The Weblog for Pharmaceutical Scientist
4-28-04
DSN Welcomes PR Web
You may have noticed that the home page has returned to a three column format. This is to allow PR Web a side column to post the latest news. "PR Webâ„¢ has offered free online press release distribution services since August 1997. Since then PR Webâ„¢ has gradually made the transition to a fully integrated press release newswire service. They are the largest Newswire catering to small and medium sized companies and organizations and one of the largest online press release newswires." Check out the latest headlines refreshed daily by PR Web.
Book Of The Week: Introduction to Medicinal Chemistry: How Drugs Act and Why
"This work bridges the compartmentalized undergraduate organic and biochemistry and biology subjects to the pharmacology and the clinical areas a modern pharmacy practice requires. The changes and constantly increasing responsibilities of today's pharmacist have dictated a restructuring of the pharmacy curriculum, including individual course content. This book reflects and addresses these developments. This is a well-written work that covers most major areas of pharmaceutical research. The text is presented in a logical and concise fashion being divided into chapters based upon therapeutic topic... more"
FDA Requires Pancreatic Extract Manufacturers to Submit Marketing Applications
"The Food and Drug Administration (FDA) today formally notified manufacturers of pancreatic insufficiency products that these drugs must get approval by FDA within the next four years in order to remain on the market. Pancreatic extract products have a long history of use, some preceding the Federal Food, Drug, and Cosmetic Act of 1938, and more than three dozen different products are being marketed. Only one such product has received formal FDA approval but it is no longer marketed. The other products continue to be available because of their established use as replacement therapy to treat serious conditions associated with pancreatic insufficiency, including chronic pancreatitis and cystic fibrosis (CF)... more"
New Blend Uniformity Draft Guidance
Are you ready to up the ante? Can you prove your blends are really well mixed? Look at this excerpt from the new draft guidance. "Use a minimum of 20 appropriately spaced in-process dosage unit sampling points. There should be at least 7 samples taken from each of these locations for a total minimum of at least 140 samples...more"
Dictionary of Research Phrases
"It has long been known...": I didn't look up the original references.
"A reasonable trend is evident...": These data are practically meaningless.
"Of great theoretical and practical importance...": It is interesting to me.
"While it has not been possible to provide definite answers to these questions...": An unsuccessful experiment, but I still hope to get it published.
"Three of the data sets were chosen for detailed study...": The results of the others didn't match my conclusions.
"Typical results are shown...": The best results are shown.
"These results will be shown in a subsequent report...": Haven't gotten around to it.
"The most reliable results are those obtained by Jones...": He was my graduate student.
"It is believed that...": I think...
"It is generally believed that...": A couple of other guys think so, too.
"Much more work is needed before a complete understanding of the phenomenon can be reached.": I don't understand it.
Finally, my favorite...
"This result is correct within an order of magnitude...": It is wrong.
Until next week,
Peter Scott
4-21-04
The news is starting to pick up again this week. Thanks to all the contributors and news spotters who routinely send me links to add. Here's an interesting article that looks at the whole batch and deals with the mathematics of the complete population.
Nonlinear mixed-effects model for the dissolution assays of drugs
"The aim of this work was to study the release characterization of the whole batch, therefore, we have developed a population model, taking into account the differences between tablets, experimental conditions, heterogeneity, and autocorrelation of residuals. The study of dissolution profiles was carried out using a mixed-effect model, which has provided a satisfactory tool for this kind of data... more"
PharmaQuest Dissolution Testers by Cecil Instruments
Look who's getting into the dissolution field. I guess everyone sees the potential of the growing field of pharmaceutical testing. Hey Vivian, Let's start our own dissolution company.
"Since its formation by Mr Cecil Tarbet, the Company had led the way in the development of UV-Visible Spectrophotometers and was the first to manufacture a commercially available variable wavelength UV-Visible detector for HPLC."
"Cecil Instruments offer complete dissolution systems as well as all the components of the system individually. The dissolution tester is common to the systems and may be used in conjunction with a choice of spectrophotometers. It is fully USP, EP and JP compliant...more"
PAT – Quality ‘by Design’
Nancy Mathis has written another great PAT Article. Does she ever rest? I don't think so. Not as long as PAT is here.
