The Dissolution Solutions NetworkThe Resource for Pharmaceutical Scientists |
Ramblings of a Pharmaceutical Scientist or Two (or Three or...)
03-06-08
The tide is high ...
The days of big pharma are changing. There are so many small biotech startups here, that I trip over one weekly
just walking down the street while looking for a starbucks.
So, Here is a question I asked a year ago on entering the biotechnology field.
What is an oligonucleotide?
Well, I got this definition from the Online Medical Dictionary:
Oligonucleotide: a linear sequence of up to 20 nucleotides joined by phosphodiester bonds.
Above this length the term polynucleotide begins to be used.
Why is everyone concerned with oligonucleotides?
Antisense oligonucleotides are single strands of DNA or RNA that are complementary to a chosen sequence.
In the case of antisense RNA they prevent translation of complementary RNA strands by binding to it.
Antisense DNA can be used to target a specific, complementary (coding or non-coding) RNA.
If binding takes places this DNA/RNA hybrid can be degraded by the enzyme RNase H.
more"
1-15-08
Advanced Dissolution
(NEW COURSE - 2 day) January 23 and 24th
Sotax Facility
Horsham, Pennsylvania
Nearest hotel: Hampton Inn - Willow Grove (approx 5 miles/10 minutes), located at 1500 Easton Rd, Willow Grove, PA. 215.659.3535
Register with Marc Finn at Sotax (see attached email address)or fax to: 215-442-1514
...
more"
Advanced Dissolution
(NEW COURSE - 2 day) February 12 and 13th
Classroom
Chicago, IL
more"
11-27-07
HPLC Troubleshooting Guide
How to identify, isolate, and correct the most common HPLC problem
Although HPLC method development has been improved by
advances in column technology and instrumentation, problems
still arise. In this guide we offer you a systematic means
of isolating, identifying, and correcting many typical
problems.
The important segments of an HPLC system are the same,
whether you use a modular system (See Figure A, page 2) or
a more sophisticated unit. Problems affecting overall system
performance can arise in each component. Some common
problems are discussed here. Solutions to these problems
are presented in easy-to-use tables.
...
more"
11-13-07
Sterling Hoffman Life Sciences...
Want to know about the latest research findings and hottest jobs in the Pharmaceutical and Biotechnology Industry?
Sterling-Hoffman Life Sciences is the premier clinical staffing and recruitment firm in North America. Leveraging a network of relationships in every major city, including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, and Denver - Sterling-Hoffman Life Sciences is ideally positioned to assist North America's fastest growing biotech players and CROs in their quest to recruit the best people...
more"
10-22-07
Dissolution Theory, Methodology, and Testing Book
I just ot the latest copy of Dissolution Theory, Methodology, and Testing, by Anthony Palmieri! Stayed tuned as peruse the pages.
Things that make you go Hmmmmm.
My son asked me the other day if global warming was real. I told him global warming was a complex term that meant two different things, but that they were combined by most people.
One way we can describe global warming is climate change. This has been shown to be a fact. Everything changes, we are coming out of an ice age. The Earth has been warmer and the Earth has been cooler. From 1940 to 1970 many scientist were concerned about global cooling. This period was much cooler than had previous been documented!
The other term is Man-made versus Naturally occurring processes. That is what the debate is all about. Did we do it, or is it the Man upstairs turning up the thermostat? I told him that we knew too little to say absolutely one way or the other. Sometimes there are way too many variables to fully understand what is going on. So he asks me again: Is it real or not? I told him there was change coming but no one fully understood why. I told him I thought it was just the end of the Ice Age.
This was something that was sent to me by one of my coworkers. He knew that I was highly involved in dissolution and decided to pass this one for my opinion. I told him I didn't think we had a good enough grasp on all of the variables. I told him that I thought that it would never fly. Check it out and tell me what you think...
Guidance for Industry
The Use of Mechanical Calibration
of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)
...
more"
08-28-07
May the Source be with you...
They say that if you have an infinite number of monkeys typing at an infinite number of keyboards for an infinite period of time, you will get the collected works of Shakespeare.
If you want to get the source code to Microsoft Windows, you need to add more monkeys.
A Review of the 2nd Annual USP 4 Workshop and Seminar
Special thanks to Marc Finn for this submission.
Marc Finn
Sotax National Sales and Marketing Manager
Correspondence to marc.finn@sotax.com
Presentation transcripts at sotaxusa@sotax.com
On June 13th and 14th, SOTAX Corporation hosted the 2nd Annual Workshop and Seminar on USP Apparatus 4 in Horsham, PA. This years meeting focused on industry applications as well as uses for IVIVC. Below is a short summary of the event.
On the first day, Dr Eric Beyssac, Professor of Pharmaceutics, University of Auvergne, Clermont-Ferrand, France presentation entitled “Establishing In Vitro and In Vivo Correlations for Modified Release Products” outlined the different parameters for in vitro and in vivo used to perform IVIVC, the rationale for the development of IVIVC, the development of IVIVC for a new formulation and the interest and limits in IVIVC. Examples were given with discussions on the importance of IVIVC to fix in vitro dissolution limits.
The workshop in the afternoon was also conducted by Dr Beyssac and focused on an introduction to the USP 4 method with hands on demonstration. His presentation "Application of USP 4 for API and specific drug dosage forms" began with a brief introduction to dissolution testing and its goals for QC, a development tool, validation of the formulation and importance of IVIVC. It was clear that under certain circumstances more than one type of apparatus is needed to evaluate all dosage forms. A review was given of the different cell types, open and closed loop configurations as well as comparison to USP 2.
Dr Beyssac explained the difference between a laminar and turbulent flow and how to achieve those, thus minimizing hydrodynamics and controlling how the dosage form resides in the flow cell. Examples were given of a poorly soluble compound in an open loop set up, using Nifedipine compared with the flow cell method. Another application of USP 4 provided solutions for multiparticulate dosage forms where USP 1 and USP 2 methods cause lower release for heavy pellets compared with lighter ones, formation of a heap of pellets within the stagnant zone under the paddle, and difficulty testing pH sensitive release pellets where a pH change is needed. Examples were also given for in vitro testing of suspensions using USP 4. Challenges for suspensions include limited solubility, uniform sample preparation and introduction, wettability, and minimizing variability during the experiment. Paddle methods tend to cause problems with homogeneity in the vessel, dispersion in the vessel with areas of high concentration or agglomeration. Using the flow cell, it was shown that samples can be easily introduced and weighed if necessary before the test, a reduction of variability, and a prevention of agglomeration using glass beads.
His work on dissolution testing of oily suspensions, emulsions, and soft gelatin capsules using the dual chambered flow cell solved sample preparation and introduction challenges compared with USP 2, as well as dealing with oils that tend to float in vessels. The last example given was using the implant cell where challenges such as limited volume, a simulation of in vivo conditions where a very slow flow is required, as well as a discussion of real time and accelerated testing. At the end of the workshop, a demonstration was given on how to load several commercially available samples into the variety of flow cells.
On the second day, a series of applications were presented by industry.
Michael Wang, Merck & Co., presented "Predicting in vivo Performance of BCS II/IV Compounds By Dissolution on USP 4 Apparatus". In vitro dissolution for several compounds were conducted on USP 4 apparatus in biorelevant media to support their clinical formulation development. The results were successfully applied in the prediction of their in vivo performance i.e. in ranking formulations and food effect. In addition, the in vitro tests on USP 4 apparatus have been demonstrated an important tool in understanding the possible in vivo dissolution mechanism for the formulations. An IVIVR was established for a compound based on the dissolution and animal study results.
Dr Diane J. Burgess, Department of Pharmaceutical Sciences, University of Connecticut, USA presented "In Vitro and In Vivo Correlation of MR Parenterals: Use of USP Apparatus 4"
IVIVC issues are more challenging for MR parenterals compared to MR oral products and an important factor that is often overlooked is stability of the therapeutic agent in the release media. In vivo factors that influence release from MR parenterals can be: injection site specific; delivery system specific; and drug specific. Dr Burgess showed results of her work with microsphere, liposomes and dialysis bags.
Mel Merciadez , Cordis Corporation presented " A Novel Method for the Elution of Sirolimus in Drug Eluting Stents" A sensitive and robust method for the determination of elution of the active drug substance, Sirolimus, in drug eluting coronary stents was developed using a USP Apparatus 4 elution system. The closed loop configuration of the elution apparatus and the low volume of elution eluent allow the low drug levels that elute from a single stent to be reproducibly monitored. The USP apparatus profile over 24 hours mirrors the 30 day in-vivo porcine profile, providing an in vitro release method that captures the entire release profile of the stent. The method discriminates between common purposely-made manufacturing and formulation defects. The method employs an elution media which permitted fitting the in-vivo elution curve to the in-vivo porcine profile. The method has been accepted by FDA as a release method for the elution of Sirolimus in cardiovascular stents.
