.

ISSN 2063-5346
For urgent queries please contact : +918130348310

FORMULATION AND EVALUATION OF BUDESONIDE MINI-TABLET IN ENTERIC-COATED CAPSULE FOR THE TREATMENT OF ULCERATIVE COLITIS USING A FACTORIAL DESIGN APPROACH

Main Article Content

Donepudi Pradyumna1*, Lankalapalli Srinivas2
» doi: 10.48047/ecb/2023.12.si5a.0557

Abstract

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. The utilisation of ECDDT can potentially mitigate programme risk and expedite development timelines by removing the preparatory and applicative measures involved in enteric coating. Mini-Tablets present a viable option for administering low porosity pellets, as they share the same dimensions and morphology, exhibit uniform surface characteristics, demonstrate minimal inter-batch variation, and are readily manufacturable. 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. 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 Cros povidone as a super disintegrant at 2-5% on in vitro drug release to meet desired Q points of dissolution.

Article Details