Formulation and Drug Delivery

The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.

In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.

The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.

A Q&A with John Plachetka, chair, president, and CEO of POZEN, on recent industry trends.

The EU debt crisis portends of possible negative repercussions for the dose CMO industry.

Might European officials reverse their position on acceptable production methods?

Reauthorization of pediatric exclusivity provisions looms in 2012 and debates begin anew.

International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.

Researchers at MIT and Harvard University report on new methods for producing microscale hydrogels.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

We're all familiar with traditional pills and medicines, but how about medicated chewing gum? Marc Ribe of Cafosa Gum explains how APIs can be incorporated into a novel dosage form that can aid patient compliance.

Clarifying GMPs for excipients used as actives.

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.

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.

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.

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.