Drug Development

How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future?

The closing date for comments to be received by the US Pharmacopeia (USP) for proposed revisions to Chapter <231>, which deals with analysis of heavy metals, is 15 December 2008. The USP has been working towards for approximately 4 years and the task has not been easy.

Microcrystalline cellulose is the main excipient used in the industrial manufacture of pellets by extrusion/spheronization, but pellets containing this spheronizing aid do not readily disintegrate and are expensive.

Research shows that both drug prescription and alcohol consumption increase within the elderly population. It is, therefore, necessary to fully understand the impact of alcohol consumption on solid oral dosage forms, especially extended release formulations.

Also, Johnson & Johnson will acquire Omrix Biopharmaceuticals for $438 million; Charles River Laboratories promoted Foster Jordan to corporate senior VP of endotoxin and microbial detection products; more...

Companies at the American Association of Pharmaceutical Scieintists (AAPS) unveiled technologies, expansion plans, and services for formulation development, manufacturing, and drug delivery at the AAPS Annual Meeting and Exposition held in Atlanta last week.

The American Association of Pharmaceutical Scientists (AAPS) recognized researchers in the pharmaceutical sciences at AAPS Annual Meeting and Exposition in Atlanta last week.

Also, BASi opens European office in Warwickshire, UK; Acusphere's Howard Bernstein Resigns; More...

US marshals seized 11 lots of heparin from Celsus Laboratories (Cincinnati, OH) at the request of the US Food and Drug Administration.

Also, Patheon opens new European headquarters, Cynvec appoints Frank D. Stonebanks president and CEO, more...

Also, Sartorius Stedim Biotech GmbH to acquire Wave Biotech; AstraZeneca's John Patterson to retire; more...

This review provides an update of how dendrimer technology is being applied to the development of novel systems for various topical delivery applications.

Policymakers weigh new rules to ensure the safety and quality of drugs made with tiny particles.

Optimizing the solid form of a drug reaps scientific and technical awards.

A well-balanced guide to industrial bioseparations provides valuable information.

The authors evaluate the effect of various mill types on particle-size distribution, flowability, tabletability, and compactibility.

The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.

Novel hydrophobic bioadhesive polymers and dosage designs are now available to effectively achieve tailored release kinetics of a broad range of drugs to meet the clinical needs.

Pharma companies could benefit from the lessons learned in this fall's financial crisis.

Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.

Pharmaceutical Technology will feature video coverage of AAPS this month.

Molecules called "chaperones" facilitate correct protein folding.

Rapid advances in drug discovery have led to the identification of a number of compounds with good therapeutic potential.

During the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries.

The US Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE), a not-for-profit organization comprising 11 universities, a $1.19 million contract to develop quality by design (QbD) guidance elements for design space and scale-up of unit operations.

Also, Maxygen looks to costs, jobs; Receptor BioLogix appoints Dale R. Pfost CEO; more...

Pfizer and UCB formed a technology company named Cyclofluidic with the aim of accelerating the drug-discovery process.

Also, MedImmune opens Cambridge, UK, facility and makes reverse engineering pact with Omninvest; BD Medicine appoints Carol Adiletto VP of clinical and regulatory affairs; more...

Also, Millipore opens new membrane-casting manufacturing facility in Ireland; Surface Logix appoints Keith Dionne president, CEO, and a member of the board; more...