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The ways in which chemicals or drugs are administered have gained increasing attention in the past two decades. Normally, a chemical is administered in a high dose at a given time only to have to repeat that dose several hours or days later. This is not economical and sometimes results in damaging side effects. As a consequence, increasing attention has been focused on methods of giving drugs continually for prolonged time periods and in a controlled fashion. The primary method of accomplishing this controlled release has been through incorporating the chemicals within polymers. This technology now spans many fields and includes pharmaceutical, food and agricultural applications, pesticides, cosmetics, and household products.
In the pharmaceutical field, in addition to polymers, an understanding of the physiological barriers in the human body is also critical to developing appropriate controlled release systems. The skin, the gastrointestinal tract, the nose, and the eye are of particular importance. Finally, recent advances in genetic engineering have spawned numerous new polypeptide agents and DNA and siRNA. Approaches for delivering and stabilizing these molecules will be discussed.
The lectures will be presented by faculty members at MIT and other universities who are leaders in the fields. The lectures are intended to review the recent advances in the art and science of controlled release technology and to assess the prospects and directions of future developments.
Takeaways from this course include:
- Understanding controlled release of small molecules, polypeptides, and proteins
- Understanding stabilization of proteins and peptides
- Identifying approaches for delivering small molecular weight drugs and polypeptides via the oral delivery route
- Examining approaches for development of bioadhesive systems
- Comprehending transdermal drug delivery systems
- Investigating strategies for nasal and pulmonary drug delivery
- Modelling strategies for drug delivery to the brain and crossing the blood-brain barrier
- Evaluate ocular drug delivery
- Recognize important factors related to drug delivery applications in pesticides and agriculture
- Examine methods of fabrication technology related to polymer-drug formulations
- Investigating factors affecting toxicology and regulatory considerations and approvals
- Comprehending polymer technology
Who should attend:
The program is designed for chemists, chemical engineers, pharmaceutical scientists, and technical managers with an interest in controlled release technology. Scientists in other fields such as food, agricultural, etc., may also benefit from this course.
Laptops are encouraged but not required; lecture materials will be projected on a large screen and provided on a USB stick for those who wish to follow along on their laptops. Tablets will not be sufficient for the computing activities in this course.
The program will consist of lectures and discussion periods devoted to topics representing the areas of active research. The presentations will concentrate on principles and illustrative examples. Laboratory instruction in specific techniques will be provided. The topics to be discussed will include:
Fundamental Principles of Controlled Drug Release
Advantages and disadvantages of controlled release technology as compared to conventional drug delivery; systems for achieving controlled drug release including membrane encapsulated reservoir devices, bioerodible polymers, matrix systems, polymers containing pendant drug substituents, and osmotic systems; new developments in controlled release technology.
Consideration of factors essential to the controlled release of drugs in humans; approaches for achieving zero release kinetics; development of systems with pulsatile release patterns, including approaches for self-regulated delivery involving enzymes and antibodies.
Controlled Release of Small Molecules, Polypeptides, and Proteins, and DNA and siRNA
Many new polypeptides are now being produced by genetic engineering. New drugs based on siRNA and DNA are being developed. Approaches for delivering these large molecules will be discussed.
Stabilization of Proteins & Peptides
One of the additional problems in delivering peptides is their loss of activity or the occurrence of aggregation due to hydrolytic, thermal, or other effects. Understanding and preventing these phenomena will be discussed.
The latest advances and approaches for delivering small molecular weight drugs and polypeptides through this route will be discussed.
Approaches for developing bioadhesive systems will be discussed.
Transdermal Delivery Systems
The skin is an important barrier to controlled drug delivery. Approaches for delivering drugs throughout the skin as well as recent advances in iontophoresis, ultrasound, chemical enhancers, and chemical treatment of drugs for transdermal delivery will be discussed.
Pulmonary and Nasal Delivery
The lung and nose are attractive routes for delivering large molecules such as proteins. Strategies for nasal and pulmonary delivery will be discussed.
Delivery to the Brain
In many cases, it is desirable to cross the blood-brain carrier. Strategies for accomplishing this goal and experimental approaches to test it will be discussed.
Approaches for delivering drugs via the eyes will be discussed.
Other Delivery Routes
Buccal, rectal, and other delivery routes will also be discussed.
Applications in Pesticides and Agriculture
Consideration of factors essential to effectively design controlled release preparations for pesticides, livestock, herbicides, fertilizers, and crop protection.
The effect of fabrication parameters on the design and performance of controlled release preparations; methods for effectively preparing polymer-drug formulations and polymer membranes; examples of fabrication.
Factors affecting the toxicology of controlled release systems and test for regulatory approval will be discussed. Case studies will be examined.
Polymer synthesis, structure, morphology, crystalline and amorphous polymers, glassy vs. rubbery state, polymer networks, membranes, mechanical properties, and processing as they relate to the design of effective controlled release formulations.
Diffusion of Drugs in Polymers
Diffusion of drugs through rubbery and glassy states; mathematical considerations and their use in effectively designing polymer-drug formulations.
New methods for producing liposomes, strategies for using liposomes to target drugs to specific cells or organs, and clinical trials with liposomes.
Methods of microencapsulation including coacervation, phase separation, polymerization, spray-drying, electrostatic methods, and air suspension approaches.
Class runs 8:30 am - 4:45 pm on Monday, 8:15 am - 5:00 pm on Tuesday, 8:15 am - 5:45 pm on Wednesday, 8:15 am - 3:30 pm on Thursday, and 8:15 am - 11:45 am on Friday.
Special events include a networking luncheon on Monday for course participants and faculty and a lab demonstration on Wednesday (attire required for the lab demonstrations: long pants, closed-toe shoes; no shorts, no sandals). All activities are included in tuition.
