The Weblog for Pharmaceutical Scientist
6-30-04
This week I have been getting a surge of visitors to the D-Talk Forum. There has been much discussion about why one would need Fiber Optics. There is a related thread as to why one would need automated HPLC online. I just realized I spent the whole of last week's column and never mentioned PAT, stratified sampling, or any of the other new initiative. I guess I'm losing it.
Did you hear about the homeopath who forgot to take his medicine ?
He died of an overdose.
"New drug delivery systems are being researched and launched almost every day. Drug delivery is the administering of a drug with the optimum structure and form that can provide the intended treatment. Aimed at higher efficacy, better patient compliance, greater patient convenience and longer product lifecycles with sustained release effects from lower dosages, new delivery systems are giving patients new hopes. This article discusses the challenges and latest developments in five such delivery systems?oral, nasal, pulmonary, transdermal and topical.
PAT Summer Summit - July 27-29, 2004, Rio Grande, Puerto Rico
Learn the practical aspects of PAT, Process Analytical Technology as it is applied to the Pharmaceutical Manufacturing Environment. Real Applications or Case Studies will be used to clearly illustrate the key components and the benefits of PAT - Process Analytical Technology. Broaden your knowledge about the PAT initiative, and how industry is responding to the PAT opportunity. Established and emerging PAT applications and technologies for the Pharmaceutical Industry will be described.
3456 free chromatography applications
"Advanced Chemistry Development (ACD/Labs) has updated its free Public Chromatography Applications Database, which brings the number of HPLC and GC applications provided through collaboration with major column vendors from 1830 to 3456 in total. Public chromatography applications database has been almost doubled in size, through collaboration with a number of leading column suppliers..."
Diverse Measurements through NIR
"The use of NIR in the pharmaceutical industry continues to increase as new applications are developed and established applications become more widespread. Many of these new measurements are designed specifically to give detailed information enabling manufacturers to better control their processes..."
6-23-04
For those of us in the northern hemisphere, summer started this week. Actually it was an uneventful start, since the warm days had already arrived weeks before. The past few days were clouds threatening to rain.
Calorimetry: The Universal Detector
So what's new in the pharmaceutical industry? Here's a company named Thermalcal, who claim is that microcalorimetry is the universal detector. They tell us that the detector can be used in a wide variety of test, such as batch excipient compatibility, forced degradation, oxidative susceptibility, monitoring effect of milling, rate of hydration,freezing of peptide, lyophilized peptide, unstable polymorphs, polymorph conversion, polymorph stability, and finally dissolution screening.
Controlled Drug-Delivery Systems
"Controlled-release systems also known as modified-release systems include extended release (ER), which controls release rate and time, and delayed release (DR), which controls release location. Modifying release profiles offers more convenience, better efficacy and reduced side effects. Developing controlled-release forms can also extend market exclusivity and product differentiation..." The most recent cover story in Pharmaquality.
New and Emerging Tablet Technology
In the field of controlled release there are many new tools in out tool box that allow us to make better products for the consumer. To learn more visit this article in the most recent Pharmaquality.
Finally, I found a quote this week and would like to share it with those of you who have a new idea, and are afraid to try it...
The man who follows the crowd will usually get no further than the crowd. The man who walks alone is likely to find himself in places no one has ever been. -Alan Ashley-Pitt
6-16-04
Today's my son's birthday. He'll be getting a new bike when he wakes up. Ain't life grand when you're a little boy.
Taste Like...PUCE?
If you haven't been to the D-Talk forum lately you haven't seen the change in their appearance. There's this funny color in the first column. I can't name it, but someone suggested puce.
Seriously, the D-Talk forum and DSN have both undergone major programming updates. In order to reflect these internal changes, a single style sheet was switched and viola, the whole site changes. Isn't XML a great language to work in?
So what's up in the pharmaceutical industry news? Let's have a look at a few headlines as well as a blurb from Derek Lowe on bioavailability.
FDA Finds Fault With Canadian Pharmacies
"Three Canadian pharmacies shipped unauthorized medication to Wisconsin residents, newly released documents show, underscoring federal concerns about state and local programs that encourage cheap drug imports... more"
Schering to cut 900 jobs, halve production sites
"Schering, the world’s biggest maker of birth-control pills, plans to eliminate 900 jobs and half of its 24 production sites as it seeks to reverse a decline in profit...more".
