R E L E A S E P A T T E R N A N D P O T E N C Y S T A T U S O F S O M E D I C L O F E N A C S O D I U M E N T E R I C C O A T E D T A B L E T S O F T H E P H A R M A -M A R K E T O F B A N G L A D E S H
DOI:
https://doi.org/10.53808/KUS.2002.4.2.0305-LKeywords:
Diclofenac Sodium; enteric-coated tablets; disintegration test; dissolution test; potency estimation.Abstract
Fifteen brands of commercially available Diclofenac Sodium enteric-coated tablets were purchased from different regions of Bangladesh and were studied for their in-vitro release behaviors as well as for their potency status. Of the fifteen samples, three (DS-03, DS-10, DS-15) were found noncompliance in respect of disintegration test requirements of USP (United States Pharmacopoeia). All of the brands complied with the USP dissolution specifications for their drug release in the simulated gastric fluids and intestinal fluids except four brands (DS-03, DS-05, DS-10, DS-15) and were found to be substandard in respect of dissolution test. DS-05 complied with the compendial specification in respect of drug release in gastric fluid but failed to comply in intestinal fluids (76.97%). According to BP (British Pharmacopoeia), two brands (DS-10, DS-15) were found to be substandard in respect of potency.
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References
Augsburger, L. L., Shangraw, R.F and Giannini, R. P. 1983. Dissolution survey of marketed hydrchlorothiazide tablets. J. Pharm. Sci. 72(8): 876-81.
Ayres, J.W. and H. Hsu, 1989. J. Pharm. Sci.78: 844.
British Pharmacopoeia, 2000. London Her Majesty’s Stationery Office (general notices section, CD-ROM ver. Version 4.0. May 2000.): p A141.
Chambliss, W.G., Chambliss, D.A., Cleary, R.W., Jones, A.B., Harland, E.C. and Kibbe, A. H. 1984. Development and evaluation of enteric coated penicillamine tablets. J. Pharm. Sci. 73(9): 1215-1219.
Gouda, M.W., Moustafa, M. A and Molokhia, A.M. 1980. Effect of storage on erythromycin tablets marketed in Saudi Arabia. Int. J. Pharm.5: 345-47.
Hossain, M. G., Rafiquzzaman, M. and Hoque, M. M. 1999. Quality and stability studies of marketed antibiotic dry syrups in Bangladesh- amoxicillin a case study. Indian Drugs, 36(8): 529-530.
Juhl, W.E and Kircchhoefer, R.D. 1980. Aspirin- A national survey IV: In-vitro dissolution of aspirin formulations. J. Pharm. Sci.69(8): 967-70.
Liu, C.H., Kao Y.H., Chen S.C., Sokoloski T.D and Sheu M.T. 1995. In-vitro and in-vivo studies of the Diclofenac Sodium controlled release matrix tablets. J. Pharm. Pharmacol. 47(5): 360-364.
Malik, K.M.A., Alam, A.M.S., Ghosh, S.K., Hossain, M.A. and Siddique, M.A. 1991. Analysis of some antacid preparations for their active ingredients and for possible contamination by trace metals and microorganisms. J. Bangladesh Chem. Soc.4(1): 87-91.
Miyagawa, Y., Okabe, T., Yamaguchi. Y., Miyajima, M„Sato, H., and Sunada, H. 1996. Controlled release of Diclofenac Sodium from wax matrix granule. International Journal of Pharmaceutics, 138: 215-224.
Nargis, M. 1993. Effect of antacid tablet on the in-vitro dissolution of Diclofenac Sodium from its enteric release dosage form. M. Pharm. Thesis, Jahnangimagar University, Savar, Dhaka, pp 41-65.
Nargis, M„ Haider, S. S., Saha, P., Rahman, H., and Shahriar, S.M. 1997. Quality of marketed metoclopramide hydrochloride tablets in terms of drug content, disintegration time and dissolution profile. J. Bangladesh Academy Sci.21 (2): 179-188.
National Formulary 18, 1995, United States Pharmacopeial Convention, Rockville. MD 20852: 1791-1796.
Pijus Saha and Mukarram Hossain, 2002. Status of various paracetamol liquid dosage forms marketed in Bangladesh. Bangladesh Pharmaceutical Journal, 12(2): 42-44.
Ridwan Ullah Shahidi, 2001. Quick Index of Medical Products and Problems. 1 llh edition, Dhaka, 391p.
Romero, A.J., Grady L.T.& Rhodes, C.T. 1988. Dissolution Testing of Ibuprofen Tablets. Drug Dev. Ind. Pharm. 14(11): 1549-86.
Roy, J. 1994. The menace of substandard drugs. World Health Forum, 15: 406.
Safiullah, S. and Roy, J. 1986. Quality of drugs in Bangladesh, The Weekly Bichitra, (Bengali), October 24: 26 p.
Safiullah, S. and Roy, J. 1987. Quality of drugs in Bangladesh, The Weekly Bichitra, (Bengali), March 06: 34 p.
The Daily Ittefaq (Bengali) 1999. February 24: 1 p.
The daily Sangbad (Bengali) 1993. June: 5 p.
United States Pharmacopoeia 23, 1995. United States Pharmacopeial Convention, Rockville, MD 20852:1791-1796.
Wood, R.W., Martis, L., Gillum, A. W„Roseman, T. J., Lin, L and Bernardo, P. 1990. In-vitro dissolution and in-Vivo bioavailability of commercial levothyroxine sodium tablets in the Hypothyroid Dog Model. J. Pharm. Sci.79(2): 124-7.
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