Please tell us about your background and what you’re currently working on.
I am a professor of industrial pharmacy at St. John's University, where I joined 10 years ago. Before that, I worked for 30 years in the pharmaceutical industry. At St. John's, we are building an innovation center in pharmaceutical technology. We are involved with double upping new drug delivery systems, as well as a new processing agreement. In addition, we are focussing on personalized medications.
What is “personalized medicine” and why is it important?
In personalized medicines, we take people as individuals. All human beings have different combinations of systems in our body. I am different from another person, therefore, for example, I may have a different need for my medication or need a certain dose or certain types, compared to another person. Personalized medication allows us to individualize the medication to the needs of the patient and the genetic structures of that person, as well as their health condition.
Current conventional medication is very different. For example, if you have a 100 mg tablet, you have to dispense a 100 mg tablet to the patient, even if you need another dose. You may have varying quantities such as 100 mg, 50 mg or 25 mg, and that is what you are limited to. If you need 75 mg, you cannot provide that and therefore this is a big challenge with the current system. In addition to this, all doses for all medicine don't fit all patients, and so you need to individualize medication.
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Pharmaceutical companies are now using personalized medication in clinical research. In research a person may not respond to a certain medication or certain dose or they may experience a toxic affect with a certain dose, so in that case, you have to possibly formulate a different dose or different drug delivery system for that system. This means that you could not continuously do the clinical research, you have to double up the dose response that will create a lag time. Also, if you think about being in a pharmacy, if a person, for example, needs 5 mg but you have only 25 mg, you cannot dispense only 5 mg.
How can 3D printing advance personalized medicine?
If you are making medication individualized, it is possible to use 3D printing to print the exact dose that's needed for a patient. In clinical research, this will accelerate the whole process because if a patient doesn't respond to a certain dose, you can try giving another dose and make it immediately. This is a huge benefit of individualized medications.
At St. John's, we have started working on additive manufacturing by fused diffusion modelling. We have the complete line of facilities here and we use a hot melt extruder for making the filaments, and then we use them for 3D printing. Before we create the filaments, we have to select the polymers. There are many polymers available in the market, but most of them are not suitable for pharmaceutical use, therefore, we have to select the right polymers to use. If you make 3D printer tablets, you might have a polymer that dissolves very slowly. However, we have to identify polymers that dissolve fast, because most of the drugs need to act immediately.
Therefore, we have to select the polymers that don't extrude well. We characterize their glass transition temperatures i.e. the point at which the polymer becomes soft. Then, using our facilities, carry out the glass transition temperature. We also identify the viscosity of those materials so that it can be extruded through the extruder. In addition, we need a certain viscosity for them to be printed. Then, for the purpose of printing, there needs to be a certain flexibility on those filaments, therefore it is important to measure the flexibility of the filaments. This is some of the work that is going on in my lab.
This sort of manufacturing pharmaceutical process in the future will impact clinical research of individualized medication, allowing the process to move more quickly, because you don't have to wait to prepare different doses of drugs. And then, once you have it, you don't have to limit yourself to certain doses. For example, you'll give your filaments to the pharmacies that can print the medications with the dose that the patient needs. The technology is progressing so rapidly that in the future, the pharmacies will be able to print their tablets in the pharmacy.
How are medications going to be prescribed for a patient?
This is something that needs to be addressed, because there is a big forecast on individualized medication in this country. For example now, you look at the opiate crisis, which illustrated that different people have different incentives. What would happen in the future is if your person needs a small dose, that person will get the dose.
If the person needs a bigger dose, that can be also printed. You can also change all the polymers in your formulation in such a way that makes them abuse resistant e.g., you can use a polymer where your materials cannot be ground, so that the people cannot take powder and sniff it; or you can you take a polymer that cannot be dissolved in alcohol and drunk; or even choose a polymer that is so viscous, people cannot dissolve it in a small amount of water and inject it. You can make all of these things by using this technology, I should however mention that we added endless days of research in this area, and in the future I am seeing even more progress.
