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

Promising Results Pave the Way to Inhaled TB Vaccine

The 59th Pittsburgh Conference gathered more than 1000 exhibitors on its showroom floor this week.

Pittcon 2008 Unveils Innovations in Analytics

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

New Dimensions in Tablet Imaging

The pharmaceutical industry has experienced a number of difficulties during recent years. Greater competition from generics (more than 60% of prescription drugs are supplied from the generic market) and increased gaps in the drug pipeline that result in acquisitions or strategic alliances has led to a feeling of uncertainty in the bio/pharma marketplace. There have also been changes in the marketplace with a shift from primary care to specialty drugs, the introduction of personalized medicine driving the need for biomarker/diagnostic technology and the introduction of biopharmaceuticals.

Supporting critical Phase I–IV clinical studies by outsourcing supporting elements

To ensure an effective treatment, a patient often must take equal doses of an active pharmaceutical ingredient (API) at regular intervals.

Consistent Capsule Filling

Recent developments in dry coating

As part of a major project to design and build a new bulk vaccine antigen plant, the authors were asked to investigate and implement a suitable fumigation system for clean room decontamination. The facility was designed to handle and contain live influenza virus, and has clean room suites designed to containment levels CL2 and CL3 according to the Approved Code Of Practice and Guidance (ACOP, Control of Substances Hazardous to Health 4th Edition). From the outset, specific areas within the facility were identified as requiring fumigation and this formed part of the initial design brief.

Cycle development for hydrogen peroxide clean room decontamination

We are currently experiencing a problem with one of our tablet lines. While the tablets appear white immediately after manufacture, after a time many of the tablets begin to take on a yellowish appearance. Could this be an issue that surface analysis could help resolve?

Tablet discolouration

The authors propose extending initial solvent screening for a single-solvent system to the cocktail solvent screening of binary and ternary solvent mixtures.

Cocktail-Solvent Screening to Enhance Solubility, Increase Crystal Yield, and Induce Polymorphs

Christopher C. DeMerlis is a regulatory affairs manager at Colorcon, a division of Berwind Pharmaceutical Services, Inc., 415 Moyer Blvd., West Point, PA 19486, tel. 215.661.2766, fax 215.661.2778.

David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon.

Natural gums and mucilage are biocompatible, cheap, readily available, and represent a potential source of excipients. The authors examine the functionality of mucilage extracted from the leaves of Hibiscus rosa-sinensis Linn as an excipient in a sustained-release tablet formulation.