Development

Articles

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

IPEA Excipient GMP Certification Program

The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Flexible Approaches to Accommodate Excipient Variability Using the Principles of QbD

Brigitte Skalsky is with Degussa Pharma Polymers, Kirschenallee, D-64293 Darmstadt, Germany.

The authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Controlling the Release of Highly Dosed and Highly Soluble Drugs

Why spray drying processes offer a range of particle engineering possibilities.

The possibilities and challenges of spray drying

Dr Jean-Paul Rila is Regulatory Affairs Manager at NOTOX BV (The Netherlands).

Dr Marie-Elene Y. Boivin is Section Head Regulatory Affairs at NOTOX BV (The Netherlands).

The pharmaceutical industry must understand its responsibilities to improve the safety of chemicals as defined by the REACH initiative.

REACH: has the cloud of confusion cleared?

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

Week Of April 26, 2010: Company And People Notes: Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The Society of Chemical Manufacturers and Affiliates is raising concerns over a recently introduced bill in the US Senate, which seeks to reform the Toxic Substances Control Act.

SOCMA Raises Concerns about Toxic-Substances Reform Bill

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

Week Of April 19, 2010: Company And People Notes: FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the April 2010 edition from Camfil Farr and K-Tron.

April 2010 Editor's Picks: Products from Camfil Farr and K-Tron

Cephalon Completes Acquisition of Mepha; Xcellerex Appoints President and CEO; and More.

Ingredients