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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Control Development's (South Bend, IN, www.controldevelopment.com) blend uniformity and dryer monitor consists of a NIR spectrometer, a sampling head, computer, and software.

New dryer monitor released

Generally, tablet and capsule film coatings are applied as aqueous or organic-based polymer solutions or dispersions, graduate student Sagarika Bose (University of Connecticut) explained during her Tuesday AAPS Graduate Student Symposium presentation, "Development and Evaluation of Solventless Photocurable Pharmaceutical Film Coating." However, organic film coatings can be flammable, toxic, and must comply with strict environmental regulations. Aqueous film coating can lead to the degradation of certain drugs by heat and water.

Solventless Photocurable Film Coating

When it comes to developing a robust lyophilization process, formulators can "pay now or pay later," says Jeff Schwegman, PhD, founder and chief scientific officer for BioConvergence. Because 30% of new drugs in clinical trials are biotech-based therapeutics (compared with 7% 10 years ago), more than ever, the US Food and Drug Administration is paying close attention to lyophilization data and questioning pharmaceutical companies about their development cycles, especially cycle development transfer, shelf-temperature mapping, dryer-to-dryer comparison studies, formulation time, process validation, and cycle deviation. Consequently, this is pushing formulators to optimize formulation variables, conduct additional testing during early-stage development, and understanding critical process parameters, equipment qualifications, and manufacturing conditions that can influence formulation behavior at a large scale. Not taking the time or effort to achieve these goals during early development could lead to redundancies in formulation work - a reality observed too often in today's practices.

Lyophilization Experts Show How to Avoid Common Formulation Mistakes

Robert R. Reich is the president of PSI, 909 Orchard Street, Mundelein, IL 60060, tel. 847.566.9229, fax 847.566.4960, rreich@pharmsystems.com

The authors focus on the effects of cellulosic materials during the performance qualification validation of a transfer barrier isolator used for the purpose of sterility testing.

The Adverse Effects of Cellulosic Material in Isolator Barrier Technology

The common crystal form of ibuprofen was changed to optimize processing and manufacturing properties. Six modified crystal forms were prepared and assessed for dissolution, morphology, particle size, density, thermal characteristics, powder x-ray diffractometry, flow properties, and tabletability.

Improving the Physical and Chemical Properties of Ibuprofen

Biomanufacturing managers believe the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.

Training the Biomanufacturing Workforce

Industry, FDA, and World Health Agencies Boost Pandemic Preparedness

Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic

Laura Bush is a former managing editor of Pharmaceutical Technology and Editor-in-Chief of BioPharm International.

Collaboration Targets Single-Shot Japanese Encephalitis Vaccine

A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.