Dosage Forms

The EMA's Guideline on Similar Biological Medical Products provides overarching guidance, but since its introduction a range of more specific guidelines have also been developed.

As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.

The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

The FDA has approved the first generic version of the blockbuster low molecular weight heparin Lovenox (enoxaparin sodium), much to originator sanofi-aventis's displeasure.

Teva and Sun Pharmaceuticals? motion to overturn a verdict issued against them in April 2010 for patent infringement has been denied by a US court, leaving the companies at the mercy of pharma giants Pfizer and Nycomed, who have said they will "vigorously" pursue damage claims.

Researchers claim that a dissolving microneedle patch may be able to offer improved vaccination against influenza compared with traditional needles, and also allow people without medical training to easily and safely administer the vaccine.

Teva's and Sun Pharmaceuticals' motion to overturn a verdict issued against them in April 2010 for patent infringement has been denied by a US court, leaving the companies at the mercy of pharma giants Pfizer and Nycomed, who have said they will "vigorously" pursue damage claims.

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products.

States can reduce their Medicaid programs' healthcare expenditures by changing laws to enable generic drugs to be substituted for branded medications more easily and quickly, according to a new study conducted by CVS Caremark, a large pharmacy healthcare provider.

The functionality and performance of three types of commercial superdisintegrants were evaluated in the application of orally disintegrating tablets.

Xavier Parissaux of Roquette explains why the pharma industry's need to reduce organic solvent use is driving innovation in film coatings.

Editors' picks of pharmaceutical science and technology innovations.

Compressed tablets are the most popular solid dosage form and, despite having been used for many years, still offer numerous advantages.

The market for tablet compression technology and the demands placed on equipment manufacturers have changed quite significantly in recent years.

We regularly deal with tabletting equipment problems and malfunctions, and find that the most common cause is misuse or improper handling and transportation, which often leads to accidental damage to tablet punches (including nicks and dents to the punch tip edges).

The market for tablet compression technology and the demands placed on equipment manufacturers have changed quite significantly in recent years. This has been driven by a number of factors.

Fifty percent of the marketing authorization applications for human medicines submitted to the European Medicines Agency (EMA) in 2009 were for generic and hybrid medicines — 60% higher than the agency?s forecast.

Fifty percent of the marketing authorization applications for human medicines submitted to the European Medicines Agency (EMA) in 2009 were for generic and hybrid medicines?60% higher than the agency's forecast.

FDA Clears Infant Rotavirus Vaccine

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.

In response to stringent price cuts introduced in Spain, the European Generics Association (EGA) is urging the Spanish government to adopt mechanisms that will help increase the dispensing of generic medicines.

The traditional lines of demarcation between innovator-drug and generic-drug companies are blurring as each sector responds to changing industry fundamentals.

Further consolidation, slowing growth in established markets, and growth in smaller and emerging markets are important factors influencing the direction of the global generic-drug market.

The authors demonstrate that sustained-release delivery can help avoid the risk of sudden higher-blood concentration of a drug to avoid toxicity.

The author outlines the key concepts of ISPE's recently revised Baseline Pharmaceutical Guide for New and Renovated Facilities. This article is part of a special supplement on Excipients and Solid Dosage.

Testing the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.

A new automated factory in Boston (MA, USA) has been developed that uses non-genetically modified green plants to quickly produce large quantities of vaccines and therapeutics.

After several years of debate and review, the US Food and Drug Administration is calling for the removal of metered-dose inhalers.

Tablets and capsules are mainstay product forms, so what are the spending and innovation trends for solid-dosage manufacturing equipment and machinery?