APIs and Excipients

Is There A Need For Stringent Regulations For Excipients?

January 07, 2011

Pharmaceutical Technology Europe

Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.

Exploring Custom Synthesis

January 02, 2011

Contract manufacturers strengthen their toolboxes and partnerships as they navigate the changing drug-development model.

Pharmaceutical Technology Europe

The Criticality Of Excipient Purity

January 01, 2011

Excipient purity is critical in all applications of drug formulation. Typically, the more sensitive or reactive an API, the more critical excipient purity becomes.

Advances in Small-Molecule Synthesis

December 02, 2010

Approaches in cyclization, palladium-catalyzed cross couplings, fluorination, and natural product synthesis help to optimize routes for select drugs.

Inside IPEC: Global Initiatives to Expand to Latin America

December 02, 2010

IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.

Formulation Development Forum: Abuse-deterrent combination drugs

November 02, 2010

Abuse-deterrent combination drugs represent a niche area in formulation development.

Advances in Solid-State Chemistry

November 02, 2010

Industrial and academic partnerships forge new territory in solid-state chemistry.

Solutol HS15 as a Novel Excipient

November 02, 2010

The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.

Q&A with Stuart Needleman, Aptuit

November 02, 2010

Stuart Needleman, president of active-ingredient development and manufacturing at Aptuit, discusses industry trends and challenges.

Risk Mitigation in High-Potency Manufacturing

October 02, 2010

A recently released industry guide outlines a science- and risk-based approach to control the risk of cross-contamination.