3-24-04
Firms To Get Help From Office of Generic Drugs on Dissolution
"As part of an ongoing effort to help firms improve the quality of their generic drug applications, the FDA's Office of Generic Drugs (OGD) will soon post a dissolution-methods database on its website and start updating the Orange Book daily.
Measuring the dissolution, or breaking down, of a drug product in the body is one of the key factors in determining the bioequivalence of a generic drug. The FDA's dissolution-methods database will provide recommendations for firms to establish dissolution, including recommended sampling times.
The database, which is scheduled to go online this month, is searchable by a product's generic name. The database will initially contain older products; newly approved products will be added incrementally, according to OGD. The office also is planning to develop an in vivo bioequivalency recommendations database...more"
Conference Recommendation:
If you're like me you are probably looking for the next new technology to help improve your job, your company, or the science of drug delivery and testing. Here's the latest in cutting edge technology; Barnett Educational Services presents: Nanotechnology for Drug Delivery.
Listen to Experts Explain Nano-Particle Manufacture:
* Hear Multiple Application Studies of Nanotechnology
* Understand How to Improve the Chances of Clinical Success and
Commercialization of Poorly Soluble NCEs and APIs
* Hear a Case Study of a Self-Assembled, Targeted Nanoparticle for Small
Interfering RNA (siRNA)
* Hear Practical Nanotechnology Solutions to Solubility, Stability, Particle
Sizing and Gene Delivery
* Investigate Neovasculature Targeted Delivery of Anti-Angiogenic
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* Understand the Nanotechnology Science of Dendrimers and How They Can Be
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* Regulatory Session with FDA's Dr. Ajaz S. Hussain Deputy Director, Office
of Pharmaceutical Science, FDA/CDER
Attend All Three ROUND TABLE DISCUSSION SESSIONS and Interact with our
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Unit Dose Operations for Tablet and Capsule Manufacturing
This is one of the best article that I have seen explaining the manufacturing of tablets. This is a link to a great pdf from Dipharmatech. It explains the complex process of solid oral dose manufacturing in simple easy steps. Please bookmark this link and refer to it often.
Here's an e-mail from a friend:
"Hey Pete,
This quote came up during conversation the other day and I thought you might like it. One of our sales representative was using this of course as a sales argument ..."
"If you have to watch it, then it's not automation."
That's a good quote, I think I'll post it.
3-17-04
Interphex, For Best Results Take Annually...
This is the week of Interphex. "INTERPHEX2004 opened in New York, March 16th with a record number of exhibitors, attendees from over 40 countries, and more than 60 leading business and trade press. With 2 days left, there is still plenty to see and do at INTERPHEX...more"
FDA's New Moves
"Janet Woodcock, acting deputy commissioner of the Food and Drug Administration (FDA), today addressed a packed house in a keynote speech at INTERPHEX2004, the nation's oldest and largest pharmaceutical conference and exposition.
Woodcock, who simultaneously issued a report in Washington on the same topic, told the gathering that the FDA needs to keep in step with the speed of technology and to use a "science-based process" in its regulatory dealings. She noted that the agency has not always kept up with the times and that this has slowed down the approval process of many drugs unnecessarily. Among the new steps: guidelines will be issued that fall short of regulation but whose intent is to separate the true risk factors that should be regulated from historical precedent that has little effect on safety...more"
FDA unaware of most drug complaints
"The Food and Drug Administration receives more than 300,000 reports annually about adverse effects caused by drugs on the market, but officials say those reports don't include most patients' concerns because local health care professionals are not required to report complaints to the federal level...more"
Register Today for the Fundamentals of Dissolution Workshop
April 7 - 8, 2004
Cary, North Carolina
"The hands-on workshop sponsored by Varian, include dissolution tester familiarization, performing the dissolution test, and physical suitability testing. This course will most benefit the novice dissolution analyst and those in Quality Control and Assurance, Calibration, and Metrology. This course also serves as a refresher for those individuals with limited or intermediate dissolution experience...more"
Don't Synthesize Anything I Wouldn't Synthesize!
Flanders and Swann sing The Laws of Thermodynamics. This performance dates from the mid 1960s. Very Dry Humor, but a must for those scientists who love the lighter side of science.
Deep Thought
Some people can tell what time it is by looking at the sun, but I have never been able to make out the numbers.
