title: Solid form screening--a review.
abstract: Solid form screening, the activity of generating and analysing different solid forms of an active pharmaceutical ingredient (API), has become an essential part of drug development. The multi-step screening process needs to be designed, performed and evaluated carefully, since the decisions made based on the screening may have consequences on the whole lifecycle of a pharmaceutical product. The selection of the form for development is made after solid form screening. The selection criteria include not only pharmaceutically relevant properties, such as therapeutic efficacy and processing characteristics, but also intellectual property (IP) issues. In this paper, basic principles of solid form screening are reviewed, including the methods used in experimental screening (generation, characterisation and analysis of solid forms, data mining tools, and high-throughput screening technologies) as well as basics of computational methods. Differences between solid form screening strategies of branded and generic pharmaceutical manufacturers are also discussed.
authors: School of Pharmacy, University of Otago, Dunedin, New Zealand. jaakko.aaltonen@otago.ac.nz
authors: Jaakko
authors: J
authors: Aaltonen
authors: Morten
authors: M
authors: Allesø
authors: Sabiruddin
authors: S
authors: Mirza
authors: Vishal
authors: V
authors: Koradia
authors: Keith C
authors: KC
authors: Gordon
authors: Jukka
authors: J
authors: Rantanen
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D004304:Dosage Forms; D015195:Drug Design; D016568:Drugs, Generic / Q000737:chemistry; D018973:Intellectual Property; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D004304:Dosage Forms; D016568:Drugs, Generic; D004364:Pharmaceutical Preparations