Se-cure Pharmaceuticals sets up $5m facility at Dalton
"The company, which produces a treatment for menopause symptoms, projects $22 million revenue by the end of 2005.Israeli company Se-cure Pharmaceuticals has invested $5 million in setting up a new factory at the Dalton industrial park, where it plans to produce its Femarelle drug, which combines treatment for symptoms of menopause and for osteoporosis... more"
Down The Hatch
"It seems obvious that solubility should impact bioavailability  after all, if you swallow a rock, it will just come out the other end. So why does it often not seem to work that way in practice?
Three reasons... more"
PAT and Dissolution
Will NIR analysis ever replace the majority of dissolution testing done for release? Visit the D-Talk forum and post your reply. D-Talk has one of the only open online forums for PAT and the pharmaceutical industry. There is a section on process analytical technology in the forum.
Well that's all I have for this week. See you next week, Pete.
6-9-04
Computational Fluid Dynamics Modeling of the Paddle Dissolution Apparatus
I have just found the latest article from the team of researchers over in Dublin, who have found their niche in the dissolution field. Every article by this team reveals new facts which help develop a greater understanding of the science of dissolution testing.
Evolution into A High Precision Glass Vessel
"Dissolution testing has remarkably increased in value and significance over the last 30 or so years. It has been widely employed as an important tool in formulation development, in bioequivalence studies and in quality control. It is well known that the dissolution test involves many variables that can contribute to inaccurate results."
"Therefore, the current USP, EP and JP specify in detail mechanical parameters of the dissolution tester itself such as a shaft rotation speed, shaft position, wobble, distance of blade to inside bottom of vessel and the like. However, considering the vessel alone, only height and inside diameter are stated as dimensions. In addition, the tolerances of each dimension have been actually quite wide...more"
A Different Model
Here is a new way to do dissolution. The attempt is to really mimic the GI system. You've got to see this.
Hey Where is Everybody?
Have you seen this note? "Account Locked: E-mail Moderator" Has this become more and more common on the other forum? I tried to e-Mail Faith, my old buddy from Melbourne, but alas she is no more! Where did everyone go? Where are my old friends?
Until next week...Did you know that 42.7% of all statistics are made up on the spot. Really, it is true. It really is... Sort of really...Oh, Never mind.
6-2-04
Isn't it funny how we make plans, and then things change at the last minute? I had planned to update the site last Friday while I was up in Maine visting relatives. But the internet was not connected where I was staying. These things happen sometime.
As I was saying, last week I attended a blend and dose uniformity testing conference. I learned more about v-blenders than I ever thought was possible. I learned about deblending or segregation of blends. I learned about the new stratified sampling draft guidance. I learned about effusivity, multivariate analysis and NIR. There's so much to learn. Let's get back to dissolution...
Set me free!
Do you ever wonder what dissolution is called in other countries? Here a site that list the equipment as "Setting Free Equipment." In German "dissolution test" is translated with "active substance setting free test". They also do "setting free profiles."
Was your active inprisoned correctly in the drug matrix?
Did you Hear That?
It appears that acoustic measurments are being explored as a new way to investigate your product as it is being produced. Could you optimize your dissolution results using ultrasonic waves to probe your process?
Look Ma, No Equations
Analysts are finding multivariate chemometrics a useful tool in the lab. Do you want to learn more. Sign up for the EigenVector Research Course.
"Chemometrics Without Equations (or Hardly Any) is designed for those who wish to explore the problem solving power of chemometric tools, but are discouraged by the high level of mathematics found in many software manuals and texts. Course emphasis is on proper application and interpretation of chemometric methods as applied to real-life problems. The objective is to teach in the simplest way possible so that participants will be better chemometrics practitioners and managers."
And Finally, Strange Medicine...
It never fails to amaze me what people will do. Look at this headline:
"Woman performs Caesarean section on self"
"Alone in her one-room cabin high in the mountains of southern Mexico, Ines Ramirez Perez felt the pounding pains of a child insistent on entering the world.
Three years earlier, she had given birth to a dead baby girl. As her labor intensified, so did her concern for this unborn child.
The sun had set hours ago. The nearest clinic was more than 50 miles away over rough terrain and inhospitable roads, and her husband, her only assistant during a half-dozen previous births, was drinking at a cantina. She had no phone and neither did the cantina.
So at midnight, after 12 hours of constant pain, the petite, 40-year-old mother of six sat down on a low wooden bench. She took several gulps from a bottle of rubbing alcohol, grabbed the 6-inch knife...more"
Until next week, remember my advice...Be nice to your kids. They'll choose your nursing home.