Dosage Forms

Leading experts share insight on polymorphism and crystallization.

Generic-drug manufacturers look to expand into biologics and complex dosage forms. This article contains bonus online-exclusive material.

Manual sample preparation methods for solid dose pharmaceuticals have a number of inherent disadvantages, primarily because they are time consuming and unpredictable.

What have been the key innovations that have shaped current aseptic practices and techniques?

Each sector of the pharma industry is fraught with challenges and weighty regulations; aseptic processes and techniques are no exception.

Closed vial technology has been designed to address the challenges - potential contamination, counterfeiting and process complexity - associated with the aseptic filling of injectable drugs.

After further reviewing data on the H1N1 pandemic vaccines approved in Europe, the EMEA has reaffirmed their balance of benefits and risks in the context of the current H1N1 influenza pandemic. Additionally, the World Health Organization (WHO) has issued an update on the H1N1 situation in Europe.

The European Medicines Agency confirmed the safety and efficacy of Focetria and Pandermix, and noted that data on Celvapan are still being analyzed.

GlaxoSmithKline (GSK) has agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

Following its $68-billion acquisition of Wyeth, Pfizer has unveiled detailed plans for its global R&D network, which includes consolidation of its R&D facilities.

Last week, GlaxoSmithKline (GSK, London) agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

Following the its $68-billion acquisition of Wyeth (Madison, NJ), Pfizer (New York) Pfizer detailed plans for its global research and development (R&D) network, which includes consolidation of its R&D facilities.

FDA has approved a fifth influenza A (H1N1) vaccine, manufactured by ID Biomedical.

Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more...

A consortium led by GlaxoSmithKline (UK) intends to deliver a "step change improvement" in pharmaceutical tablet manufacturing in the UK by "substantially" increasing the country's manufacturing efficiency.

Novartis reported that German regulatory authorities approved its adjuvanted cell culture-based Influenza A (H1N1) 2009 monovalent vaccine, Celtura. The company also said it will acquire a stake in Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical.

The European Medicines Agency, the European Center for Disease Prevention and Control, and the Heads of Medicines Agencies issued a European strategy for H1N1 vaccine benefit–risk monitoring.

Leading experts from an upcoming conference on biosimilars by the Drug, Chemical, and Associated Technologies Association share their insights on the manufacturing and regulatory considerations for biosimilars.

A smart nanocage that can be filled with a medicinal substance and then activated using light has been developed by US researchers.

The European Organisation for Rare Diseases (EURORDIS) has predicted that 100 new designated orphan products will receive marketing authorization between 2009 and 2019, which equates to approximately 10 new products every year.

The author details the factors in formulation design, requirements in facilites and equipment, and validation criteria for aseptic formualtions.

The author discusses the risks involved with aseptic processing, methods and tools used to identify and control risk, and regulatory guidelines relevant to the risk-management process.

Mark Copley discusses the methods used for DPI testing and the challenges presented by the current regulatory framework.

An inhaler mouthpiece that optimizes drug delivery to the lungs and reduces the amount of wasted medication has been developed by US researchers.

The global API market has expanded from $69 billion in 2004 to more than $90 billion in 2008 at an average yearly growth rate of 7.2%, according to a report from the Italian Chemical Pharmaceutical Association (CPA).

Cheaper generic pharmaceuticals, emboldened by US law and patent challenges, restrict novel future innovations.

For the first time, cancer treatments accounted for 5% of overall drug spending in the first half of 2009, said Medco Health Solutions in a press release last week.

GlaxoSmithKline (GSK), Novartis, sanofi aventis and Baxter International have provided updates regarding the development, manufacture and shipment of pandemic (H1NI) vaccines.

A new drug delivery method developed by scientists could enable prescription drugs to be buried inside the body where drug release could be prompted by a biological trigger, such as a drop in blood sugar levels, or activated manually with a pulse of light.

A long-term joint venture between GlaxoSmithKline (GSK) and China's Jiangsu Walvax Biotech Company hopes to develop and manufacture paediatric vaccines for use in China.