Pharmaceutical Quality Evaluation of Commercial Baclofen Tablets in the Yemeni Market: An In Vitro Study
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Abstract
Background: For good health and improved trust in the pharmaceutical products, quality control tests must be conducted continuously for both local and imported products to ensure safety and effectiveness.
Objective: To evaluate the in vitro characterization of different imported and local pharmaceutical products of the muscle relaxant (baclofen 10 mg) available in Taiz City.
Methods: According to the USP standards, different quality control tests were conducted to physicochemically characterize various baclofen 10 mg tablets (one local and two imported brands) available in the Yemeni market.
Results: The results of the three brands of baclofen 10 mg tablets showed that product (C) disintegrated more slowly (6.39 minutes) than products (B) and (A) (0.35 and 3.00 minutes, respectively). Every brand has a satisfactory level of friability below 1% loss. The maximum assay content (98.39%) and drug release (105%) were displayed by local product (A). Although product (B) test content was lower (88.98%), its drug release was still satisfactory (96%). By contrast with product (B) (5.35 kg) and product (A) (5.38 kg), C product's hardness (2.26 kg) was below USP standards (4-6 kg), and its drug release was 85%; however, the assay content was significantly satisfactory (96.98%).
Conclusion: The outcomes of this study show a high dissolution rate and quick disintegration time, with assay content falling inside the acceptable range. While the imported products decomposed slowly, within the drug content limit, and had a lower hardness value than USP criteria, the local product had the best results in different characterizations. All results confirm the necessity of continuous monitoring for pharmaceutical products.
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Baclofen, Quality Control, Pharmacopeial Standards, Yemen, Generic Drugs
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