Dissolution of Amorphous Solid Dispersions: Theory and Practice

作者: Nikoletta Fotaki , Chiau Ming Long , Kin Tang , Hitesh Chokshi

DOI: 10.1007/978-1-4939-1598-9_15

关键词: Materials scienceDissolution testingWeak baseAmorphous solidDissolutionDispersion (chemistry)Dosage formPrecipitation (chemistry)SupersaturationChemical engineering

摘要: Dissolution test is an extremely valuable and powerful tool in understanding the parameters that control dissolution of amorphous formulations as well revealing supersaturation effect solid-state transformations might occur after oral administration. Supersaturated/non-sink biorelevant conditions could guide designing solid dispersion order to select optimal polymer(s), drug loading, downstream processing for desired vivo performance shelf life stability. The focus this chapter review describe different models being used characterize dosage forms containing drugs aqueous media. case studies weak base, acid, neutral compounds are presented, illustrating a rational approach development implementation characteristics product performance. Finally, successful vitro–in correlations presented. This can serve guidance dispersions.

参考文章(92)
Wei‐Guo Dai, Liang C. Dong, Xinfeng Shi, Joe Nguyen, Juli Evans, Yaodong Xu, Abla A. Creasey, Evaluation of drug precipitation of solubility‐enhancing liquid formulations using milligram quantities of a new molecular entity (NME) Journal of Pharmaceutical Sciences. ,vol. 96, pp. 2957- 2969 ,(2007) , 10.1002/JPS.20886
R. J. Davey, K. Allen, N. Blagden, W. I. Cross, H. F. Lieberman, M. J. Quayle, S. Righini, L. Seton, G. J. T. Tiddy, Crystal engineering – nucleation, the key step CrystEngComm. ,vol. 4, pp. 257- 264 ,(2002) , 10.1039/B203521A
Amin A. Elamin, Claes Ahlneck, Göran Alderborn, Christer Nyström, Increased metastable solubility of milled griseofulvin, depending on the formation of a disordered surface structure International Journal of Pharmaceutics. ,vol. 111, pp. 159- 170 ,(1994) , 10.1016/0378-5173(94)00132-4
Devalina Law, Eric A. Schmitt, Kennan C. Marsh, Elizabeth A. Everitt, Weili Wang, James J. Fort, Steven L. Krill, Yihong Qiu, Ritonavir–PEG 8000 amorphous solid dispersions: In vitro and in vivo evaluations Journal of Pharmaceutical Sciences. ,vol. 93, pp. 563- 570 ,(2004) , 10.1002/JPS.10566
Edmund S. Kostewicz, Martin Wunderlich, Ulrich Brauns, Robert Becker, Thomas Bock, Jennifer B. Dressman, Predicting the precipitation of poorly soluble weak bases upon entry in the small intestine Journal of Pharmacy and Pharmacology. ,vol. 56, pp. 43- 51 ,(2010) , 10.1211/0022357022511
Piyush Gupta, Vasu Kumar Kakumanu, Arvind K. Bansal, Stability and solubility of celecoxib-PVP amorphous dispersions: a molecular perspective. Pharmaceutical Research. ,vol. 21, pp. 1762- 1769 ,(2004) , 10.1023/B:PHAM.0000045226.42859.B8
Abu T.M. Serajuddin, Solid dispersion of poorly water‐soluble drugs: Early promises, subsequent problems, and recent breakthroughs Journal of Pharmaceutical Sciences. ,vol. 88, pp. 1058- 1066 ,(1999) , 10.1021/JS980403L
Arthur H. Goldberg, Milo Gibaldi, Joseph L. Kanig, Increasing Dissolution Rates and Gastrointestinal Absorption of Drugs Via Solid Solutions and Eutectic Mixtures I Journal of Pharmaceutical Sciences. ,vol. 54, pp. 1145- 1148 ,(1965) , 10.1002/JPS.2600540810
Paolo M. Ossi, Structural changes induced by swift heavy ions in non-metallic compounds Nuclear Instruments & Methods in Physics Research Section B-beam Interactions With Materials and Atoms. ,vol. 209, pp. 55- 61 ,(2003) , 10.1016/S0168-583X(02)02060-8