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Comparative In Vitro Study of Six Carbamazepine Products

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Abstract

The purpose of present study was to evaluate commercial preparations of carbamazepine tablets with respect to drug release through a defined sequence of experiments using Minitab software. The compliance of products with respect to United States Pharmacopeia (USP) dissolution test and comparison of the products with respect to drug release in different dissolution conditions is reported in the present paper. The different dissolution conditions studied include dissolution medium (1% SLS in purified water, 0.1 N HCl), volume (900 and 1,000 ml), rpm (50 rpm, 75 rpm). Studies indicated that all six products complied with USP dissolution criteria. However, the extent of influence of dissolution conditions on drug release was varied among the products. Distinct dissolution profiles were observed and there was no correlation with disintegration time in certain products. The in vitro dissolution experimentation helped in identifying the discriminatory dissolution conditions and also the formulations that were unaffected with change of dissolution variables. In summary, commercial preparations of carbamazepine vary widely in their dissolution behavior in multi dissolution run experimentation. Identifying this behavior of the products was essential as an in vitro tool for screening a good and a bad formulation.

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Acknowledgments

The authors would like to thank Mr. B.C. Rajesha, Apotex India Ltd, Bangalore for his support in experimental design and Council of Scientific and Industrial Research (CSIR), New Delhi for financial assistance.

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Authors and Affiliations

  1. University College of Pharmaceutical Sciences, Kakatiya University, Warangal, 506 009, Andhra Pradesh, India

    Pavan Kumar Mittapalli, Bandari Suresh, S. S. Q. Hussaini, Yamasani Madhusudan Rao & Shashank Apte

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  1. Pavan Kumar Mittapalli
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  2. Bandari Suresh
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  3. S. S. Q. Hussaini
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  4. Yamasani Madhusudan Rao
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  5. Shashank Apte
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Correspondence to Yamasani Madhusudan Rao.

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Mittapalli, P.K., Suresh, B., Hussaini, S.S.Q. et al. Comparative In Vitro Study of Six Carbamazepine Products. AAPS PharmSciTech 9, 357–365 (2008). https://doi.org/10.1208/s12249-008-9035-y

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  • DOI: https://doi.org/10.1208/s12249-008-9035-y

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