NIMESULIDE: DISSOLUTION PROFILE, VALIDATION OF ANALYTICAL METHODS FOR CAPSULES, AND ASSESSMENT OF PRODUCT QUALITY
Objective: The main objective of this paper was to evaluate the quality of similar (S, n=3) and generic (G, n=3) tablets and compounding capsules (C, n=6) containing nimesulide (100 mg).
Methods: The parameters investigated (weight, nimesulide content, uniformity of dosage units, disintegration, friability and hardness (tablets) and dissolution profile) were evaluated against the Brazilian Pharmacopeia and a reference compound (for tablets). Nimesulide content, determined by a UV/visible spectrophotometric method, and dissolution test were validated for compounding capsules.
Results: All formulations had a mean weight coefficient of variation lower than 5%. Three compounding formulations contained less than 95 mg nimesulide, with C1 (88.5 mg) also showing a lack of dosage unit uniformity. Disintegration times were lower than 5 min for all samples and friability less than 0.5% for all tablet formulations. The hardness of the reference product (25.5N) was lower compared to the other tablet samples (30-80.3N). All tablet formulations reached 75% release after 5 min of the dissolution test, but none of the compounding formulations reached the minimum 75% release after 45 min, probably due to inadequate excipient composition and amount. On average, excipient accounted for 46.3% of the capsule weight (against 74% in tablets), and some of the products did not contain water-soluble substances to promote dissolution.
Conclusion: The results of this study indicate a lack of quality in compounding nimesulide products, which could jeopardize patients' health and treatment.
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