Formulation and Evaluation of Osmotic Sustained Release Budesonide Tablet for Colon Targeting
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Abstract
In order to improve therapeutic efficacy in the treatment of inflammatory bowel illnesses (IBD), including Crohn's disease and ulcerative colitis, the current study focuses on the formulation and assessment of osmotic sustained release tablets of Budesonide for targeted drug delivery to the colon. Budesonide, a glucocorticoid with strong anti-inflammatory effects, needs to be delivered locally to minimise systemic adverse effects and enhance site-specific impact because it has a high first-pass metabolism.
Budesonide was released gradually and under control using osmotic pump technology. The bilayer core of the tablets, which had an osmotic push layer and a medication layer, was coated with a cellulose acetate semipermeable membrane that included pore formers such as polyethylene glycol (PEG 400). By assessing factors like hardness, friability, homogeneity of drug content, in vitro drug release, and swelling index, several formulations were created and improved. Additionally, the effects of membrane thickness and orifice size on drug release were investigated.
To mimic gastrointestinal transit, in vitro dissolution experiments were carried out in successive pH media. Successful targeting was shown by the optimised formulation's limited drug release in intestinal and gastric pH settings and its considerable release that started at colonic pH. A zero-order release profile that is mostly controlled by osmotic pressure and membrane properties was proposed using kinetic modelling.
The findings highlight the potential of osmotic pump tablets as a dependable method for delivering Budesonide specifically to the colon, providing a viable treatment option for colonic inflammatory diseases with increased patient adherence and fewer doses.