The Weblog for Pharmaceutical Scientist
12-29-04
Dearation?
There is a well thought-out study on the various techniques of deaeration in the latest Dissolution Technologies. It compares the techniques and addresses a phenomenon known as over deaeration. Read it in the latest Dissolution Technologies. I finished an upcoming article on vessel irregularities. Look for it in February.
Go Undercover
Countries such as China have a major problem with up to 40 percent of it's drug products believed to be fake. Thousands of deaths have been attributed to these phony pharmaceuticals. Are we prepared to fight the battle as the criminals learn the ropes of making the fakes?
"Protecting an ever more complex pharmaceutical supply chain has become one of the industry?s greatest challenges. Drugs worth many times their weight in gold, coupled with huge price discrepancies between U.S. and foreign markets, have spawned illegal profiteering operations that threaten manufacturers and patients alike.
The assurance that consumers receive prescribed drugs, at the prescribed dose, at an appropriate price is a cornerstone of the U.S. health system. Counterfeiters, diverters, importers, and compounders skim anywhere from five to ten percent?nobody knows the exact number?off the top of this $200 billion enterprise. The World Health Organization estimates that five to eight percent of the world?s drug supply is counterfeit...more"
Documentation Purgatory?
Are you overwhelmed by those endless SOPs? Why don't you give Nilsen a call?
"Writing SOPs and validation protocols, getting them approved and providing the necessary training prior to implementation, in a working environment, can pose quite a challenge. We can help alleviate some of the stress by writing these documents for you and can even provide training and implementation guidance, allowing you to get your work done and to stay productive and compliant at the same time...more"
Quote of the Week
"We've got to pause and ask ourselves: How much clean air do we need?" -- Lee Iacocca
12-22-04
No New Tale to Tell
I was watching The Wizard of Oz the other night while decorating the christmas tree. It seems that the WB wanted to promote the movie on the week of Christmas using the song "No New Tale to Tell", by Love and Rockets. Now talk about a mixed message!
When you're down.
It's a long way up.
When you're up.
It's a long way down.
Does this have something to do with being over the rainbow.
I guess that's an appropriate message for big Pharma. Some are still up, untouched by bad news. Some are down, overwhelmed with negative stories. Many companies are feeling the pressure of starting a new year with few promising prospects.
Pharmaceutical industry limps into 2005
"The pharmaceutical industry endured a disastrous 2004, and the aftermath will linger into the new year. Regulators at the Food and Drug Administration are likely to take a more cautious approach about new drug approvals in the wake of Merck & Co.'s withdrawal from the market of the pain reliever Vioxx because of potentially lethal side effects. And the ensuing firestorm has yet to die down about whether Merck muzzled the drug's dangers to keep selling it...more"
Pharma 2010: Silicon reality
"IBM believes seven technologies will be key to Pharma:
? Petaflop and grid computing
? Predictive biosimulation
? Pervasive computing
? Smart tags
? Advanced storage solutions
? Process analytical technology
? Web-scale mining and advanced text analytics.
Some of these technologies have already reached the market, although they are not
yet mature; others are still emerging. However, all of them should soon be available...more"
12-15-04
Welcome back for your weekly capsule. What's new in the pharmaceutical industry? How about a dissolution update...
Pepsin and Pancreatin Performance in the Dissolution of Crosslinked Gelatin Capsules from pH 1 to 8
Here is an interesting article in the PF. It addresses the section of the USP recommending use of enzyme during dissolution. "The authors conducted a systematic study of the use of pepsin and pancreatin in dissolution of crosslinked gelatin capsules in order to understand the digestive performance ability of the enzymes across the pH range from 1 to 8. The work presented here includes a description of the experimental design and controls, followed by actual dissolution profiles obtained with pepsin from pH 1 to 6.8 and pancreatin from pH 4 to 8. The results generally agree with published activity curves for the enzymes and bring into question the appropriateness of the recommended pancreatin level set forth in USP 711."
Warning on Herbal Remedies
"Researchers find lead, mercury, arsenic in Ayurvedic products - including many intended for children. Lead, mercury and arsenic have been found in herbal preparations imported from India, some so laden with contaminants they were potent enough to cause serious poisonings, researchers report today."
"The herbal remedies - many of them intended for children - which can be bought in health food stores and other venues, are sold for the practice of ayurvedic medicine, an ancient healing art. Dangerous heavy metals were found in 14 of 70 ayurvedic products, which are attracting a growing number of consumers in the United States, experts said yesterday...more"
Death and Tax(onomy)
In an effort to standardize names, FDA is also looking at nomenclature use in other countries. FDA and the USP Expert Committee on Nomenclature and Labeling work together on USP nomenclature for new products for which there are no USP dosage form descriptors. Many of the FDA and USP terms match or are close?but many of them do not match. The CDER Data Standards Manual has many dosage forms that USP does not have.
The currently suggested taxonomy chart was developed by the PDF EC with assistance from members of the Biopharmaceutics Expert Committee and the Nomenclature and Labeling Expert Committee. This chart is based on the tier concept, with the first tier delineating dosage forms according to the route of administration by which the drug substance is delivered.
The second tier is based on the general type of dosage form involved and its physical properties, i.e., solid, semi-solid, liquid, gas, or aerosol. Each one of these groupings contains its own subsections listing the specific presentation of the dosage form, e.g., tablet, cream, insert, etc. This second tier facilitates downward expansion into the third tier, which is based on the type of release pattern of the drug substance and performance characteristics of the dosage form.
With such a scheme, any dosage form for any drug substance can be unambiguously identified by a combination of taxonomic terms from each tier, taking the form:
[drug substance] [route of administration] [physical state] [release pattern].
For example: Acetaminophen oral solid immediate release
12-08-04
A Beautiful Equation (eat your heart out, PV=nRT)
Physics World has an interesting article on the greatest equations of all time. Everything from Einstein's general theory of relativity to the Fourier transform to the Hubble equation to Euler's equation to Newton's second law. My favorite equation is Euler's. I was very happy that it made the list.
