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Formulation Optimization and Evaluation of Taste Masked Oro-dispersible Tablet of Levocetrizine Dihydrochloride by Ion Exchange Resin


Affiliations
1 Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner. Tal - Jamner, Dist. Jalgaon, Maharashtra, 424206., India
2 Medley Pharmaceuticals Ltd., Andheri (East), Mumbai - 400093., India
     

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The aim of this study was to prepare ODT of taste masked levocetrizine dihydrochloride by using ion exchange resin. Levocetrizine Dihydrochloride is bitter in taste, Kyron T-134 a weak cationic exchange resin was used to mask the bitter taste of the drug. The ODTs were prepared by using drug-resin (DRC) complex using batch process. Compression of ODTs was done by using direct compression method with the technique of addition of superdisintegrants. Central composite design (CCD) was applied as an optimization technique. FTIR and DSC studies indicated drug and excipients were compatible with each other. The prepared orodispersible tablet blend and tablets were evaluated for various pre-compression and post-compression parameters. The Batch LH3 was given as optimized batch by central composite design. This optimized batch LH3 was passed all the pre compression and post- compression parameters. The prepared ODTS showed successfully rapid onset of action with decrease in disintegration time 26 sec and %drug released was found to be 98.26%. It was concluded that levocetrizine dihydrochloride ODTs were prepared successfully by taste masking method using Kyron T-134 ion exchange resin and croscarmellose sodium as Superdisintegrant using CCD. AS per CDER guidelines, it shows DT within 5-30 sec.

Keywords

Levocetrizine Dihydrochloride, Kyron T-134, Croscarmellose Sodium, direct compression, ODTs
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  • Guidance for Industry. Orally Disintegrating Tablets. Centre for Drug Evaluation and Research December 2008; 1-3.
  • Singh Satvinder, Nautiyal Ujjwal, Singh Ramandeep and Kaur Sarabjot. Fast Dissolving Tablets Future aspect. International Journal of Pharmaceutical and Medicinal Research 2015; 3(2); 216-231.
  • Ashwin Shinde, Vishal Yadav, Vinay Gaikwad and Shree Dange. Fast disintegrating Drug Delivery System. International of Pharmaceutical Sciences and Research 2013; Vol. 4(7): 2548- 2561.
  • Lampman G. M, Pavia D. C, Kriz. G. S. and Vyvyan. ‘IR Spectroscopy’, Fourth Edition, 2014, Cengage Learning India Pvt. Ltd. Delhi; 29-73.
  • www.sciencedirect.com
  • Bolton Sanford, ‘PharmaceuticalStatistics’, Third Edition, James Swarbrick, North Carolin; 336-338.
  • Jain N. K., ‘Pharmaceutical Product Development’ Second Edition, CBS Publisher and Distributors Pvt. Ltd.; 369-391.
  • Sharma and Singh. Optimization of Taste masked Mouth Dissolving Tablets using Design of Experiment. Drug Development and Therapeutics, Vol. 6 Issue, Jan-Jun 2015; 20-26.
  • Rao Y. Madhusudan, Jithan A. V., “Advances in drug delivery system”, volume II, 57 – 100.
  • Barar F. S. K, “Textbook of Pharmacology”, IST edition, S Chand and Company, New Delhi-501.
  • Indian Pharmacopoeia, Government of India Ministry of Health and Family Welfare, Published by Indian Pharmacopoeia Commission, Volume-III, 2014, Ghaziabad, 2426-2428.
  • Skoog, Holler, Couch, “Instrumental Analysis”, Cengage learning India edition, 2007, 506-525.
  • Shital J Bidkar, Rutuja J. Bidkar, Dr. G. Y. Dama. Taste Masking of Bitter Pharmaceutical Agents by Using Ion Exchange Resin. World International of Pharmacy and Pharmaceutical Sciences Vol7 Issue 9, 463-482.
  • Ajay Bilandi, Amiya Kanta Mishra. Ion Exchange Resin: An Approach to Words Taste Masking of Bitter Drugs and Sustained Release Formulations with their Patent. International Research Journal of Pharmacy.2013, 65-74.
  • Garg Ashish, Gupta M.M. Taste Masking and Formulation Development and Evaluation of Mouth Dissolving Tablets Levocetrizine Dihydrochloride. Journal of Delivery and Therapeutics; 2013, 3(3): 123-130.
  • Moumita Barmann, Roosaline Mishra. Formulation and Evaluation of Taste masked Mouth Dissolving Tablet of Levocetrizine Dihydrochloride by using Ion-Exchange Resin. International Journal of Research and Development in Pharmacy and Life Science;2018;7(5):3104-3109.
  • Bhupendra Kumar Poudel, Shyam Raj Subedi. Taste Masking and Formulation of ondensetron Hydrochloride Mouth Dissolving Tablet. International Journal of Pharma Sciences and Research 2015; Vol.6 No.5 : 856-864.
  • Yihong Qiu, Yisheng Chen, Geoff G. Z. Zhang, ‘Developing Solid Oral Dosage Forms’ 2011 Published by Else3vier , A Division of Reed Elsevier India Private Limited, ; 168-170.
  • The United State Pharmacopoeia NF 2014, The Asian Edition; 2621, 2649.
  • Jaiswal Hema. Oral Strip Technology. Journal of Pharmaceutical and Biological Research. 2014:2 (2); 130-143.
  • Guidance for Industry. Orally Disintegrating Tablets. Centre for Drug Evaluation and Research, December 2008; 1-3.
  • Arora Pooja, Arora Sethi Vandana. Orodispersible Tablets: A Comprehensive Review. International Journal of Research and Development in Pharmacy and Life Sciences. Feb-March, 2013, Vol 2, No.2n, 270-284.
  • www. ich.org.
  • Drugs.com/monograph/Levocetrizine Dihydrochloride
  • https://www.drugbank
  • www.Wikipedia.com
  • Sharma and Singh. Optimization of Taste masked Mouth Dissolving Tablets using Design of Experiment. Drug Development and Therapeutics, Vol. 6 Issue, Jan-Jun 2015; 20-26.

