ISSN : 0975-9492


Open Access

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Title : Formulation and In-Vitro evaluation of Ibuprofen tablet for colonic delivery: Optimization of Formulation variables Using Box-Behnken Design
Authors : Ramprasad Sharma, Ashwinee Shrestha, Panna Thapa, Rajan Shrestha
Keywords : Ibuprofen, Pulsatile, Box Behnken experimental design, Ethyl cellulose, Polyethylene Glycol
Issue Date : May 2014
Abstract :
The aim of the study was to develop a pulsatile drug release system of Ibuprofen for colon with a pre-determined lag time of about 6 hour using Ethyl Cellulose as a coating material, Polyethylene Glycol 6000 as a channelling agent and Potassium Chloride as an osmotic agent. A 3-factor, 3- level Box- Behnken design was used to construct polynomial models correlating the dependent and independent variables. Independent variables were potassium chloride, ethyl cellulose coating thickness and polyethylene glycol. The cumulative percentages of drug released at 3rd, 4th 5th, 6th and 7th hour were selected as dependent variables. A second order polynomial equation fitted to the data was used to optimize the independent formulation variables. Based on Box-Behnken experimental design, different release profiles were obtained. The optimized formulation containing 16.027 g potassium chloride in the batch size of 1000 tablets of 400 mg each was prepared. Similarly, the coating solution per litre containing 75 g ethyl cellulose and 0.16 g polyethylene glycol 6000 was prepared and applied to achieve 5 % w/w gain in the core tablet. It provided a release profile which was very close to the targeted release profile, where the calculated values of similarity factor (FS) and dissimilarity factor (FD) were 85.958 and 38.663 respectively.
The optimum formulation using Box-Behnken experimental design showed that low levels of the independent variables were in the optimum zone and had the potential for time controlled pulsatile delivery of Ibuprofen.
Page(s) : 204-212
ISSN : 0975-9492
Source : Vol. 5, No.5