FORMULATION AND OPTIMIZATION OF BUDESONIDE COLON-TARGETED TABLETS USING CONTROLLED POROSITY OSMOTIC PUMP TECHNOLOGY

VOLETI VIJAYA KUMAR; ISMAIL Y.

doi:10.22159/ijap.2025v17i1.52544

Authors

VOLETI VIJAYA KUMAR Crescent School of Pharmacy, B. S. Abdur Rahman Crescent Institute of Science and Technology, GST Road, Vandalur, Chennai-600048, Tamil Nadu, India https://orcid.org/0000-0003-4735-3105
ISMAIL Y. Crescent School of Pharmacy, B. S. Abdur Rahman Crescent Institute of Science and Technology, GST Road, Vandalur, Chennai-600048, Tamil Nadu, India https://orcid.org/0000-0003-4735-3105

DOI:

https://doi.org/10.22159/ijap.2025v17i1.52544

Keywords:

Design of experiments, CPOP tablets, Box-behnken design, ANOVA test, Enteric coating, Semipermeable membrane, Polysaccharides

Abstract

Objective: Formulation and optimization of Budesonide (BDU) controlled porosity osmotic pump tablets (CPOP) to treat Nocturnal Asthma (NA) by adopting the Quality by design approach was set as objective of this research work.

Methods: Solubility of Budesonide was enhanced by converting in to the form of BUD Solid dispersions, using poloxamer 188. Controlled Porosity Osmotic pump (CPOP) tablets of budesonide were formulated by wet granulation technique. Quality by design approach using Box-Behnken design was adopted to optimize the selected critical factors. The optimized formulation was compared with the marketed extended-release formulation.

Results: The percentage of drug released at 4 hours (D4), 7 hours (D7), and 10 hours (D10) were identified as response factors during the optimization phase. Statistical analysis showed that a combination of 200 mg of the SPM coat, 19.72 mg of Eudragit S 100 for the enteric coating, and 69.74 mg of guar gum in the core could achieve drug release rates of 9.4% after 4 hours, 55.9% after 7 hours, and 96.6% after 10 hours of administration for the CPOP tablets.

Conclusion: The results indicated that the CPOP tablets were successfully formulated for colon-targeted drug release.

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