Until next week...Pete
3-10-04
Many of our loyal readers are at Pittcon this week. I don't know how many e-mails I have sent to my contributors, in which I received an "out of office" reply stating "I am out of the office attending Pittcon and will return next week", or something similar.
Micropipetting? Not Me!
Call me old fashioned, but when it comes to volumetric dilutions I prefer glass pipettes. Give me a good old 1 to 100 volumetric dilution everytime. Even If I have to do serial dilutions, I feel more confident. Am I insecure? Do I fear micropipittes, you bet your life. Check out this article from Cal Lab Magazine on micropipettes.
Light Induced Fluorescence
For those of us who are working on PAT and implementing non-destructive, rapid online techniques of analysis, we are accustomed to the traditional analytical methods. These include NIR, Raman, and Effusivity. But there are other way to analyze your tablets. Here's one that will be interesting to all, Light Induced Fluorescence (LIF). This was featured recently in Pharm. Sci. Tech.
Apparatus 2 and 3
Many people have done studies evaluating the results of apparatus 1 against apparatus 2 results. Here one that compares 2 to 3. This also appeared in Pharm. Sci. Tech.
AAPS Workshop
I am finishing my presentation for AAPS today. It's the deadline to send them out today too. Funny how those things work out. I has come to my attention that one of my favorite speakers has just agreed to speak at AAPS this month, Dr. James Polli. With some last minutes shuffling Ruben and Vivian were able to fit him into the schedule. I wonder how Ruben bribed Jim into speaking? Just kidding, Ruben.
ASTM Effusivity Standard
Are you using Effusivity or planning to? Then you better cast your vote on the effusivy standard being developed by ASTM for the use in the pharmaceutical industry. The balloting is ongoing and will close later this month. What! You've never heard of effusivity? You will. Just ask Nancy Mathis of Mathis instruments for an explanation.
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...
My Story
When I first started out, I was going to be a mathematician.So I took
algebra, but I found that was highly variable.
So, I tried geometry, and that's where I learned all the angles.
Then I took calculus, that was truly an integrating experience, but it
definitely had its limits.
After a great deal of consideration, I decided to turn away from math and
give some serious thought to science.
I tried geology, but found that was kind of hard.
Next I tried physics but I knew that would never work.
I tried biology because, but found I couldn't make a living.
I finally realized chemists had all the solutions.
3-4-04
Again, Computer transitions have delayed the Capsule for a day. I switched from Windows 98 to Windows XP. I had to reinstall my software. Let's see what we have this week.
Manufacture and Dissolution Studies of Lipid Spheres
"In vitro dissolutions were conducted using the paddle method on spheres of 300 mg with sizes ranging from 0.315–0.80 mm. Similar profiles were observed regardless of batch size or the percentage of active drug (Figures 7 and 8). Batches T14 and T15, which had the same formulations, showed particularly good reproducibility...more"
Demonstration of Dissolution Automated Software Solutions
The IDIS EE Dissolution software provides a single source of automation, Calculations, Report generation of results for all dissolution testing for Closed Loop, Sample Collection, Dilution and Measurement with UV or Injection into any HPLC, pH and Media Change configurations.
This unique dissolution system can automate dissolution testing for baths from:- Distek, Vankel, Hanson, Sotax, Logan, Pharmatest and Erweka etc for USP 1&2, 3 and 4 and spectrophotometers from different manufacturers on one testing platform at Pittcon Booth 361
Book of the Week
"Analytical Method Validation and Instrument Performance Verification: Teaches proper procedures for using tools and analytical methods in a regulated lab setting. All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibration of instruments and validation of analytical methods. Following correct procedures ensures the generation of reliable data, which leads to the manufacture of safe and effective products.
Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions...more"
Sepracor, Makers of insomnia therapies gain as sector trades mixed
"Tuesday's gains added to a whopping 57 percent advance in the previous session that was triggered by news Sepracor had won conditional U.S. approval for Estorra, an anti-insomnia drug. By granting Estorra "approvable" status, the Food and Drug Administration appears to be opening the way for the drug to reach the U.S. market later this year.
Sepracor said the FDA hadn't asked for additional patient testing of Estorra, a significant victory for the specialty pharmaceutical company because such testing would have been costly and time consuming...more"
Mom
My mother is a mathematician, so she knows how to induce good behavior.
"If I've told you n times, I've told you n+1 times...."
-Peter Scott, DSN