Dr Daniel Abran, Sandoz Inc presented "Experience with bioequivalence study of suspensions; relevance of dissolution data ". The dissolution behaviors of three suspensions were evaluated using the USP 4 apparatus. The impact of these studies on the formulation process as well as their relevance to bioequivalence studies was discussed. He concluded that the impact of particle size and dissolution parameters can be discriminated using the USP 4 method. The technique developed by Dr Abran and his team is used for submissions.
Eldomar Cabotage, Lilly, presented "Performance testing of a suspension dosage forms". He discussed a challenging in vitro dissolution method development for a limited solubility product. Early development determined USP 2 to be inappropriate due to lack of sink conditions, sample introduction issues, paddle speeds, and a fast release. USP 4 was chosen to develop a real time test and a QC method. His method development on USP 4 was discussed.
Dr Eric Beyssac, University of Auvergne, presented "In vitro dissolution test of API as a quality control for drug dosage form development". He discussed the key parameters in drug dosage form development with emphasis on the importance of API and intermediate product characterization. Dr Beyssac presented traditional intrinsic methods and apparent dissolution using the powder flow cell. Apparent dissolution rate can be determined with out the use of compaction of the drug using this technique. Other powder methods such as the sprinkle method or filling a capsule can be challenging. He showed that physicochemical parameters such as particle size and specific area with results were obtained using the powder flow cell.
Dr Hitoshi Masui, PharmEng Innovations presented "Flow-Through Dissolution Testing of Low Solubility Drugs: Effects of Near Saturation and Supersaturation." He observed deviations from expected dissolution behavior during flow-through dissolution tests due to near-saturation and supersaturation effects. These deviations were described and their origins were explained theoretically. The first case study involved 2 injectable suspensions where he showed examples of how to calculate sample size, the effect of sample sizes, flow rate and their effect on discrimination ability. He concluded that the dissolution rate is limited by saturation and flow rate for large sample sizes and that faster flow rates give better distinguishing abilities. However, smaller sample sizes give better distinguishing abilities but lower concentrations give a weaker analytical signal. In his second case study, he performed dissolution testing of an API. He developed a cup holder for the intrinsic device and put it into a standard 22.6 mm flow cell. He also performed this test using the powder flow cell. His results were discussed.
Stuart Ritchie, Eurand presented "Influence of Different HPMC Capsule Shells on the Dissolution of Immediate-Release and Extended-Release Formulations of Propranalol HCl" His presentation on the dissolution behaviors of four commercially available hydroxypropyl methylcellulose (HPMC) capsules were investigated in different physiologically relevant media by USP dissolution apparatus I and IV. Dissolution differences among the capsules shall was discussed. He concluded that USP Apparatus 4 provided his work valuable complimentary information to standard USP 1 and 2 methods.
Dr Lijuan Tang, Primera PharmaLab, presented "Selection of Bio-relevant Dissolution Media for Poorly Water-soluble Drugs" With the new rules from the FDA, ANDA submission now requires both fasted and fed bio-equivalence studies to obtain approval status. It is always a challenge for formulators and analysts to develop a discriminatory and bio-relevant dissolution method suitable for evaluating a poorly water-soluble drug. The case study discusses a selection of dissolution medium on three bio-enhanced formulations of a poorly water-soluble new chemical entity. It will focus on the dissolution data interpretation and analysis; general practice on selecting different dissolution media; and In Vivo bioavailability data.
07-27-07
2007 Readers' Choice Awards: Readers put their seal of approval on technology providers
"Results of the 2007 Readers’ Choice Awards are in and have been tabulated to determine the top technology providers in 47 categories, according to our readers. Find out which vendors rate highest with your peers. For the fourth consecutive year, the results are in and the votes have been tabulated for Chemical Processing’s 2007 Readers’ Choice Awards. This reader-driven survey is important to a lot of people for many reasons ..."more"
07-07-07
Tracking Adverse Event “Signals” With Databases & Social Media
"Two of my passions are pharma and technology. As such, I find myself frequently seeking out their nexus. I like to seek out applications of technology in the pharma industry as well as pharma represented in technology ...more"
06-08-07
DSN is changingLook for upcoming changes to the design, form, and function of DSN over the summer...
02-15-07
Bio/PharMOS 2007Bio/PharMOS is a global networking event focusing on development & manufacturing contract services for nutraceuticals, pharmaceuticals and biopharmaceuticals. On 20-21 March 2007 the 6th edition of the event - exhibition & conference - will take place at the Grimaldi Forum in Monte Carlo, Principality of Monaco.... ...more
an Update on PAT Standards DevelopmentEmil Ciurczak met with Gary Ritchie at the 2007 IFPAC conference to discuss the latest in standards development for process analytical technologies (PAT) at USP... ...more
01-19-07
That Sinking Feeling...Here I sit in my kitchen with dishes in the sink. I am reminded of an old joke. An engineer, a physicist, and a mathematician, and a statistician are all staying at a hotel. In the middle of the night the engineer wakes up to find that his trashcan is on fire. He runs to the sink, fills his ice bucket with water and douses the flames. Then, just to be sure, he runs back to the sink, refills the bucket and dumps more water into the trashcan. With the fire out, he goes back to sleep.
A little while later, the trashcan in the physicist's room spontaneously breaks into flame, waking the physicist. He whips out his slide rule, does some calculations, then runs to the sink, fills his bucket with exactly .75 liters of water, and douses the flames. Having put out the fire, he goes back to sleep.
A few minutes later, the mathematician wakes up to see that his trashcan is on fire. He whips out a piece of paper, scrawls out some equations, then goes back to sleep, comfortable that a solution exists.
Meanwhile, the statistician is running from room to room lighting trashcans on fire -- he needed more samples....
Sink conditions refer to the excess solubilizing capacity of the dissolution medium. To calculate sink divide the concentration of the saturated solution by 3, 5 or 10, depending which limit you use, to determine the maximum working concentration of the active drug in the proposed media. Fick's first law of diffusion states: Rate of solution=(D*A*(Cs-Cb))/h ,where D is the diffusion coefficient, A the surface area, Cs the solubility of the drug, Cb the concentration of drug in the bulk solution, and h the thickness of the stagnant layer. If Cb is much smaller than Cs then we have so-called "Sink Conditions" and the equation reduces to Rate of solution=(D*A*Cs)/h. In this case the Rate of solution is directly proportional to the concentration of the drug in bulk solution. This should give a nice sigmoid curve.
Where's pharma?
"Two of my passions are pharma and technology. As such, I find myself frequently seeking out their nexus. I like to seek out applications of technology in the pharma industry as well as pharma represented in technology ...more"
KnowPharma Intelligence Report
Keep on top of the best new listings of white papers, case studies, webcasts and other product information that have been added to the KnowPharma.com website. This monthly intelligence report will keep you up to date on the entire pharmaceutical field.
Everything But the Kitchen Sink
I caught my daughter playing with the electrical outlet, and she gave herself quite a shock. I had to ground her...I have a quantum car. Every time I look at the speedometer I get lost...Someone once said that the point of higher education was so that you could understand more jokes...until next time.
10-05-06
What's In a Color? One Form of I.D.
"Pearlescent pigments, now approved by the FDA, may add another level of product differentiation, potentially protecting the consumer and establishing a stronger brand identity...more"
9-20-06
N.C. drug company lets patients watch medicine get made
"Stacy Miller was healthy enough to suit up in two layers of coveralls, a hard hat, safety glasses, a face mask, gloves and three sets of booties to see where the medicine that keeps her alive is made. She was among 70 patients, relatives and support group organizers from around the country who took up Talecris Biotherapeutics on a rare, all-expenses-paid invitation: Tour the Clayton plant where Talecris makes treatments for immune disorders, hemophilia, burns and severe blood loss...more"
HCL Technologies launches eCompliance product suite for Pharmaceutical Firms
"HCL Technologies Ltd has announced the launch of its eCompliance product suite, a first of its kind complete submissions and labeling solution that facilitates global regulatory compliance. The suite features the Company's eCTD Compliance Manager for creating, publishing and managing eCTD submissions as per the specifications laid out by International Conference on Harmonization (ICH), as well as asy Labeling, a global drug labeling solution that addresses the U.S. FDA?s Structured Product Labeling (SPL) standard, the Physician Labeling Rule (PLR) and European Medical Agency EMEA?s Product Information Management (PIM) compliance...more"
6-13-06
A culture in ferment: Why it's kill or cure for the world's pharmaceutical giants
At GlaxoSmithKline's annual general meeting last week, chief executive Jean Paul Garnier at times sounded as much like a field general as he did the head of the UK's biggest pharmaceutical company...more"
5-3-06
PAT in Perspective: ?One Size Fits All? Software May Not Fit PAT
Excel, with its rounding errors, is a prime example of software written without the input of ?science-types.? I recently returned from Pittcon 2006, where I was impressed by the variety of instrumentation and software being displayed. At one point, I stood in one of the larger vendor?s booths and listened to the cacophony of sounds. It occurred to me that that was what a LIMS, or laboratory information management system, ?hears? as it receives data from all the newfangled monitors being employed for process analytical technology...more"
02-28-06
So here I am sitting at the computer thinking, what am I going to talk
about this week?
