Drug Designing: Open Access
Open Access

Interchangeability of medicines using Metformin as a surrogate product (II)

9^th Annual Congress on Drug Design & Drug Formulation

October 19-20, 2017 Seoul, South Korea

Jacob Adegboyega Kolawole, Atibli Godwin and Keturah Smith

University of Jos, Nigeria

Scientific Tracks Abstracts: Drug Des

Abstract :

Interchangeability of medicines, either over-the-counter or prescription drugs is a general and wide spread practice in health institutions. In our recent publication on interchangeability, it was discovered that cost, physical quality and full consent of the patient were employed in the substitution process. The current study was aimed at undertaking a bioequivalence Metformin hydrochloride tablets as a surrogate medicine for general interchangeability. USP methods were used for the quality assurance on the following parameters-uniformity of weight, hardness testing and identification, friability, disintegration and dissolution tests. The physicochemical evaluation of the samples showed compliance with USP specifications. All the formulations disintegrate within 15-30 minutes. Thirteen (13) brands complied with the monograph specifications (95-105%) for percent drug content, while four brands did not comply. Similarity factor (f2) value calculated for the brands were >50 indicating similarity with the innovator product hence can be interchanged except for the six brands (F, L, M, N, P and Q). Fifteen (15) of the seventeen (17) brands including the innovator brand passed the USP 32 general specifications standard for dissolution rate test for conventional release tablets. This study concludes that good pharmaceutical practice is required, so that a brand should pass percent drug content and dissolution tests and that those with f2 values >50 can safely be interchanged with the innovator product. Though cost and consent of the patient should be added advantage after selection based on bioequivalence studies.

Biography :

Jacob Adegboyega Kolawole has completed his PhD from the Ahmadu Bello University, Zaria and The Robert Gordon, University, Aberdeen, United Kingdom . Presently, he is the Dean, Faculty of Pharmaceutical Sciences, University of Jos and Consultant to West African Health Organization, on development of guidelines and training manuals for pharmaceutical finished products, pharmaceutical raw materials, standard operating procedures for laboratories and bioavailability/ bioequivalent. He has more than 40 publications in international journals.