The use of Cyclodextrin-SLS-PEG 4000 Complex to Solubilize Three BCS Class II and IV Drug´S through A Factorial Study Design

Abstract

Objective: Drugs classified as Class II and IV on the Biopharmaceutical Classification System are commonly associated with solubility challenges. This research aims to investigate the impact of cyclodextrin combined with both PEG 4000 and SLS, individually and in combination, on the enhancement of solubility and dissolution rate of three drugs belonging to BCS Class II (celecoxib and Valsartan) and Class IV (Furosemide). Methods: A series of 23 factorial experiments were conducted to assess drug solubility in eight selected fluids containing Beta Cyclodextrin, Poly Ethylene Glycol 4000, Sodium Lauryl Sulphate, both separately and in binary and ternary combinations. Solid inclusion complexes of each drug with beta Cyclodextrin, PEG 4000 and SLS were prepared using the kneading method. The impact of each excipient on dissolution rates was evaluated through a23 factorial design. Results: The presence of the studied excipients significantly improved the solubility of the three drugs under investigation. Celecoxib solubility was highly enhanced by Cyclodextrin combined toPEG 4000 and SLS(2,77 ratio). Furosemide solubility was highly enhanced by Cyclodextrin combinedto SLS (ac) (2,96 ratio). And valsartan solubility by beta cyclodextrin combined to PEG 4000 and SLS(2,43 ratio). Among dissolution rates, the addition of PEG 4000 and SLS alongside Cyclodextrin led to even more substantial improvements: 14.96-ratio and 7.34-ratio enhancements, respectively on celecoxib dissolution rates, and 9,22-ratio and 11,73-ratio increases, respectively, for furosemide dissolution rates, then.2,09-ratio and 1,88-ratio, respectively on valsartan dissolution rates. Conclusion: Sodium Lauryl Sulphate demonstrates efficacy as a solubilizer both independently and in conjunction with ßCD and PEG 4000, effectively enhancing the solubility and dissolution rate of the selected BCS Class II and IV drugs.