Short Programs
Controlled Release Technology: Polymeric Delivery Systems for Pharmaceuticals, Proteins, and Other Agents [20.02s]
Date: July 19-23, 2010 | Tuition: $3,150
Overview | Learning Objectives | Outline of the Program | Teaching Faculty | Updates
Overview
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 the importance of 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, in morning and afternoon sessions, will be presented by faculty members at MIT and other universities who are leaders in the topics to be covered. 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. 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.
Fundamentals: Core concepts, understandings and tools (30%)
Latest Developments: Recent advances and future trends (30%)
Industry Applications: Linking theory and real-world (40%)
Lecture: Delivery of material in a lecture format (85%)
Discussion or Groupwork: Participatory learning (10%)
Labs: Demonstrations, experiments, simulations (5%)
Introductory: Appropriate for a general audience (25%)
Specialized: Assumes experience in practice area or field (25%)
Advanced: In-depth explorations at the graduate level (50%)
Learning Objectives
- Explain controlled release of small molecules, polypeptides, and proteins
- Understand stabilization of proteins and peptides
- Identify approaches for delivering small molecular weight drugs and polypeptides via the oral delivery route
- Examine approaches for development of bioadhesive systems
- Comprehend transdermal drug delivery systems
- Investigate strategies for nasal and pulmonary drug delivery
- Model 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
- Investigate factors affecting toxicology and regulatory considerations and approvals
- Comprehend polymer technology
- Understand diffusion of drugs in polymers
- Evaluate strategies for using liposomes to target drugs to specific cells and organs
- Model methods of microencapsulation
- DNA and siRNA delivery
Outline of the Program
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.
Pharmaceutical Applications
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.
Oral Delivery
The latest advances and approaches for delivering small molecular weight drugs and polypeptides through this route will be discussed.
Bioadhesives
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.
Ocular Delivery
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.
Fabrication Technology
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.
Regulatory Considerations
Factors affecting the toxicology of controlled release systems and test for regulatory approval will be discussed. Case studies will be examined.
Polymer Technology
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.
Liposomes
New methods for producing liposomes, strategies for using liposomes to target drugs to specific cells or organs, clinical trials with liposomes.
Microencapsulation
Methods of microencapsulation including coacervation, phase separation, polymerization, spray-drying, electrostatic methods, and air suspension approaches.
Teaching Faculty
Dr. Robert Langer, Program Director
Professor Langer is one of 13 Institute Professors (the highest honor awarded to a faculty member) at the Massachusetts Institute of Technology (MIT). Dr. Langer has written approximately 1,000 articles. He also has more than 600 issued or pending patents worldwide. Dr. 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. Dr. 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 (click here to read the article), 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 Dr. 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 Klibanov, Professor of Chemistry at MIT.
Dr. Frank W. Harris, Professor of Polymer Science at the University of Akron's Polymer Institute.
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, Professor for the College of Pharmacy at the University of California, San Francisco.
Updates
Robert Langer is a Chairman of the 10th US-Japan Symposium on Drug Delivery Systems being held December 16-20, 2009. For more information, visit the Langer Lab website.
