The Weblog for Pharmaceutical Scientist
jan 30, 2003
USP Pharmacopeial Forum (PF) Is Now Available Online PF Online provides the same important preview of proposed changes to the United States Pharmacopeia and National Formulary (USP–NF), as the print PF edition. However, it gives users the benefits of an online publication.
jan 29, 2003
Many people ask me what changes are ahead for dissolution testing?
The pharmaceutical industry is about to experience a change in the way we analyze our pharmaceutical products. We have new tools to create better products with less time and expense. A snapshot in time would seem to show a crystalized set of unchanging standards. This is far from reality.
The early days of pharmaceutical testing brings us back to the use of titrimetric analysis. Its problem is that it is subject to errors and analyst biases. The need for greater discrimination arose, as well as the trend towards investigating the properties of the drug matrix. One of the first attempts of removing analyst biases was through the use of analytical instrumentation. One method was the introduction of ultraviolet and visible spectroscopy (UV/VIS). This gave us the advantage of highly reproducible results and lower subjective data collection. The trend toward matrix testing included the addition of disintegration testing.
The trend continues. While UV/VIS gave us much better results than titrimetric analysis, there was still error due to inference, impurity, and matrix absorption. What the regulatory bodies suggested was greater discriminating power, and forced many to develop Liquid Chromatographic (LC) techniques for the analysis of the drug products. This allowed a greater separation and identification of interfering chemicals.
It was also determined that a test was need that gave a better description of the drug matrix properties and how the drug substance was released in the gastrointestinal system. This led to the development of the dissolution test, also known as drug release testing. The goal was to test whether the disintegrated tablets had released the product on the microscopic level. Recent developments have been made in the areas of correlating the dissolution results to what is progressing in the human body. This technology is known as the In-Vitro In-Vivo Correlation. An additional area of growth in response to these new testing techniques has been in the emergence of automated systems for the collection and testing of analytical samples.
Achieve faster results with process analytical technology. If we were to look at this trend and extrapolate into the future then we would see that the trend is towards more discriminatory analytical testing, a better understanding of the drug matrix, and an increase in the automation of our analytical testing. The promises of Process Analytical Technology include reduced testing requirement, increased control of the process, and more complete data of each product. The use of Near Infrared (NIR) probes in the process gives us a complete picture of the product, its matrix, and process parameters. This data can be used to create models of Assay, Uniformity, or dissolution results. Companies have successfully correlated NIR data to dissolution results. Since dissolution results can often be correlated to what happens in-Vivo, it may be possible to leave out the middle step. This could produce NIR/In-Vivo correlation.
Is this the end of dissolution testing? Probably not. However, the amount of future dissolution testing may be reduced.
XML technology will change our world. There is a technology new to the world of data storage and handling. Our Field is entering an age in which computers will be able to store data in a new way. This data storage technique is known as Extensible Mark-up Language (XML). The advantage of XML is that one computer can easily recognize a piece of data stored by another computer, and be told what type of data it is. Web developers (who are looking toward the future of computer knowledge and search engine techniques) realize the advantages of XML and are rapidly converting to XML and it's offspring language XHTML. They know they will be lost when the computer start sharing and exchanging information and they get left out.
Using XML means that data from NIR probe, UV/VIS analysis results, and LC chromatograms could be sent to the computer, then the computer could create process models, correlate it to finished product results, e-mail the results to a reviewer, and complete the final report. Also there are many tools available to convert XML data into other formats without the intervention of a human. This means that data could be converted to be viewed on excel spreadsheets, web pages, e-mails, and Word documents without any changes in the original data. Information can be include to display and format the data for each using style sheets.
How can I prepare for the future? Learn the tools of the 21st century. Educate yourself in PAT, Chemometrics, and XML. This year there are many conferences on PAT scheduled. It seems like everyone woke on January first and realized they were falling behind if they did not know about PAT! They were right. Sign up for a conference today and educate your self on PAT.
Be prepared for change for change is coming.
jan 26, 2003
It looks like Pharma Test of Germany has introduced their own vibration meter. Be aware that their displacement units are in micrometers, rather than the unusual but commonly used USP recomendation of mils.
jan 25, 2003
Recently overheard in a pharmaceutical laboratory hallway...
How dissolution scientist does it take to change a broken light bulb?
One... But he isn't sure if he should calibrate it before he uses it.
jan 24, 2003
Would you like to see a new revolutionary way to search the internet? KartOO! is a relational search engine interface. Instead of displaying a list of links, in ranked order, it displays the results of a given search in a graphical, networked format. Nodes are linked to each other by common terms, which you can add and remove to further restrict the search graphically. The links between the nodes are color coded, allowing you to, with minimal effort, see how terms relate different sites, and nodes are displayed by size, according to relevance to the search term. Try a search for dissolution calibration on KartOO!...
