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November 07, 2005
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.
November 06, 2005
"We must add our light to the sum of lights," declared Ron Reagan in his Nov. 6 keynote address to the 2005 Annual Meeting of the American Association of Pharmaceutical Scientists. He was quoting Billy Kwan, the half-Indonesian, half-Australian photojournalist of divided loyalties in the 1982 film, "The Year of Living Dangerously," a character who redeems himself by taking bold action in the face of moral crisis. Reagan encouraged the audience to take similar action to defend science, which he said is currently subordinated to political convenience.
November 02, 2005
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.
November 01, 2005
Recent advances in transdermal technologies challenge the paradigm that only a few drugs can be delivered transdermally.
October 27, 2005
Industry, FDA, and World Health Agencies Boost Pandemic Preparedness
New Room Temperature Ionic Liquids Offer Better Viscosity
October 06, 2005
Collaboration Targets Single-Shot Japanese Encephalitis Vaccine
October 02, 2005
A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.
Although agitation improves drying efficiency and ensures uniformity of the final dry material, it can also affect the physical properties of the product as it dries. This study evaluates the effect of scale up and equipment selection on an active ingredient undergoing granulation during the drying process.
September 20, 2005
A polymer excipient that reportedly reduces spray time has received its first registration in a finished drug product.