Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

A spate of drugs are scheduled to come off patent, offering vast potential and competition.

Favorable Outlook for Generic APIs

Catalytic routes to producing atorvastatin and sitagliptin are recent advancements.

Improving Routes in API Manufacturing

Nanotechnology is emerging as a tool for resolving challenges in delivering poorly water soluble and highly potent drugs.

Nanotechnology Advances in Drug Delivery

Reflecting strong growth prospects for certain biologic-based drugs, the biotechnology and pharmaceutical majors are proceeding with a strategy of expanding their internal manufacturing networks and partnering with select contract manufacturing organizations (CMOs).

Mapping a Biologics Supply Strategy

Excipients facilitate formulation design and perform a wide range of functions to obtain desired properties for the finished drug product. The article reviews excipient development and functionality of these materials, including their importance in formulation design, potential processing challenges directly related to excipients, and therapeutic benefits.

Review of Current Issues in Pharmaceutical Excipients

The pharmaceutical majors build their capabilities in peptide technology, and contract manufacturers expand to meet growing demand for bulk peptides.

Advancing the Peptide Pipeline

San Juan, PR (Apr. 25)-Regulatory and quality issues were prominent discussion topics at this year?s ExcipientFest conference and exhibition.

ExcipientFest Attendees Discuss Regulatory and Quality Concerns

Brussels, Belgium (Mar. 22)-The European Commission?s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.

EC Plans Directive on GMPs for Excipients

China creates a potential outlet for specialty excipients as its pharmaceutical market grows.

Expanding Opportunities for Specialty Excipients

The pharmaceutical supply chain lengthens as generic drug manufacturers build production platforms offshore and CMOs position in India and China to meet demand for lower-cost production.

APIs and Excipients