Dosage Forms

More than 235 biotechnology companies call New Jersey home. They range from early start-ups with just a few employees to fully functioning companies with research, marketing and sales offices.

Although California remains the country's biotech leader, Michigan anticipates that the wind is shifting direction, albeit slowly

There are many challenges upstream and downstream in manufacturing a biotech drug.

Richard Kilner, Managing Director of the Commonwealth of Pennsylvania European Investment Office, is incredibly enthusiastic about both his State and the potential it offers investors: "We are the number one State in pharmaceuticals (by number of establishments, employment and GDP output) and rapidly closing in on Massachusetts, the number two in biotech."

Access to the capital markets of the US has always been a key attraction for Europe's biotech businesses.

Many compounds fail in preclinical development because of safety-related problems, but identifying 'predictable' safety or toxicity liabilities earlier in the process could lead to improved design and selection of compounds that are more likely to be approved.

California's forward-thinking reputation, well-funded research universities and world leadership in the potentially life-saving field of stem cell research and green energy provide a progressive and positive business environment for biotech companies.

Speaking to Pharmaceutical Technology Europe, Georgia Bio's Director of Innovation and Technology, Carol Henderson, outlined the unique assets that make Georgia an attractive location for international bioscience companies.

According to Deputy Director, Alexander Bothmann, of Enterprise Florida Inc., in Germany, the 'Sunshine State' is: "Committed to building a world-class biotechnology sector by investing in research facilities, fostering the growth of local biotech companies and welcoming progressive newcomers, such as the Scripps Research Institute, the Burnham Institute for Medical Research and Torrey Pines Institute for Molecular Studies."

The author describes the benefits, processes, and practicality of using hot-melt extrusion to mix active pharmaceutical ingredients with pharmaceutical-grade polymers.

The use of PVA copolymer-based film can solve the problems associated with lack of film adhesion... to tablets containing large amounts of waxy excipient or a lubricant.

...an uninformed decision based on commercial requirements alone may, ultimately, have disastrous consequences on the efficacy of the target recombinants.

FDA has issued a Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals."

USP announced an interim revision to its monograph for levothyroxine sodium tablets, which will become official in USP 32-NF 27.

Sterile manufacturing may be the next aspect of pharmaceutical manufacturing to consider in the continuous process paradigm.

With economics and politics in the way, can we defeat the malaria epidemic before it defeats us?

The author explains the planning, equipment, and facility design requried for manufacturing HPAPIs and specialized requirements for handling these compounds.

We have to make the politicians understand that if we don't take biotech seriously then tourism will be our premier industry in the future.

Biotechnological developments have led to an increased number of recombinant proteins or antibodies in drug development that offer high potential in various diseases, such as cancer, growth disturbances and diabetes.

The authors describe the critical aspects of an ideal fermentation services provider.

The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.

To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.

Pharmaceutical companies developing new drug candidates for Hepatitis C virus infection now can test their compounds with a novel culture system that mimics the biology of HCV infection in humans.

Teva Pharmaceutical Industries and Barr Pharmaceuticals (Montvale, NJ) signed a definitive agreement under which Teva will acquire Barr, the fourth-largest generic-drug company in the world. Teva will buy each share of Barr common stock for $39.90 in cash and 0.6272 Teva shares. Based on the closing price of Teva?s shares on July 16, 2008, the price per share of Barr common stock is $66.50, and the total value of the acquisition is $7.46 billion. Teva will assume Barr?s outstanding net debt of approximately $1.5 billion.

3M Drug Delivery Systems has successfully designed a proof of concept device using a solid microstructured transdermal system for the systemic delivery of high-potency pharmaceuticals. The technology was showcased at a poster session at the annual meeting of the Controlled Release Society held this week in New York City.

The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa.

The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the Biologics Price Competition and Innovation Act of 2007.

The introduction of biomolecules into cells is a key technology for research in biological sciences.

Also, Stiefel Laboratories will acquire Barrier Therapeutics, Danube Pharmaceuticals appoints Brian Levy COO, more...

The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers now because chlorofluorocarbon-propelled inhalers will not be available in the US after Dec. 31, 2008.