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American Journal of Pharmacy and Pharmacology

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Pharmaceutical Evaluation of an Augmentin Brand Manufactured in Different Countries

American Journal of Pharmacy and Pharmacology
Vol.2 , No. 4, Publication Date: Sep. 22, 2015, Page: 35-44

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Authors

[1]	Mohamed N. El Attug, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya.
[2]	Amal Ammar, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya.
[3]	Serag Tunsi, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya.
[4]	Sohail Elmjrab, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya.
[5]	Shukri Al-Sharif, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya.
[6]	Abdulmonem Gobassa, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya.
[7]	Emhemmed Elgallal, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya.

Abstract

Physicians often continue to prescribe brand-name drugs from the country of origin of the inventor to their patients even when less expensive of same brand drugs that are manufactured in different countries are available, despite it has been made by the same company. Some national authorities attract the inventors to establish their business and manufacture these brands to offer a cheaper brand drug than which made in country of origin to their citizens. Unfortunately Physicians in general and in Libya in particular tend to prescribe brand-name drugs which made in country of origin of the inventor, even without evidence of their therapeutic superiority. The objective of this project was to evaluate and compare the physicochemical equivalence and efficacy of different tablets of Augmentin^® brand, that are available in Libyan local market, this brand is manufactured by GSK company in five different countries as; United Kingdom, Turkey, Greek, Ireland and Malta, the patients conscious about the selection of safest, effective as well as economical medicine. The proposed study has been performed to provide the evidence to the physicians and pharmacists that there is no superiority between among these products despite are manufactured in different countries, when they select the drugs for their patients. The physical parameters i.e. weight variation, thickness, hardness, disintegration, dissolution, potency (Antimicrobial susceptibility), as well as chemical assay were considered during the present study. All of these products had contents compatible with that required by Pharmacopeias and the dissolution profiles for all the drugs showed more than 92% of the active ingredient dissolved within 30 minutes. All drugs were approved with regard to tablets weight uniformity, thickness and hardness where the RSD % are between 0.74 % - 1.69 %, 0.35 % - 0.51 %, and 7.0 % - 8.9 %, respectively. The disintegration time of all samples also proved satisfactory, had completely disintegrated in less than 14 seconds.

Keywords

Pharmaceutical Evaluation, Quality Control, Augmentin, Brand Medicines

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