"Earlier this year I asked readers to send me their shortlists of great equations. I also asked them to explain why their nominations belonged on the list and why, if at all, the topic matters (Physics World May p19)....One of the most frequently mentioned equations was Euler's equation, ei? + 1 = 0. Respondents called it "the most profound mathematical statement ever written"; "uncanny and sublime"; "filled with cosmic beauty"; and "mind-blowing". Another asked: "What could be more mystical than an imaginary number interacting with real numbers to produce nothing?" The equation contains nine basic concepts of mathematics -- once and only once -- in a single expression. These are: e (the base of natural logarithms); the exponent operation;?; plus (or minus, depending on how you write it); multiplication; imaginary numbers; equals; one; and zero...More"
Drug makers seek better program for needy
The drugmakers in New Jersey are thinking about helping the poor. This is a great way to boost the sagging reputation of the pharmaceutical industry.
"Help may be on the way for some New Jersey consumers who have trouble paying for their prescription medicines. A program sponsored by a consortium of New Jersey drug makers -- which could become a model nationwide for an industry under attack for rising drug prices -- is expected to begin early next year, according to an executive and officials with a trade group...more"
UN pricks pharma's conscience
"The United Nations special rapporteur on the ?right to health? says better policing is needed to ensure the pharmaceutical industry fulfills its social responsibilities...more"
Come to Hawaii
I got an e-mail from Vivian. She thinks we should all go to Hawaii and learn dissolution. Are you new to dissolution? DO you want to learn in a great place? Do you want to learn from one of the top scientists in the field? Go to Dissolution Today; A new one-day course presented by Vivian Gray on JUne 5 at the Hilton Waikoloa, Kona, on Hawaii's Big Island. So set the time aside and plan to learn dissolution.
12-01-04
Chemo What?
There are many stereotypes. They exist in both the pharmaceutical world and the rest of the world. Let?s take horses as an example. What is the fastest breed of horse? Most would guess the thoroughbred from watching the Kentucky derby. Some might guess it is the Arabian. But in reality, the quarter horse is the fastest breed. What, the traditional plow horse used by farmers during the previous century? Yes, the Quarter Horse is the king of speed. In fact, racing American Quarter Horses have been clocked at nearly 50 M.P.H. as they cross the finish line, while the thoroughbred clocks in at just under 40 M.P.H."
Now take the area of chemometrics. Stereotypes abound. Some will claim "Chemometrics is too bizarre and exotic to be used be the pharmaceutical industry." Others look at you like you have three heads when you start talking about equations other than PV=nRT. Some say "I'm a chemist I don't do math we let the statisticians do that." Some consider it voodoo science... But the reality is that chemometrics is a rapidly growing area in analytical chemistry. It is highly used in the food industry, the farmer is checking his grain moisture using analyzers with chemometric software built into his combine, while the Pharmaceutical scientist next door is using the farmer's old thief sampler to sample a V-blender.
Chemometrics is a way to reduce large volumes of data in chemistry to smaller more manageable volumes, using combinations of multivariate techniques, computer-based data analysis, and chemistry, without losing any important information. In mathematics, a square (n n) or rectangular (m n) array of elements (numbers or algebraic variables) used to facilitate the study of problems in which the relation between the elements is important. The advantage of matrices is that they can be studied algebraically by assigning a single symbol to a matrix rather than considering each element separately. The symbol used is usually a bold capital letter, but often a matrix is denoted by a symbol like (aij), meaning ?the matrix with element a in row i column j?. The size of a matrix is described by stating the number of its rows and then the number of its columns so, for example, a matrix with three rows and two columns is a 3 2 matrix? more
I attended at talk by the USP recently. The speaker said "By now everyone is familiar with a PCA plot, so I won't go into details." I thought "wow, is everyone in this room truly familiar with PCA?" I believe that many are not. Can I explain PLS theory and use the terms scores and loading correctly? I know I need to better educate myself. How about you?
The most commonly used tools of chemometrics include Principle Component Analysis (PCA), Principle Component Regression (PCR), Multilinear Regression (MLR), and Partial Least Squares Regression (PLS). Everywhere more and more data are produced and presented, making it more difficult to realize what is going on, and to get an overview of the problem. To make intelligent decisions is harder than ever. Want a good place to learn more? Try the Homepage of Chemometrics ,a wealth of resource for the internet. Chemometrics, PAT, and MVA are the new tools of the pharmaceutical scientist. Be prepared for you will see it more and more.
I have been asked if dissolution testing and HPLC go away. No. There is always a need for some physical testing techniques. Dissolution and HPLC will always play a role in the development of new drug products. But there are new tools that may lessen the role of our traditional work horses. Chemometrics will take a prominent role in the upcoming future. ...Did I say work horses?
Dissolution Technologies New Site
It's December first and I'm waiting for my latest issue of the November Dissolution Technologies. Vivian e-mailed me and said it was sent out. Blame the postal service. I want to point out that there are changes to the Dtech website. They are no longer frames based, but now a more usable non-frames site is up. Stop over and see the latest at Dissolution Technologies
New Site
Here is a useful site that makes regulatory information accessible reg-info.com
11-24-04
Dissolution Service Engineer Wanted
This is a role for an experienced service engineer with a mechanical or
electrical engineering qualification, ideally with experience in the
pharmaceutical industry - in particular dissolution testing in the UK.
Benefits include: CAR + PENSION + ALLOWANCES
More Info...
Strong Medicine
I sit here watching my son's karate class. He seems to have the upper hand. He forces his opponent backward. He has thrown him off balance. But the opposition returns with an unexpected kick to the waist.
The business world is similar. It is amazing what one week can do to the whole industry and the whole stock market. Suddenly the hot news story is drug safety. It's funny how perceptions change . Two decades ago, the FDA was being criticized for being too strict and slowing down drugs from getting to the consumers. People did not want to wait for the screening and evaluating. They wanted their drugs now. They said lives were being lost and people suffered because they had to wait for the next new drug to be available.
It amazes me how such a strong perception can change over time. "Even critics concede that the FDA's task is daunting: If it moves too slowly, as AIDS activists and others charged it did in an earlier era, patients may suffer or die. Move too quickly, and patients may be exposed to unrecognized risks...more
Gradient-release Delivery System
Nitrendipine, a dihydropyridine calcium antagonist, was used as a poorly water-soluble model drug. To improve its dissolution rate and extend the therapeutic period in vivo as well, a novel pH-dependent gradient-release drug delivery system for nitrendipine having a solid dispersed matrix structure was developed. The release behavior of the system under simulated gastrointestinal tract conditions exhibited obvious gradient-release characteristics, showing that the release rate of the active drug could be controlled efficiently before the microspheres reached the appropriate region of the gut for absorption. These findings suggest that the pH-dependent drug delivery system could be fabricated by using present microspheres...more
AAPS Poster Presentation
Hey. Did anyone see this poster at AAPS? "Investigation Of The Rosbustness Of USP And Modified USP Methods Of Weighting Floatable Dosage Forms During Dissolution" It looks like it would have been something I would have like to have seen. Do you ever look over a program after a show and wish you had a chance to go again to see what you missed? Am I the only one who does this?
