G. Uma Rani,
K. Aswini,
- Professor, Department of Pharmaceutics, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India
- Student, Department of Pharmaceutics, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India
Abstract
Candesartan cilexetil, a BCS class II drug with low aqueous solubility and poor bioavailability (15%), poses challenges for oral delivery. To address this limitation, the present study focuses on polymer-based inclusion complexation and composite formulation strategies to enhance solubility and dissolution behavior. The drug was incorporated into β-cyclodextrin (β-CD), a cyclic oligosaccharide polymer, by the kneading method in different drug-to-carrier ratios. Among these, the 1:1 molar ratio complex exhibited the most significant solubility enhancement, demonstrating the potential of polymeric host–guest interactions in drug delivery. The β-CD inclusion complex was subsequently incorporated into Oro dispersible tablet (ODT) systems using both natural and synthetic polymeric disintegrants. Natural biopolymers such as banana powder and oat powder were employed alongside synthetic disintegrants including microcrystalline cellulose (MCC) and sodium starch glycolate (SSG). Formulations prepared by direct compression were characterized for their mechanical strength, friability, disintegration efficiency, water absorption, and in vitro dissolution behavior. Optimized formulations containing banana powder (B4) and a banana–oat composite (OB2) demonstrated rapid disintegration (19 s and 26 s, respectively) and significantly improved drug release, achieving 98.7% within 3 min and 97.2% within 5 min. Short-term stability studies confirmed no significant changes in the physicochemical or dissolution properties of the optimized composites. This work highlights the utility of polymeric inclusion complexes and natural–synthetic polymer composites as multifunctional excipients in the design of advanced oral drug delivery systems. The approach underscores the role of polymer science in tailoring solubility, disintegration, and release kinetics of poorly soluble therapeutic agents.
Keywords: Oro dispersible tablet, Candesartan cilexetil, Banana powder, Oat powder, Microcrystalline cellulose (MCC), Sodium Starch Glycolate.
[This article belongs to Special Issue under section in Journal of Polymer & Composites (jopc)]
G. Uma Rani, K. Aswini. Comparative Study on Oro Dispersible Tablets of Candesartan Cilexetil Formulated with Natural and Synthetic Disintegrants. Journal of Polymer & Composites. 2026; 14(01):687-695.
G. Uma Rani, K. Aswini. Comparative Study on Oro Dispersible Tablets of Candesartan Cilexetil Formulated with Natural and Synthetic Disintegrants. Journal of Polymer & Composites. 2026; 14(01):687-695. Available from: https://journals.stmjournals.com/jopc/article=2026/view=236075
References
1. Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy. 3rd ed. Bombay: Varghese Publishing House; 1986.
2. Banker GS, Rhodes CT. Modern pharmaceutics. 4th ed. New York: Marcel Dekker; 2002.
3. Aulton ME. Pharmaceutics: the science of dosage form design. 2nd ed. London: Churchill Livingstone; 2002.
4. Kuchekar BS, Bhise SB, Arumugam V. Design of fast disintegrating tablets. Indian J Pharm Educ. 2001;35(4):150–2.
5. Indurwade NH, Rajya guru TH, Nakhat PD. Novel approach—fast dissolving tablets. Indian Drugs. 2002;39(8):405–9.
6. Reddy LH, Ghosh B, Rajneesh. Fast dissolving drug delivery systems: a review of the literature. Indian J Pharm Sci. 2002;64(4):331–6.
7. Sreenivas SA, Dandagi PM, Gadad AP, Godbole AM, Hiremath SP, Mastiholimath VS, et al. Oro dispersible tablets: new-fangled drug delivery systems—a review. Indian J Pharm Educ Res. 2005;39(4):177–81.
8. Anand N, Singh L, Sharma V. Emergence of natural super disintegrants in Oro dispersible tablets. Int J Pharm Sci. 2013;5(8):17–20.
9. Mishra V. Enhanced antihypertensive activity of candesartan cilexetil nanosuspension: formulation, characterization and pharmacodynamic study. Sci Pharm. 2011;79(3):635–51.
