Abstract

Objective: The present study was performed to compare the quality of conventional tablets loaded with candesartan cilexetil. The selected candesartan cilexetil tablets were commercialized in the Iraq market and produced by different companies. 
 Methods: Different batches of candesartan cilexetil oral tablets (the concentration of candesartan was 8 mg) were subjected to quality control tests. Tests included weight variation, friability, hardness, drug content, disintegration time and in vitro release study. The protocols of these tests were performed according to USP pharmacopeia.
 Results: The results, in this study, revealed that all the used batches of candesartan cilexetil oral tablets complied with the specification of USP pharmacopeia for weight uniformity, friability value (% loss) was<1. Hardness results of the tablets were 4.9-6.6 Kg/cm2, which was within the required limits (i.e. 4-8 Kg/cm2). Disintegration time was<15 min in both Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). The percentage of drug content in all marketed tablets was found between 96.2 % and 99.8 %, reflecting compliance with the pharmacopeia limits (i.e. 85-115 %). An in vitro release study indicated that the release of all marketed tablets exceeds 80 % within 15 min.
 Conclusion: All the studied tablets, loaded with candesartan cilexetil, were produced within the standard criteria of tablet production. The quality control analysis of the selected tablets, in this study, revealed satisfactory pharmaceutical properties (including safety and effectiveness) that comply within the limits of USP pharmacopeia.

Highlights

  • Quality control of drug products is an important process of the pharmaceutical industry, which is referred to as all processes that must be undertaken to ensure the purity and uniformity of marketed pharmaceuticals

  • Quality control study of multisource conventional pharmaceutical drug products was performed to assess the level of quality of drug products that present in the market and this assessment reflected on the patient's safety and acceptability, efficacy, potency, stability, and elegance of medications, providing assurance to consumer that a given drug product carries out uniformly and in a satisfactory manner for the objective to which it recommended [1]

  • Dosage forms for oral administration such as tablets and capsules have a high level of importance in the pharmaceutical markets, so quality control administrative estimates quality tests of these dosage forms for passing drug products into markets

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Summary

Introduction

Quality control of drug products is an important process of the pharmaceutical industry, which is referred to as all processes that must be undertaken to ensure the purity and uniformity of marketed pharmaceuticals. Quality control of active ingredients, excipients, and final drug products, standards, specifications and test methods that are used in the pharmaceutical industry to ensure the quality of pharmaceuticals were regulated and provided by pharmacopeias. Dosage forms for oral administration such as tablets and capsules have a high level of importance in the pharmaceutical markets, so quality control administrative estimates quality tests of these dosage forms for passing drug products into markets. These are orderly checked by FDA bodies [3]. The aim of this study was to compare the quality and assure safety and optimal therapeutic activity of candesartan cilexetil oral conventional tablets that were manufactured by different companies and existed in the Iraq pharmaceutical market

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Results
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