Were you invited to Tommy Thompson's big birthday bash this past weekend? Everyone was there. George Bush stopped in, Condy, Dick, Arnold, the FDA, CDER...No, I wasn't invited either. Hey Tommy, don't expect an invitation to mine. Just kidding.
11-17-04
The Iceman Cometh...
Last week I was raking leaves. This week I was shoveling snow. It look like next week I?ll be raking leaves again. Hmm-short winter...global warming? Not likely, just good old unpredictable fall. My children get excited at the snow, and try unsuccessfully with fresh snow to make a humble snowman. They fall backwards into snow to make snow angels. I think, there?s no way I?m gonna fall into that snow just to make a mutant looking form in the snow. I guess we grow up much too quickly. Maybe I?ll make a snow man with them. We?ll, I guess not since the snow is gone. Could I make a man of the leaves that I didn?t rake yet?
What is new on the pharm this week?
The Voice of Radio
"2005 will be the year of RFID -- radio frequency identification." "RFID is a state-of-the-art technology that uses electronic tags on product packaging to allow manufacturers and distributors to more precisely keep track of drug products as they move through the supply chain. It is similar to the technology used for tollbooth and fuel purchasing passes."
"Radio Frequency Identification technology is an innovative response to the challenge of counterfeit drugs," said Health and Human Secretary Tommy G. Thompson. "It is our goal to insure that the drugs available in the United States are among the safest in the world. However, we still must continue to be on guard against those who would exploit patients by selling counterfeit drugs."
According to Webopedia.com: "RFID systems can be used just about anywhere, from clothing tags to missiles to pet tags to food -- anywhere that a unique identification system is needed. The tag can carry information as simple as a pet owners name and address or the cleaning instruction on a sweater to as complex as instructions on how to assemble a car. Some auto manufacturers use RFID systems to move cars through an assembly line. At each successive stage of production, the RFID tag tells the computers what the next step of automated assembly is."
"One of the key differences between RFID and bar code technology is RFID eliminates the need for line-of-sight reading that bar coding depends on. Also, RFID scanning can be done at greater distances than bar code scanning. High frequency RFID systems (850 MHz to 950 MHz and 2.4 GHz to 2.5 GHz) offer transmission ranges of more than 90 feet, although wavelengths in the 2.4 GHz range are absorbed by water (the human body) and therefore has limitations..."
Direct to consumer marketing
Dr Kevin writes from a physician perspective on how many of his patients are unfairly pressured into asking him for drugs they know little about. He tellls us that he's not against educating the patient, but sometimes the bottom line of the drug comapnies has too much sway.
"My point is simple and not nearly as nuanced. If the majority of DTC marketing were based on sound evidence-based medical principles, I would be in strong favor of it. After all, the more information patients have at their disposal, the better. However, this is simply not the case, as the evidence seems to always interfere with profits. All we see are countless ads for erectile dysfunction,...more"
11-14-04
Fear and Loathing in Washington DC
ASTM Committee E55 was created following an FDA overhaul of regulations governing drug manufacturing, the first such overhaul in 25 years. Recognizing that the pharmaceutical industry was in need of new processes and techniques in manufacturing, the FDA created "PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance.? PAT was the first step in facilitating the development, implementation and regulation of manufacturing processes based on fundamental process understanding.
This Committee addresses issues related to process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. Stakeholders include manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia. A large number of members are involved in this multinational initiative; all participating actively within a three-tiered subcommittee structure focusing on PAT system management, PAT system implementation & practice, and PAT terminology.
I was at the ASTM E55 Pat for the Pharmaceutical Industry Committee in D.C. this past week. I was attending E55.02 subcommittee on effusivity testing. When the meeting let out, I was invited to go up to Baltimore to visit AAPS. I was at AAPS for a few hours. During that time I had good talks with Marc Finn, Gary Dromgoole, Jeff Seely, Bruce Renslow, Eric Wethington, Dave Kwajewski, Bryan Crist, Sarah Kelly, Ann Coulter, Barb Cox, Bob Spock, Leroy Sanders, and a few others. Somehow I missed Vivian and Saeed, who I heard were walking around somewhere. I also missed Tahseen, who was just at a display where I was speaking to someone. But then I had to slip out to an effusivity talk at the Hyatt next door. While I didn?t talk to everyone, I did meet with many people. The best new thing I saw was the drain/fill valve on the bottom of a Sotax vessel.
11-10-04
Yes, I was at AAPS!
More to come this weekend...
11-03-04
I Love the night life
Yes. I was up until 1:30am watching the US presidential election coverage last night. It looks as though the broadcasters are watching the elctoral numbers better this year. No one is calling any close states. How long will we have to wait? Hey 56 minutes ago incumbent Hamid Karzai was declared winner of last month's historic Afghan presidential election. How long did they wait?
On the issue of candidates, Craig Westover points out that neither candidate understands flu vaccine issue. I just need to catch up on sleep. Dr. Emer pointed out to me this morning that we don't work well without sleep. Coffee anyone?
Another Black Eye?
I pointed out 2 weeks ago that the pharmaceutical idustry got a black eye from recent drug news. Well, it appears as though the other eye got slammed. The Wall Street journal published a group of e-mails from 2000 in which a researcher warned of definate cardiac events.
"If the e-mails actually exist and say what they are purported to say, they appear at least superficially to be a smoking gun that lawyers could pull up as evidence against Merck," said Trevor Polischuk, a drug analyst for Orbimed Advisors...more"
Searching the web
Do you search the web looking for the information that you need? I do. I don't know how I got by in the past without Mapquest, Google, or Weather.com. I guess I used other resources, such as the news paper, or phonebook. But did you know that workers gathering information for their jobs spend 15 percent of their time looking for business information or research on the web - but half of their searches find nothing. Half of your customers who are trying to find you will fail. Why don't you get your company to efficiently and effectively target the audiences you care about. Contact us about advertising.
