Formulation and evaluation of Mesalamine mini-tablets in enteric-coated capsule for the treatment of ulcerative colitis using a factorial design approach

The Enteric Capsule Drug Delivery Technology (ECDDT) was designed to enable oral administration while ensuring complete enteric protection and swift release in the upper gastrointestinal (GI) tract, without the need for coatings. 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. Mesalamine, an amino salicylate, was used as a model drug to study the effects of independent variables like HPMC K4M as a release retarding polymer at 10-20% and Crospovidone as a super disintegrant at 2-5% on in vitro drug release to meet desired Q points of dissolution. higher value of T_max (10 Hours) and T1/2 (9 Hours) was observed for the Optimized formulation with C_max value of (35.24 ± 0.45 ng/mL), AUC_(0-48) (411.58 ± 1.45 hr.ng/mL) and Ke (0.077 ± 0.010 hr^-1) it may be due to delayed release formulation.