Oct 29, 2003
They market themselves as "the only technical publication devoted exclusively to readers in the tablet and capsule processing industries." Yes, it's the newest journal, Tablets & Capsules. We are even acknowledged as a resource for dissolution information in the article on dissolution testing by Vivian Gray.
Great niche you've filled T&C! You are a much needed resource. Look for them every two months with the latest in tablet technology. October 2003:Tablet Presses, January 2004:Fillers and Counters, March 2004:Contract Manufacturing Packaging, May 2004:Coating etc...
I look forward to your future issues.
Have you any NIR questions? I was searching the internet for an NIR discussion forum. This is the only one I could find. Good questions, old format, too bad we can't update their forum. At least the Yankees didn't win the series this week.
How about this for a title? R&D is From Mars, Marketing is From Venus. Yes, Read this great article from Drug Delivery Technology...They travel all over the world flying first class and sipping white wine, stay in luxury hotels, and entertain customers over gourmet dinners and expensive bottles of wine. And, oh yes, take orders for the technology that we have spent years researching and developing, coming home heroes to management for "making a sale." We R&D folks are the ones who have it tough. We work very long hours, often times all day and all night never leaving the lab...
Welcome, to all the Nutraceutical companies who quiver and fear that one day the FDA will knock on your door and say "Show us your dissolution testing." It seems a few are scared of such a scenario, and have paid much attention lately to the dissolution talk...
One of the world's leading pharmaceutical companies, once again has been named a "Top Employer," by Science magazine. Similar to a 2002 Science ranking of biopharma employers, the 2003 survey sought to identify the companies with the best reputations as employers
It seems like there's a lot of talk on the high price of prescription drugs these days. Many people are looking to Canada as a source for cheaper drugs. One concern is the risk of counterfeit drugs sneaking in. Some internet companies have taken the risk to market directly to Americans. Sometimes you get away with breaking the law, sometimes they catch up to you... What do you think? E-mail me.
I'm always interested in the internet since I spend so much time on-line looking for the latest news. Some people recently studied internet trends. They asked an interesting question; why aren't more european women online?
Hey, this guy writes a blog and gets interviewed by CNN? A Research group says the typical blog is written by a teenage girl who updates it about twice a month. At least two thirds of the blogs out there today have not been updated in months. Well, I'm not a teenage girl, I'm updated weekly, and don't talk about things like my opinion of the latest Eminem CD.
Oh well, I'll get off my high horse and share this From: "V. ROGERS" *****@leeds.ac.uk
This was a story told to us by our chemistry master at school. A female student wished to make some potassium hydroxide solution (aqueous) and decided to throw a large lump of potassium into a bucket of water. Her professor observed what she was about to do, out of the corner of his eye and hurried towards her, and after confirming this was what she was intending to do, asked her first to stir the water in the bucket for five minutes before adding the potassium. She was puzzled and ran after him to ask the purpose of this action.
'It will give me time to get away' said the professor.
Until next week...
Pete Scott, DSN
Oct 22, 2003
FDA's boss hits imported drugs bill
"The head of the Food and Drug Administration last night criticized a measure in Congress that would lift the ban on importing prescription medicine from Canada and other countries.
Foreign drugs may be more affordable, but it would be too risky to allow consumers to buy medicine that does not meet U.S. safety standards...more"
Books
Anthony Palmieri's book is due out this November. I guess I know what's going on my Christmas list... How about some In Vitro-In Vivo Correlations? Or would you rather learn about those surfactants you are working with?
Drugmakers may be struggling to replace top sellers
"The $300 billion drug industry appears to be experiencing a challenging period in maintaining profit growth as patent expiries allow generics to erode sales and drugmakers struggle to come up with new products to maintain momentum, news sources report...more"
FDA offer could prove remedy for drug crisis
"It had to happen. For increasing thousands of Americans and now even cities and some states, the “Canadian Connection” has been a virtual godsend. It’s where they’ve been getting their prescriptions drugs up to 50 percent cheaper than medications sold in the United States...more"
Oct 15, 2003
Glaxosmithkline Opens State-Of-The-Art Manufacturing Plant
"GlaxoSmithKline celebrates the opening of a new 220,000 square foot, high technology manufacturing plant to make inhaled respiratory products in North Carolina.The plant, which will employ 250 people, is the first of its kind in the U.S. Employees will manufacture and package the Advair Diskus. This facility represents the future of North Carolina ...more"
Do you have a habit of losing things? Oh Woz, What's Next?
"Steve Wozniak, the guy who brought us the personal computer, has another idea. His new company has created a wireless network that he says can help you find almost anything -- lost keys, lost dog, lost child. His Los Gatos company -- Wheels of Zeus (WOZ, get it?) -- has designed tags that you can attach to a child, a dog or just about anything. A handheld monitor uses global-positioning-system satellites to show where the tagged items are...more"
Fiber Optics Archives
Here is an article I stumbled across this week. Although it is two years old, I found it very well written and great for those looking into fiber optics. Many are new to dissolution and its now familiar concepts. So I thought it would be good to dig back into the internet archives.
J&J Third-Quarter Profit Rises 20 Pct
"Johnson & Johnson on Tuesday said third-quarter earnings rose 20 percent on sizzling sales of its prescription drugs and medical devices, including a new stent to clear clogged arteries...more"
FDA to Allow Back Door for Some Generic Drugs
"In a blow to the world's big pharmaceutical companies, the Food and Drug Administration (news - web sites) today is expected to signal that it will allow makers of some generic drugs to use a little-known route to approval that could shave years off their time to reach the market, Tuesday's Wall Street Journal reported...more"
Remember, if you're not part of the solution, you're part of the precipitate!
