Industry News August 2010

Dr. Kailas Thakker to Speak Globally on the Use of Franz Diffusion Cells in Drug Product Performance Testing

Research Triangle Park, NC

On July 11th Dr. Kailas Thakker spoke to an audience of pharmaceutical scientists at the 37th Annual Controlled Release Society Meeting in Portland, Oregon, on the topic of Drug Product Performance Testing Using Franz Diffusion Cells. She will continue sharing her knowledge of the subject though educational workshops as she travels to San Paulo, Brazil, in September and then to Boston and New Jersey later in the fall.

Dr. Thakker, president and founder of Analytical Solutions in Research Triangle Park, North Carolina, recently celebrated the company's 15-year anniversary. In that time she and her staff have become globally recognized experts in the field of in vitro release rate testing (IVRT) for topical and transdermal drug products, cosmetics, and nutraceuticals.

Over the years, Analytical Solutions has developed numerous in vitro release rate methods to support both formulation development and post marketing changes in manufacturing processes, sites, or product compositions.

Working with large, midsize, and small pharmaceutical companies, Analytical Solutions provides CMC-related analytical services to the pharmaceutical industry including HPLC method development and validation, stability sample testing, and storage. Work is conducted in compliance with FDA GLP and GMP regulations as required.

For further information about release rate testing for drug products, please contact Dr. Kailas Thakker at Analytical Solutions.

Analytical Solutions, Inc.
info@asi-rtp.com
(919) 549-9700


Report on Current and Future Activities

  1. Dissolution Technologies will have an exhibitor booth at the AAPS Annual Meeting in New Orleans, November 15-17, 2010. The booth number is #436. Please come and network with your Dissolution colleagues.
  2. The Dissolution Technologies website, www. dissolutiontech.com, is now searchable. A Google search engine is now located on the Home Page.
  3. A new book titled "Dissolution Technologies-Questions and Answers" will be available for purchase in November, 2010. A German translation of the "Handbook for Dissolution Testing," Third Edition, is in progress.

For more information contact:
Vivian Gray
Managing Director
Dissolution Technologies, Inc.
Hockessin, Delaware USA
1-302-235-0621
vagray@rcn.com


A New AAPS Focus Group: The QbD & Product Performance Focus Group

The QbD & Product Performance Focus Group evolved from the 2009 workshop Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit that took place in Rockville, MD. The meeting was organized by a small group that recognized the patient benefit in integration of QbD principles and biopharmaceutics. The path forward for effective integration of QbD and biopharmaceutics for improving product quality and specification setting (dissolution acceptance criteria) emerged with active participation of the attendees during plenary and breakout sessions. It was defined as a collaborative effort that places the focus of drug development on patient needs.The path forward would be supported by Quality Target Product Profile driven specifications, Biopharmaceutics Risk Assessment Road Map, efforts to advance and leverage science and technology, and knowledge sharing, all enriched by multidimensional collaborations.The Focus Group report on the breakout sessions and recommendations is in the AAPS Journal, and the meeting report authored by the AAPS In Vitro Release and Dissolution Testing Focus Group is in Dissolution Technologies.

The QbD and Product Performance Focus Group, with the active participation of its members, will leverage and advance science- and risk-based approaches and technologies and develop strategies for linking critical quality attributes, product, process, and the patient throughout the product life cycle.

The Focus Group will be publishing its first newsletter in July and will be seeking member input for creating and fostering multidisciplinary collaborations leading to enhanced product quality for patient benefit.

To join the QbD and Product Performance Focus Group: http://www.aaps.org/inside/focus_groups/QBDPP/index.asp


Hanson Research Corporation
9810 Variel Avenue
Chatsworth, CA 91311 USA
Tel 818.882.7266
Fax 818.882.9470

Hanson/Agilent Driver Upgrade
Chatsworth, CA, USA-June 28, 2010-Hanson Research Corporation, a world leader in dissolution test technology, is proud to announce that it now fully supports Agilent's 8453 PDA 32-bit ChemStation software platform (version B) with the release of its version 4.0 Dissolution System Drivers. Hanson is a worldwide OEM provider of the Agilent 8453 PDA ChemStation for dissolution; this new upgrade will provide seamless integration with Hanson's legacy SR8-Plus™, as well as its newer Vision® dissolution testers and its AutoPlus™ and Vision-Enabled AutoPlus™ autosamplers.

About Hanson
Hanson Research is a world leader in dissolution test technology for the pharmaceutical industry. Founded in California in 1951, we design, manufacture, install, and service equipment for pharmaceutical research and quality control. We offer a complete line of tablet dissolution, topical, and transdermal test systems, and we support customers throughout the United States and the world.

Contact
Ren´┐Że Patton
Technical Communications Coordinator
Hanson Research Corporation
T. 818.882.7266 x270
F. 818.280.0831

hansonresearch.com


Quality Lab Accessories, LLC Announces NEW Lab Services Division

Bridgewater, NJ-June 1, 2010-Quality Lab Accessories, LLC (QLA), a leading global provider of dissolution accessories and consumables for over 14 years, announced the launch of a new Lab Services Division. QLA will now offer dissolution instrumentation validation, calibration, and repair services headed by Raymond Majeski, Director of Lab Services.

"We are pleased to have Ray assume this vital role for our Lab Services division," said Robert Spock, President of QLA."With Ray's 25 years of hands-on dissolution testing, QLA is uniquely positioned to apply his experience in the dissolution industry and provide superior service in addition to our high quality products to all of our valued customers."

Services will include Enhanced Mechanical Calibration (EMC), Preventative Maintenance (PM), and Repair Services (RS). EMC is performed and documented to verify that all physical parameters of the dissolution tester are within tolerance as described in the new FDA specifications, which outline the use of the EMC procedure as an alterna- tive approach to current apparatus suitability procedures described in the USP. PM is performed to ensure that the dissolution tester continues to operate properly and that no component of the system is compromised due to wear and use. RS includes general instrument repairs that are available on-site or at our new service center in Dublin, PA.

To learn more about QLA's Lab Service offerings, please call 908-685-7500 or visit our website at www.qla-llc.com