Formulation and Drug Delivery

Buffalo, NY (Mar. 7)-Scientists at the University at Buffalo?s Institute for Lasers, Phtonics, and Biophotonics and Roswell Park Cancer Institute have developed a drug delivery system comprising 100-nm nanocrystals of pure HPPH, (2-devinyl-2-1'-hexyloxyethyl pyropheophorbide).

Gurgaon, Haryana, India (Mar. 13)-Ranbaxy Laboratories Limited confirmed that it has made a nonbinding bid for the generic drug business of Merck KGaA.

Contraceptives that are sprayed onto the skin are under development to offer a more convenient alternative method of birth control.

Vancouver, BC, Canada-Researchers from the University of British Columbia are developing a new method for delivering Amphotericin B, a potent antifungal agent for fatal blood-borne fungal infections that currently must be administered intravenously.

The Parenteral Drug Association recently held its first global conference on emerging manufacturing technologies. Among the presentations were those discussing the latest in disposable technologies, aseptic filling and closing, and barrier systems. Clearly, technology vendors have stepped up efforts to streamline processes and better handle complex drug products.

Many companies are coming up with innovative materials and manufacturing methods to feed the growing demand for prefilled syringes.

As big pharmaceutical companies restructure and reevaluate the way they do business, contract research and manufacturing organizations could reap greater financial rewards.

The book is written for drug-delivery scientists experienced in the dermatological or transdermal fields.

Washington, DC (Feb. 22)-The Biotechnology Industry Organization criticized two separate studies respectively released by the Pharmaceutical Care Management Association and Express Scripts, Inc. regarding the cost-savings, interchangeability, and market penetration of follow-on biologics.

Brussels (Feb. 13)-The European Generic Medicines Association raised concerns over what it terms ?the serious lack? of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.

Enschede, Netherlands (Feb. 26)-Scientists from the University of Twente?s MESA+ Institute for Nanotechnology have designed a novel delivery system by combining synthetic iron-containing polymers with DNA macromolecules.

Disposables simplify the flow of people and materials through a facility, decreasing both its footprint and amount of equipment needed, as well as minimizing upfront capital costs.

Large stability studies for drug products and devices with multiple strengths, packaging configurations and orientations can cost millions of dollars for the analytical testing alone.

While single-use technologies can be used for filtration, storage and at connection points in egg-based vaccine production, their use multiplies in cell-based applications.

Princeton, NJ (Feb. 15, 2007)-Ranbaxy Inc., confirmed that federal officials conducted a search of its New Jersey offices on Feb. 14, 2007 and commented on its reported plan to acquire Merck's generics business.

Geneva, Switzerland (Feb. 16)-During a two-day meeting, the World Health Organzation announced ?encouraging progress? in the development of a pandemic influenza vaccine but admitted that the industry still ?lacks the manufacturing capacity to meet potential pandemic influenza vaccine demand.?

InformexUSA, San Francisco (Feb. 14)-NPIL Pharma unveiled a $100-million investment program in formulation development and manufacturing services.

InformexUSA, San Francisco (Feb. 14)-Almac Sciences plans to collaborate for cytotoxic fill-and-finish services with the Center for Pharmaceutical Science and Technology (CPST) at the University of Kentucky.

Washington, DC (Feb. 14)?A congressional team has reintroduced the ?Access to Life-Saving Medicine Act,? which establishes a process through which the US Food and Drug Administration can approve generic copies of biologic drugs.

London, UK (Feb. 1)?Researchers at the University of London?s School of Pharmacy have chemically modified carbon nanotubes to enable them to enter human cancer cells.

Washington, DC (Jan. 26)-The US Department of Health and Human Services has granted targeted liability protections for manufacturers of a vaccine to prevent a pandemic of influenza A (H5N1).

The same phenomena that create lightning and thunderstorms are around us every day, producing incredibly high voltages, which cause sparks and shocks. Static electricity is a mighty force. Each year excessive electrical charge build cause explosions in the grain industry.1 Look around any flammable storage area and you will see both grounding bars on the wall and cables, from the grounding bars connected to the drums of solvents. Take any material safety data sheet (MSDS) for a powder and look in section V; it highlights that any dry powder has the potential to attract and store a charge.

Over the past decade, disposable technologies have become a reality in biotech processes. The use of disposables in research and manufacturing allows high flexibility.

Brain and heart broth is still used in path labs, but, when it comes to biopharmaceutical manufacturing, cells are having to learn to do without animal components whenever possible.

Raman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.

Terpenes are widely used in topical preparations. This paper focuses on the skin penetration of terpenes depending on their physicochemical properties and influence of the type of dermatological vehicle that was used. The structure of human skin and the skin penetration process is also briefly described.

Following the sales of its global branded pharmaceutical business, 3M stays the course in drug delivery as its Drug Delivery Systems Division advances technology in inhalation and transdermal drug delivery.

The US Department of Health and Human Services (HHS, Washington, DC) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million does of the vaccine or enough adjuvant for 150 million doses within six months after the onset of an influenza pandemic.

Darmstadt Germany (Jan. 8)-Merck KGaA closed on its roughly CHF 16.6 billion ($13.3 billion) deal to acquire a majority stake in the European biotechnology company Serono (Geneva, Switzerland), officially launched Merck Serono SA as a new entity within Merck KGaA, outlined its integration strategy, and announced plans to divest its generics business.

The recent struggles of Cardinal Health's and Patheon's contract dose manufacturing businesses offer a lesson on good business practices.