Oct 08, 2003
For years there have been discussion that the location where a tablet settles affects the dissolution rate. "New research work at Rutgers University (Piscataway, NJ) may dramatically impact established practices and standards for dissolution testing...more"
"Anti-tampering technology alone won't solve the growing problem of counterfeit drugs, the government says as it looks for options to tighten the security of medicines on their way from factory to drugstore.
The Food and Drug Administration (news - web sites) is considering making manufacturers ship pills in smaller quantities. Eventually, high-tech gadgets such as hidden transmitters or chemical tags will help assure pharmacists the medications are genuine.
It will take multiple strategies because criminals can crack and copy many anti-tampering measures, such as holograms on packaging, in just a year or two, says the first report, released Thursday, of the FDA's new counterfeit task force...more"
If you're only going to one dissolution conference next year, go to the AAPS DIssolution Workshop. This one has speakers from all over the industry as well as speakers from Health Canada, the FDA, and the USP. Just look at the topics they have scheduled for this year.
Do you use Excel spreadsheets for everything? If you said yes, like many of us, how do you ensure 21CFR11 compliance? "Wimmer Systems is providing a commercial 21CFR11 compliance solution specifically for Excel. Their innovative approach provides you with a low-cost, low-overhead system that puts the technical controls required by Part 11 on your spreadsheets while maintaining the power and flexibility of Excel."
Until next week...
Oct 01, 2003
FDA SAYS MOST DRUG IMPORTS IN RECENT SWEEP MAY BE UNSAFE
"The Food and Drug Administration said a recent crackdown on drug imports into the United States -- that revealed nearly 90 percent were unapproved and potentially dangerous -- further proves its stance that restrictions on importing drugs should not be relaxed. The agency is under pressure from lawmakers who say allowing some reimportation of drugs from abroad would help Americans struggling to pay for expensive medicines."
""Given FDA's limited resources and authorities to detect and block potentially unsafe imports, we are concerned about any measures that would increase the flow of these unapproved drugs, or provide easier channels for them to enter the United States," FDA Commissioner Mark McClellan said at Monday's release of the report...more"
Since I am both in the Pharmaceutical industry, and from the State of Maine I often get asked what I think about the Maine Prescription Program...
Unintended Consequences of Maine Rx
"Under the Maine Rx program, states would provide prescription drugs at for Excel. Their innovative approach provides you with a low-cost, low-overhead system that puts the technical controls required by Part 11 on your spreadsheets while maintaining the power and flexibility of Excel."
Until next week...
Oct 01, 2003
FDA SAYS MOST DRUG IMPORTS IN RECENT SWEEP MAY BE UNSAFE
"The Food and Drug Administration said a recent crackdown on drug imports into the United States -- that revealed nearly 90 percent were unapproved and potentially dangerous -- further proves its stance that restrictions on importing drugs should not be relaxed. The agency is under pressure from lawmakers who say allowing some reimportation of drugs from abroad would help Americans struggling to pay for expensive medicines."
""Given FDA's limited resources and authorities to detect and block potentially unsafe imports, we are concerned about any measures that would increase the flow of these unapproved drugs, or provide easier channels for them to enter the United States," FDA Commissioner Mark McClellan said at Monday's release of the report...more"
Since I am both in the Pharmaceutical industry, and from the State of Maine I often get asked what I think about the Maine Prescription Program...
Unintended Consequences of Maine Rx
"Under the Maine Rx program, states would provide prescription drugs at a discount to residents who are without coverage by requiring pharmaceutical manufacturers to provide a rebate similar to that offered under Medicaid. While well-intentioned, however, Maine Rx will have unintended consequences. The reason: The policy is based on fundamentally erroneous assumptions and will have the very opposite of the intended effects...more"
A letter to you from Pittcon...
Dear Colleague,
Being a research chemist myself, I am faced with the reality of being
permitted to attend a limited number of meetings per year. It is
often difficult to decide which meeting I should attend. PITTCON is
an easy decision for me because I am part of the organizing
committee. But would I attend otherwise and why? Why should you
attend? What does PITTCON offer?
The answer to these questions can be summed up in one word, "SOLUTIONS." PITTCON offers you the complete package, or the “solution” to help you solve your laboratory analysis problems. Of course there is the largest exhibit to be found of laboratory equipment, supplies and services. Within that exhibit, you will find the technical people who have helped develop and refine the equipment. People you would normally not meet at other conferences or would have a difficult time to access by phone. They can tell you how their products can provide part of the solution to your analysis problem or exchange ideas with you that will lead to product improvements.
Part of the solutions that can be found at PITTCON is in our technical program. The most recent conference had 75 specially arranged symposia featuring 374 invited scientists who are among the most recognized experts in their fields. We typically include Nobel Laureates and other prominent award winners in our program. If you need justification at your workplace in order to attend, you are welcome to submit a paper and be part of the over 1,700 papers presented at PITTCON. The potential for networking with your colleagues is unparalleled.
Another part of the solution is our short courses. We offer numerous short courses (81 last year) where you can learn skills that will help you in your job. In addition, exhibitors also offer special educational opportunities that are specific to the products they sell.
PITTCON is not just for analytical chemists and spectroscopists, but for all fields of chemistry and related sciences that require solutions for their laboratory analysis problems. A conferee remarked that one of the advantages of PITTCON is the size and diversity of subject. He could pop in on a technical presentation or pass a booth that he initially thought might have nothing to offer for his specific needs, but then realize that it offers a key piece of knowledge or product that is part of the solution he was seeking.
Please join us in Chicago, March 7-12, 2004 as we discover solutions for better chemistry!
Sincerely,
John P. Baltrus, PhD
President, PITTCON 2004