Enhancing water solubility of a BCS Class II drug using hydrotropy, mixed solvency, co-solvency, and nanosuspension techniques

Authors

  • Vijayraj Sonawane a:1:{s:5:"en_US";s:34:"Divine college of Pharmacy, Satana";}
  • Dhanashree I. Wagh
  • Sakshi P. Bhamare
  • Khemchand R. Surana
  • Deepak D. Sonawane
  • Sunil K. Mahajan

DOI:

https://doi.org/10.56782/pps.500

Keywords:

Diclofenac sodium, Hydrotropy, Nanosuspension, Co-solvency, Solubility enhancement

Abstract

Diclofenac sodium, a BCS Class II drug, exhibits high permeability but poor solubility, limiting its bioavailability. This study investigates solubility enhancement techniques such as hydrotropy, co-solvency, mixed solvency, and nanosuspension using agents such as urea, sodium acetate, sodium citrate, polyethylene glycol 400 (PEG 400), and glycerin at concentrations of 10–60 ppm. Solubility was evaluated via Shimadzu UV-1800 UV-Vis spectrophotometry. All methods showed a linear increase in solubility, with nanosuspension demonstrating the highest enhancement. The eco-friendly, non-toxic agents used make these techniques suitable for pharmaceutical applications. Overall, the findings support nanosuspension as a promising strategy to improve the bioavailability and therapeutic efficacy of poorly soluble drugs like diclofenac sodium.

Downloads

Download data is not yet available.

References

1. Osol, A.; Hoover, J.E. Remington's Pharmaceutical Sciences, Easton: Mack Publishing Company, USA, 1985; pp. 154–196.

2. Yeola, C.A.; Sonawane, V.N.; Sonawane, V.N.; Surana, K.R.; Patil, D.M.; Sonawane, D.D. Development and validation of simple UV-spectrophotometric method for estimation of diclofenac sodium. Asian J. Pharm. Anal. 2023, 13(3), 183–189. DOI: 10.52711/2231-5675.‌‌‌‌2023.‌00030‌‌‌

3. Augustijns, P.; Brewster, M.E., Eds. Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics; Springer: New York, NY, USA, 2007; pp. 1–450.

4. Pharmacopoeia I. Government of India, Ministry of Health and Family Welfare. Indian Pharmacopoeia; Controller of Publications: Delhi, India, 1996; Vol. 2, pp. 448.

5. Sonawane, V.N.; Suryawanshi, K.G.; Wagh, K.H.; Sonawane, S.L.; Sonar, A.D.; Sakle, S.J.; Sonawane, D.D. A comparative study of dissolution profiles on various brands of diclofenac sodium prolonged release tablet formulation. Prog. Chem. Biochem. Res. 2023, 6(4), 341–355. DOI: 10.48309/pcbr.2023.411501.1280

6. Jindal, K. Review on solubility: A mandatory tool for pharmaceuticals. Int. Res. J. Pharm. 2017, 8(11), 11–15. DOI: 10.7897/2230-8407.0811210

7. Kumar, S.; Singh, P. Various techniques for solubility enhancement: An overview. Pharma Innov. J. 2016, 5(1), 23-28.

8. Patil, M.S.; Godse, S.Z.; Saudagar, R.B. Solubility enhancement by various techniques: An overview. World J. Pharm. Pharm. Sci. 2013, 2(6), 4558–4572.

9. Sikarra, D.; Shukla, V.; Kharia, A.A.; Chatterjee, D.P. Techniques for solubility enhancement of poorly soluble drugs: An overview. J. Med. Pharm. Allied Sci. 2012, 1(1), 4–11. DOI: 10.55522/jmpas.V1I1.0002

10. Kolhe, S.; Chipade, M.; Chaudhari, P.D. Solubility and solubilization techniques – A review. Int. J. Pharm. Chem. Sci. 2012, 1(1), 129–150.

