Another key aspect of excipient selection in new solubilization technologies is the structure-property correlation in the formulation. Current excipient selection is often empirical or semi-empirical. The interaction of excipients with drug in the formulation is poorly understood and development of the in vitro/in vivo correlation still remains an obstacle to the new solubilization technology based formulations. With more understanding of interactions of the drug with excipients in the formulation and the drug/excipients with the gastrointestinal tract environment, it could be possible in the future to establish structure-property correlation in the new techniques based formulations.

References

1. Lipinski CA, Lombardo F, Dominy BW, Feeney PJ 2001. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Advanced Drug Delivery Reviews 46 46:3-26.

3. Porter CJH, Trevaskis NL, Charman WN 2007. Lipids and lipid-based formulations: optimizing the oral delivery of lipophilic drugs. Nat Rev Drug Discovery FIELD Full Journal Title:Nature Reviews Drug Discovery 6(3):231-248.

4. Mullertz A 2007. Lipid-based drug delivery systems: choosing the right in vitro tools. Am Pharm Rev FIELD Full Journal Title:American Pharmaceutical Review 10(4):102,104,106-110.

5. Augustijns P, Brewster ME Supersaturating drug delivery systems: Fast is not necessarily good enough. Journal of Pharmaceutical Sciences:No pp yet given.

6. Brouwers J, Brewster ME, Augustijns P 2009. Supersaturating drug delivery systems: The answer to solubility-limited oral bioavailability? Journal of Pharmaceutical Sciences 98(8):2549-2572.

7. Gao P, Akrami A, Alvarez F, Hu J, Li L, Ma C, Surapaneni S 2009. Characterization and optimization of AMG 517 supersaturatable self-emulsifying drug delivery system (S-SEDDS) for improved oral absorption. Journal of pharmaceutical sciences 98(2):516-528.

8. Gao P, Rush BD, Pfund WP, Huang T, Bauer JM, Morozowich W, Kuo M-s, Hageman MJ 2003. Development of a supersaturable SEDDS (S-SEDDS) formulation of paclitaxel with improved oral bioavailability. Journal of pharmaceutical sciences 92(12):2386-2398.

9. Dai W-G, Dong LC, Creasey AA Inhibiting the precipitation of poorly water-soluble drugs from Labrasol formulations. Pharmaceutical Technology 35(6):50-54.

10. Dai W-G, Dong LC, Li S, Deng Z 2008. Combination of Pluronic/Vitamin E TPGS as a potential inhibitor of drug precipitation. Int J Pharm FIELD Full Journal Title:International Journal of Pharmaceutics 355(1-2):31-37.

11. Li S, Pollock-Dove C, Dong LC, Chen J, Creasey AA, Dai W-G Enhanced bioavailability of a poorly water-soluble weakly basic compound using a combination approach of solubilization agents and precipitation inhibitors: A case study. Molecular Pharmaceutics 9(5):1100-1108.

12. Chiow WL, Riegelman S 1971. Pharmaceutical applications of solid dispersion systems. Journal of Pharmaceutical Sciences 60(9):1281-1302.

13. Hancock BC, Zografi G 1994. The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids. Pharmaceutical research 11(4):471-477.

14. Hatley RHM 1997. Glass fragility and the stability of pharmaceutical preparations-excipient selection. Pharmaceutical Development and Technology 2(3):257-264.

15. Vasanthavada M, Tong W-q, Serajuddin ATM 2008. Development of solid dispersion for poorly water-soluble drugs. Water-Insoluble Drug Formulation (2nd Edition):499-529.

16. Dai W-G, Pollock-Dove C, Dong LC, Li S 2008. Advanced screening assays to rapidly identify solubility-enhancing formulations: High-throughput, miniaturization and automation. Adv Drug Delivery Rev FIELD Full Journal Title:Advanced Drug Delivery Reviews 60(6):657-672.