Author(s):
Vaishnavi Devidas Ramavat, Mangesh B. Gadekar, R. R. Pagore, K. R. Biyani
Email(s):
ramavatvaishnavi@gmail.com
DOI:
10.52711/0975-4377.2026.00043 
Address:
Vaishnavi Devidas Ramavat1*, Mangesh B. Gadekar1, R. R. Pagore1, K. R. Biyani2
1Department of Pharmaceutics, Karmayogi Tatyasaheb Bondre Institute of Pharmacy, Chikhli Dist. Buldhana, Maharashtra (India) – 443201.
2Anuradha College of Pharmacy, Chikhli Dist. Buldhana, Maharashtra (India) – 443201.
*Corresponding Author
Published In:
Volume - 18,
Issue - 4,
Year - 2026
ABSTRACT:
Objective: Azilsartan Medoxomil is a potent antihypertensive drug belonging to Biopharmaceutical Classification System (BCS) Class II and exhibits poor aqueous solubility, resulting in low dissolution rate and limited oral bioavailability. The present study aimed to enhance the solubility and dissolution behavior of Azilsartan Medoxomil using a mixed hydrotropy-based solid dispersion approach. Methods: Equilibrium solubility studies were performed using different hydrotropic agents, namely sodium acetate, sodium benzoate, sodium citrate, and urea. Based on the solubility results, sodium benzoate and sodium citrate were selected for the preparation of mixed hydrotropic solid dispersions in various drug-to-hydrotrope ratios. The prepared formulations were evaluated for solubility enhancement, drug content, and in vitro dissolution performance. Compatibility studies were carried out using Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC). The optimized solid dispersion formulation was further compressed into immediate-release tablets and evaluated for post-compression parameters and stability. Results: Solubility studies demonstrated that sodium benzoate and sodium citrate significantly improved the aqueous solubility of Azilsartan Medoxomil compared with pure water. Among all formulations, F4 exhibited the highest solubility and dissolution rate. FTIR analysis confirmed the absence of significant drug-excipient interactions, while DSC studies indicated reduced crystallinity and partial amorphization of the drug in the solid dispersion system. The optimized tablet formulation showed satisfactory hardness, friability, weight variation, drug content uniformity, and rapid drug release, achieving approximately 99% drug release within 30 minutes. Accelerated stability studies indicated that the formulation remained stable without significant changes in physicochemical properties. Conclusion: The findings demonstrate that mixed hydrotropy-based solid dispersion is an effective, economical, and safe strategy for improving the solubility and dissolution characteristics of Azilsartan Medoxomil. The developed formulation has the potential to enhance oral bioavailability and therapeutic performance of the drug.
Cite this article:
Vaishnavi Devidas Ramavat, Mangesh B. Gadekar, R. R. Pagore, K. R. Biyani. A Novel Approch for Solubility and Dissolution Enhancement of Poorly Aqueous Soluble Anti-Hypertensive Drug. Research Journal of Pharmaceutical Dosage Forms and Technology. 2026; 18(4):311-7. doi: 10.52711/0975-4377.2026.00043
Cite(Electronic):
Vaishnavi Devidas Ramavat, Mangesh B. Gadekar, R. R. Pagore, K. R. Biyani. A Novel Approch for Solubility and Dissolution Enhancement of Poorly Aqueous Soluble Anti-Hypertensive Drug. Research Journal of Pharmaceutical Dosage Forms and Technology. 2026; 18(4):311-7. doi: 10.52711/0975-4377.2026.00043 Available on: https://rjpdft.com/AbstractView.aspx?PID=2026-18-4-5
REFERENCES:
1. Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020; 16(4): 223-237.
2. Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification. Pharm Res. 1995; 12(3): 413-420.
3. Savjani KT, Gajjar AK, Savjani JK. Drug solubility: importance and enhancement techniques. ISRN Pharm. 2012; 2012: 195727.
4. Perry CM. Azilsartan medoxomil: a review of its use in hypertension. Clin Drug Investig. 2012; 32(9): 621-639.
5. Xu H, Kang L, Qin J, et al. Solubility enhancement of azilsartan medoxomil using pharmaceutical techniques. ACS Omega. 2020; 5(11): 6141-6145.