Sicko?
Now that Fahrenheit 9/11 has made a ton of cash, Michael Moore is planning his next movie, Sicko. He is aiming at both the healthcare system and the pharmaceutical industry. Join the discussion at D-Talk, the Pharmaceutical Science Forum.
Quote of the week
Warning: Dates in calendar are closer than they appear.
10-27-04
Synchronicity
One may say baseball is a metaphor for life. We all start at home, progressing the baseline, only to return from where we came. I was up watching the Red Sox win another game of the 100th world series against the Cardinals. There are signs that this week would be the end of the curse. For one, tonight there is a lunar eclipse , a first for the world series, in which the moon will turn blood red. During this event, many have speculated that Babe Ruth's ghost will visit one last time before he takes his curse and goes home. Maybe he had a bad hot dog in St. Louis? The other strange event is the oldest man alive is a big Red Sox fan who claims he is staying alive just to see them win the series.
Another thing they say is that "its not over until the fat lady sings." I see this woman putting on a viking helmet and carrying a spear getting ready to belt out the last aria of Wagner's Valkyres. I think her name is Pat.
Speaking of strange synchronicities, did anyone notice that the AAPS meeting and the ASTM Meeting of committee E55 PAT for the Pharmaceutical Industry are meeting the same week, less than one half hour apart!
This was pointed out to me by Nancy Mathis the President of Mathis Instruments. It seems that she will be attending both. Hey Vivian, I may not be at AAPS, but I'll be down the road a bit at ASTM. I let you know what happened at my meeting if you let me know what happened at your meeting.
Pfizer exec: Canadian drug imports safe
Jason at Canadapharmacynews alerted me to this story. "The regulated reimportation of prescription drugs from Canada would pose no safety risk to American consumers, according to a pharmaceutical company executive who stumped here Monday for Gov. Joe Kernan.
The executive, Peter Rost, said reimportation is common and safe in Europe, where northern European countries buy cheaper prescription drugs from southern European countries. And he said concerns about counterfeit or unregulated drugs are no reason to ban reimportation, but to legalize and regulate it." Thanks Jason.
Sharp Contrast or Error in a Production Plant?
Carla Johnson points her readers to the sharp contrast in American Health care and British Healthcare. But isn't this just a fluke that Chiron's product was lost, not an indication of the systems? My friends in Canada are waiting in line for surgery. I will be calling my surgeon today to schedule a procedure. He said when I first met him for a consult, that I could pick which day would be best for me to fit it in.
10-20-04
Another late night watching the game last night...why can't the Red Sox win their games early? Are you doing UV/VIS? DO you remember all the theoretical aspects of spectroscopy? Why don't you take the quiz.
Politics: The Flu Vaccine Shortage
"THE GREAT FLU VACCINE SHORTAGE....As everyone knows by now, the proximate cause of the flu vaccine shortage was contamination at a plant in England owned by Chiron, one of only two companies that manufacture flu vaccine for the U.S. market (the other is Aventis Pasteur). But why are there only two manufacturers of flu vaccine in the first place? After reading a slew of articles, here's a rundown of all the explanations on offer:
For starters, it's a pretty small market. The total vaccine market (for all vaccines, that is) is about $6 billion out of a market of $340 billion for drugs of all kinds. The flu vaccine business is risky: some years you sell out, but other years you make 50 million doses and only sell 20 million...more"
Scanned Like a Can of Soup
"A microchip that can be implanted under the skin to give doctors instant access to a patient's records yesterday won government approval, a step that could transform medical care but is raising alarm among privacy advocates."
"The tiny electronic capsule, the first such device to receive Food and Drug Administration (news - web sites) approval, transmits a unique code to a scanner that allows doctors to confirm a patient's identity and obtain detailed medical information from an accompanying database...more"
The Crescent Spindle
When I first saw this I thought it was a great way to wash my glassware. But Saeed Qureshi is a big advocate of the Crescent Spindle as an alternative to the apparatus 2 paddle, which is known to create dead zones in the vessel.
Dr Qureshi argues that the mixing is more complete and uniform using this unique design. "Recently a new crescent-shaped spindle has been proposed to address the issues related to poor hydrodynamics of the USP paddle apparatus and its associated artifacts of high variability and lack of bio-relevant results. For improved comparison of drug dissolution characterization, it is highly desirable to conduct testing using common experimental conditions such as spindle rotation speed. A study was conducted in which different products were tested using the crescent-shaped spindle to propose a common rpm speed for improved comparative drug dissolution testing...more"
Quote of the Week
"The ballparks have gotten too crowded. That's why nobody goes to see the game anymore." -- Yogi Berra
10-13-04
It seems that the Pharmaceutical industry is getting a black eye these days. Did they deserve it? "During the past 18 months, the nine largest pharmaceutical companies have spent a greater percentage of their money on dividends for shareholders and on company stock buy-backs than they have spent on research and development," The other fact that is not mentioned is that they also pay more for advertising than R and D. So how is the high cost justified now.
On the issue of reimportation, Dr Bradley has this comment: "Pharmaceutical companies have no problem with you getting your drugs from overseas, as long as you find them after they have washed ashore in the wake of giant statin tanker spills."
Guess who just had a birthday...PAT of course, it seems he was just born, and coming home from the hospital. Now PAT is up and crawling about. Even the FDA wrote him a new guidance. It seems last years guidance no longer fit him. He grew out of it so fast!
Pills are Western medicine's most ubiquitous symbol, yet they were never a fashion statement until Louis Hohenstein, a San Francisco sound engineer, decided to bring them out of the cabinet and turn them into earrings.
The idea was born when a friend joked about needing painkillers while playing Ultimate Frisbee. So Hohenstein mounted a couple of ibuprofen, though getting the job done made the pills unswallowable. (Each pill is dipped in urethane to preserve it and add luster.) He later advanced to crowdpleasers like Valium, Sudafed, Pepcid AC and Paxil, selling or giving them as gifts.
10-06-04
Vioxx Withdrawn
This has been an eventful week in the Pharmaceutical Industry. First, Merck voluntarily withdraw Vioxx from the market because of the risk of strokes and heart attacks. Now the European Medicines Agency is to review all drugs in the same class as Vioxx. The law suits are starting to pop up. Many claim it was too late. The argument is that Merch knew of the risk, yet failed to properly inform the consumer. What do I think. I think it may be a good time to buy stock in Pfizer.
