In-vivo study of Budesonide mini-tablets in enteric coated capsules for the treatment of ulcerative colitis

Abstract

Budesonide, a corticosteroid, was used as a model drug to study the effects of independent variables like HPMC K4M as a release retarding polymer at 2-6% and Crospovidone as a super disintegrant at 2-5% on in vitro drug release to meet desired Q points of dissolution. Current study used a 32 factorial design (Stat-Ease Design Expert v12) to formulate a mini-tablet in an enteric-coated capsule to treat ulcerative colitis utilising ECDDT and mini-tablets. An in vivo study was conducted in New Zealand rabbits to determine the pharmacokinetic parameters for the optimized formulation (BF4-O). Time vs. plasma concentration plots of the Pure drug and Optimized formulation was observed. Plotted Area under the curve indicates the extent of drug absorption inside the body. Pharmacokinetic analysis of Budesonide pre drug plasma concentration–time data provided the following pharmacokinetic parameters like Cmax value ranging (1.42 ± 2.12 ng/mL), Tmax value (4.0 Hours), AUC value (12.77 ± 0.15 h.ng/mL), Half Life (3.5 Hours) and other pharmacokinetic parameters are depicted. Study demonstrates the variability in pharmacokinetic parameters like Tmax, Cmax, T1/2 (Hours), AUC and Ke. Henceforth, the newly developed Mini-Tablet in Enteric Coated capsule could be utilized clinically for the treatment of Ulcerative Colitis, alternatively with cost-effectiveness.