期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 105, 期 8, 页码 2260-2269出版社
WILEY
DOI: 10.1016/j.xphs.2016.05.024
关键词
Biopharmaceutics Classification System; formulation; bioavailability; amorphous; solid dispersion
资金
- University of Nottingham Doctoral Training Centre in Targeted Therapeutics and Formulation Science
- Juniper Pharmaceutical Services
- EPSRC [EP/I01375X/1]
- Engineering and Physical Sciences Research Council [1365655] Funding Source: researchfish
The need for solubility enhancement through formulation is a well-known but still problematic issue because of the numbers of poorly water-soluble drugs in development. There are several possible routes that can be taken to increase the bioavailability of drugs intended for immediate-release oral formulation. The best formulation strategy for any given drug will depend on numerous factors, including required dose, shelf life, manufacturability, and the properties of the active pharmaceutical ingredient (API). Choosing an optimal formulation and manufacturing route for a new API is therefore not a straightforward process. Currently, there are several approaches that are used in the pharmaceutical industry to select the best formulation strategy. These differ in complexity and efficiency, but most try to predict which route will best suit the API based on selected molecular parameters such as molecular weight, lipophilicity (logP), and solubility. These methods range from using no tools, trial and error methods through a variety of complex tools from small in vitro or in vivo experiments or high throughput screening, guidance maps, and decision trees to the most complex methods based on computational modelling tools. This review aims to list available support tools and explain how they are used. (C) 2016 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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