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  • Formulation Optimization and Evaluation of Taste Masked Oro-dispersible Tablet of Levocetrizine Dihydrochloride by Ion Exchange Resin

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Authors

Patil Swati P
Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner. Tal - Jamner, Dist. Jalgaon, Maharashtra, 424206., India
Pati Ashwini V
Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner. Tal - Jamner, Dist. Jalgaon, Maharashtra, 424206., India
Bari M. M.
Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner. Tal - Jamner, Dist. Jalgaon, Maharashtra, 424206., India
Barhate S. D
Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner. Tal - Jamner, Dist. Jalgaon, Maharashtra, 424206., India
Mohd. Nasir
Medley Pharmaceuticals Ltd., Andheri (East), Mumbai - 400093., India

Abstract


The aim of this study was to prepare ODT of taste masked levocetrizine dihydrochloride by using ion exchange resin. Levocetrizine Dihydrochloride is bitter in taste, Kyron T-134 a weak cationic exchange resin was used to mask the bitter taste of the drug. The ODTs were prepared by using drug-resin (DRC) complex using batch process. Compression of ODTs was done by using direct compression method with the technique of addition of superdisintegrants. Central composite design (CCD) was applied as an optimization technique. FTIR and DSC studies indicated drug and excipients were compatible with each other. The prepared orodispersible tablet blend and tablets were evaluated for various pre-compression and post-compression parameters. The Batch LH3 was given as optimized batch by central composite design. This optimized batch LH3 was passed all the pre compression and post- compression parameters. The prepared ODTS showed successfully rapid onset of action with decrease in disintegration time 26 sec and %drug released was found to be 98.26%. It was concluded that levocetrizine dihydrochloride ODTs were prepared successfully by taste masking method using Kyron T-134 ion exchange resin and croscarmellose sodium as Superdisintegrant using CCD. AS per CDER guidelines, it shows DT within 5-30 sec.

Keywords


Levocetrizine Dihydrochloride, Kyron T-134, Croscarmellose Sodium, direct compression, ODTs

References