COMPARATIVE IN-VITRO BIOEQUIVALENCE STUDY OF BRANDED AND GENERIC AMOXICILLIN CAPSULE IN FOUR

Abstract

Comparative in-vitro bioequivalence study using dissolution profile data of immediate release oral solid
dosage form of Biopharmaceutics class 1 and 3 has been advocated by World Health Organization
(WHO), Food drugs Administration (FDA) and other international regulatory agencies. In-vitro
dissolution offered many benefits compared to conventional in-vivo bioequivalence studies because, it
reduces the cost and time of product release as well as avoiding unnecessary use of human volunteers
thereby improving access to drugs from multisource for all persons as encouraged by WHO, to guarantee
right to health for all.To evaluate and compare the in-vitro dissolution profiles of branded and generic
brand of amoxicillin capsules available in Dutse, Jigawa, Nigeria.Dissolution profiles of branded and
generic amoxicillin capsules containing amoxicillin 500 mg which are available in Dutse market were
determined using the developed UV spectrophotometric method. The obtained dissolution profile data
were assessed and comparedusing two different statistical methods: the fit factors (F1&F2) and the
dissolution efficiency (D.E.) model. The tested generic brand of amoxicillin capsule can be
interchangeable with the innovator brand. The computed F1 factor for the Generic brand are3.35, 6.12,
8.83 and 7.94 for simulated physiological pH (1.2, 4.5, 6.8 and 7.4) respectively which are within the
acceptable limit of (0-15). While the F2 factor values are 69.00,57.15, 42.67and 46.76 for simulated
physiological pH (1.2, 4.5, 6.8 and 7.4) where at SGF (pH 1.2) and Buffer (pH 4.5) were within the
recommended range of ≥50 while values at SIF and Blood (pH 6.8 and 7.4) falls short of the accepted
limit of ≥50. Similarly, the mean dissolution efficiencies (D.E.) were 4.00, 6.885.19 and 2.05 which are
within the acceptable limit of ±10 for pH (1.2, 4.5, 5.19 and 7.4 respectively).Therefore, tested generic
brand of amoxicillin capsule was found to be similar with the innovator brand, thus can be
interchangeable with each other in clinical use.