Format

Send to

Choose Destination
See comment in PubMed Commons below
Drug Discov Today. 2003 Oct 1;8(19):898-905.

Solid-state analysis of the active pharmaceutical ingredient in drug products.

Author information

1
SSCI, West Lafayette, IN 47906, USA. anewman@ssci-inc.com

Abstract

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.

PMID:
14554018
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Support Center