Abstract
Background: Metoclopramide hydrochloride (MCP), a derivative of para-aminobenzoic acid, which is a freely soluble drug, gets rapidly absorbed from the gastrointestinal tract and is used in the management of gastrointestinal disorders such as gastric stasis, gastroesophageal reflux and for the prevention of cancer chemotherapy induced emesis. Several brands of MCP are available in Saudi Arabia.
Objective: The objective of the present study was to evaluate the quality of different marketed products of MCP tablets 10mg, which were purchased from the retail pharmacy outlets in Abha, Riyadh and Jeddah, Saudi Arabia with a view to determine their interchangeability in clinical practice.
Methods: The study was carried out on branded tablets by quality control tests such as weight variation, hardness, friability, disintegration and dissolution. The results of all marketed products complied with the official specifications.
Results: The results showed that all the parameters for MCP tablets were in accordance with the USP limits. All the tested four brands were bioequivalent and complying with the official tests for weight variation, friability, disintegration and dissolution tests. The percent friability was also within the specified limit. Moreover, all formulations disintegrated within 2-6 min. The percentage content of the active ingredient of four brands of MCP tablets showed values within the monograph specifications (95-105%).
Conclusion: All the four brands evaluated in the present work could be considered bio pharmaceutically equivalent and therefore, patients can safely switch from one brand to another when there is the unavailability of a particular brand.
Keywords: Tablets, metoclopramide, gastrointestinal reflux disease, quality control, bioequivalence, chemotherapy.
Graphical Abstract
[PMID: 23310934]
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