Volume : 13, Issue : 10, October – 2026

Title:

DEVELOPMENT AND CHARACTERIZATION OF BELZUTIFAN FLOATING DRUG DELIVERY SYSTEM FOR IMPROVED GASTRIC RETENTION

Authors :

Prathyusha Madireddy*, Chilakuri Shreya, A. Saritha

Abstract :

The present study aimed to develop and characterize a floating drug delivery system (FDDS) of Belzutifan to improve gastric retention, provide sustained drug release, and enhance oral bioavailability. Belzutifan floating tablets were prepared by the direct compression method using sodium alginate (F1–F4) and Tragacanth (F5–F8) as matrix-forming polymers, while sodium bicarbonate and citric acid were incorporated as gas-generating agents to impart buoyancy. All formulations exhibited acceptable physical characteristics with weight variation between 399–401 mg, hardness ranging from 5.2–6.9 kg/cm², and friability below 1%, indicating adequate mechanical strength. Floating lag time ranged from 40 to 57 seconds, confirming rapid buoyancy. In vitro dissolution studies showed sustained drug release over 8 hours, with cumulative drug release ranging from 93.25% to 98.58%. Among all formulations, F7 demonstrated the highest drug release (98.58%), shortest floating lag time (40 seconds), and superior overall performance. Accelerated stability studies conducted according to ICH guidelines demonstrated that the optimized formulation remained stable over three months without significant changes in drug release characteristics. The optimized formulation (F7) showed promising physicochemical properties, buoyancy, controlled-release behaviour, and stability, indicating its potential as an effective gastro-retentive oral delivery system for Belzutifan.
Keywords: Belzutifan, Floating Drug Delivery System, Gastro-retentive Drug Delivery System, Floating Tablets, Sodium Alginate, Tragacanth, Sustained Release, Direct Compression, Drug Release Kinetics.

Cite This Article:

Please cite this article in press Prathyusha Madireddy et al., Development And Characterization Of Belzutifan Floating Drug Delivery System For Improved Gastric Retention.,. Indo Am. J. P. Sci, 2026; 13(10).

REFERENCES:

1. Klausner EA, Lavy E, Friedman M, Hoffman A. Expandable gastroretentive dosage forms. Journal of Controlled Release. 2003;90(2):143–162.
2. Streubel A, Siepmann J, Bodmeier R. Gastroretentive drug delivery systems. Expert Opinion on Drug Delivery. 2006;3(2):217–233.
3. Bardonnet PL, Faivre V, Pugh WJ, Piffaretti JC, Falson F. Gastroretentive dosage forms: Overview and special case of Helicobacter pylori. Journal of Controlled Release. 2006;111(1–2):1–18.
4. Sauzet C, Bruno CM, Nicolas M, Kister J, Piccerdle P, Prinderre P. An innovative floating gastro retentive dosage system. Formulation and in-vitro evaluation. Int J Pharm 2009;378:23-29.
5. Abrahamsson, B., Alpsten, M., Hugosson, M., Jonsson, U.E., Sundgren, M., Svenheden, A., Tölli, J., 1993. Absorption, Gastrointestinal Transit, and Tablet Erosion of Felodipine Extended-Release (ER) Tablets. Pharm. Res. 10, 709-714.
6. Agrawal, A.M., Manek, R.V., Kolling, W.M., Neau, S.H., 2003. Studies on the interaction of water with ethylcellulose: effect of polymer particle size. AAPS Pharm. Sci. Tech. 4, E60.
7. Alvisi, V., Gasparetto, A., Dentale, A., Heras, H., Felletti-Spadazzi, A., D’Ambrosi, A., 1996. Bioavailability of a controlled release formulation of ursodeoxycholic acid in man. Drugs Exp. Clin. Res. 22, 29-33.
8. Amaral, M.H., Lobo, J.M., Ferreira, D.C., 2001. Effect of hydroxypropyl methylcellulose and hydrogenated castor oil on naproxen release from sustained-release tablets. AAPS Pharm. Sci. Tech. 2, E6.
9. Andrews, G.P., Laverty, T.P., Jones, D.S., 2009. Mucoadhesive polymeric platforms for controlled drug delivery. Eur. J. Pharm. Biopharm. 71, 505-518.
10. Atyabi, F., Sharma, H.L., Mohammad, H.A.H., Fell, J.T., 1996b. In vivo evaluation of a novel gastric retentive formulation based on ion exchange resins. J. Control. Rel. 42, 105-113.
11. Babu, V.B., Khar, R.K., 1990. In vitro and in vivo studies of sustained-release floating dosage forms containing salbutamol sulfate. Pharmazie 45, 268-270.
12. Badve, S.S., Sher, P., Korde, A., Pawar, A.P., 2007. Development of hollow/porous calcium pectinate beads for floating-pulsatile drug delivery. Eur. J. Pharm. Biopharm. 65, 85-93.