How about SDS page?
Some of you in the small molecule field may ask, What is SDS Page?
SDS-PAGE (PolyAcrylamide Gel Electrophoresis) The purpose of this method is
to separate proteins according to their size, and no other physical feature.
In order to understand how this works, we have to understand the two halves
of the name: SDS and PAGE. SDS Since we are trying to separate many different
protein molecules of a variety of shapes and sizes, we first want to get them
to be linear so that the proteins no longer have any secondary, tertiary or
quaternary structure (i.e. we want them to have the same linear shape).
Consider two proteins that are each 500 amino acids long but one is shaped
like a closed umbrella whle the other one looks like an open umbrella. If you
tried to run down the street with both of these molecules under your arms,
which one would be more likely to slow you down, even though they weigh
exactly the same? This analogy helps point out that not only the mass but
also the shape of an object will detrmine how well it can move through and
environment. So we need a way to convert all proteins to the same shape - we
use SDS.
more
02-07-06
So what's new in Pharmaceutical science? Well I just got an e-mail from Eloctrolab. Who is Electrolab? That's what I was wondering so I set out to visit their website. Here's what I found.
Electrolab established in 1984, manufactures pharmaceutical testing equipment, including dissolution testers, disintegration devices, friabilators, and tap density machines. They are located in India but have a distibution network worldwide. visit them here.
11-29-05
Break is over!
I took a short break between jobs from updating The Capsule to get things together. But now things are going smoothly. So let's talk about polarography... It has often been called the forgotten chapter of the USP.
Let's see what Columbia Encyclopedia says about it.
"Polarography is a method for analyzing the composition of a dilute electrolytic solution (see electrolyte). Two electrodes are placed in the solution: One has a fixed potential (voltage) and is called the reference electrode, and the other has a variable potential and is called the polarizable electrode. As voltage is applied to the polarizable electrode, the resulting change in the current through the solution is monitored. By plotting the pairs of values for voltage and current, a series of current-voltage curves (polarograms) can be generated...more"
Voltammetric study of danazol and its determination in capsules and spiked biological fluids
"The voltammetric behaviour of danazol DZ (antigonadotropin) was studied using cyclic voltammetry, direct current, differential pulse polarography (DPP) and alternating current polarography...more"
Determination of noretisterone in tablets by differential pulse polarography.
"A rapid differential pulse polarographic method for quantitative determination of norethisterone (NE) in a tablet is described. The procedure involves disintegrating the tablet with a few drops of distilled water inside a 100 ml volumetric flask, addition of 40 ml methanol, addition of 20 ml .2 M tetramethyl ammonium bromide solution, and dilution to the mark with distilled water. 25 ml of the solution are then transferred to a polarographic cell, dissolved air is removed by bubbling nitrogen through the liquid, and the differential pulse polarographic peak is recorded...more"
An Idea with Potential?
I think in the field of dissolution we need always to look at the alternatives and learn from them. Polarography is one of those alternatives that we need to look into closer. More next week. :)
09-20-05
Busy days, busy nights
Have you heard of Siphs?
Siphs is an online collaboration and social networking tool for the life sciences community. With Siphs, you can:
1. Manage scientific contacts.
2. Create research groups.
3. Search for potential collaborators.
4. Host scientific forums.
Automated Dissolution Testing Services and Analysis
Boston Analytical provides dissolution testing services and analysis utilizing numerous USP Dissolution systems that can be operated in either manual or automated sampling modes.
One sampling system is directly connected to a Beckman Spectrophotometer. Our Beckman systems utilize a flow-through process that enables samples to be analyzed by UV-Spec and then returned to the vessels...more
08-31-05
Back to work...
I have started my first week in a new pharmaceutical company. There is much to learn but it gets easier each day. Eventually it'll be as easy as falling off a horse. WHich I happen to be good at! Because my schedule is so uncertain right now the blog may not be updated Wednesday mornings. I may switch to Tuesday night.
Chemowhatrics?
"What is Chemometrics ? Literally (and loosely) translated, the word "chemometrics" means performing calculations on measurements of chemical data. This can be anything from- calculating pH from a measurement of hydrogen ion activity to computing a Fourier transform interpolation of a spectrum."
"More recently, the common usage of the word refers to using linear algebra calculation methods, to make either quantitative or qualitative measurements of chemical data, primarily spectra. Nearly all trained spectroscopists have the basic understanding of the concepts necessary to apply these methods. Unfortunately, like all specialty areas of science, chemometrics has a language all its own that makes it difficult for the beginner to understand...more"
08-17-05
Don't Fear the Reaper!
I was talking to Chris Walken this week and asked him what the site needed. His response? "I got a fever! And the only prescription.. is more cowbell!"
He actually mentioned that he is going to run for president. I thought he was joking, but the more I thought of it, the more it made sense. Maybe my uncle can help him with his campaign.
I have been interviewing, and have seen a multitude of companies. SOme have dissolution testing, some do not. But the most valuable skill it seems that people want is extensive cGMP experience. I was told, there are many scientist out there for hiring, but most do not know GMP.
So if you are looking like I am, then put cGMP near the top of your resume. To quote the legendary Bruce Dickinson: "Babies.. before we're done here.. y'all be wearing gold-plated diapers." What does that mean?
US FDA says Abbott obesity drug can stay on market
"Abbott Laboratories will still be able to sell its obesity drug Meridia after the U.S. Food and Drug Administration rejected a consumer group's petition to take it off the market, according to government documents released on Wednesday.The FDA said the benefits outweighed the risks when the drug was used appropriately to treat obesity but that it would continue to monitor the drug's safety.The Public Citizen group had twice asked the FDA to pull the drug, also known as sibutramine, citing 50 deaths from cardiovascular problems. The group stood by its conviction on Wednesday that the drug should be off shelves...more"
Hovione Expands its Range of Services in Particle Design Technology
"To address a significant market interest in Advanced APIs (aAPI(R)), Hovione has increased its range of services and multi-scale facilities in cGMP Spray Drying, an advanced particle design technology. Building on its accumulated expertise in all major areas of API development and cGMP manufacture, a full range of cGMP Spray Drying facilities operating at lab, pilot and industrial scale have now been installed at Hovione's API manufacturing plant in Europe and are currently being installed at Hovione's Technology Transfer Centre in New Jersey, USA. Building on the state-of-the-art spray drying industrial facility installed in 2004, Hovione now operates three additional units at lab scale and two others at pilot scale. All units comply to the most stringent cGMP requirements, allowing production from just a few grams for feasibility studies to full scale commercial production. Offering process scale-up throughout all phases of product development, Hovione's multi-scale spray drying facilities further widen our ability to provide customized solutions...more"
Is he really Running?
Given the cache of great Walken lines, we stump for snappier slogans:
"When I win, everyone gets a glass of shhham-pan-ya."
"Like your father's gold watch, this country needs to be kept safe, secure and in a warm place." (See "Pulp Fiction.")
"Liberty is my weapon of choice." (Fat Boy Slim on the ticket?)
"Walken? I'm runnin'!"
"Catch me if you can."
"More cowbell."
What do you think Uncle? Do you want to help?
08-10-05
It seems that I was out of town last week and forgot to tell you. Wow, this is my last week of work at my current employeer. It seems like the layoff notification period was a couple of weeks ago, not 60 days. The interviews are starting and all looks very promising.
