Drug Development

Most CROs are entering China with expectations that a significant local market opportunity will develop as major pharmaceutical companies establish research development operations there...

The blood–brain barrier (BBB) forms an interface between the circulating blood and the brain, and functions as a tremendously effective barrier for the delivery of potential neurotherapeutics into the brain parenchyma. Conversely, the BBB possesses various carrier-mediated transport systems for the uptake of small molecules, such as essential nutrients and vitamins. These transporters have become an attractive target for drug/prodrug design in an attempt to ferry drug molecules across the BBB. Central nervous system (CNS) drug delivery is often limited by poor brain penetration of the potential drug candidate. As a result of its unique barrier properties, the BBB poses a huge challenge for the delivery of potential neurotherapeutics into the brain parenchyma.1 It is estimated that only 2% of small-molecule drugs and ,0.1% of novel protein and peptide pharmaceuticals developed for CNS diseases reach therapeutic concentrations in the brain.2,3 Many of the pharmacologically active drugs tend to fail..

Manufacturing facilities must be inspected by members of regulatory bodies. However… these bodies are woefully inadequate at performing the task.

Our company is involved in developing and manufacturing APIs that can be utilized with drug-eluting stents (DES). Despite ensuring constancy in pharmaceutical composition, we are experiencing issues with variations in drug release during in vitro studies. We are working closely with a stent manufacturer to develop the system, but could surface analysis techniques investigate the problem further?

Spraying techniques can be used to produce powder form formulations. The concept works by the adsorption/absorption of a liquid SELF onto a neutral carrier…

A microelectronic system based on radio-frequency (RF) cell ablation addresses limitations of other transdermal drug-delivery methods. This system expands the transdermal spectrum to include the delivery of water-soluble molecules, peptides, proteins, and other macromolecules.

Investigators are exploiting the tremendous structural diversity of polypeptides and their biophysical properties to develop novel drug carriers. Peptide-based materials hold out much promise for tailor-made targeting, penetration, and release of contents in a host of biological microenvironments.

For pediatric and geriatric patients, fast-dissolving drug-delivery systems provide an easier way to take medications and vitamins. Oral thin films have evolved to provide systemic delivery of active pharmaceutical ingredients for over-the-counter and soon, prescription drugs. The authors review the practical benefits of dissolvable films, their manufacture, and their market potential.

Liquid and semisolid encapsulation using two-piece hard capsules is an ideal drug delivery approach for highly potent compounds and poorly water-soluble drugs. The authors detail the factors to reduce risk when designing and operating a facility for secondary manufacturing of highly potent drugs.

The nature of their application and their mode of use mean that prefilled syringes meet the regulatory definitions of immediate packaging or container–closure systems.

Also, Alkermes announces restructuring and reduction of workforce, Icagen announces several senior management promotions, more...

Scientists at the University of North Carolina at Chapel Hill have successfully tested a new inhaled tuberculosis (TB) vaccine.

Sandoz introduced its "Omnitrope Pen 5" with liquid cartridge in the United States. The product was approved by the US Food and Drug Administration and is a new form of the first follow-on version of a recombinant biotechnology drug.

Also, Pipex Pharmaceuticals implements cost-cutting measures, Pfizer's Senior Vice-President and General Counsel Allen Waxman leaves the company, more...

Hoping to provide a better understanding of its role in the heparin contamination investigations, the US Food and Drug Administration has posted a series of information sheets on its website.

Also, PDL BioPharma will no longer pursue sale of the company, executives resign from Topigen Pharmaceuticals, more...

Also, Millipore plans to open Singapore facility, Michael J. Simms joins Alexza Pharmaceuticals, more...

After two centuries, there's no reason to maintain two tablet compression tooling standards.

Mannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).

New research and ideas for March 2008

Chemical imaging of solid dosage forms has become a powerful analytical tool for the development of solid dosage forms.

The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient compliance.

The European Union's REACH initiative has the potential to affect the flow of chemicals into the pharmaceutical suppy chain.

Show blasts off this month in Philadelphia with more suppliers, new trends, and real-world solutions.

A news roundup for March 2008.