Flu Vacine Stopped
Other big news, Britain stopped influenza vaccine manufacturing at US-based Chiron Corporation, wiping out a huge supply of the world's supply for this flu season. Aventis, the only other major flu vaccine supplier to the United States can possibly squeeze out another 10 percent more in flu vaccine from its own inventory, Last year MedImmune had to convince people their nasally administered FluMist was just a good as the vaccination. It appears as though they will have a winner this year when the crowds starts scrambling for their flu shots.
"The CDC said the 54 million doses of conventional flu vaccine expected from Aventis Pasteur, the world's leading supplier, would be enough if healthy adults skip the shots this flu season and save them for the people most vulnerable to effects of the flu, including children ages 6 to 23 months, the elderly and those with chronic illnesses. On the other hand, FluMist is approved for use only in healthy people ages 5 to 49. That limitation proved a big disadvantage in marketing FluMist last year, Wang said, but may turn into a small advantage this year...more"
We, Robot
I was surfing the internet last week when I stumbled across an unexpected fan of DSN, a blog that links to us, We, Robot. Hey Drudge, eat your heart out. Jeff Zeldman, is this how you started out? Hey Ana Marie, can I co-host the next Blog show with you on MTV. No, oh well I guess I'm not ready for prime time yet. It appears from their address that this must be a child of Leaptec. The tag line reads: thoughts, questions, and links from humans at a small laboratory automation company. I like the link to us, but maybe a slightly more subtle website url may be more befitting. How about a game of LeapBlog, AutoBlogger, or Blogtech?
9-29-04
There comes a time in the life of every blogger when they want to comment on things other than what they originally decided to focus on. You will find some blogs that list their subject in a super inclusive tagline such as: Dogs, training, breeding, popular culture, politics, and just about everything else. But the ideal blog sticks closely to the topic and occasionally reminds us we are in the real world. Even science relates to what is going on around us. Nothing occurs in a bubble.
I guess it is expected that bloggers may occasionally wander from their chosen topic to comment on Janet Jackson and her wardrobe malfunction, John Kerry, George Bush, Iraq, Tony Blair, Ana Marie Cox, Wonkette, and the Blogosphere. People send me leads on many stories, I decide what to use and what not to use. I feel like the editor of a news gathering organization, picking a choosing what to report. No, Not Dan Rather... If you have a story, an article or a link you want to send to me, please do. Blogs are becoming the number one source of news for many people. Hop on board and ride with me to the future.
People often ask me where to find information over the internet. Well, if you want pharmaceutical news, I would hope you stop here. But if you want another source then I would say talk to Corey Nahman. Who is Corey Nahman? Online since 1999, Corey Nahman has become a highly influential destination for current pharmaceutical news and information. I guess you would say he is the Drudge Report for the Pharma Industry.
This week's New York Times Magazine made bloggers their front page story: "Are they ruining political journalism or recharging it?" The same question could be asked of scientific reporting. Are we following the traditional method of scientific reporting with several to dozen of levels of oversight? When Watson announced the discovery of the DNA double helix to the world he broke every rule of scientific reporting. But something unusual happened. He caught the attention of the world and they listened! In the face of question of media bias and unfair reporting, bloggers are neither the poison nor the cure. We are merely another voice reaching the thousands or millions who yearn for knowledge.
Do you want to be a part of the Blog revolution? Contact us today and
volunteer to be a news-spotter. Just send us any links, stories, or articles
which you find related to pharmaceutical analysis. Be an active part of the
Blogopsphere, email us today.
9-22-04
This has been the week when bloggers have gotten recognition. Blog writers were able collectively to take forged documents, and by using the power of the internet to force the major networks to admit their mistakes. As a blogger I will not dwell into the nature of the politics, but rather point out the power of online media sources run privately and honestly such as this site. Bloggers are people only trying to inform or express their opinions. Blogging has created the democratization of media, the era of corporate media and information has ended.
This week we will look into a post by famous blogger, Derek Lowe, a useful website by Dr. Shula Levin, and finally a site by Chata Solutions.
Drug Development: The Current Odds
The August issue of Nature Reviews: Drug Discovery has an alarming article on the attrition rates in drug development. I often get questions about these figures, and it's good to have a fresh look at the data. Among the ten largest pharma companies, in the period 1991-2000, here's the breakdown:
38% of the drugs taken in the the clinic dropped out in Phase I (safety / blood levels.)
60% of those remaining failed in Phase II (basic efficacy.)
40% of the remaining candidates failed in Phase III (big, expensive efficacy.)
And 23% of the ones that made it through the clinic failed to be approved by the FDA.
You can do the math as quickly as I can: that translates to about a 11% success rate from starting in the clinic. And consider that for someone like me, back in the research labs, a successful program is one that makes it to Phase I. It's no wonder that so few medicinal chemists have ever worked on a drug that's made it all the way to market!
High Performance Liquid Chromatography (HPLC) Course
Here is the homepage of Dr. Shula Levin. This is one of the best places to get a complete education on all there is to HPLC analysis,method development, and theory. Don't let the campiness of the site fool you. It is a great collection of resources.
CHATA produces several hundred standard and custom solutions. Many of our solutions are used for tablet dissolution in pharmaceutical quality control. CHATA prepares a three-month supply of your dissolution media according to GMP methods in a class 10,000 clean room. If CHATA degasses your dissolution media, dissolved oxygen levels at the time of packaging are included in the batch record. Our 13-page batch record also includes a double witness sign-off, filter integrity validation, and complete raw material traceability. A Certificate of Analysis records the results of any quality control testing ordered and an expiration date, if a stability study has been performed.
Quote Of The Week
Never underestimate the power of stupid people in large groups.
9-15-04
Who is this organization known as the USP? Here's a great article knock on the doors of Twinbrook parkway. Hey, Laura Bush wrote this! hmm...Great picture, Ron.
A contract manufacturer is about to begin manufacturing a new product, and the director ofquality control needs to know what tests to conduct for batch release.Where does she go? To her trusty United States Pharmacopeia?National Formulary, of course. But how do those pages get into that tome? And why is it that everyone seems to trust the methods described there? How are they written, updated, and verified?
In other words, we know the what of the United States Pharmacopeia. But USP is also a who. That?s the part that most of us don?t know. We know USP is not a government agency, although its headquarters in Rockville,Maryland, are less than a mile from the Food and Drug Administration. So how did it get to be so official?
