Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Frontrunners in Bispecific Antibodies

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Articles

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.

The Evolving Pharmaceutical Value Chain: Forecasting Growth for Small and Large Molecules

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.

A Tracking Tool for Lean Solid-Dose 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.

Turning the Tide for Protein Formulation and Delivery

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.

Drug Delivery Trends for Parenteral Therapeutics

Louis Rey, PhD, is biologist, scientific and industrial adviser, and lyophilization pioneer based in Switzerland.

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

Lyophilization is not a freeze-dried technology

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.

Selecting Superdisintegrants for Orally Disintegrating Tablet Formulations

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

Science and innovation is the UK's future

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

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.

Strategies for Manufacturing High-Potency APIs Outlined at Recent Conference

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.

Cytotoxic Drug Market Will Influence Growth of High-Potency Active Ingredients

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.