Formulation and Evaluation of Sustained Release Matrix Tablets of Ibrutinib

The present study focuses on developing sustained release matrix tablets of Ibrutinib aiming to increase the therapeutic efficacy, reduce the frequency of administration and to improve the patient compliance. Sustained release matrix tablets of Ibrutinib, were developed by using different drug polymer ratios HPMC phthalate, Eudragit L 100, Eudragit S 100 as matrix former. All lubricated formulations were compressed by direct compression and by wet granulation method. Compressed tablets were evaluated for uniformity of weight, content of active ingredient, friability, hardness, thickness, in-vitro dissolution, and swelling index. All the formulation showed compliance with pharmacopoeial standards. Among the different formulation, B8 showed sustained release of drug for 12 hours with 86.55% release. The selected formulation (B8) was subjected to stability studies for three months at 25°C/60% RH, 30°C/65% RH and 40°C/75% RH and showed stability with respect to release pattern and all physical parameters. The regression coefficient value of Higuchi plot was found to be 0.9925 that showed that drug was released by diffusion mechanism. The slope value of korsmeyer-peppas equation was found to be 0.5062 which indicating that drug was released by non-fickian release mechanism. The R2 value for Hixson Crowell plot was found to be 0.9919 which indicates that drug release was limited by drug particle dissolution rate and erosion of the polymer matrix. Thus, drug in combination with Eudragit S 100 were found to be effective in retarding the release of Ibrutinib.