Formulation

The study evaluates near-infrared analysis of tablets nominally containing 4 mg of chlorpheniramine maleate and 10 mg of phenylephrine hydrochloride per dose.

The authors describe the operational qualification of test accuracy with regard to temperature drift using a thermal-compensation algorithm on several freeze dryers.

The authors experiment with a resonant acoustic mixer as a method for dry powder coating.

Average deal size and amounts invested increased in the second quarter, but totals trail funding of last year.

AAPS Global Health Focus Group's Kishor M. Wasan discusses new initiatives.

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

Could oral absorption-enhancing technologies change the shape of protein delivery?

The authors describe the concept of the limiting discriminatory the limiting discriminatory threshold (LDT) as an objective means of evaluating the inherent quality requirement of a large-sample content-uniformity test.

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

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.

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

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.

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

Clarifying GMPs for excipients used as actives.

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.

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

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

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

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.

Can microdosing make medicines safer and more effective for children?