Development of topical gel containing aceclofenac-crospovidone solid dispersion by “Quality by Design (QbD)” approach |
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Authors: | Sougata Jana Syed Ansar Ali Amit Kumar Nayak Kalyan Kumar Sen Sanat Kumar Basu |
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Affiliation: | 1. Department of Pharmaceutics, Gupta College of Technological Sciences, Ashram More, Asansol 713301, W.B., India;2. Department of Pharmaceutics, Karnataka College of Pharmacy, 33/2 Thirumenahalli, Bangalore 560064, India;3. Department of Pharmaceutics, Seemanta Institute of Pharmaceutical Sciences, Jharpokharia, Mayurbhanj 757086, Odisha, India;4. Division of Pharmaceutics, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, W.B., India |
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Abstract: | This article describes the development, optimization, and evaluation of Carbopol 940 topical gel containing aceclofenac-crospovidone (1:4) solid dispersion using “Quality by Design (QbD)” approach based on 23 factorial design. The effect of crospovidone, tri-ethanolamine, and ethyl alcohol amount on the drug permeation profile of the topical gel containing aceclofenac-crospovidone solid dispersion was optimized by 23 factorial design. The optimized gel showed improved permeation profile with cumulative drug permeation of 26.262 ± 2.157%, and permeation flux of 0.059 ± 0.011 μg/cm2/h. These gels were characterized by pH, viscosity, gel strength and FTIR study. The in vivo anti-inflammatory activity of the optimized gel was evaluated in rats using carrageenan-induced rat-paw oedema model and found excellent anti-inflammatory comparable with a marketed gel without producing any skin irritation. |
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Keywords: | Topical gel Carbopol 940 Aceclofenac Factorial design QbD Optimization |
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