Sep 24, 2003
Welcome back for this week's installment of the capsule. Don't forget to visit our newest feature, the D-Talk forum. While you're there leave a comment or ask a question. The forum is doing surprisingly well. By word of mouth or e-Mail many well known scientists in the field have joined and added their comments and knowledge...
Have you read the newly released guidance on PAT yet? The scientific, risk-based framework outlined in this guidance, Process Analytical Technology or PAT, should help manufacturers develop and implement new efficient tools for use during pharmaceutical development, manufacturing, and quality assurance while maintaining or improving the current level of product quality assurance. Why don't you drop by and give the draft guidance a look.
In other news...Always well known for their excellent educational programs, next month you have the choice of Fundamentals of Dissolution Workshop, October 14 - 15 and Advanced Dissolution: Principles and Theory, on October 16 - 17, 2003 in Cary, North Carolina at Varian.
The Fundamentals of Dissolution Workshop is a comprehensive two-day course designed for new and emerging dissolution analysts. The course places emphasis on basic dissolution fundamentals and theory, along with focused discussions on current compendial dissolution testing apparatus, USP physical parameter requirements and the current USP calibration procedure.
The Advanced Dissolution includes principles and theory is co-sponsored with the School of Pharmacy of the University of North Carolina at Chapel Hill. It is a two-day program designed for the advanced dissolution analyst, as well as those involved in drug metabolism, drug disposition, pharmacokinetics, and analytical methods development.
You Might Be a Chemist if...
I'll leave this week with these parting words, "You do not really understand something unless you can explain it to your grandmother." - Albert Einstein
Sep. 17, 2003
Have you heard of effusivity? What's that? Well in the field of PAT it's one of the areas getting attention as an alternative to NIR. effusivity.
Mathis tells us "When you walk from a hardwood floor onto a ceramic floor in bare feet, the ceramic floor feels colder-even though they are both room temperature. What your feet are detecting is the difference in effusivity between wood and ceramic-in other words, the rate at which these two different materials absorb heat and draw it away from your warm feet. The ceramic has a higher effusivity, and therefore absorbs heat from your feet more quickly, creating the sensation that it is colder." Check out Mathis's site...
Look who has a new web site...
SOTAX Corp, Horsham, PA (Automated Dissolution and Tablet Testing Instruments) and the Laboratory Robotics Information Group (LRIG) would like to take this opportunity to invite you and your colleagues to this month's regional meeting on Laboratory Automation for Pharmaceutical Dosage Forms.
Location:Marriot Hotel, 110 Davidson Ave,Somerset, NJ
Call 732-560-0500 for reservations and tell them you are there for the LRIG meeting as many rooms have been set aside and we have a discounted rate.
Tuesday, September 30th, 5-9pm.
If you are interested in attending please visit www.lab-robotics.org and fill out the "sign up form." You should also drop an email to:karenrakoczy@hotmail.com
OK, every now and then I find a site that's just pure fun. So I like to share those sites with you. Here's a clock site developed using FLash, frames and HTML, by the innovative Yugo Nakamura.
Sep 10, 2003
Another week has gone by? Since hydrodynamics are getting more attention in the dissolution field, I thought that I would link to this article for you to visit.
Here's their introduction:
"The combined use of experimental fluid dynamics
(EFD) and computational fluid dynamics (CFD)
methods effectively identifies and addresses flow
problems in the pharmaceutical industry. Process
performance and reliability can be improved with the
application of this technology. This article
demonstrates the use of EFD/CFD with diverse
examples, including a laboratory dissolution
apparatus, stirred tanks in various configurations,
mixing of non-Newtonian fluids, static mixers, and
roller bottles. Flow patterns, mixing structures, and
complex behavior are all revealed with the
combination of EFD and CFD methods."
Sep 3, 2003
Today we highlight Pharmabiz, India's most comprehensive portal on pharmaceutical news, tenders, patents, notifications, projects, stocks, drugs, medicines, promoted by iPharma India Ltd in Mumbai. This portal has a dedicated team of senior journalists, marketing professionals and key industry representatives.
The team is headed by Mr P A Francis, who has been tracking the pharmaceutical industry for more than 20 years now. He has worked with leading Indian newspapers like The Economic Times and The Observer of Business and Politics. He was also the founder editor of the Express Pharma Pulse, a weekly.
In other news...
Here's a very good paper for all of you to look over it's entitled The Composite Solubility Versus pH Profile and Its Role in Intestinal Absorption Prediction
Here's their abstract..."The purpose of this study was to examine absorption of basic drugs as a function of the composite solubility curve and intestinally relevant pH by using a gastrointestinal tract (GIT) absorption simulation based on the advanced compartmental absorption and transit model. Absorption simulations were carried out for virtual monobasic drugs having a range of pKa, log D, and dose values as a function of presumed solubility and permeability. Results were normally expressed as the combination that resulted in 25% absorption. Absorption of basic drugs was found to be a function of the whole solubility/pH relationship rather than a single solubility value at pH 7. In addition, the parameter spaces of greatest sensitivity were identified. We compared 3 theoretical scenarios: the GIT pH range overlapping only the salt solubility curve, the salt and base solubility curves, or only the base curve. Experimental solubilities of 32 compounds were determined at pHs of 2.2 and 7.4, and they nearly all fitted into 2 of the postulated scenarios. Typically, base solubilities can be simulated in silico, but salt solubilities at low pH can only be measured. We concluded that quality absorption simulations of candidate drugs in most cases require experimental solubility determination at 2 pHs, to permit calculation of the whole solubility/pH profile."