Greetings from beautiful Vancouver, British Columbia where the 4th IATA World Cargo Symposium is about to get underway.

It seems like I'm constantly running a day behind. So before getting consumed in pharmaceutical air cargo issues, I thought I would take a moment to link you to my latest Contract Pharma article. For all the controversy that can surround industry award competitions, the net gain here is that the patient ultimately benefits — and regardless of what you think about industry awards, that is a very good thing. The 2010 IQPC Cool Chain Excellence Awards.

Keep it real.

There has been much discussion (and confusion) regarding the applicability of MKT in the handling, storage and distribution of temperature-sensive pharmaceuticals over the past 18 months or so. Late last spring, a posse of five industry experts published a paper to add clarity to this often confusing topic. The group consisted of an Eli Lilly & Company engineer, regulatory scientist, a retired QA / Technical Support Director, and a Research Advisor, who collaborated with a Distribution QA Director from Abbott Laboratories. Their five page article was published in the May/June issue of Pharmaceutical Outsourcing Magazine.

At issue, and the answers the authors strove to assess and resolve was: can the impact of a reuslting MKT from excursions encountered over short periods of time, (excessive heat exposure during transport for example), have a significant impact on product degredation or quality?

The paper does an excellent job of illustrating the importance of establishing upper and lower limits on the use of MKT based on available stability data. The authors conclude that under certain circumstances it can be appropriate to use the calculated Mean Kinetic Temperature for a drug product as a valid means to approximate the effects of temperature variation that may occur during transport in the absence of product specific kinetic data, but that it is limited to temperatures for which there are stability data to support it, and not beyond.

The entire article has been made available in a printable pdf format (click on the paper clip icon below) thanks to the kind permission of the authors, Bob Seevers, Ph.D., Jeffery Hofer, Paul Harber, and Rafik Bishara, Ph.D. , David Ulrich; Nathan Collins, Editor Russell Publishing, and Henry Ames at Sensitech..