Formulation and Evaluation of Buccal Drug Delivery System of Ketorolac Tromethamine Using Mucoadhesive Polymers
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Author:
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NARENDRA CHOTAI, PARAS R. MODI, HARDIK K. PATEL, RAJNIKANT M. SUTHAR
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Abstract:
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The aim of the present work was to prepare, evaluate and optimize mucoadhesive buccal tablet formulation of ketorolac tromethamine using 32 factorial design. In present investigation, attempt was made to prepare buccal tablets containing carbopol 934p and PEO N-80 alone or in combination by direct compression method. Nine batches were prepared as per 32 factorial design, to investigate the combined effects of independent variables namely amount of carbopol 934p (X1) and amount of PEO N-80 (X2) on dependent variables namely swelling index, mucoadhesive strength, t50% and t90% using design expert software version 8.0.7.1. Tablets were evaluated for pharmaceutical parameters such as hardness, thickness, friability, weight variation, drug content, surface pH, ex-vivo residence time, mucoadhesive strength, swelling index, ex-vivo drug permeation study and in-vitro drug release study to optimize the formula. Tablets were found to be satisfactory when evaluated for tests per se. Out of all factorial batches (F1 to F9), batch F7 (55 mg carbopol 934p and 35 mg PEO N-80) showed desired drug release up to 12 hr. The release kinetic of F7 batch was found to be best fitted to zero order kinetic model and exhibited anomalous diffusion release mechanism. The formulation F7 exhibited good correlation (R2= 0.996) for in vitro drug release. In conclusion the prepared buccal tablet of ketorolac tromethamine with 55 mg of carbopol 934p and 35 mg of PEO N-80 (batch F7) seems to be promising formulation.
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Keyword:
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Mucoadhesive buccal tablet, Ketorolac tromethamine, Carbopol 934P, PEO N-80, 32 factorial design.
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EOI:
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DOI:
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