OPTIMIZATION AND CHARACTERIZATION OF COLON TARGETED DRUG DELIVERY SYSTEM USING COMPRESSION COATING TECHNIQUE
Dhaval Suthar*, Dinal Patel*, Vaishali Thakkar and Tejal Gandhi
ABSTRACT
Objectives: The impetus of the present study was to develop colon specific drug delivery system using compression coating technique by Box-Behnken design for the treatment of inflammatory bowel disease (IBD). Experimental methods: A colonic drug delivery with a new concept based on a combination of time-, pH-, and enzyme-controlled system was developed. To begin with the methodology core tablet of Mesalamine with lower strength (50 mg) and Spray dried Chitosan acetate were prepared. A Box-Behnken design was used to derive polynomial equation and construct contour plots to predict responses. Critical process parameters (CPPs) were taken as concentration of Spray dried Chitosan (X1), Percentage ratio of HPMC K15M: Guar gum (X2) and Coating Mass (X3). Seventeen batches were prepared as per the Design expert 8.0.7.1 and Critical quality attributes (CQAs) were taken as: Cumulative percentages of drug release at 5th hr (Y1), Time to dissolve the drug for 50% (Y2) and Cumulative percentages of drug release at 14th hr (Y3).. The computer optimization process and contour plots predicted the levels of independent variables X1, X2, and X3 (respectively) and total percent of drug released up to 14 hr. The optimized batch is further evaluated for Invivo drug release study. Results: Based on Box-Behnken experimental design, different release profiles were obtained. The optimized formulation containing Chitosan acetate: HPMC K4M: guar gum at 23.76: 51.82: 24.42% weight ratio and the this optimized batch shows 44.61% and 93.75% drug release in absence and presence of Rat cecal respectively.
Keywords: Compression coated tablets, Box-Behnken design, Mesalamine, Chitosan acetate, Hydroxy-propyl methyl cellulose (HPMC) K15M.
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
