Abstract
Many active pharmaceutical ingredients (APIs) can exist in more than one solid-state form, including crystalline polymorphs, solvates, salts, cocrystals, and noncrystalline or amorphous solids (Fig. 1; Table 1). Hence, assessment and control of the solid-state structure of APIs is necessary to ensure efficient and reproducible processing, manufacturing, and storage; to satisfy regulatory authorities; to protect intellectual property; and ultimately to deliver safe, effective, and high-quality medicinal products. This section introduces key practical aspects of solid-state pharmaceuticals, with a specific emphasis on crystalline solids and their preparation, handling, and analysis, particularly in the context of preclinical drug development and pharmaceutical manufacture.
Original language | English |
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Title of host publication | Modern pharmaceutics, Fifth Edition |
Place of Publication | New York, USA |
Publisher | Informa Healthcare |
Number of pages | 500 |
Volume | 1 |
ISBN (Print) | 9781420065657 |
Publication status | Published - May 2009 |
Keywords
- solid state
- drug delivery
- excipients
- tablets
- aerosols
- techniques
- pharmaceuticals
- drug absorption
- pharmacokinetics
- dose forms
- preformulation
- optimization
- systems
- release
- bioequivalence
- processes
- products
- pharmaceutics
- personalized medicines
- evaluation
- physics
- in vivo imaging
- biotechnology