A Comparative Study for Evaluation of Five Formulations Of Amlodipine 10 mg Tablets Marketed in Libya
AbstractObjective: Amlodipine is a calcium channel blocking agent prescribed for treatment of hypertension. However, there are many Amlodipine brands marketed in Libya, with different quality and prices The objective of this study was to evaluate the quality of five commercial Amlodipine (10 mg) products available in the Libyan market such as: Amlor (Pfizer, Morocco), Amlodipine (Bristol, UK), Amlodipine (Blue pharm, Portugal), Amlodipine (Sandoz, UK) and Amady (Ajanta Pharm, India).Methods: To assess quality, all products were examined visually for their organoleptic properties, weight uniformity test, friability, hardness, disintegration test, dissolution test and IR were assayed. We carried out a physical comparison of all Amlodipine tablet products and assessed their quality. The second part of study was carried out a survey upon mentioned formulations of Amlodipine tablets. This survey was including: (45) pharmacist (9) Physicians and (32) Patients volunteers. All the brands are within their expiry dates but there is major difference in price.Results: All the tested five brands were equivalent and complying with the official tests for weight variation, friability, disintegration and dissolution tests. The Hardness of the tablets was failed to pass this test and the range was between 3.8 kg to 11.0 kg of five brands according to USP specifications. The friability test between 0.054% to 0.223%. All formulations were disintegrated between 35 second to 2.15 min. The tested brands were identical according to their dissolution evaluation. The percentage content of active ingredient of fiveÂ brands of Metformin tablets showed values within the monograph specifications (75-94.8%). Infra-Red (IR) spectroscopic investigations were revealed no any difference between Amlodipine five brands and showed identical peaks compared to the reference. The simple Survey forwarded to patients , pharmacists andÂ Physicians to explore their opinion, the most preferable brands is Amlodipine (Bristol) 41%, 44% & 59%respectively. They have chosen Amlodipine according to effectiveness & healthiness. Conclusion: All the available brands in local market of Libya are having, with in the specified quality range and considerably, can be chosen according to good quality and cost, to improve the therapeutic benefit and patient compliance without interchangeability.
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