Dosage Forms

Interphex2007, New York, NY (Apr. 25)-As governments begin to contemplate the possibility of biological terrorism or a pandemic event, a new problem begins to emerge: in the case of a pandemic or an attack, even if a vaccine or treatment exists, how could it be produced in sufficient numbers to prevent the deaths of millions of people? That question was addressed in at the conference session, "Responding to Bioterrorism and Pandemic Events: A Case for Development of Flexible Manufacturing Space for Vaccine Production," at Interphex today.

Lyon, France (Apr. 17)-Sanofi Pasteur, the vaccine division of the Sanofi-Aventis Group, announced that the US Food and Drug Administration has licensed its H5N1 vaccine, making it the first avian-influenza vaccine for humans in the United States.

The authors prepared and tested press-coated tablets with various weight ratios of ethylcellulose to hydroxypropylcellulose (HPC) and various ratios of two different batches of HPC as an outer coating shell and fillers in core tablets. The tablets were examined for changes in time lag and release patterns of salbutamol sulfate.

Hydrogels are biocompatible drug delivery systems by which the physical properties can be controlled by the cross-linking density. Hydrogels were prepared by copolymerization of acrylic acid monomers in the presence of poly(ethylene glycol)(PEG) to form polyethylene diacrylate (PEDGA). Various molecular weights of PEGs were used for the synthesis of PEGDA to study the effect of molecular weight of PEG on the properties of hydrogels. These hydrogels were further characterized for free water, swelling behavior, water diffusion, drug loading, and drug release profile. By analyzing the swelling behavior and release pattern of the hydrogels, the authors show that these systems can be suitably used for controlled delivery of drugs.

Near-infrared (NIR) assay and content uniformity of tablets provide fast, accurate means of monitoring tablet production that are in step with FDA's process analytical technology initiative.The authors discuss the process for testing a newly released NIR tablet analyzer to determine instrument precision and accuracy using chlorpheniramine maleate tablets.The data show promising results that could relieve laboratory workload of high-performance liquid chromatography analysis and bring analysis closer to real time for process monitoring.

A wealth of citations helps illustrate the applicability of the analytical methods and also highlights their pitfalls.

... there is a huge manufacturing challenge involved in bringing cell therapies (especially stem cell therapies) from the lab bench into the clinic.

When a dosage form or an API is introduced to the gastrointestinal tract, or dissolution media mimicking it, a transformation from a metastable to a more stable form with lower solubility and bioavailability is possible.

Aventrx, ImmBio, Eli Lilly, more

Cobra, InterMune, Pall, More

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

Just because the wheels are turning doesn't mean they're going forward.

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.

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.

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)-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.

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 objectives of this study were to prepare and characterize inclusion complexes of lovastatin with hydroxypropyl-β-cyclodextrin (HPβ-CD) and to study the effect of the complexes on the dissolution rate of lovastatin (LVS). The findings suggest that LVS's poor dissolution profile can be overcome by preparing its inclusion complex with HPβ-CD.

For solid oral-dosage forms, water testing usually is performed to control the chemical, physical, or microbiological properties of the drug product. Measurements of total water as made with Karl Fischer (KF) techniques is not needed and water-activity often will provide a better correlation with changes in chemical, physical, or microbiological properties than KF techniques. In these cases, water activity testing can easily replace KF testing. Water-activity measurements are nondestructive, require little labor, and the equipment required is generally inexpensive. Only a few simple checks are needed to ensure the validity of measurements. Strategies for implementing water activity testing are described.

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.

Pfizer's restructuring plan provides yet another example of new supply-chain strategies by the pharmaceutical majors, which involve rationalization of manufacturing facilities and cost improvement. A review of these moves, an outlook for the pharmaceutical market in 2007, and analysis of US pharmaceutical production and trade.

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.