Preliminary Program - American Association of Pharmaceutical ...

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60 2009 AAPS Annual Meeting and Exposition Physical Pharmacy and Biopharmaceutics (PPB) Programming New INTERACTIVE FEATURE for all Roundtable Sessions! Click on roundtable moderator names to submit questions that you would like to be addressed at the roundtable session in Los Angeles. Sunday, November 8, 2009 8:00 am – 4:00 pm Rational Design and Development of Solid Dispersions with Amorphous Drug for Improving Oral Bioavailability Short Course #6 An additional fee is required to attend this short course It has been estimated that over 50% of the new chemical entities (NCEs) are too insoluble for efficient oral absorption. Increasing dissolution rate and in vivo exposure of poorly soluble drugs by the use of high energy solids (e.g., amorphous state) and the application of polymer matrices for delivery purpose have been broadly employed. In recent years, there has been a large increase in the number of scientific publications and patents in this area of research. Reports in the literature have shown remarkable enhancement in dissolution rates and enhanced oral absorption of high energy solids generated by spray drying, antisolvent precipitation, and hot-melt extrusions. The advances in fundamental understanding of high energy solids as well as development of practical approaches to overcome inherent limitations with high energy solids have made the field highly attractive for pharmaceutical scientists. However, discussions on recent exploration of high energy solids and related technical challenges at national and international forums have been limited. Although some aspects of amorphous systems, solid dispersions, crystal engineering, etc., were presented in different meetings, there was no general discussion of various aspects of amorphous solids in one forum. This short course will focus on all aspects of high energy, amorphous solids and related drug product development, including generating amorphous materials via different manufacturing processes, selecting polymer to stabilize the amorphous state, making appropriate formulations intended for oral administration, characterizing and understanding solid state physical stability, applying appropriate analytical methodologies, etc. All of these aspects will profoundly influence the scientific community of formulation scientists and analytical scientists for exploration of amorphous solids and facilitating technical breakthroughs in this field. Numerous challenges exist in consistently and reproducibly generating amorphous solid materials, characterizing of amorphous solids regarding its in vitro performance, selecting and optimizing the appropriate polymeric matrices for achieving physical stability, selecting desired manufacturing process (e.g., spray drying, hot-melt extrusion, etc.) with optimal conditions, and achieving improved in vivo exposure, and developing formulation products intended for oral use. This short course will focus on all aspects of amorphous solids towards successful oral delivery of insoluble compounds. Moderators Ping Gao, Ph.D. Abbott Laboratories Jiansheng Tang, Ph.D. Mylan Pharmaceuticals, Inc. Eric Munson, Ph.D. University of Kansas Crystallization and Stabilization of Amorphous Solids Lian Yu, Ph.D. University of Wisconsin-Madison Enablement of Drug Discovery through Supersaturation and Amorphous Solids Michael J. Hageman, Ph.D. Bristol-Myers Squibb Crystallization from Amorphous Systems Lynne Taylor, Ph.D. Purdue University Assessing and Optimizing Supersaturation in Amorphous Solids and Dispersions Marcus Brewster, Ph.D. Johnson & Johnson Predicting Amorphous Drug Stability in Drug Formulations Eric Munson, Ph.D. University of Kansas Characterization of In Vitro Release Attributes of Amorphous Solids and their Relevance to In Vivo Absorption Ping Gao, Ph.D. Abbott Laboratories Turning Challenges into Opportunities: Formulation Development for Poorly Soluble Drugs — The Meltrex Approach Ulrich Westedt, Ph.D. Abbott Laboratories Enhancing Bioavailability of Low Solubility Compounds: Amorphous Dispersion Delivery Platforms David Vodak, Ph.D. Bend Research Inc. Monday, November 9, 2009 MONDAY MORNING ROUNDTABLES Funded by a Grant from 8:00 am – 10:00 am Optimization of Systemic Exposure in Preclinical and Clinical Development: “Success Stories” of Proven Methods for Challenging Drug Candidates — What You Did Not Already Know! Roundtable The identification and development of new drug candidates with a desirable systemic exposure that is both efficacious and safe in humans with “developable” formulations based on preclinical data remains a major challenge in the pharmaceutical sciences. One reason is that oral systemic exposure is determined by a variety of physicochemical and metabolic factors including drug solubility, permeability, dissolution, dosage forms, as well as, first-pass, transporter effects, and varying gastrointestinal physiology. Another reason is that multidisciplinary teams often cannot reach consensus which formulation and modeling approaches can be used with confidence to select a dosage form for first in human studies. Thus, science driven strategies to determine the systemic exposure rate limits will be presented based on new compounds and new data to correct analysis of factors controlling exposure for drugs of all BCS classes. When low exposure is seen, there can be the incorrect perception that formulation improvement works for every compound. In other cases, controlled release formulations should be attempted to optimize the PK profiles. Modeling and simulation are also meaningful tools in designing PK/formulation/ADME/TK studies, as well as, species scaling to human. Specific formulation strategies, and proven modeling approaches that can be used when facing different BCS classification compounds will be shared. In addition, the role of transporters in drug disposition with a focus on BCS Class II-IV drugs will be discussed, as well as, science-driven optimization of formulation selection studies for clinical trials and final marketing formulations. Moderators Tycho Heimbach, Ph.D., M.S. Novartis Hyo-Kyung Han, Ph.D. Chosun University
