Solubility Prediction of Lornoxicam in Different Pure Solvents Using Semi-Empirical Correlations and Thermodynamic Models

Abstract

The solubility data of Active Pharmaceutical Ingredients in organic solvents is an essential for pharmaceutical crystallization and drug formulation. In this work, two semi-empirical correlations- the Yaws model and λ-h model- and two thermodynamic models – Wilson Model and the Non-random two-liquid model- are used to estimate the solubility of lornoxicam in ethanol and water. The model parameters and correlations coefficients are calculated by optimizing the average relative deviation. The values of these parameters will be helpful to estimate the solubility of lornoxicam at different temperatures where the experimental solubility data is not available. The predicted solubility data of lornoxicam can be further utilized in the pharmaceutical crystallization and drug formulation.

Keywords

• Solubility
• Crystallization
• lornoxicam
• thermodynamic models
• mixing property

Supporting Institution

University of Petroleum & Energy Studies Dehradun

References

1. A. Dadej, A. Woźniak-Braszak, P. Bilski, H. Piotrowska-Kempisty, M. Józkowiak, A. Pawełczyk, D. Dadej, D. Łażewska, A. Jelińska, “Improved solubility of lornoxicam by inclusion into SBA-15: Comparison of loading methods,” Eur J Pharm Sci, 171, 106133, 2022.
2. E. Merisko-Liversidge, G.G. Liversidge, E.R. Cooper, “Nanosizing: A formulation approach for poorly-water-soluble compounds,” Eur J Pharm Sci, 18,113–120, 2003.
3. W. Wu, L. Wang, S. Wang, “Amorphous silibinin nanoparticles loaded into porous starch to enhance remarkably its solubility and bioavailability in vivo,” Colloids Surf. B: Biointerfaces, 198, 111474, 2021.
4. R.U. Khan, S.U. Shah, S.A. Rashid, F. Naseem K.U. Shah, A. Farid, K.R. Hakeem, M.R. Kamli, E.H. Althubaiti, S.A. Alamoudi, “Lornoxicam-Loaded Chitosan-Decorated Nanoemulsion: Preparation and In Vitro Evaluation for Enhanced Transdermal Delivery,” Polymers, 14, 1922, 2022.
5. N.T. Tung, T.H.Y. Dong, C.S. Tran, T.K.T. Nguyen, S.C. Chi, D.S. Dao, D.H. Nguyen, “Integration of lornoxicam nanocrystals into hydroxypropyl methylcellulose-based sustained release matrix to form a novel biphasic release system,” Int. J. Biol. Macromol., 209 , 441–451, 2022.
6. M.B. Zewail, G. F.Asaad, S.M. Swellam, S.M. Abd-allah, S. K.Hosny, S.K. Sallah, J. E.Eissa, S. S.Mohamed, W.A. El-Dakroury, “Design, characterization and in vivo performance of solid lipid nanoparticles (SLNs)-loaded mucoadhesive buccal tablets for efficient delivery of Lornoxicam in experimental inflammation,” Int. J. Pharm., 624, 122006, 2022.
7. H. Chen, J. Zhang, Q. Qiao, E. Hu, Y. Wei, Z. Pang, Y. Gao, S. Qian, J. Zhang, W. Heng, “A novel soluble lornoxicam-sodium chelate monohydrate with improved plasticity and tabletability,” Int. J. Pharm., 624, 122060 2022.
8. S.R. Yarraguntla, V. Enturi, R. Vyadana, S. Bommala, “Formulation and evaluation of lornoxicam nanocrystals with different stabilizers at different concentrations,” Asian J. Pharm., 10, 198–207, 2016.

9. P. Zhang, Y. Wan, C. Zhang, R. Zhao, J. Sha, Y. Li, T. Li, B. Ren, “Solubility and mixing thermodynamic properties of levamisole hydrochloride in twelve pure solvents at various temperatures,” J. Chem. Thermodyn, 139, 105882, 2019.
10. Y. Hu, Z. Cui, J. Ye, L. Yao, Z. Wang, T. Wang, “Determination and analysis of solubility of l-prolinamide in ten pure solvents and three binary solvent mixtures at different temperatures (T = 278.15-323.15 K),” J. Chem. Eng. Data, 66, 1172–1184, 2021.
11. K. Wu, Y. Li, “Solubility and solution thermodynamics of p-toluenesulfonamide in 16 solvents from T = 273.15 to 324.75 K,” J. Mol. Liq., 293, 111577, 2019.
12. C. Ren, Y. Bao, Y. Wang, H. Zhao, “Equilibrium Solubility of p-Nitroacetanilide in Fifteen Neat Solvents: Determination, Correlation, and Solvent Effect,” J. Chem. Eng. Data., 67, 267–275, 2022.
13. F. Shakeel, N. Haq, F.K. Alanazi, I.A. Alsarra, “Solubility of anti-inflammatory drug lornoxicam in ten different green solvents at different temperatures,” J. Mol. Liq., 209 280–283, 2015
14. B E Poling, J M Prausnitz, J P O’Connell, “The properties of gases and liquids,” 5th ed., McGraw Hill, 2001.
15. M. Kharwade, G. Achyuta, C.V.S. Subrahmanyam, P.R.S. Babu, “Solubility behavior of lornoxicam in binary solvents of pharmaceutical interest,” J. Solution Chem, 41, 1364–1374, 2012.
16. M. Nijhawan, A. Santhosh, P.R.S. Babu, C.V.S. Subrahmanyam, “Solid state manipulation of lornoxicam for cocrystals-physicochemical characterization,” Drug Dev. Ind. Pharm., 40 ,1163–1172, 2013.
17. W. Kui, L. Yajun, “Solid-liquid phase equilibrium and solution thermodynamics of 2-chlorobenzenesulfonamide in 16 monosolvents at temperature ranging from 273.15 K to 324.65 K, ” J. Mol. Liq., 304, 112795, 2020