Pharmaceutical Technology-10-01-2019

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.

Pharmaceutical Technology

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.

Pharmaceutical Technology

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.

Pharmaceutical Technology

This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.

Pharmaceutical Technology

Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.

Pharmaceutical Technology

An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.

Pharmaceutical Technology

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.