61 2009 AAPS Annual Meeting and Exposition Physical Pharmacy and Biopharmaceutics (PPB) Programming Successful Methods for Systemic Exposure Optimization: IVIVC and Proven Formulation Strategies to Predict Clinical and Preclinical Outcome for Drugs of All BCS Classes Handan He, Ph.D. Novartis Systemic Exposure and Oral Absorption Assessment of Poorly Water-soluble Drugs in the Fasted and Fed State to Predict Clinical Outcome Makoto Kataoka, Ph.D. Setsunan University BDDCS vs. BCS as an Enabling Tool in Drugs Discovery: Evolving Understandings of Disposition for BCS Class II-IV Drugs Leslie Benet, Ph.D. University of California San Francisco JOINT MEMBERSHIP MEETING AND RECEPTION 5:30 pm – 7:30 pm Physical Pharmacy and Biopharmaceutics (PPB) Section Joint Membership Meeting and Reception Tuesday, November 10, 2009 TUESDAY SUNRISE SESSIONS 7:00 am – 8:15 am Solve Your Problems in a Smarter Way: Use Design of Experiments Sunrise Session Too many variables to control in your experiments? What is the optimal set of conditions that will lead you to the desired results? The traditional approach to answer the above questions is to do experiments and evaluate the contribution of the different factors (variables), one factor at a time, while the other factors are held constant. One problem in this approach arises when there are too many factors to test. You can bypass this frustration and reach your goal by designing experiments in an intelligent way, using Design of Experiments. Design of Experiments (DOE) is a strategy to gather data from experiments in order to optimize a process, understand a phenomenon,or improve a performance. DOE consists of designing a set of ten to twenty experiments in which all relevant factors are varied in a systematic way. The analysis of the results of these experiments will help us discover the factors that most influence the results and the factors that do not, and spot patterns of interactions between factors. In other words, DOE helps to identify the optimal conditions of a process based on a few key experiments. DOE’s beauty is that it allows you to find the best answer much more quickly and has broad applications across all natural sciences. In this session, we will give the basics of DOE, discuss real-life case scenarios and learn how to organize experiments in order to get the right type and number of data to answer our questions. Moderator Maria Polikandritou-Lambros, Ph.D. Western University of Health The Basics of Experimental Design Mike Nicolaou, Ph.D. Nicopharm Pharmaceutical Solutions TUESDAY MORNING SYMPOSIA 8:30 am – 11:00 am Application of Nanoparticulate Technology in the Development of Oral Dosage Forms: Impact on Drug Product Performance Symposium Session description not available at time of publication. Moderators S. Russ Lehrman, Ph.D. Lehrman Biopharma Vijai Kumar, Ph.D. Pharmaceuticals International, Inc. Pharmaceutical Nanoparticles: Current Design Concepts and Challenges Mansoor Khan, Ph.D., M.S., R.Ph. U.S. Food and Drug Administration Oral Delivery of Poorly Water-soluble Drugs by In Situ Nanoparticle Formation Applying Microemulsion and Solid Dispersion Technologies Abu T.M. Serajuddin, Ph.D. St. John’s University Application of Nanocrystal Technology to Poorly Water Soluble Compounds Gary Liversidge, Ph.D. Elan Drug Delivery Inc. Engineering Pharmaceutical Nanoparticles Cory J. Berkland, Ph.D. University of Kansas AAPS Graduate Student Symposia and Research Achievement Awards 8:30 am – 11:00 am AAPS Graduate Student Symposium in Physical Pharmacy and Biopharmaceutics (PPB) Sponsored by During this Symposium, a presentation from the Research Achievement Award winner will be given. AAPS David Grant Research Achievement Award in Physical Pharmacy Sponsored by TUESDAY AFTERNOON ROUNDTABLES Funded by a Grant from 2:00 pm – 4:00 pm Characterization of Amorphous Pharmaceutical Solids and Solid Dispersions Roundtable Discussions on recent exploration of amorphous pharmaceutical solids and related solid dispersion technology at national and international forums have been limited. Numerous challenges exist in consistently and reproducibly generating high energy solid materials, characterizing high energy solids regarding its in vitro performance, selecting and optimizing the appropriate polymeric matrices for achieving physical stability, selecting desired manufacturing process with optimal conditions, achieving improved in vivo exposure, and developing formulation products intended for oral use. It is proposed that this roundtable will focus on key aspects of amorphous solids and related drug product development, including generating amorphous materials via different manufacturing processes, selecting polymer to stabilize the amorphous state, making appropriate formulations intended for oral administration, characterizing and understanding solid state physical stability, applying appropriate analytical methodologies, etc. This will profoundly influence the scientific community of
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