Pantoprazole is a substituted benzimidazole proton pump inhibitor used in treatment of patients with serious or refractory acid-related diseases. The objective of the present study was to undertake comparative in vitro evaluation of different brands of pantoprazole sodium tablets available in different retail outlets in Addis Ababa, Ethiopia. All brands were evaluated using established procedures to assess the pharmaceutical quality characteristics. The measured thickness of studied brand tablets was found to be in the range of 2.79 to 3.49 mm.Brand E (175.4 ± 3.73 N) exhibited maximum hardness while brand C (110.2 ± 6.43 N) had the lowest hardness. When the mean weights of the sample brands are compared,brandC had maximum weight (151.22mg) and brandD weighed the least (79.18 mg).The disintegration time test indicated that any of the pantoprazole sodium tablet brands did not disintegrate in 0.1N HClacidic medium for 2 hrs but all disintegrated in the time range of 12.43 min to 24.42 min in phosphate buffer.The in vitrodrug release study depicted that all brands of pantoprazole sodium tablets released not more than 10% of the labeled amount within 2 hrs under 0.1N HClmedium but showed similar drug release in the buffer medium ranging between 89 and 92% within 45 minutes.Therefore, the results of the present study revealed that all of the tested brands of the pantoprazole sodium enteric coated tablet fulfilled the criteria set in the official monograph for in vitro quality control tests.
Metformin hydrochloride is a biguanide class of drug widely used to treat Type 2 diabetes mellitus. Its oral bioavailability is about 50 to 60 % with a half-life of about 3 h. This study focused on evaluation and comparison of the physicochemical properties of different brands of metformin hydrochloride (500mg) film coated tablets available in drug retail outlets in Addis Ababa, Ethiopia. Some different in vitro tests including hardness, weight variation, disintegration time, dissolution study, and assay were conducted as per United States Pharmacopeia. To compare dissolution profiles of the generic products against the innovator product (product A), a model independent method, similarity factor (f2), was also used. Weight variation result showed that all brand fall within the 5% limit from the average which is acceptable. Disintegration time of less than 15 minutes was observed for all brands. The in vitro drug release study results for the products ranged between 82 and 93% release within 30 minutes which is above 80% limit as per the United States Pharmacopeia requirement. The similarity f2 values for generic products ranged from 53 to 75%. Furthermore, assay value of the studied brands varied from 95.60 to 104.37% which was within standard limit (95-105%). It can be concluded that all brands of metformin hydrochloride tablets met pharmacopoeial specification for the tested parameters of physicochemical properties like weight variation, hardness of tablets, disintegration time, drug release study and assay.
Nifedipine has been formulated and marketed as extended-release-film coated tablet. A certain degree of success has been achieved in reducing the incidence of adverse effects by the use of slow-release formulations such as nifedipine retard. The aim of the present study was to evaluate the physicochemical quality attributes and in vitro equivalence of six brands of nifedipine retard tablets available in different retail outlets in Addis Ababa, Ethiopia. After constructing the calibration curve, the in vitro drug release studies were carried out using USP type I dissolution apparatus at 100 rpm. The dissolution was done in a medium of 0.1N HCl containing 0.5% sodium lauryl sulfate for 12 hrs. All the tablets met the requirement for tablet weight uniformity. The mean crushing strengths of sample tablets ranged from 49.2 to 111.2 N. All the brands studied released more than 80% within 12 hours which is within the tolerance limit. However, the release profile revealed that five of the brands showed over 15% drug release at 1 st hour except product F which released only 14.32%. In conclusion, all the brands of tablets had uniform thickness and good hardness. Despite all the brands had sustained the release for over 12 hours recommended for such formulations, five of them showed higher release in the first hour which may affect their in vivo performance.
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