
PLoS ONE, Journal Year: 2024, Volume and Issue: 19(11), P. e0310828 - e0310828
Published: Nov. 19, 2024
Background The incidence of hypertension in persons 25 years age and older is estimated to be 46% Africa, where it still very common. This concerning rate could explained by the pharmaceutical markets’ accessibility poor quality antihypertensive drugs. Thus, purpose this study was evaluate compare different brands Amlodipine Tablets Commercially available Jimma Town, South-western Ethiopia. Methods control test conducted from August 30, 2019 February 27, 2020 at University Laboratory Drug Quality Control (JuLaDQ). laboratory carried out accordance with WHO inspection guidelines United States Pharmacopeia. A statistically significant considered when P<0.05. For further comparison in-vitro dissolution profiles amlodipine tablets, model-independent model-dependent parameters statistical Dunnetts tests for ensuring bioequivalence were used profiles. Results With exception brand AMD-5 (1/10), remaining nine (n = 9) within visual criteria. such as friability, weight variation, identity, assay, model independent (f1, f2) confirmed that, all generic products bio-equivalence, interchangeable comparator product. dependent approaches revealed Weibull (AMD-10), Zero order (AMD-3), Korsemeyer-Peppas models most effective predictions release substance dosage form. (r2 ≥0.9695) best descriptive determining drug kinetics point view examined. evaluated tablets line standards. methods that clinical practice. tested follow more than two kinetics. Conclusion a manifest discrepancy profiles’ releases. Therefore, strongly advised use appropriately designed profile evaluation various pH values media, well do comprehensive inspections. will make easier thorough investigation any potential issues might related market.
Language: Английский