Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

PAT: A New Dawn for Drug Product Quality

The authors sought to improve the productivity of protein synthesis by using a highly active cell-free extract from Escherichia coli and by optimizing buffer conditions and shaking conditions.

Large-Scale Protein Production with a Cell-Free System

Leading experts share insight on polymorphism and crystallization.

Solid-State Chemistry: A Technical Forum

The authors discuss a study that demonstrates the use of polyethylene oxide mixtures to investigate the effect of polymer viscosity on formulation robustness.

Using Polyethyline Oxide Blends to Assess the Effect of Excipient Variability

In response to a request from the FDA, the US Pharmacopeial Convention (USP) has revised its standards for propylene glycol and sorbitol solution, excipients widely used in prescription and over-the-counter drugs.

USP revises excipient standards to limit contamination

In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution

USP Revises Excipient Standards to Limit Contamination

Functionalized supramolecular catalysts and an enantioselective route to unnatural amino acids are some recent developments.

Advancing Chiral Chemistry in API Synthesis

A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.

Whatever Happened to Classical Chemistry?

The authors explain a process for moisture-activated dry granulation in detail and provide guidance for the selection of excipients and equipment.

Moisture-Activated Dry Granulation—Part I: A Guide to Excipient and Equipment Selection and Formulation Development

Ranga Velagaleti is the manager of laboratory and stability at BASF Corporation, 8800 Line Ave., Shreveport, LA 71106, tel. 318.861.8040, fax 318.861.8004, velagar1@basf-corp.com

Christopher C. DeMerlis is a regulatory affairs manager at Colorcon, a division of Berwind Pharmaceutical Services, Inc., 415 Moyer Blvd., West Point, PA 19486, tel. 215.661.2766, fax 215.661.2778.

William Brock, PhD, is principal of Brock Scientific Consulting.

Robert Osterberg, PhD, is a senior consultant of pharmacology/toxicology at Aclairo PDG.

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.

APIs and Excipients