Dosage Forms

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

Biologics are forecast to account for roughly 60% of revenue growth through 2010 for Big Pharma as growth in small molecules slows. The author analyzes the factors driving demand and how the technology life cycles of these two sectors will affect market potential.

Pharmaceutical companies are facing increased competition, cost pressures, and a need to improve the performance of their manufacturing operations. Lean manufacturing offers methods, tools, and heuristics for improved efficiency in manufacturing. Process analytical technology offers alternative analysis techniques that could greatly improve manufacturing quality and efficiency. Mathematical tools exist for assessing the efficiency of manufacturing processes. Internal benchmarking is recommended for determining the efficiency and tracking improvements in pharmaceutical manufacturing.

Protein formulation specialists have long sensed that something big could be just around the corner. Over the past few decades, countless companies have attempted to bring to market new protein therapeutics that offer improvements-be they more patient friendly, more effective, or easier to manufacture-over traditional formulations. Earlier this year, the launch of Pfizer's "Exubera" pulmonary insulin met this anticipation head on. The fast-acting, inhaled-powder form of recombinant human insulin brought hope to the millions of diabetic patients waiting for an alternative to injections.

There is a growing need for patient-compliant dosage forms within the cancer therapeutics and biotechnology areas. Ease of administration, enhanced therapeutic efficacy, and reduced side effects are factors that differentiate drug delivery products from conventional dosage forms and provide a competitive advantage. This article reviews salient trends in the parenteral drug delivery sector within the realms of a changing regulatory environment, drivers to growth, and recent advances in this field. Challenges associated with bringing parenteral drug delivery concepts to commercialization are discussed.

In view of the nature of its complexity, it might be desirable to apply FDA's process analytical technology to lyophilization.

The increasing popularity of orally disintegrating tablets has led to growing interest in the advantages of superdisintegrants. This article presents some practical considerations in selecting these ingredients.

UK science has an outstanding record and we remain strong internationally in terms of achievement, productivity and efficiency.

High-containment manufacturing for highly potent active pharmaceutical ingredients (HPAPIs) represents a niche, but growing niche, in API manufacture. Strategies on serving this sector were discussed at a recent program, ?High-Potency Active Ingredients: Realizing the Opportunities,? organized by the Drug, Chemical, and Associated Technologies Association (Robbinsville, NJ) in conjunction with Pharmaceutical Technology.

The market potential for high-potency active ingredients will be influenced by growth patterns in the cytotoxic drug market. Strong growth is projected for cytotoxics through 2009, but the market then will see generic drug erosion, according to Sarah Terry Johnston, vice-president, healthcare, Datamonitor PLC.

As with pharmaceutical manufacturing as a whole, a risk-based approach is important in manufacturing highly hazardous or potent compounds. Industry groups are working with US Food and Drug Administration (Rockville, MD) to develop a baseline guide for a risk-management approach to determine containment controls required to minimize cross contamination.

Scientists from GlycoFi, Inc., a wholly owned subsidiary of Merck & Co, in collaboration with Dartmouth-Hitchcock Medical Center, have engineered yeast cells capable of producing a broad range of recombinant therapeutic proteins with fully human sugar structures (glycosylation).

The overall market size of the Southeast Asia region totals $7 billion, with a projected compound annual growth rate of about 13% through 2010.

For once, casting originators against generic players might end up strengthening the industry across the board.

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

Potent-compound awareness training for operators is important to understand why the containment and controls are in place.

Washington, DC (Aug. 14)?A new report issued by the Pharmaceutical Research and Manufacturers of America identifies 418 drugs and vaccines developed through biotechnology. All of the biotechnology medicines and vaccines are now in clinical trials or awaiting approval by the US Food and Drug Administration (Rockville, MD).

West Point, PA (Jul. 31)?A survey of 150 US pharmacists found that nearly 80% believe that "multiple look-alike medications" make it difficult for consumers to identify the correct medication, especially when the drugs are moved to unlabeled containers.

Aegis Therapeutics (San Diego, CA) has launched a new formulation technology to increase the stability of proteins and peptides.

GlaxoSmithKline (London, England) has developed a vaccine against the H5N1 bird flu strain that, the company says, shows better immune response than other vaccines in development.

Quantitative data from the literature show strong relationships among average particle size, powder densification, tensile strength, and hardness.

Formulation development can involve several complex technical challenges, but an approach incorporating design of experiments can help address these difficulties.

Using a novel automated microfilling system, the authors demonstrate that roller compaction followed by milling is a viable preprocessing technique for high-dose chemical-in-capsule dosage forms. The process results in higher bulk and tapped densities for drug substances compared with milling alone.

Roxane Laboratories (Columbus, OH), a Boehringer Ingelheim company, is conducting a voluntary recall in the United States and Puerto Rico of a single manufacturing lot of "Azathioprine"tablets, USP 50 mg.

Novartis (Basel, Switzerland) will build a cell culture-derived influenza vaccines manufacturing plant in Holly Springs, North Carolina. Construction is expected to begin in 2007.

In a move to strengthen its position in Western generic drug markets, Ranbaxy Laboratories Ltd. (Gurgaon, Haryana, India) acquired the Mundogen generic drug business of GlaxoSmithKline (GSK, London, England) in Spain, through Ranbaxy's Spanish subsidiary, Laboratorios Ranbaxy S.L.

Although the number of anti-infective vaccines (as distinct from therapeutic vaccines for cancers and other noninfectious diseases) entering clinical study each year since 2000 has been higher on average than it was in the 1990s, this product area may see little additional growth through the rest of this decade, according to a recentanalysis from the Tufts Center for the Study of Drug Development (Boston, MA).

Dutch biotechnology company Crucell NV (Leiden, Netherlands) and its technology partner DSM Biologics BV, a business unit of Royal DSM NV (Heerlen, Netherlands) will open a new research and development center that will specialize on further developing the "PER.C6" human cell line for the expression of recombinant pharmaceutical proteins.

Does the competition from authorized generics really help lower drug prices and boost healthcare savings?

MedImmune, Inc. (Gaitherburg, MD) reports that US Food and Drug Administration (Rockville, MD) has approved the company's supplemental biologics license application to use reverse genetics technology to construct new vaccine strains to produce seasonal influenza vaccines.