Want to be trained in Dissolution in Ireland? Visit AGB.
jan 23, 2003
BRRRR.... It's cold out there. It looks like we have another dissolution manufacturer that I did not know about...Grovers.
These are for all those statisticians you know. Try these on them today.
A mathematician, an applied mathematician, and a statistician all apply for the same job. At the interview, they are asked the question, what is 1+1. The mathematician replies, "I can prove that it exists but not that it is unique." The applied mathematician, after some thought, replies, "The answer is approximately 1.99, with an error in the region of 0.01." The statistician steps outside the room, mulls it over for several minutes, and eventually returns in desparation and inquires, "So what do you want it to be?"
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Q: How many statisticians does it take to change a light bulb?
A: One: plus or minus three.
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Statistics means never having to say you're certain.
In God we trust. All others must bring data.
Robert Hayden, Plymouth State College
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The Japanese eat very little fat and suffer fewer heart attacks than the British or the Americans. On the other hand, the French eat a lot of fat and also suffer fewer heart attacks than the British or the Americans. The Japanese drink very little red wine and suffer fewer heart attacks than the British or the Americans. The Italians drink excessive amounts of red wine and also suffer fewer heart attacks than the British or the Americans. Conclusion: Eat and drink whatever you like. It's speaking English that kills you.
jan 22, 2003
Are you working on making your systems compliant with 21 CFR part 11? Many of the Americans are working the tails off of that one. Here's my must see at Pittcon recommendation... Qaudrichem.
If you are searching the internet for relevant information, you look for the best search engine. Most people are using Google today for their searches. Have you seen the changes to Hotbot? They have redesigned to comply with XHTML standards (allowing future accessibility). Although they have a few mistakes in their coding, They are trying when no one else seems to be. I think I found a new favorite search engine.
jan 21, 2003
I get the most unusual collections of E-Mail theses days. I guess that comes with managing a website. I've gotten the usual round of questions from companies. I've gotten a question from the FDA asking for advice on automation and filters. I've gotten a recent E-Mail from consultants on Process Analytical Technology. Another Consultant had a question on OOS investigation and the Barr Case.
But it's the other E-Mails that I don't expect that throw me off. I've gotten one from a woman in Florida seeking a dissolution to her marriage. I got another E-Mail from a woman who was pregnant and wanted my advise on the use of prednisone during pregnancy. The only thing I haven't been asked is to help with a corporate dissolution. Maybe next month:::
jan 20, 2003
How did the pharmaceutical industry do in the past year...
jan 19, 2003
Sometimes I wonder why we do somethings a certain way. Is it because everyone else is doing it that way? Someone who knows what their talking about (as opposed to me...) told me that was why some tests are like they are. These penguins seem to have the same idea. Hey I've got a great idea for a new mixing apparatus...:::
jan 17, 2003
Do you wonder why we don't use latex gloves anymore? Natural rubber latex contains proteins that can cause allergies. Lubricating powder used on gloves absorbs latex, and when gloves are snapped on or off, the powder is released in the air. Inhaling it or touching the gloves can result in symptoms such as hives, a dramatic form of shock and even death. At least 15 people nationwide have died of latex-related illnesses, according to the Food and Drug Administration.:::
jan 16, 2003
To all my friend in Europe...Don't forget the USP Course on the
Fundamentals of Dissolution in Europe, Basel, Switzerland. custsvc@usp.org,
www.usp.org
To the rest, are you all set for Pittcon in Orlando. I know with all this
snow many are ready for a break. I on the other hand love this time of the
year. It's the viking in me?:::
jan 15, 2003
Have we found a new dosage form to test? Will gelatin be the means of gene therapy. Get your old western blots out to test this one:::
From Ohio State University: BIODEGRADABLE GELATIN PARTICLES SHOW PROMISE FOR DELIVERING THERAPEUTIC GENES IN TREATMENT OF KIDNEY DISEASE
Researchers at Ohio State University have successfully tested micro-sized gelatin particles that may one day deliver therapeutic genes to treat a type of kidney disease. The biodegradable gelatin particles are so small that at least 10 would fit on the period at the end of this sentence. The researchers injected these extremely small, biodegradable particles into arteries that led to an animal subject's kidneys. Gelatin appears to be a good choice for delivering potentially therapeutic genetic material.
jan 14, 2003
Congratulations to the DDG for their first Chat Session last week. The transcript has been posted on their bulletin board...
What's with the new lot number for Salicylic acid reference material? J2B147! I feel like I'm back in the military working on some top secret project.
It seem like they are doing this with all of their newer standards. Is this some marketing idea? Hey, put some bigger numbers on those lots. We need more customers... I miss lots like J-1 and H. Just call me an old traditionalist.