In Vitro Bioequivalence Study of 8 Generic and 3 Brands of Sertraline-HCl Tablets in Iran Market
Amine Sadat Tajani1, Atoosa Haghighizadeh2, Vahid Soheili1, Salim Mirshahi3 and Omid Rajabi1,4

1Department of Drug and Food control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

2Department of Research and Development, Dr Rajabi pharmaceutical Company, Mashhad, Iran.

3School of Mechanical Engineering, Sharif University of Technology, International Campus, Tehran, Iran.

4Department of Medicinal Chemistry, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

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Abstract: The majority of patients and doctors in Iran still prefer to consume the brand-name drugs for treatment of various diseases. Sertraline-HCl is one of the drugs that the generic and brand-name ones distribute widely in the market. In this study, drug product specifications such as content uniformity, uniformity of mass, dissolution test including dissimilarity (F1) and similarity factors (F2) and dissolution efficiency (DE%) values of 8 generic and 3 brands of sertraline-HCl  tablets (100 mg) were compared. Regarding to the results, relative standard deviation (RSD) ranges of weight variation test for generic and brand-name samples were 0.88 to 3.43% and 0.70 to 1.22%, respectively. For the amount of active pharmaceutical ingredient (API) per tablet RSD were 4.27 to 28.08% and 4.10 to 4.72%, respectively. Moreover, F1 and F2 in dissolution test indicated the lack of similarity between generic and brand-name ones. In the case of DE%, there was similarity between brand-name samples while most of the generic drugs showed less DE% (P<0.005). Consequently, it seems that the distribution of API in generic samples was not homogenous. The average amounts of API in most of generic samples were also less than 100 mg. Finally, the amount of API per tablet, DE% and drug release pattern of the generic drugs show lack of consistency for a suitable formulation.

Keywords: Bioequivalence; Dissolution test; API; Sertraline; Drug release pattern

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