Formulation and Drug Delivery

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business during the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.

Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.

Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.

The authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.

Are biosimilars the next big thing or just the next big bubble?

O-arylation and O-alkylation, a one-pot protein synthesis, a combined approach in continued and chemocatalysis, and green-chemistry applications are the target of some recent advances in API synthesis.

New studies reveal the promise and feasibility of transdermal vaccine delivery.

Terry Novak, president of Norwich Pharmaceuticals, on recent industry trends.

A path to personalized medicines creates a new paradigm for development and manufacturing.

The article examines a cross-functional supplier integration model to facilitate project management.

Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.

The article examines the drivers of customer perception of contract service providers of pharmaceutical development and manufacturing.

An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.

FDA Approves the Influenza Vaccine Formulation for the 2011-2012 Flu Season.

A bill introduced by Senators Scott Brown (R-MA), Ron Wyden (D-OR), and John McCain (R-AZ) on July 13, 2011, aims to encourage states to reduce Medicaid spending by offering financial incentives to substitute generic drugs for branded ones where possible.

Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.

FDA, in cooperation with IPEC, is building a spectral library of excipients to detect improper ingredients within a drug product on site.

The performance of biotechnology venture capital and investment is lackluster at best.

A new report places pharmaceutical and healthcare companies ahead in corporate and social governance.

Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.

High demand could lead to innovation in controlled-release injectables.

Pharmaceutical manufacturers look to various solutions to resolve the challenge of poorly soluble drugs

The authors investigate the influence of hydro-alcoholic media on hydration and drug release from polyethylene oxide extended-release matrices.

The current review describes the role and selection of excipients, pellet core, coating materials, and compression with various cushioning agents.