International Journal of Drug Delivery Technology
Volume 14, Issue 4

Development of an Optimized Budesonide Delivery System: A Controlled- Release Approach for Targeting the Colon

Prajapati B*, Atara S

Department of Pharmaceutics, School of Pharmacy, RK University, Rajkot, Gujarat, India. 

Received: 30th Sep, 2024; Revised: 23rd Oct, 2024; Accepted: 11th Nov, 2024; Available Online: 25th Dec, 2024 

ABSTRACT

This study focused on the development and optimization of a colon-targeted Budesonide tablet formulation designed for controlled release and targeted delivery to the colon. A combination of controlled-release polymers (Xanthan Gum and Hypromellose K4M) and coating polymers (Eudragit S100 and Eudragit L100) was utilized to achieve the desired drug release profile. A systematic approach using fractional and full factorial designs was employed to identify the key variables influencing drug release at specific time points. The formulation was optimized to ensure minimal premature release in the upper GIT and maximum release in the colon. In vitro dissolution studies revealed that the optimized formulation closely matched the reference-listed drug (RLD), with 18.07% release at 2 h, 42.63% at 4 h, 84.78% at 8h and 91.32% at 12 h. The similarity factor (f2) of 83 and difference factor (f1) of 3 confirmed the high level of similarity between the two formulations. The optimized formulation successfully delivered Budesonide in a controlled manner, providing a cost-effective and scalable solution for treating inflammatory bowel diseases.

Keywords: Colon-Targeted; Controlled Release; Polymers; Inflammatory Bowel Diseases; Enteric Coating,

How to cite this article: Prajapati B, Atara S. Development of an Optimized Budesonide Delivery System: A Controlled- Release Approach for Targeting the Colon. International Journal of Drug Delivery Technology. 2024;14(4):1971-80. doi: 10.25258/ijddt.14.4.5

REFERENCES

  1. Hussian SE, Mahood Association of Inflammatory Bowel Disease and Tumor Necrosis Factor-863 C/A Polymorphism in Iraq. Int J Drug Deliv Technol. 2023;13(1):82–5.
  2. Alatab S, Sepanlou SG, Ikuta K, Vahedi H, Bisignano C, Safiri The Global, Regional, and National Burden of Inflammatory Bowel Disease in 195 Countries and Territories, 1990–2017: A Systematic Analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(1):17–30.
  3. Mak JWY, Sun Y, Limsrivilai J, Abdullah M, Kaibullayeva J, Balderramo D, et al. Development of the Global Inflammatory Bowel Disease Visualization of Epidemiology Studies in the 21st Century (GIVES- 21). BMC Med Res Methodol. 2023;23(1):129.
  4. Sawicki T, Ruszkowska M, Danielewicz A, Niedźwiedzka E, Arłukowicz T, Przybyłowicz KE. A Review of Colorectal Cancer in Terms of Epidemiology, Risk Factors, Development, Symptoms and Diagnosis. Cancers. 2021;13(9):2025.
  5. Saraf A, Dubey N, Dubey N, Sharma M. Formulation and Optimization of Colon-Specific Nanoparticles Containing A Herbal Anticancer Agent. Int J Drug Deliv Technol. 2023;13(2):591–6.
  6. Cai Z, Wang S, Li Treatment of Inflammatory Bowel Disease: A Comprehensive Review. Front Med (Lausanne). 2021;8:765474.
  7. López-Sanromán A, Clofent J, Garcia-Planella E, Menchén L, Nos P, Rodríguez-Lago I, Domènech E. Reviewing the Therapeutic Role of Budesonide in Crohn’s Disease. Gastroenterol Hepatol. 2018;41(7):458–71.
  8. Adepu S, Ramakrishna S. Controlled Drug Delivery Systems: Current Status and Future Directions. Molecules. 2021;26(19):5905.
  9. Nicolaides NC, Pavlaki AN, Maria Alexandra MA, Chrousos GP. Glucocorticoid Therapy and Adrenal Suppression [Internet]. In: Feingold KR, Anawalt B, Blackman MR, Boyce A, Chrousos G, Corpas E, et al., editors. Endotext. South. MDText.com Dartmouth (MA), Inc. 2000 [cited 2024 Sep 9]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK279156/.
  10. Reilev M, Hallas J, Thomsen Ernst M, Nielsen GL, Bonderup Long-Term Oral Budesonide Treatment and Risk of Osteoporotic Fractures in Patients with Microscopic Colitis. Aliment Pharmacol Ther. 2020;51(6):644–51.
  11. O’Donnell S, O’Morain CA. Therapeutic Benefits of Budesonide in Gastroenterology. Ther Adv Chronic Dis. 2010;1(4):177–86.
  12. Seoudi SS, Allam EA, El-Kamel AH, Elkafrawy H, El- Moslemany RM. Targeted Delivery of Budesonide in Acetic Acid Induced Colitis: Impact on miR-21 and E- Cadherin Expression. Drug Deliv Transl Res. 2023;13(11):2930–47.
  13. Soltani F, Kamali H, Akhgari A, Garekani HA, Nokhodchi A, Sadeghi F. Different Trends for Preparation of Budesonide Pellets with Enhanced Dissolution Rate. Adv Powder Technol. 2022;33(8):103684.
  14. Ibrahim IM. Advances in Polysaccharide-Based Oral Colon-Targeted Delivery Systems: The Journey so Far and the Road Ahead. Cureus. 2023;15(1):e33636.
  15. Mahmood A, Mahmood A, Ibrahim MA, Hussain Z, Ashraf MU, Salem-Bekhit MM, Elbagory I. Development and Evaluation of Sodium Alginate/Carbopol 934P-Co-Poly (Methacrylate) Hydrogels for Localized Drug Delivery. Polymers. 2023;15(2):311–34.
  16. Sharma P, Chawla A, Pawar P. Design, Development, and Optimization of Polymeric Based-Colonic Drug Delivery System of Naproxen. Sci World J. 2013;2013:e654829.
  17. Wasay SA, Jan SU, Akhtar M, Noreen S, Gul R. Developed Meloxicam Loaded Microparticles for Colon Targeted Delivery: Statistical Optimization, Physicochemical Characterization, and In-Vivo Toxicity Study. PLOS ONE. 2022;17(4):e0267306.
  18. Padmasree BA, Vishwanath BA. Comparison of In- Vitro Release Study of Pegylated and Conventional Liposomes as Carriers for the Treatment of Colon Cancer. Int J Pharm Qual Assur. 2022;13(2):204–7.
  19. Dignass A, Stoynov S, Dorofeyev AE, Grigorieva GA, Tomsová E, Altorjay I, et al. Once Versus Three Times Daily Dosing of Oral Budesonide for Active Crohn’s Disease: A Double-Blind, Double-Dummy, Randomised J Crohns Colitis. 2014;8(9):970–80.
  20. S J, Dhanapal CK, Khan NA. Comparative Characterization of Reference Market Product and Generic Product Developed Using Reverse Engineering Methodology. Int J Pharm Qual Assur. 2023;14(4):987–92.
  21. Jadav M, Pooja D, Adams DJ, Kulhari H. Advances in Xanthan Gum-Based Systems for the Delivery of Therapeutic Agents. Pharmaceutics. 2023;15(2):402–
  22. Mughal MA, Iqbal Z, Neau SH, Gum G. Guar Gum, Xanthan Gum, and HPMC Can Define Release Mechanisms and Sustain Release of Propranolol Hydrochloride. AAPS PharmSciTech. 2011;12(1):77–