Analytics

May 01, 2007
Pharmaceutical Technology Europe
One of the major concerns with introducing PAT, however, is that the bias towards process engineering may not ultimately lead to complete control of product quality.
May 01, 2007
Pharmaceutical Technology Europe
There is a tremendous need to enhance delivery of potential therapeutics to the brain for treatment of central nervous system (CNS) disorders. The blood brain barrier (BBB) restricts and controls the exchange of compounds between the CNS and the blood, which requires discovery of new modalities allowing for effective drug delivery to the CNS. Polymer nanotechnology has now become one of the most attractive areas of pharmaceutical research. This review focuses on the current progress in polymeric nanoparticles, where the specific arrangement of the polymeric matter at the nanoscale is utilized to design drug delivery systems that provide safe and efficient transport of CNS drugs across the BBB.
Apr 27, 2007
Pharmaceutical Technology
Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a conference session, "Performing Analytical Method Validation Robustness for Regulatory Compliance," at Interphex on Thursday.
Apr 25, 2007
Pharmaceutical Technology
Interphex2007, New York, NY (Apr. 25)-One of the challenges facing pharmaceutical manufacturers is how to implement process analytical technology (PAT) into their commercial manufacturing processes. Michael Abad, engineering section manager, Abbott Laboratories shared insight from a project within Abbott in his presentation "Engineering for PAT" at Interphex today.
Apr 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A wealth of citations helps illustrate the applicability of the analytical methods and also highlights their pitfalls.
Apr 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors prepared and tested press-coated tablets with various weight ratios of ethylcellulose to hydroxypropylcellulose (HPC) and various ratios of two different batches of HPC as an outer coating shell and fillers in core tablets. The tablets were examined for changes in time lag and release patterns of salbutamol sulfate.
Apr 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The concept of Acceptable Analytical Practices (AAPs) was developed by the Analytical Technical Group of the Pharmaceutical Research and Manufacturers of America to share information about how the pharmaceutical industry has implemented chemistry, manufacturing, and controls and quality guidances of the International Conference on Harmonization and worldwide regulatory authorities. The AAP process identifies and addresses critical issues in which guidance is lacking, ambiguous, or contradictory. AAPs were designed to provide a forum where one could learn from the experience of experts in pharmaceutical analysis and enhance the understanding of analytical practices that reflect good science and sound regulatory compliance. This article summarizes the discussion points from a meeting regarding the Justification of Specifications topic.
Apr 01, 2007
Pharmaceutical Technology Europe
When a dosage form or an API is introduced to the gastrointestinal tract, or dissolution media mimicking it, a transformation from a metastable to a more stable form with lower solubility and bioavailability is possible.
Apr 01, 2007
Pharmaceutical Technology Europe
There have been significant advances, especially in understanding the role of carrier properties on the aerosol performance of the API.
Apr 01, 2007
Pharmaceutical Technology Europe
Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities.
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