6. Kawabata Y, Wada K, Nakatani M, Yamada S, Onoue S. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system. Int J Pharm. 2011; 420(1): 1-10.
7. Maheshwari RK. Novel application of hydrotropic solubilization in the analysis of poorly water-soluble drugs. Indian J Pharm Sci. 2006; 68(1): 36-41.
8. Saleh AM, El-Khordagui LK. Hydrotropic agents: a new definition. Int J Pharm. 1985; 24(2-3): 231-238.
9. Maheshwari RK, Jagwani Y. Mixed hydrotropy: novel science of solubility enhancement. Indian J Pharm Sci. 2011; 73(2): 179-183.
10. Jain NK, Patel VV. Advances in hydrotropic solubilization. Int J Pharm Pharm Sci. 2015; 7(5): 1-6.
11. Patel SK, Patel NM. Hydrotropy: a promising tool for solubility enhancement of poorly water-soluble drugs. Int J Pharm Sci Rev Res. 2014; 27(2): 1-6.
12. Aulton ME, Taylor KMG. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. Elsevier; 2018. p. 12–25, 300–320.
13. Allen LV. Remington: The Science and Practice of Pharmacy. 23rd ed. Pharmaceutical Press; 2020. p. 400–420.
14. Ranade VV, Hollinger MA. Drug Delivery Systems. CRC Press; 2003. p. 45–60.
15. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification system. Pharm Res. 1995; 12(3): 413–420.
16. Lipinski CA, Lombardo F, Dominy BW, Feeney PJ. Experimental and computational approaches to estimate solubility and permeability. Adv Drug Deliv Rev. 1997; 23(1–3): 3–25.
17. Savjani KT, Gajjar AK, Savjani JK. Drug solubility: Importance and enhancement techniques. ISRN Pharm. 2012; 2012: 195727.
18. Maheshwari RK, Bishnoi SR. Mixed hydrotropy: novel concept for spectrophotometric analysis of poorly water-soluble drugs. Asian J Pharm. 2011; 5(1): 22-25.
19. Box KJ, Comer JEA. Using measured pKa, logP and solubility to investigate drug absorption. J Pharm Pharmacol. 2008; 60(2): 149–159.
20. Stegemann S, Leveiller F, Franchi D, de Jong H, Linden H. When poor solubility becomes an issue: from early stage to proof of concept. Drug Discov Today. 2007; 12(23–24): 1068–1075.
21. Hatwar PP, Hudekar GS, Sanap GS, Hudekar GG, Pawar RR. Formulation development studies. Int J Pharm Sci. 2022; 10(1): 63–70.
22. Bergström CAS, Avdeef A. Perspectives in solubility measurement and interpretation. ADMET DMPK. 2019; 7(2): 88–105.
23. Maheshwari RK, Upadhyay N, Jain J, Patani M, Mathuria KC. New spectrophotometric estimation of poorly water-soluble drugs using hydrotropic solubilizing agents. Indian J Pharm Sci. 2006; 68(2): 195-198.
24. Jankovic S, Tsakiridou G. Application of solubility parameter concept for oral delivery of poorly water-soluble drugs. J Pharm Pharmacol. 2019; 71(4): 441–456.
25. Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersion. Eur J Pharm Biopharm. 2000; 50(1): 47–60.
26. Chaudhary A, Nagaich U, Gulati N, Sharma VK, Khosa RL, Partapur MU. Enhancement of solubilization and bioavailability of poorly soluble drugs: A review. J Adv Pharm Educ Res. 2012; 2(1): 32–67.
27. Ain S, Ain Q, Parveen S. An overview on solubilization techniques for poorly soluble drugs. Pharma Res. 2009; 2: 84–104.
28. Yadav K, Sachan AK, Kumar S, Dubey A. Techniques for increasing solubility: a review of conventional and new strategies. Asian J Pharm Res Dev. 2022; 10(2): 144-153.
29. Kumar S, Singh P. Various techniques for solubility enhancement: an overview. Pharma Innov J. 2016; 5(1): 23-28.