Then There Was Light: A New Fiber Optic Company enter the Field
The development of fibre-optical systems has caused a small revolution in chemical analysis. The technology makes it possible to carry out photometric measurements not only under laboratory conditions with cells, but through the development of fibre-optical probes, analysis has moved directly to the process measurements. Continuous measurements can be made in situ without sampling. This allows for better control of ongoing processes with much less effort.
Orally disintegrating tablets: An overview of melt-in-mouth technologies and techniques.
Here's an interesting articles, But T and C will not give it to you. So if you have the current issue, you may want to save it or scan it in to your computer. "Melt-in-mouth tablets are solid dosage forms that rapidly disintegrate or dissolve in the oral cavity without water. They thus overcome swallowing problems and improve patient compliance. This article gives an overview of these tablets, their formulation technologies, and the considerations that are important in their development."
Now that I think about it, I wonder if Tand C will last as a journal with the pay for reprint policy. It may seem a little archaic to charge for reprints in this age of electronic documentation. If one would pay for an electronic document, would it makes sense to pay $7.50 for a reprint of a PDF file? It could be upload and download with no human intervention. So what's the cost. Pure Profit. I pay $0.99 for an MP3 download. I make PDFs of any article which I want to keep which is worth saving. I don't save paper copies of any articles, I just scan them in as PDFs myself. If Vivian asked me to E-mail an article to her I could. If Ruben wanted a PDF of my notes I could burn a CD or FTP it. Does ordering reprints makes sense anymore?
So the question is this. Does it makes sense to charge per article when most journals offer their articles for free? Would I publish in Tablets and capsules? No, since Dissolution Technologies, AAPS PharmSciTech, and Pharmaceutical Technology offer offline access to past articles. Do I want my article to dissappear into obscurity, or do I want it online for all to use for future reference? The choice is obvious.
The Truth About Drug Companies: How They Deceive Us and What to Do About It
I was walking through Barnes and Noble last week, with my daughter, when I stumbled across this book."For the first time, in just a few short years, the gigantic pharmaceutical industry is finding itself in serious difficulty. It is facing, as one industry spokesman put it, "a perfect storm." To be sure, profits are still beyond anything most other industries could hope for, but they have recently fallen, and for some companies they fell a lot. And that is what matters to investors. Wall Street doesn't care how high profits are today, only how high they will be tomorrow. For some companies, stock prices have plummeted.
9-01-04
List of Useful ASTM STandards for PAT
D 3764 - 01: Standard Practice for Validation of Process Stream Analyzer Systems.
D 6624-01: Standard Practice for Determining a Flow-Proportioned Average Property Value (FPAPV) for a Collected batch of Process Stream Material Using Stream Analyzer Data.
D 4855 - 97: Standard Practice for Comparing Test Methods.
D 6299 - 02: Standard Practice for Applying Statistical Quality Assurance Techniques to Evaluate Analytical Measurement System Performance.
E 178 - 02: Standard Practice for Dealing with Outlying Observations.
E 1655 - 00: Standard Practices for Infrared Multivariate Quantitative Analysis.
E 1866 - 97: Standard Guide for Establishing Spectrophotometer Performance Tests.
E 131-00a: Standard Terminology Relating to Molecular Spectroscopy.
E 456-02: Standard Terminology Relating to Quality and Statistics.
Don't Miss...USP's ANNUAL SCIENTIFIC MEETING
"The Science of Quality"
September 26?30, 2004
Sheraton at Woodbridge Place ? Iselin, NJ
Viva Las Vegas, Viva Las Vegas!
Las Vegas, think about it. Ah, ...Wayne Newton, Tony Bennett, Celine Dion, the city of lights, blackjack, poker, roulette, hey wait! No, no, no. Its the Pharmaceutical Engineering and Technology Series course: Test method validation in pharmaceutical development and production. Two intensive days focusing on regulations and guidelines for test method validation, method development and validation parameters,method transfer from the development environment into the quality control laboratory, and method validation process. October 27-28, 2004 in Las Vegas, Nevada.
Practical Applications for Examining, Measuring, Predicting and Automating Solubility
Discussing Solubility in GI Milieu and Impact of GI Physiology on Oral Bioavailability
Exploring Crystal Engineering of the Composition of Pharmaceutical Phases
Examining Surface Activity Measurements to Predict Solubility Limits
Discussing Solubility of Organic Compounds in DMSO and DMSO ? Water Mixtures
Minimizing Regulatory Bottlenecks in the Development Process
Options for Automating Solubility Measurement in Discovery and Development
Improving the Solubility and Bioavailability of Drugs Using Cyclodextrins
Improving Solubility With Good Solubility Data ? How to Get Them
Out of Whack?
Hey... Did you ever wonder when is something in whack?
-Pete
8-25-04
Impurities and Degradation Products in Drug Substances and Products
This event will cover the approach to dealing with impurities and degradation products in drug substances and products, and methods for their detection, identification and control. Specific attention will be paid to the changing regulatory environment including ICH guidelines, changes to the various Pharmacopoeia and CPMP guidelines. With speakers drawn for regulatory agencies, Pharmacopoeia, industry and academia, your questions and concerns are sure to be addressed.
Flow of Solids in Bins, Hoppers, Chutes, and Feeders
Do you wonder what problems occuring in production could cause your product to fail? Jenike & Johanson engineers will be presenting the following ASME/AIChE sponsored courses on the theory and practice of effective bulk solids handling: FLOW OF SOLIDS IN BINS, HOPPERS, CHUTES, AND FEEDERS. September 20-21, Houston, Texas and PNEUMATIC CONVEYING OF BULK SOLIDS. September 22, Houston, Texas.
With both courses, you'll gain a strong, fundamental understanding of bulk solids and their behavior, along with the general principles and practical applications of solids flow. You'll find out how and why typical flow problems occur, and what simple, practical steps you can take to solve them.
What are you doing today? Want to learn about effusivity? Attend a Webinar on Mathis' effusivity technology:
Wednesday, August 25, 2004 @ 1pm EST
Wednesday, September 29, 2004 @ 1pm EST
Wednesday, October 27, 2004 @ 1pm EST
To register for upcoming webinars s imply reply or call toll free: (866) 4BLENDS or register on their website. From the comfort of your office, you can watch the presentation on your computer monitor while participating on a conference call. Webinars are informative, interactive and are FREE to attend.
