Appraisement of Ranitidine Hydrochloride Tablet (USP150mg) Preparations from Few Selected Companies in Bangladesh
DOI:
https://doi.org/10.3923/pjn.2013.966.972Keywords:
Bangladeshi generic drug, dissolution test, quality control, ranitidine HClAbstract
The study was aimed to evaluate the pharmaceutical properties of few selected generic products of ranitidine hydrochloride tablets available in retail pharmacies of Bangladesh. We collected 10 nationally manufactured generic ranitidine HCl tablets from local Market who followed USP specifications and examined their physical parameters and potency to check their compliance with the USP. The intention was to evaluate the quality of this pharmaceuticals after 20 years of implementing the National Drug Policy in 1982. All tested ranitidine tablet samples (Rt1-Rt10) were selectively collected from local retail pharmacies in Savar, Dhaka-1344, Bangladesh. Before purchasing the samples, their physical appearance, name of manufacturer, batch number, date of manufacturing, expiry date, manufacturing license number and Maximum Retail Price (MRP) were properly checked. The various parameters of the selected samples such as diameter, shape, size, weight variation, thickness, hardness, disintegration, dissolution and potency have been determined according to the American Pharmacopoeia USP 27 requirements. It was found that all ten selected products met the USP 27 specifications. The differences in hardness among the tablets were significant. Interestingly, dissolution profiles of some tablet products were not weighty different from one another, whereas those of tablets were significantly different. However, all brands complied with USP 27. It could be concluded that the selected ranitidine HCl tablets met the required USP specifications and are considered quality products in terms of the mentioned parameters.
References
Abad-Santos, F., A.J. Carcas, P. Guerra, C. Govantes, C. Montuenga, E. Gomez and J. Frias, 1996. Evaluation of sex differences in the pharmacokinetics of ranitidine in humans. J. Clin. Pharmacol., 36: 748-751.
Ahmed, F., A.K. Das, U.K. Karmakar, T. Khaleque and M.C. Shill, 2003. Quality of marketed metronidazole preparations in Bangladesh-an analytical overview. J. Biological Sci., 3: 940-950.
Alagusundaram, M., B. Chengaiah, S. Ramkanth, S.A. Parameswari, C. Madhu, S. Chetty and D. Dhachinamoorthi, 2009. Formulation and evaluation of mucoadhesive buccal films of ranitidine. Int. J. PharmTech. Res., 1: 557-563.
Anand, O.M., X.Y. Lawrence, D.P. Conner and B.M. Davit, 2011. Dissolution testing for generic drugs: An fda perspective. AAPS J., 13: 328-335.
Ashok, K.G., 1986. Introduction to Pharmaceutics-I. 4th Edn., CBS Publishers and Distributors, New Delhi (India), pp: 266-274.
Banker, G.S. and N.R. Anderson, 2009. The Theory and Practice of Industrial Pharmacy. Lea and Febiger, Philadelphia, pp: 293-300.
Borst, I., S. Ugwu and A.H. Beckett, 1997. New and extended application for USP drug release apparatus 3. Disso/lItionTech11ologiesI February 1997, pp: 1-6.
Bushra, R., M.H. Shoaib, N. Aslam, D. Hashmat and M. Rehman, 2008. Formulation development and optimization of ibuprofen tablets by direct compression method. Pak. J. Pharm. Sci., 21: 113-120.
Cameron, A., M. Ewen, D. Ross-Degnan, D. Ball and R. Laing, 2009. Medicine prices, availability and affordability in 36 developing and middle-income countries: A secondary analysis. Lancet, 373: 240-249.
Cappola, M.L., 2001. A better dissolution method for ranitidine tablets USP. Pharm. Dev. Technol., 6: 11-17.
Chowdhury, F.R., H.A. Ahasan and M.M. Rahman, 2006. National drug policy of Bangladesh: Some pitfalls in implementation. J. College Phys. Surg. Pak., 16: 368-368.
Dave, B.S., A.F. Amin and M.M. Patel, 2004. Gastroretentive drug delivery system of ranitidine hydrochloride: Formulation and In vitro evaluation. AAPS PharmSciTech., 5: 77-82.
Islam, N., 1984. On a National drug policy for Bangladesh. Trop. Doctor, 14: 3-7.
Lachman, L., H.A. Lieberman and J.L. Kanig, 1991. The Theory and Practice of Industrial Pharmacy. 3rd Edn., Vargheese Publishing House, Mumbai, India, pp: 296-302.
Makooi-Morehead, W.T., J.D. Buehler and B.R. Landmann, 2003. U.S. Patent No. 6, 555, 133. Washington, DC: U.S. Patent and Trademark Office. http://www.google.com/patents/US6555133
Mullaicharam, A.R., J.A. Jehangir Ahmed and N. Halligudi, 2012. Evaluation of pharmaceutical equivalents of different brands of ranitidine tablets from multinational brands in oman. Int. J. Nutr. Pharmacol. Neurol. Dis., 2: 40-44.
Mycek, M.J., R.A. Harvey and R.C. Champe, 1997. Lippincott's Illustrated Reviews Pharmacology. 2nd Edn., Lippincott-Raven, Philadelphia.
United States Pharmacopeia, 2000. United States Pharmacopeia (USP No. 24-NF 19). The United States Pharmacopeial Convention Inc., Rockville, MD., USA., ISBN-13: 978-1889788036, pp: 856-857.
Yasmeen, R., M.H. Shoaib and H. Khalid, 2005. Comparative study of different formulations of atenolol. Pak. J. Pharm. Sci., 18: 47-51.
Robinson, M. and X. Zhang, 2011. The World Medicines Situation 2011 -Traditional Medicines: Global Situation, Issues and Challenges. 3rd Edn., WHO Press, Geneva, Switzerland.
Yu, L.X., J.T. Wang and A.S. Hussain, 2002. Evaluation of USP apparatus 3 for dissolution testing of immediate-release products. AAPS J., 4: 1-5.
Downloads
Published
Issue
Section
License
Copyright (c) 2013 Asian Network for Scientific Information

This work is licensed under a Creative Commons Attribution 4.0 International License.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.