"Checking the process of manufacturing to find discrepancies rather than checking the quality of the finished product alone is the underlying theme of Process Analytical Technology
Fda and the pharmaceutical industry have recently focused on Process Analytical Technology (PAT). Defined as a system for designing, analyzing and controlling manufacturing through timely measurements of critical quality1, PAT uses tools in processes to monitor quality and deviations from the norm in real time. This provides new understanding and knowledge of critical control points and facilitates better control of process variation.
PAT’s gains in quality, safety and efficiency often focus on the manufacturing environment, but its role is rarely discussed in formulation. If quality is to be “by design†formulators must adopt PAT. By investigating PAT technologies first in a lab setting during formulation, the tool can be understood, optimized and transferred to manufacturing along with the product...more"
"In science, read, by preference, the newest works; in literature the oldest."  Edward Bulwer-Lytton (1803-1873)
4-14-04
Welcome back to this week's update. There's not much news in the dissolution filed this week. Let's look at the pharmaceutical companies.
GSK to buy Sanofi thrombosis drugs for $558 million
"GlaxoSmithKline Plc has agreed to buy two anti-thrombosis medicines and a manufacturing plant from France's Sanofi-Synthelabo for 453 million euros ($558 million), Europe's biggest drugmaker said on Tuesday... more"
J&J profit jumps, earnings forecast is raised
"Johnson & Johnson on Tuesday said first-quarter earnings jumped 20 percent on higher sales of prescription drugs and medical devices, prompting it to raise its full-year profit forecast... more"
Novartis sees opportunity in free Medicare drugs
"Novartis AG, one of the world's biggest pharmaceutical companies, sees a huge opportunity for its hypertension drugs by giving them away free to poor Medicare beneficiaries, a top company official said on Tuesday... more"
Roche cancer drug trial succeeds two years early
"A late-stage clinical trial of cancer drug MabThera for treating the relapsed indolent form of non-Hodgkin's lymphoma met its primary goals two years earlier than expected, Roche Holding AG (ROG.VX) said on Tuesday...more"
Pfizer Files Suit Against Internet Site for Selling Copy of Lipitor
"Pfizer announced that it has filed a lawsuit against the operator of "look4generics.com," an internet site selling an unapproved copy of Pfizer's cholesterol drug, Lipitor. The suit was filed today in U. S. District Court in Delaware...more"
Wrap up
Did I forget your company? I know I'll get a letter saying "hey, what about xyz company merging with abc company?" Maybe it's good if your company is not in the news. How about these headlines?
A man sued his doctor because he survived his cancer longer than the doctor predicted.
Two robbers were in the process of their crime when one changed his mind and arrested the other.
A woman had her husband's ashes made into an egg timer when he died so he could still "help" in the kitchen.
Only 68 of 200 Anglican priests polled could name all Ten Commandments, but half said they believed in space aliens.
4-7-04
Welcome back to this week's capsule.
The HPLC Troubleshooter
Are you trying to develop an HPLC method, does your current method give
your tailing, fronting, or peak related problems. The HPLC Troubleshooter says
"Tell me what your troubles are." Well Doc, I'm tired and have this
cough...I mean, I have ghost peaks. Those mysterious peak that should not be
in your chromatogram. The troubleshooter states
1. you have contamination of injector or column. Always flush injector after
each injection.
2.The other options is that you retained compound from previous injection.
Flush column with strong solvent after operation to remove late eluting
compounds.