8-18-04
I've been fighting storms and hurricanes all week. Yesterday brought the first sun I had seen in a week. I finallly got out and enjoyed a nice canter through the woods. What do I have to share this week?
SOLUBILITY: Practical Applications for Examining, Measuring,Predicting and Automating Solubility
September 29 ?? October 1, 2004 ? Brussels Marriott ? Brussels, Belgium
Discussing Solubility in GI Milieu and Impact of GI Physiology on Oral Bioavailability
Exploring Crystal Engineering of the Composition of Pharmaceutical Phases
Examining Surface Activity Measurements to Predict Solubility Limits
Discussing Solubility of Organic Compounds in DMSO and DMSO ?? Water Mixtures
Minimizing Regulatory Bottlenecks in the Development Process
Options for Automating Solubility Measurement in Discovery and Development
Improving the Solubility and Bioavailability of Drugs Using Cyclodextrins
Improving Solubility With Good Solubility Data ?? How to Get Them
Teva set to buy Pfizer's Italy unit
"The $85 million acquisition would make it that nation's largest generic-drug firm. Teva's U.S. base is in Montco. Aiming to have the largest generic-drug business in Italy, Teva Pharmaceutical Industries Ltd. has agreed to buy Pfizer Inc.'s Italian generic-drug-marketing company for $85 million. Teva, whose U.S. headquarters is near Philadelphia, said the acquisition of Dorom S.r.l. would make Teva the largest generic company in Italy, with about 60 low-cost generic versions of medicines."
MedMira donates rapid HIV tests to Kenyan orphanage
HALIFAX -- A Nova Scotia-based company, in the business of marketing HIV rapid diagnostic tests, recently donated 700 of the units for use in a Kenyan orphanage. MedMira, which has also been approved to sell test kits in the United States and China, announced the plan today.
Accelerated dissolution testing for improved quality assurance
In pharmaceutical production of controlled release tablets and capsules, a rapid and automated at-line dissolution test for quality assurance of semi-products is advantageous. For effective control of the production, the analysis should not take more than about an hour, without loss of correlation to the ordinary (USP) dissolution test of the final product. For almost a decade, the ACDRA apparatus (ACcelerated Dissolution Rate Analysis) have been used for this purpose at AstraZeneca Tablet Production Sweden (TPS). In this paper, we give examples on different ways to accelerate the dissolution process. We use the USP dissolution calibrator tablets of salicylic acid (non-disintegrating type) to illustrate the strategy. We investigate the accelerated dissolution of the dissolution calibrator tablets, and show how it can be correlated with the dissolution in the ordinary USP-II equipment. The dissolution process was accelerated by variation of temperature, solvent and stirring. For example, we show that by increasing the temperature to 70^oC, changing the solvent to water, and increasing the stirring, it is possible to accelerate the dissolution by a factor of 5, without any loss of correlation to the dissolution process in the ordinary test.
Quote ofthe Week
"Theft from a single author is plagiarism ?? from three or more it is research."
8-11-04
A good vacation is always relaxing. But it is good to be back to the website again. Whats new? I just got a reminder from Vivian: "The AAPS Dissolution Focus group is having its first meeting at the AAPS meeting on Wednesday Nov. 10 at Noon. You should join AAPS and join them." Hmmm. Maybe I should join them...
Pharmaceutical Manufacturing magazine plans to focus extensively on Process Analytical Technologies, and to cover the work of Technical Committee E55 in its print publication, on its Web site and in a new e-newsletter that will be launched next month.
Under increasing pressure to reduce costs, and improve the quality of their products, more pharmaceutical companies are adopting techniques well established in other industries--lean manufacturing, Six Sigma, process teams--to drugmaking. Many of the techniques, first developed for discrete manufacturing, can't simply be "dropped in" to the more-complex pharmaceutical plant. Nevertheless, their adoption reflects the industry's increased emphasis on manufacturing optimization.
Effusivity is a heat transfer property present in all materials in all formats ??solids, liquids, pastes, powders, and gases. As such, this property has many potential uses in the production of pharmaceuticals for controlling product consistency, homogeneity, and final product quality. This chapter provides general information on this technique, which may have application in certain cases as a manufacturing real-time control technique.
UV Detectors: A Product Profile
The majority of organic compounds can be analyzed by UV ??vis detectors, and almost 70% of published HPLC analyses were performed with UV ??vis detectors. This fact, and the relative ease of UV detector operation, makes this instrument the most useful and most popular detector for HPLC, and it has become almost ubiquitous in modern laboratories as part of HPLC systems.
Family in Town...
I have relatives staying over for the next few weeks. My brother-in-law Scott and son Joey were digging for fishing bait in my garden. Uncovering a many-legged creature, Joey proudly dangled it before his father.
"No, he won't do for bait," his father said. "He's not an earthworm."
"He's not?" Joey asked, his eyes wide. "What planet is he from?"
Until next week...
8-4-04
I am away, resting in a cabin at a lake this week. So there will be no update.
The D-Talk forum was started one year ago. It has proven to be a great success. Expert users from all around the world frequent the D-Talk forum. All the major vendors have representatives, as well as the fiber optic companies. One company has three participants. Why don't you spend a little time at D-Talk.
Until next week...
7-28-04
Camo announces the launch of The Unscrambler version 9.1
Are you using chemometrics to solve your data overload problems? "The Unscrambler is a user-friendly chemometrics software bundling multivariate data analysis and experimental design. The Unscrambler includes Exploratory Analysis (PCA), Multivariate Regression and Prediction (Three-Way PLS, PLS-R, PCR, MLR), Classification (SIMCA, and PLS-DA) and 7 types for Designs of Experiments (DOE)."
Drug Delivery Insight: The Latest Business Information on Drug Delivery Activities Worldwide.
Drug Delivery Insight (DDI) is a news service designed to keep you in touch with the latest developments in the rapidly expanding drug delivery market.
Taking the hard work out of staying in touch with companies, products, alliances and research activities, this publication has regular coverage of global injection devices, infusion pumps, transdermal delivery, slow/controlled release and implantable and biotech related drug-delivery technology.
A web-based publication that provides technical, application-oriented articles, and features from the pages of LCGC North America, along with original news, business, and technical content not found in our regular issue.