11. Jain, H.; Chella, N. Methods to improve the solubility of therapeutical natural products: A review. Environ. Chem. Lett. 2021, 19, 111–121. DOI: 10.1007/s10311-020-01082

12. Majeed, A.; Raza, S.N.; Khan, N.A. Hydrotrophy: Novel solubility enhancement technique: A review. Int. J. Sci. Prog. Res. 2019, 10(3), 1025–1036. DOI: 10.13040/IJPSR.0975-8232.10(3).1025-36

13. Joshi, J.; Nainwal, N.; Saharan, V.A. Review on hydrotropy: A potential approach for the solubility enhancement of poorly soluble drug. Asian J. Pharm. Clin. Res. 2019, 12(10), 19–26. DOI: 10.22159/ajpcr.2019.v12i10.34811

14. Shukla, R.S.; Patel, A.; Soni, M.L.; Modi, V.; Jaliwala, Y.A. Quantitative spectrophotometric estimation of cefadroxil using hydrotropic solubilization technique. Asian J. Pharm. 2008, 2(3). DOI: 10.4103/0973-8398.43298

15. Sharma, U.; Saroha, K. A review of hydrotropic solubilization techniques for enhancing the bioavailability of poorly soluble drugs. Int. J. Toxicol. 2024, 43(1), 63–71. DOI: 10.1177/10915818231216

16. Dhapte, V.; Mehta, P. Advances in hydrotropic solutions: An updated review. St. Petersbg. Polytech. Univ. J. Phys. Math. 2015, 1(4), 424–435. DOI: 10.1016/j.spjpm.2015.12.006.

17. Neha, S.; Sania, Z.S. Hydrotropy. Int. J. Pharm. Pharm. Res. 2011, 2, 471–481.

18. Khatri, H.; Hussain, M.S.; Tyagi, S. Solubility enhancement techniques: An overview. World J. Pharm. Res. 2022, 11, 468–482. DOI: 10.20959/wjpr20225-23812

19. Vemula, V.R.; Lagishetty, V.; Lingala, S. Solubility enhancement techniques. Int. J. Pharm. Sci. Rev. Res. 2010, 5(1), 41–51.

20. Cornell, J.A. The fitting of Scheffé-type models for estimating solubilities of multisolvent systems. J. Biopharm. Stat. 1991, 1(2), 303–329.

21. De Spiegeleer, B.; Wattyn, E.; Slegers, G.; Van der Meeren, P.; Vlaminck, K.; Van Vooren, L. The importance of the cosolvent propylene glycol on the antimicrobial preservative efficacy of a pharmaceutical formulation by DOE-ruggedness testing. Pharm. Dev. Technol. 2006, 11(3), 275–284. DOI: 10.1080/10837450600767342

22. Maheshwari, R.K. "Mixed-solvency approach"–Boon for solubilization of poorly water-soluble drugs. Asian J. Pharm. 2010, 4(1). DOI: 10.4103/0973-8398.63981

23. Maheshwari, R.K. Potentiation of solvent character by mixed solvency concept: A novel concept of solubilization. J. Pharm. Res. 2010, 3(2), 411–413.

24. Akinyelu, J.; Oladimeji, O.; Daniels, A.; Singh, M. Folate-targeted doxorubicin delivery to breast and cervical cancer cells using a chitosan-gold nano-delivery system. J. Drug Deliv. Sci. Technol. 2022, 67, Art. No: 102978. DOI: 10.1016/j.jddst.2021.102978

25. Maestri, G.; Boemo, R.L.; do Amaral Soares, L.; de Souza, A.A.; Immich, A.P. Development of drug reservoirs based on nanofibers and capsules for epistaxis treatment. J. Drug Deliv. Sci. Technol. 2020, 55, Art. No: 101398. DOI: 10.1016/j.jddst.2019.101398

26. Jacob, S.; Kather, F.S.; Boddu, S.H.; Attimarad, M.; Nair, A.B. Nanosuspension innovations: Expanding horizons in drug delivery techniques. Pharmaceutics 2025, 17(1), Art. No: 136. DOI: 10.3390/pharmaceutics17010136

27. Kumari, L.; Choudhari, Y.; Patel, P.; Gupta, G.D.; Singh, D.; Rosenholm, J.M.; Bansal, K.K.; Kurmi, B.D. Advancement in solubilization approaches: A step towards bioavailability enhancement of poorly soluble drugs. Life 2023, 13(5), Art. No: 1099. DOI: 10.3390/life13051099

Downloads

Published

2025-08-07

Issue

Section

Articles

How to Cite

Enhancing water solubility of a BCS Class II drug using hydrotropy, mixed solvency, co-solvency, and nanosuspension techniques. (2025). Prospects in Pharmaceutical Sciences, 23(4), 134-141. https://doi.org/10.56782/pps.500

Similar Articles

1-10 of 23

You may also start an advanced similarity search for this article.