I have to say that this is one of the best jobs markets that I have ever looked for work in! Maybe a decade or more of GMP experience helps in the job hunt. I remember looking right out of school and not finding a job for several months. It seems like the jobs market has gone to the other extreme. Employers are looking for qualified candidates, but many companies are not finding the candidates. They are turning to recruiters more and more.
advertising for people who don't exist
I was reading the blog of YoungFemaleSientist. It appears that she is also looking for work. But her feelings differ from mine.
Dear Ms.PhD, there are jobs out there. Yes everyone is advertising for people who don't exist. Go ahead and apply. The employers only have wish list of who they want for christmas, but they will get who comes closest. It's just like horseshoes. Most will not get a ringer.
As a child, one christmas I wanted a car for a present, but instead got a slinky. I had lots of fun with the slinky. It it probably better built that most cars and last longer. So Ms. PhD, you may not be a fast sports car that everyone wants, but you are probably what they need and will be around a lot longer when they do hire you.
07-27-05
Breaking Glass
I must have struck a chord with people since my glass vessel article. It seems as though I have gotten more commentary and e-mails from that article than any other thing which I have written. Here''s some information for those who want to learn more.
For those with a travel budget, there's the Pittsburgh Glass Center and San Francisco's Public Glass. How about coming up to my neck of the woods for Snow Farm's Glassblowing class?
So what is NIST doing these days?
"In one experiment, the JILA team made images of the two groups of atoms separately by tuning the laser to a frequency of light absorbed by only one group at a time. The two images were physically overlaid so that the shot noise in sets of corresponding pixels could be compared. Using mathematical techniques to analyze the images, the scientists found similar patterns of dark and light areas, clear evidence for correlated atoms."
"In a second experiment, scientists split the molecules with a radio wave pulse into pairs of entangled atoms flying apart with equal momentum but in opposite directions. The scientists again took images of each set of atoms and overlaid them. But this time, they systematically rotated one image to check for correlations in noise patterns. Similar patterns were found after a 180-degree rotation, in pixels on opposite sides of the cloud, clearly indicating correlated atom pairs. In this experiment the atom pairs are detected as far as 350 micrometers apart, and as a result fascinating quantum phenomena like the ?spooky action at a distance? could be studied...more"
Teva Buys Ivax
Yes yes, we've know this for days. "The merger of two of the biggest generic drug suppliers to the USA might lead to price increases for some drugs that both companies make, but the strength of competition in generic drugs is likely to mitigate broad increases...more"
Ends with -gry...
I was asked what the third word is. The answer is language. Read it again. The first statement has nothing to do with the question. It is there to throw you off. Ask the OED.
Quote of the Week
To most people, solutions mean finding the answers. But to chemists, solutions are things that are still all mixed up."
07-20-05
The D-Talk Forum, New and Improved
I'll be travelling today and tomorrow and interviewing on Friday. So why don't you spend a little time on the D-Talk forum. The software is new and the format has been changed. Welcome to 2005 where the internet allows you to do more. Actually, I surprised my self. I did not know that I could configure php based programs on a remote server...not bad for a simple chemist.
Angry? Hungry?
If you would rather do something else here this:
Think of words ending in -GRY. Angry and hungry are two of them. There are only three words in "the English language." What is the third word? The word is something that everyone uses every day. If you have listened carefully, I have already told you what it is."
Hint: Ask Oxford if you give up...
07-13-05
Overseas News
Well I'm back to health again. It has been three weeks since the horse incident. At least it wasn't like the latest Mariah Carey incident last night in Germany. How embarrassing to have your dress fall apart while in front of a crowd of viewers. What's going on with all these celebrities losing their clothes accidently on stage? I don't remember attending AAPS conferences and anything similar happening. Hmm... could it be...planned!
Indian Pharma's Poor Health
It seems that even in India the drug companies are suffering poor health. Pharma yet to get back to good health.
"Indian pharma companies continue to feel the heat. They are expected to show a muted performance in the June quarter ?05. Analysts say that these companies are suffering due to a limited recovery in sales in the domestic market following the introduction of the value added tax (VAT). ...more"
EU laws on sale of vitamins 'valid'
"Controversial new European laws which could outlaw thousands of vitamin and mineral supplements were upheld by European Court judges.The European Court of Justice rejected British health food industry claims that the proposed Food Supplements Directive, coming into force on August 1, breaches EU rules...more"
Japanese drug merger gets US antitrust approval
"U.S. antitrust authorities said on Monday they had approved the merger of Japanese drug makers Sankyo Co. Ltd. and Daiichi Pharmaceutical Co. Ltd...more"
Novel Production of Anti-Malaria Drug Ahead
"Dafra Pharma (Turnhout, Belgium) and Plant Research International (part of Wageningen UR, Wageneingen, the Netherlands) have signed an agreement to jointly develop alternative and more reliable artemisinin production methods.A two-fold research strategy has been adapted. The co-operative effort will be aimed at enhancement of production with the plant Artemisia annua, as well as the biosynthetic production of artemisinin by combining microbial fermentation and chemistry...more"
07-06-05
Summer reading time is here again. So what shall I read this summer? Well I read Vivian's book, so why don't I finish the Harry Potter book that I started and put down a couple of months ago. Here's a few good books for you to read...
Tablets and Capsules Bookstore
Tablets & Capsules is the only technical publication devoted exclusively to readers in the tablet and capsule processing industries. Let's browse through the Tablets and Capsules Bookstore...how about Advanced Pharmaceutical Solids by Jens Carstensen, Oral Drug Absorption Prediction and Assessment edited by Jennifer Dressman and Hans Lennern s, or Pharmaceutical Dosage Forms: Tablets Volumes 1, 2 and 3 Second Edition edited by Herbert A. Lieberman and Leon Lachman. The third choice is my favorite. I have the first two volumes and would love to get the third volume. But I must finish Harry Potter too.
IFPAC/PAT Summit
September 8-9, 2005, San Juan, Puerto Rico
"Learn the practical aspects of PAT, Process Analytical Technology as it is applied to the Pharmaceutical Manufacturing Environment. Real Applications or Case Studies will be used to clearly illustrate the key components and the benefits of PAT - Process Analytical Technology...more"
Random Thoughts
I saw a movie the other day. It was a movie about a cop and a scared witness who was scheduled to testify against the mob. The cop visited the witness' place of residence and knocked on the door. The door swung gently inward at his touch. Right then, I knew the witness was dead. See, if you knock on a door in the movies, and it turns out that the door was left ajar, it means somebody was killed. I think the next movie director who shoots a scene like this should have his door left open, and someone knocks...
What do you get when Steve Jobs hires and fires a lot of people in six months?
An Apple turnover.
Have you heard about the new corduroy pillows?
They're making headlines!
Until Next Week...
06-29-05
Back In the Saddle Again
One night in 1926 Gene Autry was strumming the guitar and singing to pass the time at his telegraph operator job. A man came in to send a telegram and asked him to keep singing. The man told him he thought he had talent and that he should get a job on the radio. The "man" turned out to be Will Rogers. Autry soon quit his job and headed to New York. Gene is well known for his song Back in the Saddle Again:
I'm back in the saddle again
Out where a friend is a friend
Where the longhorn cattle feed
On the lowly gypsum weed
Back in the saddle again
Gene's last movie was "the Last Pony Ride", Hopefully this won't be my last ride.
Great and Useful Links
So where do you turn when you need information on Chemistry? Sure you could weed through the results generated by Google. But where could one find a concise list? Why Henry's List of course! When it comes to chemistry Henry has accumulated one of the most useful list on the internet. How about Chemspy? Links for Chemists? The University of Wisconson Chemistry Page? You make the choice.
"Scientia Est Potentia" ("Knowledge Is Power")
One place I visit often to see the general trend of the internet, and how we can find information is Google Beta Labs. Some of the most unusual cutting edge tools are being tested here. Sounds like Willie Wonka's Factory Huh? Since we must often find research papers and articles take a look at Google Scholar, search through journal articles, abstracts and other scholarly literature. Maybe you're not sure how to search a particular topic? Try Google Suggest, as you type, Google will offer suggestions. My school motto was Scientia Est Bona, I guess they thought that knowledge was good, not great, not powerful, not beneficial, just good, like ice cream on a cool fall day.
Closing Quote
"When in doubt, let your horse do the thinkin'."
06-22-05
I injured myself this week horse back riding. I will be back next week.
Pete
06-15-05
A Hard Year
Many of those who know me realize I have been very sick for the past two years. I have recently been out for surgery and am starting to recover. Yesterday, I was informed, due to a reorganization of my department, that my job has been eliminated. Yes, it has been a hard year.
It's written that everything happens for the good. It should be an interesting journey. I'll keep you informed.
