COMPARATIVE ASSESSMENT OF THE QUALITY CONTROL MEASUREMENTS OF MULTISOURCE AMLODIPINE TABLETS MARKETED IN NIGERIA

Awofisayo Sunday Olajide,Umoh Ekaete Dennis,Olikaeze C Chidinnma

doi:10.7439/ijbar.v1i4.10

Awofisayo Sunday Olajide, Umoh Ekaete Dennis + Show 1 more

Open Access

https://doi.org/10.7439/ijbar.v1i4.10

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Abstract

The aim of this study was to evaluate some quality control parameters to assess the quality, safety and efficacy of six brands of amlodipine tablets marketed in Nigeria. The physiochemical parameters and assay of the six brands of amlodipine were assessed through the evaluation of uniformity of tablet weight, friability, hardness, disintegration, and assay of active ingredients according to established methods. The dissolution rate and disintegration time were determined in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) without enzymes. The dissolution efficiency (DE) and predicted availability equivalence (PAE) of the various brands were used to estimate their likely in-vivo bioavailability. The dissolution profile showed that none of the samples attained 70% dissolution in 45 minute in SGF and SIF while only samples A and E in 1 hour in SGF There was no significant difference in the mean values of the DE for the products in SGF and SIF in the range 0.33-0.41 and 0.32-0.43 respectively (p=0.2). Significant difference exists between the values of T70 of the products in both SGF and SIF (p 0.5). Products E and A (innovator) are equivalent and demonstrate comparable quality standards. The method is simple and rugged for evaluation of quality control parameters of amlodipine for consistent batch to batch production of generic product.

Highlights

The introduction of generic products from multiple sources into the health care delivery system of many countries was aimed at improving the system
The dissolution profile for amlodipine tablet for the different generic products in simulated intestinal fluid (SIF) and simulated gastric fluid (SGF) are shown in Fig. 1and 2 respectively
The disintegration time was lower in SGF than SIF; both values complying with the official requirement for uncoated tablets.[12]

Summary

Introduction

The introduction of generic products from multiple sources into the health care delivery system of many countries was aimed at improving the system. This has, been accompanied with a variety of problems which include the critical spread of fake and substandard drug product .1. Quality control procedures are necessary to compare the various generic products and examine batchto-batch consistency of an individual generic product.[2]. The prediction of the in vivo bioavailability of most oral drug products depends on the in vitro dissolution studies.[3] Dissolution testing of drug products is an essential quality control test for monitoring batch-to-batch consistency of drug release from a dosage form and as a surrogate for in-vivo performance.

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