• PRASENJIT SARKAR Department of Pharmaceutical Technology, Birbhum Pharmacy School, Bandhersole, Hetampur, Sadaipur, Birbhum, West Bengal, India.
  • SUTAPA BISWAS MAJEE Department of Pharmaceutical Technology, Division of Pharmaceutics, NSHM Knowledge Campus, Kolkata-Group of Institutions, Kolkata, West Bengal, India.



Carrier, Crospovidone, Hydrotrope, Skimmed milk, Solid dispersion, Solubility enhancement, Superdisintegrant, Ternary mixture, urea


Objective: Among the various strategies employed to enhance solubility, dissolution, and bioavailability of poorly soluble drugs in vivo, formulation of solid dispersion (SD) using hydrophilic and/or water-soluble carriers with varying physicochemical characteristics seems to be a developable, economically viable and easy option. The goal of the present study was to explore the possibilities of skimmed milk (SKM)-urea (U)-crospovidone (CP) as a novel ternary mixture of carrier-hydrotrope-superdisintegrant in SD of poorly water-soluble aceclofenac (ACF).

Methods: Compatibility of ACF and ternary mixture of SKM-U-CP was confirmed by FTIR spectroscopic analysis. SDs of ACF-SKM, ACF-SKM-U and ternary hydrotropic SD, and ACF-SKM-U-CP were prepared in varying ratios of 1:1–1: 5 for ACF-SKM; 1:5:0.5, 1:5:0.75, and 1:5:1 for ACF-SKM-U and 1:5:0.75:0.25–1:5:0.75:1 for ACF-SKM-U-CP by solvent evaporation technique and were characterized by their solubility enhancement (compared to pure drug) at 25°C and drug dissolution profiles in double-distilled water and phosphate buffer (pH 6.8).

Results: Based on solubility enhancement data (82.10% and 44.06%) and maximum cumulative percentage drug release data (88.45% in 9 min and 76.18% in 60 s) in double-distilled water and phosphate buffer, respectively, ACF-SKM-U(1:5:0.75) was found to the best among ACF-SKM and ACF-SKM-U SDs which were used for studying the effect of adding CP as superdisintigrant. ACF: SKM: U: CP (1: 5: 0.75: 0.50) exhibited maximum solubility enhancement of 83.92% and 49.69% and cumulative percentage release of 98.55 % in 9 min and 85.67 % in 60 s in double-distilled water and buffer, respectively.

Conclusion: Therefore, the novel ternary mixture of SKM-U-CP has demonstrated marginal superiority over SKM as carrier for from hydrotropic SDs of ACF.


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How to Cite

SARKAR, P., and S. BISWAS MAJEE. “FORMULATION DEVELOPMENT AND IN VITRO CHARACTERIZATION OF TERNARY HYDROTROPIC SOLID DISPERSIONS OF ACECLOFENAC”. Asian Journal of Pharmaceutical and Clinical Research, vol. 15, no. 9, Sept. 2022, pp. 174-9, doi:10.22159/ajpcr.2022.v15i9.45158.



Original Article(s)