EMEA PAT Guidance
My network of friends has sent me information that the EMEA has just released their own PAT guidance.
Let's ZetaSIze!
The new Malvern Zetasizer Nano series can measure a combination of three of the most important parameters for the colloid and polymer chemist, particle size, zeta potential and molecular weight.
The new technology incorporated in these systems provides unequalled sensitivity and versatility. The patented NIBS optics incorporated into the Nano Z and Nano ZS also allows measurements of samples with little or no dilution.
* Particle size - NIBS technology enables measurements of particles and molecules from 0.6nm to 6 microns.
* Zeta potential - M3-PALS technology enables accurate measurements of zeta potential in aqueous and non-aqueous dispersions.
* Molecular weight - An avalanche-photodiode detector and fibre detection optics give the sensitivity and stability required for absolute molecular weight measurement.
The Zetasizer Nano ZS is the pinnacle of the Malvern Zetasizer Nano series and can measure all three parameters with no performance compromises.
Final Advice
Walking barefoot in the sand is good. Walking barefoot on a cactus is bad.
06-08-05
Advances in Direct Compression
(Strategies for Achieving Content Uniformity, Process Control and Particle Characterization)
"Direct Compression method involves the compression of a dry blend of powders that comprises drugs and various excipients. The simplicity and cost-effectiveness of the direct-compression process have positioned direct compression as an attractive alternative to traditional granulation technologies and as the most viable tablet formulation approach today. With its popularity within the industry come many challenges in areas of research development and manufacturing process. Our conference features leaders in the industry discussing new arenas of innovations and providing hands-on solutions for problems such as uniformity, process control, particle sizing, flow, and other unique formulation insights...more"
FDA Advisory Meeting Notes
The FDA met recently to discuss drug release and dissolution specifications. Here are the slides which they presented. I recommend that you go through each of the presentations. It is well worth the time.
Multivariate Data Analysis and Modeling Course
Umetrics are experts in multivariate modeling, data analysis, and design of experiments. The goal for Umetrics Academy is to give all our course participants the knowledge and software tools for more effective production performance and innovation.
Location: USA, CA, Santa Monica
Start Date: Monday, June 13, 2005 (week 24)
Number of Days: 3
Price: $1795 US
06-01-05
Another month has come and gone, Summer is starting, and my children eagerly await the end of school. I look forward to summer too. A break from the endless activities such as soccer, baseball, and tee ball is a welcome relief. WIll I get to relax a little this summer? Maybe at the lake in August, but until then,,, who knows.
Let's look at drug eluting stents again.
Drug eluting stents: Part two...
What is a drug eluting stent?
If you missed the column two weeks ago here is a refresher. This is a helpful brochure from the University of Virginia.
Why is it important to dissolution?
First let's look at the latest thinking on dissolution by Ajaz Hussein.
According to Kathleen Miller at Boston Scientific. "Successful designs and applications are based on the
integration of many disciplines:"
? "Materials Sciences
? Engineering Fields (Mechanical, Chemical, Bioengineering)
? Pharmaceutical Sciences
? Pre-clinical and Clinical evaluation of both drugs and devices
? Pilot and Scale-up manufacturing for both drugs and devices
? Regulatory appreciation for both devices and drugs"
In my opinion, stents must be studied and understood as well if not better than solid oral dosage forms.
What do they look like?
What are the future challenges of Dissolution Testing?
I don't know. Let's let Vivian answer this one.
This month's places to be:
Barnett International NIR and Blend Uniformity Testing
June 9-10, 2005, Philadelphia, PA
Institute of Validation Technology - Process Analytical Technology
June 14-17, 2005, Philadelphia, PA, Doubletree Hotel
05-25-05
Good Advice
Well, I made it through another week. Since you made it too, here some good advice to help us to make it until next week.
Don't iron clothes while wearing them.
Don't stick screwdrivers into electrical outlets.
Don't kick stone walls very hard without wearing thick-soled shoes or boots.
And finally, don't throw a brick straight up.
Spectroscopic Solutions
"Spectroscopic Solutions is a leading consulting firm in the area of process analytical technology (PAT) and chromatographic methods. PAT is the use of spectroscopic and other advanced techniques for improved quality assurance and process control. Common PAT technologies include Near IR (NIR) spectroscopy, FT-IR, Raman spectroscopy, design of experiments, and statistical quality control...more"
We are living longer
"Life expectancy for Americans reached an all-time high of 77.6 years in 2003, and the gap between men and women narrowed, according to preliminary results from state death certificates released Monday...more"
In Closing
Here's some more good advice for this week... Don't chase a bear into the woods to get a close-up photo!
05-18-05
Drug Eluting Stents
The buzzword at the last AAPS Dissolution Focus group was stents. What is a stent? Let's see what Wikipedia has to say on the word stent. There was much talk about how one would do a dissolution test on a stent. Varian proposed a modified apparatus 3. Others may suggests apparatus 4 or 7. Let's look at stents this week and next.
"A stent is an expandable wire mesh tube that is inserted into a hollow structure of the body to keep it open.Stents are used on diverse structures such as coronary arteries, other blood vessels, the common bile duct, the esophagus, the trachea or large bronchi, and ureters."
"Traditional ("bare metal") coronary stents provide a mechanical framework that holds the artery wall open, preventing stenosis, or narrowing, of arteries feeding critical structures like the myocardium. Traditional stenting is superior to angioplasty alone in keeping arteries open."
"Newer stents (called drug-eluting stents) are coated with drugs that prevent re-stenosis of the artery. Two drugs, sirolimus and paclitaxel, have been demonstrated effective and safe in this application by stent device manufacturers and are being used in the US...more"
Let's look at what others are saying about stents and what they are.
Drug-Eluting Stents to Prevent Coronary Restenosis
"...The elution media was calf serum. This choice allowed for a simplification of the elution
protocol: the half-life of Rapamycin in serum is longer than in plasma, and the high
solubility of the drug in serum eliminates the concerns with reaching equilibrium
concentrations prior to changing the elution media...more"
Polymeric Drug Encapsulation on Stents
"The basic mechanism of drug delivery from a polymeric scaffold involves encapsulating a drug in a polymer that either allows the drug to diffuse outward from it or that undergoes degradation in order to release the drug directly. Polymers can be subdivided into bioerodable and nonbioerodable categories. The bioerodable polymers can be further subdivided into either bulk or surface erosion...more"
Nanotechnology
"According to the Institute of Nanotechnology, controlled and targeted drug delivery represents a frontier of science. Drugs can be encapsulated in a variety of carriers, such as a carbon nanotube that is like a silicon wafer with antibodies or other molecules that will bind to the drug. Encapsulated drugs can be protected from degradation. The drugs may be in particles with coatings only a few nanometers in thickness. The drugs are normally ingested or implanted and designed to deliver a controlled release of drug, which may last for many months and can be activated at different sites in the body. Nanopores can act as tiny turnstiles for releasing drugs. By making the nanopores only slightly larger than the molecules of drugs, they can control the rate of diffusion of the molecules, keeping it constant, regardless of the amount of drug remaining inside a capsule. Drugs in nanocrystalline form can be administered in smaller doses because they can be delivered directly to the tissue and in controlled doses....more"
USP Launches Redesigned Web Site
"Rockville, Md., May 16, 2005?U.S. Pharmacopeia (USP) today announced that it has redesigned its Web site to better serve an increasingly diverse audience of international partners and constituents. The Web site, located at www.usp.org, will streamline navigation as well as provide improved archiving for news and information. The Web site content is intended to educate various audiences and enable viewers to find the information they are searching more quickly and more accurately."
05-11-05
Book, Book, Book...Again
Here we are another week. Another book. I am sure that you read my review of Royal Hanson and Vivian gray's new book. But it looks as though Anthony Palmieri is finally finished with his book, Dissolution Theory, Methodology, and Testing. "This title is a guide to the theory, practice and regulations relating to pharmaceutical dissolution testing. Written by contributors from industry and academia in the US and UK, it should be of value to all pharmaceutical scientists with an interest in formulation and pharmacology." But I can only find it in the U.K. Hmm, I wonder why? I guess I'll just have to finish my latest endeavor. Too many highly valuable books, not enough time...
What's your name? What's your number? Are you legit? Counterfeit?
"Silently, invisibly, the scanner broadcasts its radio signal, and the tag responds: I am product #3439887349787958738. Or: I am a Holstein cow who lives at Farmer John's. Or: My name is Scribo von Alphabeticus. Cylindrical microchip implant pinched by two fingers.
