outpatient pharmacy sites located in the four Regional Health Authorities in Trinidad. Statistical Package for the Social Sciences (SPSS) version 24 was used for statistical analysis. Key findings A total of 547 persons completed the questionnaire. Knowledge of the dangers of improper medication disposal was highest in those aged 18–25 years (P = 0.007) and having secondary/tertiary level education (P = 0.002). Disposal of unused/expired medication via household thrash (86.1%) was the most commonly encountered practice. Only 14.1% (n = 77) of respondents asked the pharmacist for advice on best disposal practice, although 47.3% (n = 259) thought that the pharmacist should be the main source of advice for information on medication disposal practices. There was a willingness to participate in a medicine takeback programme from 82% (n = 449) of the respondents, and the majority (67.5%) (n = 303) would prefer it if medication takeback programmes were implemented at private community pharmacies. Conclusions Patients in Trinidad utilized household garbage as their main disposal method. There is a need to implement a medication takeback programme and educate the public on proper medication disposal.
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