Discriminative Disintegration Techniques For Various Brands of NimesulideTablets Available in the Market

RGUHS Journal of Pharmaceutical Sciences

article

Vasanth PM¹  Venkatesh Goli²  Paul Richard³  V Sarath⁴  DS Charan⁵  Deepak K⁶ 

[1]Department of Pharmaceutical Analysis, SVU College of Pharmaceutical Sciences, SV University

[2]Department of Pharmaceutics, SVU College of Pharmaceutical Sciences, SV University

[3]Department of Pharmaceutical Analysis, Aditya Bangalore Institute of Pharmacy Education and Research

[4]SVU College of Pharmaceutical Sciences, SV University

[5]Seven Hills College of Pharmacy

[6]Ranchi College of Pharmacy, Ranchi

关键词: Nimesulide;    Dissolution;    Bioequivalence;    Bioavailability;    Pharmacopoeia;   

DOI  :  10.26463/rjps.13_1_7

学科分类：药学、药理学、毒理学（综合）

来源: Rajiv Gandhi University of Health Sciences

【 摘 要 】

Background: Nimesulide is a non-steroidal anti-inflammatory selective inhibitor of the enzyme cyclooxygenase with analgesic and antipyretic properties. It is approved to treat acute pain, symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years age.Objective: This article describes the recent research on the bioequivalence of six brands of Nimesulide tablets. Due to the large variety of Nimesulide tablet brands accessible in the Indian market, medical practitioners face a tough challenge of selecting the best brand or using alternative treatments. The study presented assessed all six tablet brands in accordance with Indian Pharmacopoeia (IP) guidelines, and the appropriate methods were provided for choosing the best options.Methodology: All six tablet brands were evaluated utilizing in vitro tests using various evaluation techniques. Six different brands of tablets were used in the in vitro dissolving experiment and all of the tablets cleared the standards for general quality evaluation tests such as hardness, friability, disintegration time, and dissolve time. All of the tested brands met the requirements for the disintegration time. With the exception of brand names Nimek and Bigesic, every brand released more than 45% of the Nimesulide after 30 min. Auronim, Novogesic, Zega, and Nise have a very sluggish rate of dissolution, which indicates that their bioavailability is most likely to be low. The variations in the reported dissolving profiles could be due to differences between the manufacturers in terms of formulation ingredients, the physical form of medicine used in the tablet and the manufacturing method.Results: The result emphasizes the importance of continuous monitoring of new Nimesulide brands introduced to the drug market to ensure bioequivalence and compliance with pharmacopoeia standards.Conclusion: 45 percent Nimesulide within 30 minutes and thus satisfied the Indian Pharmacopoeia criterion for uncoated tablet dissolution. Auronim, Zega, Nise and Novogesic are interchangeable and bioequivalent. Background: Nimesulide is a non-steroidal anti-inflammatory selective inhibitor of the enzyme cyclooxygenase with analgesic and antipyretic properties. It is approved to treat acute pain, symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years age.Objective: This article describes the recent research on the bioequivalence of six brands of Nimesulide tablets. Due to the large variety of Nimesulide tablet brands accessible in the Indian market, medical practitioners face a tough challenge of selecting the best brand or using alternative treatments. The study presented assessed all six tablet brands in accordance with Indian Pharmacopoeia (IP) guidelines, and the appropriate methods were provided for choosing the best options.Methodology: All six tablet brands were evaluated utilizing in vitro tests using various evaluation techniques. Six different brands of tablets were used in the in vitro dissolving experiment and all of the tablets cleared the standards for general quality evaluation tests such as hardness, friability, disintegration time, and dissolve time. All of the tested brands met the requirements for the disintegration time. With the exception of brand names Nimek and Bigesic, every brand released more than 45% of the Nimesulide after 30 min. Auronim, Novogesic, Zega, and Nise have a very sluggish rate of dissolution, which indicates that their bioavailability is most likely to be low. The variations in the reported dissolving profiles could be due to differences between the manufacturers in terms of formulation ingredients, the physical form of medicine used in the tablet and the manufacturing method.Results: The result emphasizes the importance of continuous monitoring of new Nimesulide brands introduced to the drug market to ensure bioequivalence and compliance with pharmacopoeia standards.Conclusion: The results conclude that with the exception of Nimek and Biogesic, all of the Nimesulide tablet brands investigated appear to have a high dissolution rate, with extremely good bioavailability releasing >45 percent Nimesulide within 30 minutes and thus satisfied the Indian Pharmacopoeia criterion for uncoated tablet dissolution. Auronim, Zega, Nise and Novogesic are interchangeable and bioequivalent.

【 授权许可】

CC BY