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Q 1) If you had to explain your fields of delivery systems and formulation design to a 4th grade science class, what would you say?
A) “What we do in delivery and formulation design is to take a drug and formulate it together with other components so that it can be administered to the patient. For example, let’s say you have a headache. We know that certain drugs can alleviate this pain caused and, therefore, get rid of your headache. So, our field is the science behind taking these drugs that can alleviate the pain and formulating them with other ingredients into a medicine that a patient can take. Medicines are therefore the drug plus a whole bunch of different ingredients that are required to formulate the drug into a usable form, such as a tablet, capsule, patch, liquid formulation or injection, that alleviate a medical condition or disease state.”
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Q 2) What is the overall goal of your field?
A) “The overall goal is to formulate drugs into medicines that improve drug therapy. Many drugs that are coming into the market are very hard to formulate into medicines for the body because they have inherent delivery system problems. For example, we can’t take them orally because enzymes and pH levels might break them down in the stomach. Some of these new drugs are very large macromolecules that can’t be absorbed through the membranes that are present in the stomach. This poses a major challenge since all oral drugs need to go through this membrane in order to get access into the bloodstream to be circulated to their sites of action in the body. In order for us to overcome these barriers and continue to improve drug therapies, we need to develop techniques other than oral types of delivery for medicines. Scientists in my field work on alternative drug delivery methods—we look at ways the drug travels directly through the skin, is delivered through the lungs, or enters the body via injection.
We are also looking into very exciting ways of delivering drugs as extended release medications, so patients wouldn’t need to take a tablet or an injection every day. In this area, we are exploring formulations that can be injected into the body where they are released over an extended period of time, ranging from weeks to several months.
Another great issue facing us right now is the genomic revolution and our recent ability to map the whole human gene. We want to turn this incredible knowledge into practical medical uses for the health and wellness of the global population. This is a very challenging area, but with incredible growth potential. As mentioned earlier, oral delivery of large macromolecules into the body is very difficult. Molecules that are made up of DNA, or derivates of DNA, face that problem. In addition, these molecules have their actions inside the cells in the body, so not only do we have to deliver the drug into the body, but then we need to get them into the cell nucleus. The body has been designed to protect our genetic material to not let that type of cell invasion happen, so you can imagine how huge the challenges are that are facing us today.”
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Q 3) What are some of the landmark achievements in delivery systems and formulation design to this date?
A) “The formulation of insulin was a landmark achievement. In the 1960's scientists in this field finally succeeded in creating insulin formulations for injections. At that time, animal insulin was developed as the first effective treatment for diabetes, which was a huge step in formulation design. More recently, a major success is the ability to admit drugs into the body via transdermal delivery systems, such as patches. Patches are now widely used for smoking cessation and hormone replacement, for example. Delivering drugs through the skin has been a big achievement, since it allows us to bypass the stomach, gastrointestinal track and liver, and therefore enables us to work on those important molecules that do not fair well via oral delivery. This delivery route also lends itself to long-term controlled release of drugs.”
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Q 4) What is a typical day for a delivery systems and formulation design scientist look like?
A) “I am academic so my day consists of a lot of teaching. I spend a large part of my day advising my graduate students that are working on different formulations for different drugs and dosage forms. Also, I teach my undergraduate pharmacy students about formulations, since they will be on the forefront dispensing the medicines to the public when they become pharmacists. They need to understand the medicine so that they can advise their patients on their uses and any special considerations. In addition, I do some lab work myself in conjunction with my students. Also as the past-president of the American Association of Pharmaceutical Scientists, I continue to be quite involved with that organization.
A typical day for a formulation design scientist working in the industry may be quite different from mine. They might be at a technical level where they would be at the laboratory bench all day. But today, even the bench scientist spends a large part of their day at the computer analyzing data. For example, they would be given a project from their manager to make a new formulation of, for example, aspirin. They may be told they are to develop a delivery system of aspirin that dissolves under the tongue, to avoid some of the negative side affects that aspirin may have on the stomach.
As a first step, the scientist would research what has been done before by looking up articles that have been published. Based on previous research, they would decide which components they would want to put into that delivery system to assist solubility of the drug under the tongue. They would then go about ordering those different ingredients if they didn’t have them.
Next they would start to make up a formulation based on their previous experience on similar formulation and what they found in their literature searches. This is a little bit like cooking. Let’s say you want to make biscuits. You might look at one cookbook and you don’t really like the way that one is written so you look at two or three and you decide which formulation for the biscuits looks most appealing to you based on your previous cooking experience. That is what this scientist does. Then, once they had their formulation, they would have to test to see if it would release under those conditions. They would simulate the conditions that were found under the tongue in a beaker, incorporating all the different factors of the saliva such as pH levels, etc.
Once it works in the beaker, they would move on to animal testing, then human testing in order to bring the new drug delivery method to the market place. The manager of such a scientist would spend most of their time in their office monitoring the progress of the formulation scientist and the available market potential for a new drug design, as well as strategic planning for the company which would involved attending a lot of meetings.”
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Q 5) What part of your job do you like best?
A) “Teaching the graduate students is very rewarding--it’s nice to see how far they have come during their five or so years of graduate study. Between the day they walked in to the school to the day were they walk out with Ph.D. to their name, you see such a metamorphosis in these people. It is a wonderful thing to watch and be a part of.”
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Q 5b) What is the most challenging?
A) “Writing the grant applications is probably the most challenging. I write these huge grant applications to NIH and other agencies. The process is exhausting--you probably spend a month writing during which you get hardly any sleep, maybe two to four hours a night. At the end though, if your grant does get funded, it is extremely rewarding, so it’s worth it.”
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Q 6) What achievement at work are you most proud of?
A) “That is hard--I have had a few. Being asked to run for AAPS President and then to be the winning candidate was great. I was absolutely flabbergasted to be asked at such an early age. I thought they were just kidding! I am also proud of achieving my Ph.D., getting my tenure at University of Illinois and being promoted to full professor here in Connecticut. These are all big achievements I was able to make at fairly young age. I think I can be proud of that.”
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Q 7) What type of educational background does your field require?
A) “You can enter into delivery systems and formulation design at a number of levels, even at the B.S. level. A B.S. in pharmacy, chemistry, chemical engineering or biology would allow you to enter into the pharmaceutical industry to work on different aspects of pharmaceutical science. Particularly in the drug delivery formulation area, a B.S. or masters degree in chemical engineering or chemistry will definitely allow you to work at a bench level. There is not too much of a distinction between B.S. and M.S. in terms of bench level science. Where there is a big distinction is someone coming in at the Ph.D. level, especially if it is in pharmaceutical science formulation or pharmacokentics. Then you enter at a manager level.”
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Q 8) How would you direct someone into your line of work? (Any tips to help them get their foot in the door?)
A) “Someone who is working on getting their B.S. in chemistry and would like to get into formulation science might look to see if there is a pharmacy department in their university or if there is a professor that they could work with in the summer to do a project in formulation design. If that was not available, then take a look at programs offered by drug companies. Many have summer internships for students in pharmacy, chemical engineering, chemistry and biology.”
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Q 9) Is there anything you wish you would have known about your field prior to choosing it as your career?
A) “I didn’t know how time intensive this job can be. It’s a major commitment. But, the fact that I work so many hours is a testament of how interesting this field is. I wouldn’t work this hard if it wasn’t something I really, really enjoyed.”
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