You'll receive updated, unique content about two weeks after your print issue every month. To ensure regular receipt of this issue, please provide information in the box below.
Unique Features you won't find in your print edition...
I ASKED FOR YOUR SPAM-STOPPING SECRETS, and, man, did you let me have it. I received hundreds of e-mails detailing tried-and-true methods for getting rid of unwanted e-mail advertising.
The ugly truth is that spam messages are growing more annoying, more objectionable in content and much greater in number with each passing day. So as technology-savvy users like you and I get better at preventing spam, the spammers continue to seek fresh meat among the uninitiated. Novices, the elderly and children will increasingly become the new targets for spammers' odious messages.
Quote of the Week
"There is a theory which states that if ever anybody discovers exactly what the Universe is for and why it is here, it will instantly disappear and be replaced by something even more bizarre and inexplicable. There is another theory which states that this has already happened." — Douglas Adams
7-21-04
Logan Istruments has a new website.
Looks like our friends on SchoolHouse Road have a great new website. Everytime I see a new dissolution site design, I immediately look at the source code and test it on all my browsers. Their new design is sleek and highly usable to find information. Contact information is easy to find. It also includes a phone number for those who want to talk to a real person. Most web designer leave this out. The colors are modern and sharp.
It looks great in Internet Explorer, Mozilla, and Opera. Unfortunately, It is based on spacer gif hacks, javascript loads, and table based layout, which don't work in my handheld, standards-based, and text browsers. While the web designer used the latest tool, Dreamweaver MX, he or she used old code and web hacks, (HTML 4.0, spacer gif hacks), not a single style sheet, no XHTML, or XML anywhere.
I'm glad I don't have to work on this site to update or modify it. This site will be impossible to make changes to it. Logan, I like the looks of your site. Unfortunately it is designed to work only in internet explorer, which several companies are moving away from due to spyware and web-based virus concerns. Jeffrey Zeldman always tells me " 99.9% of Websites Are Obsolete." Next time hire a standards based web company.
Transdermal Delivery of Hydrophilic Drugs: The Current Status & Potential For Future Drug Delivery
"Transdermal delivery through the skin has a number of advantages over oral delivery for hydrophilic drugs. Transdermal delivery leads to better absorption, greater flexibility in how the drugs are administered, and more choices for patients in how they receive these important drugs."
USP's ANNUAL SCIENTIFIC MEETING
"The Science of Quality": September 26–30, 2004, Sheraton at Woodbridge Place • Iselin, NJ
"The Annual Scientific Meeting provides an opportunity for pharmaceutical scientists and other scientific and regulatory stakeholders to directly contribute and participate in USP's standards-setting processes. Attendees will interact with USP's scientific experts both on the Council of Experts and on staff and help establish standards-setting priorities for the organization"
Tablets are coated for a variety of reasons, such as aesthetics; taste or odor masking; enhanced mechanical strength; and protection from moisture, light, and/or air. Here, the influence of the four most commonly used aqueous immediate-release film coating systems on the performance of hypromellose tablets, stored under different conditions up to 12 months, is investigated.
7-14-04
Have you seen the latest journal dedicated to laboratory techniques?
Nature Publishing releases new journal for lab techniques
" 'Nature Methods appeal to life scientists and chemists alike will be its quality, novelty and diversity' said Rachel Burley, publisher of Nature Methods. Nature Methods's content will include highlights of recent methodology developments, detailed protocols, application notes, technology reviews, methods and techniques papers, professions and events."
Are USB flash memory sticks the promotional item of the year?
It appears that in the past, coffee cups were the promotional items given away at conference and conventions. But look out! Has the coffee cup found competition at the next conference which you will attend? Flash memory devices come mainly in the form of small, portable devices often referred to as memory sticks or keychains. They require no cable, no external power and no separate drive reader, just plug them into your USB port and your operating system will recognize it as a removable hard drive. They range in size from 16MB to 2GB. I recently saw one on sale for $12 USD.
Gone are the days when you could save everything on that floppy disk you carried around. I remember when intel said no one would ever need more than 1Mb of memory ever.
"Good bye floppy disk, can I have a copy of that 10MB powerpoint
presentation which you just gave?"
"Could you give me a copy of that product flash demo which you just showed so
I can show it to my manager?"
"Sure, no problem."
The Development of IPECs Excipient Qualification Guideline
In the past, the lack of good, clear communication between the users and makers of excipients has resulted in many technical and commercial problems in the industry. Many of these problems probably could have been averted if appropriate information had been shared earlier about the way in which a specific excipient was to be used or the way in which it was made. In today’s world, it is critical that there be improved openness between the user and maker to avoid pitfalls in the future. So, where do we start?
Quote of the week
I have nothing to say, and I'll only say it once.
-- Floyd Smith, NHL Hockey coach
7-7-04
The latest news in the dissolution field, brought to you at your desktop...
"Fully automated Dissolution Tester MultiDis presented for the first time on the occasion of the ANALYTICA 2004 in Munich: a fully automated dissolution tester capable of carrying out up to 10 USP Method 2 tests has been developed by ERWEKA. The specification of the complete MultiDis system includes Media Preparation from Deionized Water and Concentrate, Media Warming, Media Degassing (Vacuum/stirring), Simultaneous Vessel Filling, Tablet Drop, USP/Pharm.Eur. compliant Sample Withdrawal, Sample Analysis by UV-VIS Spectrophotometer, Test Completion, Filter Change, Vessel Emptying, Cleaning of Tubing, Media Preparation Unit and Test Vessels."
Do you know how to really find that information on the internet? Can you find those old archived articles? You could if you speak to the leet. I am always scouring the internet, searching for information, doing web archeology, searching through the internet archives of sites that are no longer up, but their information freely persists. There is a phenomenon that one must endure when trying to gathering information from the elite users of the internet, those technophiles who know the true workings of the web.
One must be able to understand all they tell you by speaking the language. Sometimes they will give you the answers you need, but in a form called leet. They don't want the information getting out to just anyone! Here's an example of one of the most useful bits of information I ever learned about the internet... "J00 c@|\| ph1|\||) del3+3d 4|\|d p4$5\/\/Or|) pr0t3CTe|) \/\/38 p49E5 A+ @RC|-|1\/e.0r9" Easy huh?
Are you hiring, or are you looking for a new job? There comes a time when change happens. Are you prepared, do you know where to find the chemistry jobs or chemists you need?