NIMESULIDE: DISSOLUTION PROFILE, VALIDATION OF ANALYTICAL METHODS FOR CAPSULES, AND ASSESSMENT OF PRODUCT QUALITY

Abstract

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. 

Authors and Affiliations

Beatriz Werneck Lopes Santos, Eloisa Dutra Caldas, MÔnica Valero Da Silva

Keywords

Related Articles

INVESTIGATION OF THE CLINICAL SIGNIFICANCE OF ESCITALOPRAM-INDUCED ELECTROCARDIOGRAPHIC CHANGES IN MEN: A PILOT OBSERVATIONAL STUDY

Objective: We sought to investigate the clinical significance of secondary electrocardiographic (ECG) changes in men after using escitalopram. Methods: This pilot observational cohort study recruited male patients takin...

SYNTHESIS, CHARACTERIZATION AND ANTI INFLAMMATORY ACTIVITY OF NOVEL QUINOXALINE DERIVED CHALCONES

Objective: Quinoxaline derivatives were reported with wide range of biological activities. Hence it was planned to synthesize and screen for their anti inflammatory (in vivo) activity.Methods: Orthophenylene diamine was...

ANTIHEPATOTOXIC POTENTIALITY OF 2-3-6 TRIMETHYLOCT-6-ENAL AGAINST PARACETAMOL INDUCED LIVER DYSFUNCTION

Objective: We investigated the liver protective activity of 2-3-6 trimethyloct-6-enal from the methanol extract of Pajanelia longifolia (Willd.) K. Schuman. The liver protective activity of 2,3,6 trimethyloct-6-enal was...

CYTOTOXIC ACTIVITY OF ACIDIC RIBOSOME INACTIVATING PROTEINS MIRABILIS JALAPA L. (RIP MJ-C) NANOPARTICLE FORMULATED WITH LOW-CHAIN CHITOSAN AND LOW-METHYLATED PECTIN

Objective: This study aimed to formulate acidic ribosome inactivating protein isolated from Mirabilis jalapa L. (RIP MJ-C) nanoparticle, using low chains chitosan and low methylated pectin, and to evaluate its cytotoxic...

AN UPDATE ON NEUROPATHIC PAIN MODELS

An rodent animal model of pain offers a powerful tool in order to understand the mechanism involved in peripheral nerve injury for preclinical study of pain. A battery of neuropathic pain models has been developed to sim...

Download PDF file
  • EP ID EP577911
  • DOI -
  • Views 157
  • Downloads 0

How To Cite

Beatriz Werneck Lopes Santos, Eloisa Dutra Caldas, MÔnica Valero Da Silva (2016). NIMESULIDE: DISSOLUTION PROFILE, VALIDATION OF ANALYTICAL METHODS FOR CAPSULES, AND ASSESSMENT OF PRODUCT QUALITY. International Journal of Pharmacy and Pharmaceutical Sciences, 8(1), 27-32. https://europub.co.uk/articles/-A-577911