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Do you think in the future that all tablet medicines will be using this technique?
It depends whether all tablets can be manufactured this way, for example, tablet manufacturing in the pharmaceutical industry now is very much well doubled up and you can make millions of tablets in a day. Therefore, it could not possibly replace all tablet manufacturing, because they're available and everyone may not need the individualized medication. Some patients take medications for chronic conditions and require long term use, they will already know what dose to take on a daily basis, and so don't need individualized medication.
This will have an impact in clinical research, when you don't know the generic components of a person, a physician can look at the genomic structure and can prescribe a certain dose, and that dose can be taken by the person, so it is individualized. That can have a big impact, but at this time it's difficult to say whether it will replace all the tablet manufacturing that we have now.
What are the challenges you're still facing in making this a reality?
The challenges we are currently facing is the identification of the polymers. There are some polymers available in the market, being used for 3D printing purposes, for example making models of different cars, but most of those polymers are not useful for pharmaceutical use, and don't dissolve in water. We are looking for water-soluble polymers, and currently, many polymers dissolve slowly in water, so the drug is released over six to eight hours. We are looking for drugs that can be released in half an hour, 15 minutes or less than an hour.
We need new polymers that are available for pharmaceutical use, and that are water-soluble, as well as polymers or polymer combinations that are flexible enough that we can print them in a 3D printer. Additionally, in my group, we are trying to double up polymers or polymer systems, that do not need high temperatures for printing purposes.
Many of the publications in the current research literature, the printing is done around 200 degrees. But we are trying to double up polymers or combinations that can be printed at a much lower temperature, for example 100 degrees, or even less.
One other area that we are looking is to take some polymers, for example I gave you the example of opioid crisis, we are looking for polymers that dissolve in water but cannot be crushed, cannot be dissolved in alcohol for abusing purposes. So these are some of the challenges. In addition, we are looking for assistance where we can make this whole process much faster. This, we cannot do in a pharmaceutical lab alone, and we have to work with the equipment manufacturers. What I am hoping is that if we can make progress in the laboratory, and if the equipment manufacturers think that this is really useful, this has a big future, and involve coming up with newer equipment.
There are many 3D printers that are available, not for pharmaceutical but for other purposes. We can build on these other printers for the pharmaceutical field. 3D printing has doubled up in the last few years, the primary reason that all this progress has been made, is because we have a melt extruder. For all companies, melt extruder are available in the pharmaceutical field, and by using a melt extruder, and so we can make the filaments. We can make the formulations by using different drafts and different polymers and those we extrude through the extruder, we can get the filaments and then clean them before use.
If you don't have the melt extruder, it cannot be possible to 3D print. This is the most commonly used equipment in the pharmaceutical field for 3D printing, and is critically important. My belief is that there are other similar technologies that are available for 3D printing, nowadays diffuse disposition modelling is the one that is mostly used, and the melt extruder is the key component in the whole process.
About Professor Abu Serajuddin
Abu Serajuddin, Ph.D, joined St. John’s University in September 2008 as Professor of Industrial Pharmacy after working for over three decades in the pharmaceutical industry in scientific and managerial positions.
Prior to joining Novartis, he worked for 12 years in Bristol-Myers Squibb and 10 years in Sanofi-Aventis (through mergers). In 2005, Novartis named him Novartis Leading Scientist, a top honor bestowed by the company, for extraordinary contribution to the development and growth of the company through scientific excellence. He received the Bristol-Myers Squibb President's Award for unprecedented 3 times (1996-1998) for his contribution and leadership in solving difficult issues in drug development.
Dr. Serajuddin is internationally recognized for his contribution to pharmaceutical sciences, especially in (a) the development of drug delivery systems for poorly water-soluble drugs, (b) formulation design and development, and (c) pharmaceutical processing. Additionally, he received two of the highest awards given by the American Association of Pharmaceutical Scientists (AAPS). He also serves in the Editorial Advisory Boards of Journal of Pharmaceutical Sciences and Journal of Excipients and Food Chemicals.