SAFETY, TOLERABILITY AND BIOEQUIVALENCE ASSESSMENT OF A DISPERSIBLE TABLET FORMULATION OF PYRAZINAMIDE
Abstract
Pyrazinamide is a widely used drug for the treatment of tuberculosis. A 150 mg Dispersible Tablet (DT) formulation of the drug was prepared by Micro Labs, a generic drug company. The formulation was developed for easy administration into paediatric patients. It was tested for bioequivalence in healthy adult human volunteers in fasting condition. A total of 36 subjects were enrolled in the study and all the 36 subjects completed both the two periods of the study without showing major adverse events. The pharmacokinetic parameters determined for bioequivalence were Cmax and AUC0-t. The two parameters were within the limit of bioequivalence criteria. The 150 mg DT formulation developed by Micro Labs was found to be bioequivalent to 500 mg immediate release tablet formulation of Riemser Pharma. Both the formulations were safe and well tolerated among the tested human subjects. No major adverse events were observed.
Keywords:
Pyrazinamide, dispersible, bioequivalence, safe.DOI
https://doi.org/10.25004/IJPSDR.2017.090503References
Whitfield MG, Soeters HM, Warren RM, York T, Sampson SL, Streicher EM, Van Helden PD, Van Rie A. A global perspective on pyrazinamide resistance: systematic review and meta-analysis. PloS one. 2015 Jul 28;10(7):e0133869.
Pouplin T, Phuong PN, Van Toi P, Pouplin JN, Farrar J. Isoniazid, pyrazinamide and rifampicin content variation in split fixed-dose combination tablets. PLoS One. 2014 Jul 8;9(7):e102047.
Deepu S, Mathew M, Shamna MS. Controlled Drug Delivery System. International Journal of Pharmaceutical and Chemical Sciences. 2014; 3(3):636-641.
Rewar S, Singh CJ, Bansal BK, Pareek R, Sharma AK. Oral Dispersible Tablets: An Overview; Development, Technologies and Evaluation. International Journal of Research and Development in Pharmacy and Life Sciences. 2014;3(6):1223-35.
Venkateswarlu K, Thirumaran J. Review on Bioavailability and Bioequivalence Studies. Int. J. Pharm. Sci. Rev. Res. 2013; 18(1): 56-64.
Steele MA, Des Prez RM. The role of pyrazinamide in tuberculosis chemotherapy. Chest. 1988 Oct 31;94(4):845-50.
Vetchý D, Frýbortová K, Rabisková M, Danecková H. Bioequivalence studies of pharmaceutical preparations. Casopis lekaru ceskych. 2007;146(5):431-3.
Kumar SA, Sanjita D. A Review Article on Bioavailability and Bioequivalence Studies. International Journal of Pharm Tech Research; 5 (4). 2013:1711-21.
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