The author provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or drug product, and avoiding negative product regulation late in the development and/or marketing process, including expensive recalls.
High-throughput platforms can be used to develop tertiary phase diagrams, which can be leveraged to identify the most stable SEDDS formulations and excipients for lipid-based drug delivery systems.
Technological advancements can address the formulation and dissolution challenges of HPMC polymers.
In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.
Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.
An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.
New therapies, new technologies, global supply chain challenges, and political pressures draw pharma professionals to major industry event.
Click the title above to open the Pharmaceutical Technology APIs, Excipients, and Manufacturing 2019 in an interactive PDF format.
