World Journal of
Pharmaceutical and Life Sciences

INTERCHANGEABILITY OF MEDICINES USING METFORMIN AS A SURROGATE PRODUCT (II)

Atibli Godwin, Kolawole Jacob* and Kolawole Olanike

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 major considerations while making substitution. The current investigation was aimed at undertaking a bioequivalence study of Metformin hydrochloride tablets as a surrogate medicine for general interchangeability. USP methods were used for the quality assurance assessment of the following parameters; uniformity of weight, hardness testing, identification, friability, disintegration and dissolution tests. The physicochemical evaluation of the samples showed compliance with USP specifications. All the formulations disintegrated within 15-30 minutes. Thirteen brands complied with percentage drug content specifications (95-105%), while four brands did not. 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 of the seventeen brands including the innovator brand passed the USP 32 general specifications standard for dissolution test for immediate release tablets. Interchangeability of different brands must be based on satisfactory similarity factor (pharmaceutical equivalence), percentage drug content and dissolution rate test while cost and consent of the patient should be added advantage.

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