QUALITY CONTROL EVALUATION OF BRANDS OF MEBENDAZOLE 100 mg TABLETS ON THE ILLEGITIMATE PHARMACY OUTLETS
Keywords:
Mebendazole, Illegitimate pharmacy outlet, Quality control, Chewable tabletAbstract
Objective: The objective of the present study is to assess physical properties and the quality control parameters of the marketed brands of Mebendazole 100 mg found in illegitimate pharmacy outlets
Methods: Five brands of mebendazole 100 mg were identified and purchased in February 2014. The tablets were evaluated for uniformity of weight, friability, hardness, disintegration and assay of active pharmaceutical ingredient according to established methods.
Results: Results obtained indicated that all brands comply with official requirements for uniformity of weight and hardness. One brand failed the friability test with more than 1% of weight loss. The disintegration test revealed that two brands disintegrate in less than 2 min while other brands in more than 1 hour. Titrimetric assay of mebendazole content showed only two brands containing not less than 90% (w/w) of labeled chemical content.
Conclusion: Brand MBZ3 showed better characteristics of chewable tablet. Consumers need to pay attention to the manufacturer information and chewable tablets have to be treated as such.
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References
Hotez PJ, Molyneux DH, Fenwick A, Kumaresan, Sachs SE, Sachs JD et al. Control of neglected tropical diseases. N Engl J Med 2007;357:1018-27.
De Silva NR, Brooker S, Hotez PJ, Montresor A, Engels D, Savioli L. Soil-transmitted helminth infections:updating the global picture. J Trends Parasitol 2003;19:547–51.
World Health Organization. Eliminating soil-transmitted helminthiasis as a public health problem in children: Progress report 2001–2010 and strategic plan 2011–2020. Geneva:WHO Library;2012.p. 90.
World Health Organization. Soil-transmitted helminthiasis: estimates of the number of children needing preventive chemotherapy and number treated, 2009. J Wkly Epidemiol Rec 2011;86(25):257-66.
World Health Organization. Research priorities for helminth infections:Technical report of the TDR disease reference group on helminth infections. WHO Technical Report Series;2012. Report No. 972.
Lacey E. Mode of action of benzimidazoles. Parasitol Today. 1990;6:112–5.
Horton J. Albendazole for the treatment of echinococcosis. Fundam Clin Pharmacol. 2003;17:205-12.
Shrivastava A, Nagori BP, Saini P, Issarani R, Gaur SS. New Simple and Economical Spectrophotometric Method for Estimation of Artemether in Pharmaceutical Dosage Forms. Asian J. Research Chem 2008;1:19-21.
Wertheimer AI, Chaney NM, Santella T. Counterfeit pharmaceuticals:current status and future projections. J Am Pharm Assoc. 2003;43:710-7.
Sow PS, Gueye TSN, Sy E, Toure L, Ba C, Badiane M. Drugs in the parallel market for the treatment of urethral discharge in Dakar:epidemiologic investigation and physicochemical tests. Int J Infect Dis. 2002;6:108-12.
Wogaing J. [Quest consumption of the drug in Cameroon]. RIM 2010;3:1-51. French
World Health Organization. Counterfeit medicines:guidelines for the development of measures to combat counterfeit medicines. Geneva:WHO Library;1999. 62 p.
World Health Organization. The safety of medicines in public health programmes:pharmacovigilance an essential tool. Geneva:WHO Library;2006. 61 p.
Chapman DG, Crisafio R, Campbell JA. The relation between in vitro disintegration time of sugar-coated tablets and physiological availability of sodium p-aminosalicylate. J Am Pharm Assoc. 1956;45:374–8.
United States pharmacopoeia (USP 29-NF 24) [internet]. The Official Compendia of Standards TwinBrook Parkway, Rockville. [cited 2014 May 3] Available from: http:// www.pharmacopeia.cn/v29240/usp29nf24s0_c701.html
The International Pharmacopoeia. Tests and general requirements for dosage form; Quality specifications for pharmaceutical substances and tablet. 3rd edition. Geneva: World Health Organization;2003.