RESEARCH SCIENTIST, BAUSCH & LOMB
"It was an excellent experience. The course is well organized and rich in knowledge. The speakers are great. It is also a good opportunity for networking."
DELIVERY DEVICE ENGINEER, GENENTECH
"This course was an absolutely perfect fit for me - I had the fundamental technical background to understand the material, but I had never had any formal courses in drug delivery technology. This was a great first course as a survey of the field. I am now hugely more interested in the field as a result of this course."
"The course I took was one of the best. Great place to learn and cutting-edge technologies."
SENIOR REVIEW CHEMIST, FOOD AND DRUG ADMINISTRATION
"Excellent. Far and beyond my expectation. I had expected that the course material will be outstanding; however, I had not expected that it'll be presented in such a pleasant manner. I also had not expected that I'll have such a great time on-campus and off-campus in the Cambridge general area."
EXECUTIVE DIRECTOR, CATALENT PHARMA SOLUTIONS
"Dr. Langer and Peppas shared key topics that are cutting-edge and could be of interest to other scientists in a future complimentary learning venue to encourage the application and adoption of new technologies."
PRINCIPAL ENGINEER, CSIR
"I have already started a new project from the learning I've gained from the course."
Professor Robert Langer is one of 13 Institute Professors (the highest honor awarded to a faculty member) at the Massachusetts Institute of Technology. Langer has written approximately 1,000 articles. He also has more than 600 issued or pending patents worldwide. Langer’s patents have been licensed or sublicensed to over 200 pharmaceutical, chemical, biotechnology, and medical device companies. He served as a member of the United States Food and Drug Administration’s SCIENCE Board, the FDA’s highest advisory board, from 1995-2002 and as its Chairman from 1999-2002. Langer has received over 160 major awards including the 2006 United States National Medal of Science; the Charles Stark Draper Prize, considered the equivalent of the Nobel Prize for engineers, and the 2008 Millennium Technology Prize, the world’s largest technology prize. He is the also the only engineer to receive the Gairdner Foundation International Award; 70 recipients of this award have subsequently received a Nobel Prize. Among numerous other awards Langer has received are the Dickson Prize for Science (2002); Heinz Award for Technology, Economy and Employment (2003); the Harvey Prize (2003); the John Fritz Award (2003) (given previously to inventors such as Thomas Edison and Orville Wright), the General Motors Kettering Prize for Cancer Research (2004); the Dan David Prize in Materials Science (2005); the Albany Medical Center Prize in Medicine and Biomedical Research (2005) the largest prize in the U.S. for medical research; induction into the National Inventors Hall of Fame (2006); the Max Planck Research Award (2008); and the Prince of Asturias Award for Technical and Scientific Research (2008). In 1998, he received the Lemelson-MIT prize, the world’s largest prize for invention, for being “one of history’s most prolific inventors in medicine.” In 1989 Langer was elected to the Institute of Medicine of the National Academy of Sciences, and in 1992 he was elected to both the National Academy of Engineering and to the National Academy of Sciences. He is one of very few people ever elected to all three United States National Academies and the youngest in history (at age 43) to ever receive this distinction.
Dr. Alexander M. Klibanov, is the Novartis Endowed Chair Professor of Chemistry and Bioengineering at the Massachusetts Institute of Technology. His current research interests include medicinal chemistry, new antimicrobial materials; enzyme chemistry and biotechnology; and pharmaceutical formulations. He has authored over 310 scientific papers and 21 issued U.S. patents (plus many pending), has given over 370 invited lectures, including many named ones, all over the world, and is on 12 journal editorial boards. Dr. Klibanov has received numerous prestigious professional awards, including the Leo Friend Award, the Ipatieff Prize, the Marvin J. Johnson Award, and the Arthur C. Cope Scholar Award, all from the American Chemical Society, as well as the International Enzyme Engineering Prize. He was elected to both the National Academy of Sciences and to the National Academy of Engineering of the United States. Dr. Klibanov has started six pharmaceutical companies and has been a scientific advisor, consultant, and/or director for numerous pharmaceutical, medical device, and biotechnology companies, as well as for law firms in pharmaceutical patent litigations.
Dr. Nicholas A. Peppas, Fletcher S. Pratt Chair of Chemical Engineering, Biomedical Engineering and Pharmaceutics at the University of Texas at Austin.
Dr. Frank Szoka is a Professor of Bioengineering, Therapeutic Science & Pharmaceutical Chemistry at the University of California School of Pharmacy in San Francisco. The principle focus of his research group is to exploit chemical, biophysical and physiological principles to devise vaccine, drug and nucleic acid delivery systems. In addition to his University commitments, Dr. Szoka is a founder of Sequus Pharmaceuticals, Inc. owned by Johnson & Johnson, GeneMedicine, inc. and ZoneOne Pharma, Inc. Sequus introduced the sterically stabilized liposome (Doxil™, Caelyx™) for anti-cancer drug delivery. ZoneOne Pharma, Inc. is developing liposome therapies to treat iron overload that occurs as a sequelae to sickle cell anemia and thalassemia.
This course takes place on the MIT campus in Cambridge, Massachusetts. We can also offer this course for groups of employees at your location. Please complete the Custom Programs request form for further details.
|Fundamentals: Core concepts, understandings, and tools (40%)||40|
|Latest Developments: Recent advances and future trends (30%)||30|
|Industry Applications: Linking theory and real-world (30%)||30|
|Lecture: Delivery of material in a lecture format (90%)||95|
|Labs: Demonstrations, experiments, simulations (10%)||5|
|Introductory: Appropriate for a general audience (20%)||20|
|Specialized: Assumes experience in practice area or field (40%)||40|
|Advanced: In-depth explorations at the graduate level (40%)||40|