Solid-state analysis of the active pharmaceutical ingredient in drug products.
The solid form of a drug substance is important when developing a new chemical entity. The crystalline form used in development is significant based on possible manufacturability, solubility, bioavailability and stability differences between the solid forms. Regulatory issues require that the form present in a solid dosage form or liquids containing undissolved drug substance be identified. Drug product samples can be analyzed by a variety of techniques to determine the crystal form present or changes that occur during the manufacture of a drug product. The form present will affect development, regulatory and intellectual property issues.
Newman
Ann W
AW
SSCI, West Lafayette, IN 47906, USA. anewman@ssci-inc.com
Byrn
Stephen R
SR
D002626:Chemistry, Pharmaceutical; D003460:Crystallization; D004304:Dosage Forms; D004355:Drug Stability; D004356:Drug Storage; D009682:Magnetic Resonance Spectroscopy; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D013055:Spectrophotometry, Infrared; D013059:Spectrum Analysis, Raman; D014961:X-Ray Diffraction
D004304:Dosage Forms; D004364:Pharmaceutical Preparations