Investigation of magnesium aluminometasilicate (Neusilin US2) based surface solid dispersion of sorafenib tosylate using QbD approach: In vitro and in vivo pharmacokinetic study.
| Autor: | Panda BK; Department of Pharmacy Practice, Krishna Institute of Pharmacy, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad, Maharashtra, India., Chellampillai B; Department of Pharmaceutics, Goa College of Pharmacy, Goa University, Panaji, Goa, India., Ghodake S; Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, India., Mali AJ; Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, India., Kamble R; Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, India. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | ADMET & DMPK [ADMET DMPK] 2024 Aug 09; Vol. 12 (4), pp. 687-702. Date of Electronic Publication: 2024 Aug 09 (Print Publication: 2024). |
| DOI: | 10.5599/admet.2338 |
| Abstrakt: | Background and Purpose: Sorafenib tosylate (SFN), a potent multikinase inhibitor, is used for the treatment of various cancers. However, it shows limited therapeutic applications due to its poor biopharmaceutical properties. The aim of the present investigation is to develop surface solid dispersion (SSD) of SFN using adsorbent to improve its solubility, bioavailability and therapeutic efficacy. Experimental Approach: The SFN-SSD was prepared by modified solvent evaporation technique using Neusilin US2 (magnesium aluminometasilicate) as an adsorbent and sodium dodecyl sulphate as a surfactant. SFN-SSD was optimized by adopting the design of experiment (DOE) using 3 2 factorial designs and characterized in terms of in-vitro and in-vivo efficacy. Key Results: The obtained SFN-SSD showed more than 20-fold improvement in SFN solubility. The FTIR depicted hydrogen bonding between SFN and Neusilin. Further, PXRD and DSC indicated the molecular dispersion of SFN to be amorphous. SFN-SSD and SFN immediate release tablets reflected cumulative release of 97.13 and 29.93 % in 1 h. The pharmacokinetics study of SFN-SSD showed 2 and 6.5-fold improvement in maximum concentration ( C Conclusion: The study concluded that the SSD could be a scalable formulation approach and more industry-friendly technology to improve the biopharmaceutical properties of SFN. Competing Interests: Conflict of interest: The authors declare no conflict of interest, financial or otherwise. (Copyright © 2024 by the authors.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|