This silent radio conversation occurs between a reader and a tiny, cheap radio ID tag on the product -- or in the arm of the human being. Most of these tags don't even need a battery -- they get power from the radio signal that talks to them. These days, you can hardly click a news website without seeing another RFID breakthrough...more"
Upcoming PAT Events
Barnett International NIR and Blend Uniformity Testing
Demonstrating equivalency between batch and continuous blending using PAT
June 9-10, 2005, Philadelphia, PA
Institute of Validation Technology - Process Analytical Technology
Selection, Adoption, and Validation Process for a PAT System, Normand Dubuc, Tracy Davis(Invensys), Nancy Mathis (Mathis)
June 14, 2005, Doubletree Hotel, Philadelphia, PA
Montreal International Engineering Conference
Particulate Processes in the Pharmaceutical Industry
June 26-30, 2005, Crowne Plaza Montr al Centre Hotel, Montr al, Canada
Finally
A pharmacist is going over the directions on a prescription bottle with an elderly patient. "Be sure not to take this more often than every 4 hours," the pharmacist says. "Don't worry," replies the patient. "It takes me 4 hours to get the lid off".
04-27-05
Book, Book, Book, Book...
A librarian is working away at her desk when she notices that a chicken has come into the library and is patiently waiting in front of the desk. When the chicken sees that it has the librarian?s attention, it squawks, ?Book, book, book, BOOK!?
The librarian complies, putting a couple of books down in front of the chicken. The chicken quickly grabs them and disappears.
The next day, the librarian is again disturbed by the same chicken, who puts the previous day?s pile of books down on the desk and again squawks, ?Book, book, book, BOOK!?
The librarian shakes her head, wondering what the chicken is doing with these books, but eventually finds some more books for the chicken. The chicken disappears.
The next day, the librarian is once again disturbed by the chicken, who squawks (in a rather irritated fashion, it seems), ?Book, book, book, BOOK!? By now, the librarian?s curiosity has gotten the better of her, so she gets a pile of books for the chicken, and follows the bird when it leaves the library. She follows it through the parking lot, down the street for several blocks, and finally into a large park. The chicken disappears into a small grove of trees, and the librarian follows. On the other side of the trees is a small marsh. The chicken has stopped on the side of the marsh. The librarian, now really curious, hurries over and sees that there is a small frog next to the chicken, examining each book, one at a time. The librarian comes within earshot just in time to hear the frog saying, ?Read it, read it, read it??
This joke is a precursor to the review which I have written. This week I have decided to focus on...
The New Handbook of Dissolution Testing
23 years ago, William Hanson wrote what is considered by most to be the essential reference of dissolution testing. The book was so closely identified with Hanson that it became known as Hanson?s handbook. However, at the time of writing, the science was new and changing. The reference became dated and a second edition was written and released in 1991. I have a used copy sitting in a predominant position on my desk.
Since 1991, many changes continued to occur. While the majority of the information remained intact and useful, more and more had to be weeded out from what was dated and incorrect. Sadly Dr. Hanson passed away in1994, and the book remained a legacy. A year ago I learned that Royal Hanson was working with Vivian Gray to update and revise the 2nd edition. Now the third edition is here. Vivian and Roy have combined their unique position to include information from instrument manufacturer, regulatory, consultant, and journal editor points of view. Roy Hanson has successfully stepped into the shoes of Will Hanson and created the third edition. All the black and white photographs have been replaced by well designed and highly useful diagrams. Many of which appear to be a Hanson apparatus, but this does not appear to be any sort of advertising. Probably it was available images helpfully provided by Roy Hanson. Vivian's many contributions include additional information about both the USP andFDA, and vast references from Dissolution Technologies as well as other journals.
While the book retains its small and handy handbook size, it contains many more pages. Upon looking further into the book, I see that the general structure and chapter organization remains the same, but some chapters have additions subsections to include the latest regulatory and technical changes. Some of the recent additions include sections on harmonization, automation, 21 CFR part 11, emerging technologies, computer software and more. The book also contains many useful checklist and charts including calibrations, method validation, random input variables, and apparatus comparisons.
One of the biggest additions to the handbook is the inclusion of the appendix. This section contains a functional validation guideline as well as fill-in-the-blank IQ/OQ/PQ forms.
While its price was on the steep side, the value of these documents is well worth the price of the book. In closing, I would say that this book holds the number one spot on my bookshelf. This small book is packed densely with useful knowledge for the research scientist, quality control chemist, formulator and manager. I would recommend you get yourself a copy today.
AAPS Dissolution Focus Group
Friday, Groton, I'll see you there.
04-20-05
A DayMare
Yesterday I went for a ride on my horse. She is used to going out in trail rides with many other horses. She fought the idea of going out by herself. It was a nightmare for her to go out into the woods without other horses around. Her every instinct fought the idea of change from her routine.
How much do we fight the idea of something new? Is NIR one of those things that we fight? How about 21CFR11? Is PAT fighting an uphill battle against our preservation instincts? Is Rapid Micro a nightmare to some? Will fiber optics dissolution ever become mainstream?
Here is something to really be scared of...
"A huge asteroid which is on a course to miss the Earth by a whisker in 2029 could go round its orbit again and score a direct hit a few years later...more"
Strange Landscapes
We are in a period of rapid change in drug technologies. How does one keep up with the ever changing landscape of dosage forms. Here is an article on oral disintegrating tablets, which may become more common and replace traditional tablets, maybe even injections.
Weibully at the knees
As scientist in the pharmaceutical industry, we are often more comfortable with chemistry, formulations, and instrumental analysis. We must be dragged into the mathematical areas of pharmaceutical science. But math is making bigger and bigger strides into the ring of pharmaceutical science. Let's look together at a well written profiling article which uses terms describing the types of functions which dissolution profiles may mimic, such as a weibull function or Korsemeyer and Peppas.
Focus
Are you going to the AAPS Focus Group in Groton Next Friday. Many are chomping at the bit, some are hestitant to try a new meeting. They say you can lead a horse to water, but you can't make it drink.
Done Horsing Around
Until next week...
04-13-05
I see the flowers starting to peek slowly through the early morning dew. The cold days are going away. I am sitting with Roy and Vivian's book in my bag, but the great outdoors in calling. I need to review it...
Did you see the latest? Who got the brilliant idea to send killer flu virus around the world?
One-Third Of Drug Ads Do Not Contain References Supporting Medical Claims
"UCLA investigators reviewed pharmaceutical ads in American medical journals and found that nearly one-third contained no references for medical claims; while the majority of references to published material was available, only a minority of company data-on-file documents were provided upon request; and the majority of original research cited in the ads was funded by or had authors affiliated with the product's manufacturer....more"
Upcoming Events
In Vitro and Dissolution Testing Focus Group Meeting
Pfizer-Groton Site in Groton, CT
April 29, 2005
If attending please e-mail Christopher Chabot your First Name, Last Name, and Company Name:
Christopher J. Chabot
Pfizer Global Research and Development
Groton, CT 06340
Send an e-mail to Christopher Chabot
cGMP?s FOR A NEW ERA - 2005
An FDA/Industry Workshop
An interactive workshop on today?s relevant issues:
? What are FDA?s current thinking and progress to date?
? What is industry doing to help map the future direction?
? What are the compliance implications?
? What are Industry?s practical experiences in implementing Quality systems and
risk management?
? The experience of FDA investigators and current observations.
FDA/Industry Workshops -- Drug Quality System - cGMPs for a New Era 2005
June 6, 2005
Hilton Parsippany
Parsippany, NJ
July 14, 2005
Hyatt Regency Chicago
Chicago, IL
August 4, 2005
Sheraton Delfina
Santa Monica, CA
Interphex
Have you made plans to attend Interphex yet? Your colleagues have. Look at who is going from your company.
"The annual gathering of the pharmaceutical industry is the place to be this April. INTERPHEX is the world?s most trusted source for insight into issues, education, products and services. You?ll find innovative strategies and solutions for your success, your project?s success, and your company?s success. Whether you?re looking for the latest technologies, guidance from the industry?s best, or just want to network with colleagues, register now!"
04-05-05
"Where are you Going, Where have you Been"
In the famous short story by Joyce Carol Oates, Connie disappears with the mysterious stranger, Arnold Friend. Yes, I was gone last week. But I have returned. Vacations are just too short.
New Science
Every now and then I like to comment on some cutting edge areas of science. So gather up a pile of dark matter, your tetraneutrons, and some not-so-constant constants. Let's travel to the world of 13 things that do not make sense.
