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Formulation and Characterization of Sustained Release Dosage form of Zaltoprofen using 32 Full Factorial Design
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| Author:
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KUNAL PATEL, PAWANKUMAR A. RAI, KINJAL P. MODI, HARSH J. TRIVEDI, BHAVESH S. NAYAK
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| Abstract:
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Zaltoprofen is a non-steroidal anti-inflammatory drug which has excellent effect on post-surgery or post trauma chronic inflammation of the drug. Zaltoprofen has short biological half-life and dose of 80 mg three times a day. For that in this present study, an attempt has been made to prepare the sustained release tablet of Zaltoprofen to achieve the desired drug release. Initially drug-excipients compatibility studies was carried out by using DSC which showed no interaction between drug and excipients. Tablets were prepared by wet granulation technique and evaluated for pre compression and post compression parameters. 32 full factorial design was applied to achieve controlled drug release upto 24 h. Concentration of Xanthan gum (X1) and PEO (X2) were selected as independent variables and the % CDR at 1 h (Y1) and 20 h (Y2) were taken as dependent variables. In-vitro drug release study revealed that as the amount of polymers increased, % CDR decreased. Contour plots as well as response surface plots were constructed to show the effect of X1 and X2 on %CDR and predicted at the concentration of independent variables X1 (10mg) and X2 (10mg) for maximized response. The optimized batch Z1 was also evaluated by different release pharmacokinetic models. The optimized batch was kept for stability study at 40°C ± 2°C and 75% ± 5% RH for a period of six month according to ICH guidelines and found to be stable after six months of study.
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| Keyword:
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Sustained release tablet, Zaltoprofen, Xanthan gum, PEO, 32 full factorial design
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