Abstract
Objective: The purpose of this study is to evaluate the quality control of marketed tablets containing propranolol hydrochloride available on the Iraqi market and manufactured by different companies. Methods: Different batches of propranolol hydrochloride 40 mg tablets were assessed using quality control tests. Weight variation, diameter, thickness, friability, disintegration time and dissolution study were carried out in this study. Results: Based on the data obtained in this study, all brands of PPL available on the Iraqi market showed weight variation within the acceptable limit of USP. Marketed products of Becardin and Propranolol lie within the acceptable limit of hardness and Inderal was observed to be slightly higher than the normal upper range of USP. Diameter and thickness for all brands were almost the same, except the diameter of Becardin was slightly higher and friability was zero for all brands. All brands demonstrated a time of disintegration of fewer than 30 min. The tested marketed propranolol products; Inderal, Procard, Becardin and Propranolol showed cumulative drug release of 90.08%, 94.46%, 92.4% and 79.51%, respectively at the end of the first 20 min. This variation in the release profile of marketed tablets of Propranolol HCl might be attributed to the excipients present in the marketed tablets where some of these excipients may behave as a disintegrant and enhance dissolution rate while others may act as dissolution retardants. Conclusion: All marketed tablets of Propranolol HCl employed in this study were produced within the standard criteria of tablet manufacturing. Evaluation of quality control of these selected tablets showed acceptable pharmaceutical properties that lie within the limits of USP.
Highlights
Quality plays an essential role in the development of pharmaceutical products
The results obtained from the assessment of weight variation demonstrated that all brands of PPL available on the Iraqi market showed weight variation within the acceptable limit of USP
The results of hardness evaluation showed that marketed products represented by Becardin and Propranolol lie within the acceptable limit of hardness and Inderal was found to be slightly higher than the upper normal range
Summary
Quality plays an essential role in the development of pharmaceutical products. Concerning pharmaceutical products, quality may be defined as a product that is free from contaminants and reproducibly gives the pharmacological effect as mentioned in the label [1]. The purpose of pharmaceutical development of a product is to design and establish formulation components and an efficient fabrication process that reliably meets the requirements of quality criteria needed to perform its therapeutic goal. Pharmaceutical products are available on the market when the final products are successfully tested. The evaluation of the final product should be achieved in terms of quality criteria. Quality by design (QbD) has been established to provide a product with consistent quality and minimum or no rejected bathes [2]
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