Research Article Volume 13 Issue 8 - 2025

Formulation of Naringin Solid Dispersion-Based Gel for Enhanced Solubility and Drug Release

G Naveena, Narasimha Golla, Valathuru Chiranjeevi, A Supriya and Y Sarah Sujitha*

Department of Regulatory Affairs, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh, India

*Corresponding Author: Y Sarah Sujitha, Department of Regulatory Affairs, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh, India.
Received: July 08, 2025; Published: August 01, 2025



Naringin, a natural bioflavonoid known for its therapeutic potential, faces problems in clinical use due to its low solubility. To address this, a topical gel was developed by using solid dispersions aimed at increasing both solubility and effectiveness. This was prepared using the kneading method and evaluated. Among the various formulations tested, F4 showed the highest drug release (98.6%), making it the most promising candidate. This optimized dispersion was then incorporated into a topical gel and evaluated. The final gel formulation (X5) exhibited a pH of 5.5, high drug content (98.6%), and a controlled release profile. Stability studies conducted over a period of 30 and 90 days, which demonstrated consistent physicochemical properties, with no observable changes in pH, drug content. These indicate that the developed solid dispersion gel has enhanced solubility and therapeutic use, offering an approach for topical drug delivery with the potential to improve patient adherence and clinical efficacy.

 Keywords: Naringin; Solubility; Kneading; Efficacy; Stability; In Vitro Studies

  1. Singh., et al. “Evaluation of enhancement of solubility of Paracetamol by solid dispersion technique using different polymers concentration”. Asian Journal of Pharmaceutical and Clinical Research 4.1 (2011): 117-119.
  2. M Sugwara., et al. “The use of in vitro dissolution and absorption system to evaluate oral absorption of two weak bases in pH-independent controlled-release formulations”. European Journal of Pharmaceutical Sciences 1 (2005): 1-8.
  3. J Desai., et al. “Characterization of polymeric dispersions of Dimenhydrinate in ethyl cellulose for controlled release”. International Journal of Pharmaceutics 1-2 (2006): 115-123.
  4. K Dhirendra., et al. “Solid dispersions: an overview”. Pakistan Journal of Pharmaceutical Sciences 2 (2009): 234-246.
  5. A Lipinski. “Avoiding investment in doomed drugs: is poor solubility an industry-wide problem?”. Current Drug Discovery Technologies 4 (2001): 17-19.
  6. WL Chiou., et al. “Increased dissolution rates of water-insoluble cardiac glycosides and steroids via solid dispersions in PEG-6000”. Journal of Pharmaceutical Sciences 10 (1971): 1569-1571.
  7. N Pouton. “Formulation of poorly water-soluble drugs for oral administration: Physicochemical and physiological issues and the lipid formulation classification systems”. European Journal of Pharmaceutical Sciences 3-4 (2006): 278-287.
  8. T Vasconcelos., et al. “Solid dispersions as a strategy to improve the bioavailability of poorly water-soluble drugs”. Drug Discovery Today 23-24 (2007): 1068-1075.
  9. JH Fincher. “Particle size of drugs and its relationship to absorption and activity”. Journal of Pharmaceutical Sciences 11 (1968): 1825-1835.
  10. K Sekiguchi., et al. “Studies on absorption of eutectic mixtures I. A comparison of the behaviour of eutectic mixture of sulphathiazole in man”. Chemical and Pharmaceutical Bulletin 11 (1961): 866-872.
  11. JL Kanig. “Properties of fused mannitol in compressed tablets”. Journal of Pharmaceutical Sciences 2 (1964): 188-192.
  12. H Goldberg., et al. “Increasing dissolution rates and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures III: experimental evaluation of griseofulvin-succinic acid solid solution”. Journal of Pharmaceutical Sciences 5 (1966): 487-492.
  13. H Goldberg., et al. “Increasing dissolution rate and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures I: theoretical considerations and discussion of the literature”. Journal of Pharmaceutical Sciences 8 (1965): 1145-1148.
  14. RP Rastogi., et al. “Solid-liquid equilibria in solutions of nonelectrolytes”. Journal of the Chemical Society 2 (1956): 2097-2101.
  15. H Sekikana., et al. “Dissolution mechanisms of drug-polyvinyl pyrrolidone coprecipitates in aqueous solutions”. Chemical and Pharmaceutical Bulletin 5 (1979): 1223-1230.
  16. J Breitenbach. “Melt extrusion: from process to drug delivery technology”. European Journal of Pharmaceutics and Biopharmaceutics 2 (2002): 107-117.
  17. KS Sharma., et al. “Solid dispersions: a technology for improving bioavailability”. Journal of Analytical and Pharmaceutical Research 4 (2019).
  18. S Ravetti., et al. “Naringin: Nanotechnological strategies for potential pharmaceutical applications”. Pharmaceutics3 (2023): 863.
  19. R Malkawi., et al. “Current trends on solid dispersions: Past, present, and future”. Advances in Pharmacological and Pharmaceutical Sciences (2022): 5916013.
  20. P Mallya., et al. “A novel stability indicating RP-HPLC method for the simultaneous estimation and in vitro and in vivo evaluation: Curcumin and Naringin co-amorphous system”. Food Analytical Methods 17 (2024): 751-765.
  21. T Vasconcelos., et al. “Solid dispersions as strategy to improve oral bioavailability of poor water-soluble drugs”. Drug Discovery Today 23-24 (2007): 1068-1075.
  22. , et al. “Assessing the performance of amorphous solid dispersions”. Journal of Pharmaceutical Sciences 101.4 (2011): 1355-1377.
  23. TT Pham., et al. “Development of solid dispersion lipid nanoparticles for improving skin delivery”. Journal of Drug Delivery Science and Technology7 (2019): 1019-1024.
  24. S Lakhsmi., et al. “Formulation and evaluation of topical gels incorporated with solid dispersions of an anti-inflammatory drug”. Journal of Innovations in Applied Pharmaceutical Science (JIAPS) 3-S (2023): 114-119.
  25. P Simonelli., et al. “Dissolution rates of high-energy polyvinylpyrrolidone-sulfathiazole coprecipitates”. Journal of Pharmaceutical Sciences 5 (1969): 538-549.
  26. M Sarkari., et al. “Enhanced drug dissolution using evaporative precipitation into aqueous solution”. International Journal of Pharmaceutics 1-2 (2002): 17-31.
  27. M Jafar., et al. “Enhancement of dissolution and anti-inflammatory effect of meloxicam”. International Journal of Applied Pharmaceutics 2 (2010): 231-238.
  28. , et al. “Characterization of nifedipine solid dispersions”. International Journal of Pharmaceutics 242.1-2 (2002): 313-317.
  29. KH Froemming., et al. “Problems of preparation, processing and storage of melt embedded PEG products”. Pharmaceutical Industry 40 (1978): 967-970.
  30. K Singla., et al. “Dissolution of sulfamethoxazole from polyethylene glycols and PVP solid dispersions”. Drug Development and Industrial Pharmacy 16 (1990): 875-882.
  31. M Fernandez., et al. “Characterization of solid dispersions of piroxicam/PEG 4000”. International Journal of Pharmaceutics 2 (1992): 197-202.
  32. Forster., et al. “Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis”. International Journal of Pharmaceutics 226.1-2 (2001): 147-161.

Y Sarah Sujitha., et al. “Formulation of Naringin Solid Dispersion-Based Gel for Enhanced Solubility and Drug Release”. EC Pharmacology and Toxicology  13.8 (2025): 01-12.