The New Dissolution Handbook
Yes, I am sitting here with the latest copy of the 3rd edition of the Dissolution Handbook. While on vacation it was unfortunately not on my list of things to read. Keep and eye out for an upcoming review.
ProcessAnalyticalTechnology.com
Mark Taras has created a new website. He is accumulating papers, postings and information on ProcessAnalyticalTechnology.com. "Process Analytical Technology (PAT) is the most significant change in thinking in the FDA in decades. There are currently no FDA Process Analytical Technology guidelines but this is expected to soon change. Process Analytical Technology has been successfully used in industry for several years, in research and some limited production use. We give a complete overview on what Process Analytical Technology is, what the FDA and EMEA think about it, where its being used and where you can use it. We have a question and answer section where we will answer your Process Analytical Technology questions. We have links to Process Analytical Technology articles, conferences and companies that provide Process Analytical Technology consulting. We will also discuss the effect Process Analytical Technology will have on Validation, e-records, e-sigs, and compliance with 21CFR Part 11, and other FDA regulation.".
03-23-05
Time for the FDA to Move onto Biogenerics
"As the US Food and Drug Administration continues its deliberations on generic biopharmaceuticals, the industry body representing generic drug manufacturers has said that the time has now come for the agency to make some hard decisions, reports Phil Taylor."
?There is no reason to delay consumer access to affordable biopharmaceuticals when sound science supports their approval under a shortened and less costly abbreviated approval pathway,? said the Generic Pharmaceuticals Association (GPhA) in an open letter to the agency...more"
Tableting Course
Do You KNow the Difference between dry compaction, wet granulation, and dry granulation? If not, then you are a candidate for Introduction to Tabletting, the latest course for pharmaceutial scientists trying to better understand how their tablet are made.
If someone handed you some lollipops...
"How would you approach doing dissolutions on compounded lollipops? Cut off the (plastic) sticks? Mount them so that the business end of the lollipop was as close as possible to the bottom of the vessel?...more"
Career Opportunities for Today's Pharmaceutical Scientist
"Today's analytical chemists in the pharmaceutical industry are trading lab coats for hard hats...more"
The Magnesium Stearate Solution
"When tablets fail" according to Nancy Mathis of Mathis Instruments. "They fail at dissolution testing. That is too late in the process to make any changes. With advanced tablet presses that monitor hardness real time, the problem can still occur. The culprit is the lubricant. Lubricant levels are a delicate balance between achieving good flow and achieving good compressibility. There is no magic amount of lubricant or post addition blend time that will account for variations in the excipients or the lubricant itself. By monitoring lubrication real time, physical characteristics of powder flow and tablet quality can be determined predictively." Visit the Mathis website, and view the Magnesium Stearate Solution under the tech Library.
03-16-05
Handbook of Dissolution Testing
Yes, that winning team of Roy Hanson and Vivian Gray have combined efforts to update the essential reference for every dissolution analyst. "The Third Edition of the Handbook of Dissolution Testing is now available! Well over a decade has passed since the Second Edition of the Handbook of Dissolution Testing as published. In that time, growth in automation, validation, special dosage forms, and international harmonization have significantly altered every aspect of dissolution testing. This new Third Edition expands on the fundamental teachings of the first two, providing regulatory agencies, educational institutions, and manufacturing labs in every corner of the globe the new information necessary to improve pharmaceutical quality." I have plans of getting a copy. Watch for an upcoming review.
"Smarter Labeling"
Are your labels smart? Do you understand the following: "Track and Trace", RFID, Taggants, Paperless Labels, White Labels, ...What's its all about, Alfie?
The Distek Small Volume Mini Intrinsic Dissolution Apparatus
Distek has announced a new apparatus. Please take note of this new apparatus as is related to the in-process revision of USP article #1087, and check Distek's website at www.distekinc.com within the next few weeks for the official press release...
"Distek has become aware through recent years that when newly-developed API compounds which have the "value of Gold" are first provided to pharmaceutical formulators, they can often scarcely afford to use 100mg. of API powder ( as typically required for the standard "Wood" rotating disc apparatus or newer Paddle-over-Stationary-Disc Intrinsic apparatus ) for just one Intrinsic disso test. In some cases ( not unusual ), this would use up almost half of the formulators' entire supply of API alloted for several weeks' worth of testing!"
"Distek's new mini-intrinsic apparatus would allow the use of as little as ~10mg. of API compound ( harnessing the standard 2mm mini-die cavity ) for the formation of a single Intrinsic pellet, sparing the precious powder for additional tests on other days as necessary. The problem, however, with using only 10-20mg of API dissolved into a typical 500 or 900ml. volume of disso media is that it may then be undetectable by typical UV-Vis or HPLC means due to it's low solution concentration. This problem can be alleviated by introducing the mini-intrinsic die assembly into typical 100 or 200 ml. mini vessels ( preferably flat-bottomed ) with associated mini-paddles stirring overhead. These vessels can hold as little as ~50ml. of dissolution media while the stirring paddle blade remains immersed under the disso media surface. Once used, mini-intrinsic sample concentrations would then likely be readily detectable."
On-line Seminar (or is that At-line?)
Are interested in the new Laser Diffraction chapter for the USP? Why don't you attend Interpreting the new USP 429 test for Laser Diffraction. It's an on-line seminar going on tomorrow. The new USP 429 tests marks the first official guidance for laser diffraction usage in the pharmaceutical industry. This seminar will review the 429 test, compare it with the ISO 13320 standard, and offer interpretations to sections regarding reproducibility and verification.
03-09-05
Oh My Goth!
Now that I'm back to normal some ask me what have I been up to lately? My Uncle, Alice Cooper is really into golf. Kinda funny, but he took me to this exclusive club for gothic golf. There is no greens only black, golfers have a strict dress code (piercing recommended), and everyone has Rob Smith hair. Just kidding.
Actually, I have been getting into photography. I just got a digital camera and have investigated the techniques of others. I have a new favorite site that I have been exploring. Kyle Cassidy has an unusually and unique style. Do you think he could do a dissolution apparatus photoshoot? He could Photograph an apparatus in his garage with a scythe for a paddle? How about a levitating tablet over and open vessel? How about Brainclaw sampling fiber optic probes? Maybe not, sorry Kyle.
The latest Dissolution Technologies went online last week. It has an interesting article by Tom Foster and Will Brown in which the Re-examine (gasp) calibrator tablets! Bryan Crist and Dan Spisak have an article on Induced Variance.
Hey, who did your apparatus photoshoot? Nice pictures! Yes, DT even included an article by me? I guess you can't stop me from talking about geometry, and golf. Right Uncle?
What is Surface Analysis?
"Surface analysis is the use of microscopic chemical and physical probes that give information about the surface region of a sample. (The term sample refers to any piece of material, structure, device, or substance that is under study). The probed region may be the extreme top layer of atoms (the only true surface, for purists), or it may extend up to several microns (millionths of a meter) beneath the sample surface, depending on the technique used. The analysis is done to provide information about such characteristics as the chemical composition, the level of trace impurities, or the physical structure or appearance of the sampled region. Such information is of importance to researchers or manufacturers who must understand the materials in order to verify a theory or make a better product...more"
MSDS
Wikipedia defines an msds as "A material safety data sheet or MSDS is a form containing data regarding the properties of a particular substance. It is intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner, and includes information such as physical data (melting point, boiling point, flash point, etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill handling procedures. The exact format of an MSDS can vary from source to source.
In the U.S., OSHA requires that MSDS be available to employees for potentially harmful substances handled in the workplace under the "Employee right to know" rules.
An MSDS for a substance is not primarily intended for use by the general consumer, focusing instead on the hazards of working with the material in an occupational fashion. For example, an MSDS for a cleaning solution is not highly pertinent to someone who uses a can of the cleaner once a year, but is extremely important to someone who does this in a confined space for 40 hours a week."
But where can you find an MSDS if you need it? How about MSDSsearch, MSDSprovider,
Blogging The News
We bloggers look forward to recognition from other media providers. "Another signal moment for bloggers is to occur this morning, when Garrett M. Graff, who writes a blog about the news media in Washington, is to be ushered into the White House briefing room to attend the daily press "gaggle.""
"Mr. Graff, 23, may be the first blogger in the short history of the medium to be granted a daily White House pass for the specific purpose of writing a blog, or Web log. A White House spokesman said yesterday that he believed Mr. Graff was the first blogger to be given credentials...more"
03-02-05
Green Eggs
So maybe the green days are not here yet. The snow covers everything! But we can still celebrate with green eggs and ham.