10. Patil B. Formulation and evaluation of fast dissolving tablets of candesartan cilexetil by sublimation method using natural and synthetic super disintegrant. Int J Pharm Res Dev. 2012;4(6):30–7.
11. Damodaran N, et al. Preparation and evaluation of solid dispersion of candesartan cilexetil. J Pharm Res. 2012;5(1):333–6.
12. Patil B. Formulation and evaluation of fast dissolving tablets of candesartan cilexetil by sublimation technique. Int J Pharm Chem Sci. 2012;1(4):1–7.
13. Vaculikova E. Preparation of candesartan and atorvastatin nanoparticles by solvent evaporation. Molecules. 2012; 17:13221–34.
14. Gautam S, et al. PAMAM dendrimers: novel polymeric nanoarchitectures for solubility enhancement of candesartan cilexetil. Pharm Sci. 2012; 1:1–6.
15. Sravya M, et al. Novel analytical approach for improvement of aqueous solubility of candesartan cilexetil using co-solvency. Int Res J Pharm. 2012;3(5):1–5.
16. Kamalakkanna V. Development and characterization of controlled release polar lipid microparticles of candesartan cilexetil by solid dispersion. Res Pharm Sci. 2012;8(2):125–36.
17. Panchal D. Formulation and evaluation of sustained release matrix tablets of candesartan cilexetil. Int J Pharm Res Biosci. 2012;1(4):75–105.
18. Sathali A, et al. Formulation, development and in vitro evaluation of candesartan cilexetil mucoadhesive microbeads. Int J Curr Pharm Res. 2012;4(3):109–18.
19. Mishra V. Formulation and evaluation of matrix microspheres for simultaneous delivery of candesartan cilexetil and captopril. Int J Pharm Sci Res. 2011;2(11):2969–73.
20. Al-Omari AA, et al. Effect of cyclodextrins on the solubility and stability of candesartan cilexetil. J Pharm Biomed Anal. 2011;54(3):503–9.
21. Ashok T. Design and evaluation of controlled release mucoadhesive buccal tablets of candesartan. IJPI J Pharm Cos metol. 2011;1(2):1–7.
22. Raj R, et al. Formulation and studies on candesartan transdermal patches. Int J Pharm Res Dev. 2012;4(3):234–41.
23. Sravya M, et al. Development of Oro dispersible tablets of candesartan cilexetil by β-cyclodextrin complexation. Int Res J Pharm. 2012;3(2):1–5.
24. Mehta MR. Formulation and evaluation of sublingual tablets of candesartan cilexetil. Int J Pharm Res Biosci. 2014;3(2):900–25.
25. Katti VS. Improvement of solubility and dissolution rate of candesartan cilexetil by solid dispersion. Int J Pharm Sci Res. 2014;4(4):1550–6.
26. Abdul A. Preparation and evaluation of liquisolid compact and solid dispersion of candesartan cilexetil. Int J Pharm Sci. 2014; 6:1.
27. Uma Rani, Sumakanth M, Begum A. Natural gums used in the preparation of floating drug delivery system. Int J Pharma Tech Res. 2022;15.
28. Prasanthi S, Sai Ramya B, Dogiparthi LK, UmaRani G, Sushmitha A, Nirmala Devi BN, Sarovar Reddy V, Vidyavathi M, Mallikarjuna BP. Methods of extraction of cellulose from banana plant bio-waste and applications: a review. Asian J Pharm. 2023;17(4).
29. Popa G, Gafitanu E. Oral disintegrating tablets. A new, modern, solid dosage form. Rev Med Chir Soc Med Nat Iasi. 2003;107(2):337–42

Journal of Polymer & Composites
| Volume | 14 |
| Special Issue | 01 |
| Received | 08/11/2025 |
| Accepted | 29/12/2025 |
| Published | 15/01/2026 |
| Publication Time | 68 Days |
Login
PlumX Metrics