Drug Development

Articles

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

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

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.

Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure

The author describes how Merrion Pharmaceuticals reformulates parenteral drugs into tablets and capsules that are easier for patients to take and provide better bioavailability.

From Needle to Pill: Reformulating Injectable Drugs for Oral Delivery

New nanotechnology-based delivery systems offer promise in drug delivery, particularly for anticancer therapeutics.

Delivering the Results in Drug-Based Nanotechnology

Tina S. Morris, PhD, is vice president of Biologics & Biotechnology at United States Pharmacopeia (USP) 

USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.

APIs and Excipients