PITTCON
A Short Primer on Chemometrics for Spectroscopists
"As any spectroscopist will tell you, getting useful results from a set of spectral data is not always straightforward. Whether it's problems with determining the precise amounts of the components in a mixture or the similarity of the spectral responses from those components, there are many challenges that the analytical scientist must face. And so now, spectroscopists are increasingly turning to chemometrics as a powerful statistical tool to help them get more meaningful information from their spectral data...more"
Thermo Product Training
It appears that Thermo has a wide variety of classes to choose from..."We offer a comprehensive selection of training courses to help you maximize the use of your products and achieve your professional development goals. Designed to provide in-depth instruction and hands-on experience, Thermo training courses give you the knowledge and skills necessary to use your product with confidence...more"
02-23-05
Green Day
As I look out my window I notice how early the sun is rising today. I suppose that many of you are getting ready for PittCon this week. I know a few who stated they would put back a few in my honor. But I am enjoying myself here. The days are getting longer. The snow is melting. The Sox are at spring training. This is one of my favorite times of the year. The start of the green days.
PittCon Highlights to Look For
LOOKING FOR NEW PRODUCTS FROM EXHIBITORS?
Many exhibiting companies will be showcasing their newest products and services at PITTCON 2005. You have an opportunity to be the first to learn about some of them by attending the New Product Forums on Sunday, February 27th. The Program Section of this book contains the forums to be presented which highlights the latest product offerings. Don?t forget to check out the Sunday posters and attend the Sunday Mixer that also highlights the latest product offerings. The Exposition Floor opens at 9:00 a.m. Monday, February 28th so attending Sunday is one way to plan and get a head start.
Which days are you attending? Here's a list of each day's agenda for you.
Article of the Week
I stumbled across this article a thought I would share it with you. It is entitled "Dissolution test as a surrogate for quality evaluation of rifampicin containing fixed dose combination formulations"
How Do Your Tablets Smell?
Let me throw one more interesting article out your way. I just couldn't resist once you start dealing with electronic noses! Application of an electronic nose system for evaluation of unpleasant odor in coated tablets. What fun we are having!
Stephen Wright, referring to a glass of water:
"I mixed this myself. Two parts H, one part O. I don't trust anybody!"
"They say we're 98% water. We're that close to drowning...(picks up his glass of water from the stool)...I like to live on the edge... I bought some powdered water, but I don't know what to add to it."
02-16-05
Another Novel Dosage Form
Do you remember when novel meant a good book rather than then next way to deliver medication? I guess we live in an exciting time. Here something novel.
New Alliances
One of my favorite games is Risk. I would start in South America or Australia and form an alliance with the next closest continent. Alliances can be a useful way to get everything from one vendor. No trying to tie unrelated equipment with several people. An alliance can allow you to get what you need from one source. I guess its the opposite of risk.
Distek recently announced two important new alliances;
It's Pat Again
Here's a few good PAT links.
http://www.dcpt.duq.edu/pat.html
http://www.mli.kvl.dk/staff/foodtech/brothesis.pdf
http://www.chm.bris.ac.uk/org/chemometrics/downloads/
Faster Micro, Test, Test!
Are you doing Rapid Micro?
02-09-05
It has been several weeks, but I am back. It just took me longer to get back on my feet than I thought it would. I wanted to come back on groundhog's day and tell everyone that I did not see my shadow and have decided to stay. But, that did not work out.
I guess you could say "surgery takes a lot out of you."
But now let's look at the latest...
FDA Posts PAT Presentations
There's a large list of presentation done recently at the PAT Guidance Workshop at the Royal Pharmaceutical Society, December, 2004, London, U.K. These were posted yesterday. There are some really good ones by Ajaz Hussain, Vibhakar Shah, and many others.
SOTAX introduces the new Ceramic Piston Pump
"Sotax is pleased to announce the all new SOTAX CP 7 Ceramic Piston Pump. Sotax ? as a pioneer and leader in Fully Automated USP 1 & 2 Dissolution Systems and USP 4 Flow-Through Dissolution Systems ? has designed the new Sotax CP 7 pump to meet the ever changing needs of today?s dissolution test. Flow-Through Dissolution has been gaining recognition for its use in the testing of unique and novel dosage forms like implants, stents, ER suspensions, microspheres, APIs, powders, poorly soluble compounds and CR tablets and capsules."
Workshop on Chemical Metrology.
If you are in India and want to learn more about the science of Metrology, then why don't you visit the 2005 AdMet International Conference on Advances in Metrology.Feb 22, 2005. Venue: National Physical Laboratory, New Dehli, India. Further information contact: Dr. A.K. Agrawal, National Physical Laboratory, wcm@nplindia.ernet.in, tel +91 11 25734649, fax +91 11 25726938.
NIH to Ban Deals With Drug Firms
"Federal researchers will no longer be able to accept fees to consult for companies, officials say. The lucrative pacts have sparked ethics probes...more"
Move R&D to India, Kamal Nath tells drug firms (LEAD):
"India's Commerce and Industry Minister Kamal Nath has urged Western pharmaceutical firms to outsource their research and development work to India, saying such a move would net higher profits. Portraying a win-win situation for all concerned, Kamal Nath told a meeting at the Royal Institute of International Affairs (RIIA) here Monday that profitability in the 21st century will depend on the ability of pharmaceutical companies to make the technological shift necessary to maintain their competitive edge...more"
01-12-05
I will be undergoing surgery one week from today. So if you hear little for a while that is the reason.
Big Changes for Big Pharma
Fallout from Vioxx and Celebrex will create plenty of pain in the sector. Here are six trends that will alter the industry in 2005
Canadian net pharmacies wait for dotcom diagnosis
"Canada's thriving online drugs industry could be forced to swallow a bitter pill if the Government proceeds with plans to choke the sale of prescription drugs to the US...more"
Drug Companies Unveil Discount Drug Card
"A new prescription drug discount card for uninsured Americans was announced Tuesday by 10 large drug companies. The Together Rx Access Card offers discounts of 25 percent to 40 percent on more than 275 brand name prescription drugs and numerous generic drugs. The program will be offered to people who meet certain income and age requirements, the Associated Press reported...more"
Harmonizing Chapter 711
It looks like Will Brown at the USP has been busy. The United States Pharmacopeia is the coordinating pharmacopeia in the efforts toward international harmonization of the specifications provided in general test chapter 711. The Stage 5B text for general chapter 711 has been signed off by the Pharmacopeial Discussion Group members. The text presented herein represents a merger of the Stage B text and the national USP text. This combined text, which is being published in this issue of PF for information only, not for public comment, is scheduled for publication in the Second Interim Revision Announcement with a scheduled implementation date of April 1, 2006. Earlier implementation by individual companies may be done at their discretion.
Quote of the Week
"Some people drink from the fountain of knowledge, others just gargle."
01-05-05
Health Beat
"The Health Beat goes on, but under new management. Able blogger (and ace medical reporter) Carla Johnson has left for the Windy (and sometimes rainy, slushy and snowy) City."
Heather Lalley is taking over the posting duties. "Heather Lalley works as staff writer for The Spokesman-Review. In that position, Lalley is a health and fitness features writer."
Smells Like intein Spirit
Derek Lowe, who is always on the cutting edge, introduces us to the research of Iteins and their potiential use in the pharmaceutical industry.
"... inteins are sort of DNA parasites. They insert into genes and are read off into an extraneous stretch of protein in the middle of the normal gene product. But then they quickly clip themselves out of the protein - they have their own built-in cut-and-splice mechanism - and leave the originally intended protein behind them, none the worse for wear...more"
Rhode Island Welcomes your Drugs Canada
Richard from ThingsPharma notes that Rhode Island has taken a stance that they welcome Canadian Drugs with open arms...more
Toy Miscroscope a Hit with Scientists
Do you remember the first chemistry set you ever had? Did you have a telescope or binoculars? Some scientists have been impressed with a recently available microscope from Digital Blue. But Digital Blue is a toy maker not a scientific instrument company. Maybe the instrument companies can learn from this inventive toy maker?
"Andrew Westphal, an astrophysicist at the University of California at Berkeley, says he was recently able to examine some microscopic dust from outer space with the help of the RX5's plastic lens. That is because a conventional microscope's glass lens would have suffered from the hydrofluoric acid used to separate the particles from other elements. "Had it not been for the toy, we would have been at a loss," he says...more"
Qoute of the Week
"Ignorant people think it is the noise which fighting cats make that is so aggravating, but it ain't so; it is the sickening grammar that they use."
Mark Twain
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