Conference Recommendation
Barnett Internationals Strategies for Improving Solubility:Practical Applications for Examining, Measuring, Predicting and Automating Solubility
Exploring Factors Affecting Solubility:
* Examining Insoluble Compounds and Best Practices for Profiling
Solubility
* Examining Solubility in GI Milieu and Its Impact on Oral Bioavailability
Examining Techniques for Measuring Solubility in Drug Discovery:
* Discussing Solubility and Solubilization Considerations in Drug
Discovery
* Strategies and Tactics for Achieving Potency and Exposure
Strategies for Addressing Solubility Limitations:
* Strategies to Improve Solubility Using Amorphous Material and
Co-crystals
* Enhancing Dissolution and Bioavailability of Poorly Water-Soluble Drugs
Exploring Computational Methods for Predicting Solubility:
* Examining Insoluble Compounds and Best Practices for Profiling
Solubility
* Examining Solubility in GI Milieu and Its Impact on Oral Bioavailability
Strung Out
By Woody Allen
"I am greatly relieved that the universe is finally explainable. I was beginning to think it was me. As it turns out, physics, like a grating relative, has all the answers. The big bang, black holes, and the primordial soup turn up every Tuesday in the Science section of the Times, and as a result my grasp of general relativity and quantum mechanics now equals Einstein'sâ€â€Einstein Moomjy, that is, the rug seller.
How could I not have known that there are little things the size of a "Planck length" in the universe, which are a millionth of a billionth of a billionth of a billionth of a centimetre? Imagine if you dropped one in a dark theatre how hard it would be to find. And how does gravity work? And if it were to cease suddenly, would certain restaurants still require a jacket? ...more"
4-1-04
The AAPS Dissolution Workshop
I'm back from several days of attending the AAPS Dissolution Workshop in Bethesda Maryland. I have to say, that this was one of the best dissolution conferences that I have attended in years. It started on Sunday with many people arriving and registering. The AAPS people were delighted to see many walk-ins registering that day and on the day of the conference. Estimate put the attendance around 200. Much of the attendance was attributed to the powerful persuasion of Vivian Gray.
Monday started with opening remarks from the now famous Vivian Gray. Who quickly turned the floor over to Vinod Shah for "Introduction and Overview: Current State of Dissolution Sciences." He made a statement that some may disagree with. He said that the state of science of dissolution equipment is such, that chemical calibration is not necessary. I believe that there are still problems that are not covered by mechanical calibration such as vibration, vessel shape, and others too numerous to mention. The day went on to a session of Hydrodynamics with the controversial Fernando J. Muzzio, John W. Mauger, Anne Marie Healy ( one of my favorite articles was written by Dr Healy), Peter Scott, and finally the well known James Polli (another highly informative speaker who speaks on many subject well) was snuck in on BCS since he could only be there on Monday.
After lunch, session 2 started featuring Fiber-Optic Technology. Many of speaker represented fiber optic companies, but most kept the information scientific and information. This session included Vivian A. Gray ( Vivian has a new Website!), Per Nielsen, Ishai Nir, Eric W.Wethington, and John Burmicz.
On the following day session 3 which I anticipated eagerly started. This was the New Technology session. Moderator Ruben Lozano, kept the day to a tight schedule and presented several informative speakers from Xujin Lu( the friend or enemy of many fiber optic companies), Frauke Russell (an up and coming researcher of NIR correlations), Vivian Gray, Kailas Thakker, and James Brasseur,(presenting an idealized stomach!).
The fourth session consisted of New Apparatus designs, from Saeed Qureshi, Harry Brittain (the mad scientist ), Martin Wunderlich, and Diane Burgess.
Finally the third day was one of Compendial Initiatives, moderated by Pankaj Shah, which included 3 speakers from the USP Eric Sheinin, Margareth Marques, and William Brown, as well as talks from Lyn Hughes, and Kimloan Huynh-Ba.
Each session included to the surprise of many speakers, an open forum question and answers session with the speakers from each previous session. Unfortunately many used these forums as times to make statements rather than questioning opportunities. Overall the conference included many new ideas, and provocative speakers from many areas related to dissolution.
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.
Put this link down under strange things i've found on the internet that you may find interesting. The Picture of Everything.
A Short History of Medicine
I have an earache:
2000 B.C. -Here, eat this root.
1000 A.D. -That root is heathen. Here, say this prayer.
1850 A.D. -That prayer is superstition. Here, drink this potion.
1940 A.D. -That potion is snake oil. Here, swallow this pill.
1985 A.D. -That pill is ineffective. Here, take this antibiotic.
2000 A.D. -That antibiotic is artificial. Here, eat this root.:
Until next week...