Water-Insoluble Drug Delivery - July 18-20, 2005 Philadelphia, PA

Water-Insoluble Drug Delivery
Innovative Preformulation and Formulation Approaches for Improved Delivery
July 18th - 20th, 2005
Park Hyatt at the Bellevue, Philadelphia, PA
As the advent of genomics, high-throughput screening, robotics, combinatorial chemistry, informatics, and miniaturization in the drug-discovery area, far more drug candidates than ever have been generated for development. Compounds optimized solely on the basis of receptor-based potency, which attempts to maximize the drug?s pharmacological activity, depending on the nature of the receptor, are usually hydrophobic or water insoluble. Consequently, more than 40% of newly discovered drugs or NCEs are poorly water soluble or water-insoluble. On the other hand, many currently-marketed drugs are also water-insoluble. As a matter of fact, more than one-third of the drugs listed in the United States Pharmacopoeia fall into the poorly water soluble or water insoluble categories.
While there is not a universal solubilization technique for any water-insoluble drugs, various solubilization techniques are addressed to suit for a specific need in pharmaceutical development. Solid dispersions, solid state manipulation, lipid based self-emulsifying systems, liposomes, complexation, nanocrystals/nanoparticles, polymeric micelles, and percolation techniques as well as the discussion in preformulation and biopharmaceutical aspects, impact on oral absorption, pharmacokinetic behaviors, strategies of early formulation and scalable manufacturing are among the topics in this seminar. Water-insoluble drug delivery systems developed can be incorporated into various pharmaceutical oral dosage forms such as tablets, capsules, softgel capsules, and injections depending on a particular solubilization technique used. The solubilized drugs generally improve the pharmacokinetic properties of the drugs. For example, absorption and bioavailability of the drugs can be increased. Many case studies are discussed during the two-day seminar. Specific learning points include how to:
Recognize the impacts of insolubility on drug release, absorption, and pharmacokinetics
Establish solubilization concepts/ideas
Design early formulations to support toxicology and pharmacology studies
Identify feasible solubilization systems for early development
Test the formulations in animals and humans for biopharmaceutics enhancement
Develop water-insoluble drug formulations and incorporate them into appropriate dosage forms for full development
Manufacture scalable batches
Provide quality based improved products to the marketplace
Conference Agenda:
Day 1 (July 19, 2005)
Biopharmaceutical Considerations of Water-Insoluble Drugs for Oral Drug Delivery
John Crison
Pfizer
Impact of GI Physiology on Oral Absorption
Sesha Neervannan
Amgen
Strategies in Deciphering the Pharmacokinetics of Water-Insoluble Drugs
Honghui Zhou
Centocor, Inc, Johnson & Johnson
Formulation Strategies and Practices Used for Water-Insoluble Drug Candidates at Early Phases of Drug Development
Lien-feng Huang
Johnson & Johnson
Use of Lipid-based Drug Delivery Systems to Enhance Solubilization and Bioavailability of Poorly Soluble Drugs
John Cannon
Abbott Labs
Liposomes in Solubilization
Rong (Ron) Liu
Bristol-Myers Squibb
Phospholipid Solid Dispersions: Physical Properties, Dissolution and Bioavailability
Muhammad Habib
Howard University
Amphiphilic Block Copolymer Micelles for Nanoscale Drug Delivery
Glen Kwon
University of Wisconsin
Day 2 (July 20, 2005)
Water-Insoluble Drug Delivery in Life Cycle Management
Rong (Ron) Liu
Bristol-Myers Squibb
Solubility Enhancement by Manipulation of the Solid State
Mike Joqwiakowski
3M Pharmaceuticals
Improving Delivery of Poorly Soluble Compounds by Designed Synthesis of Co-Crystalline Supramolecular Complexes
Narayan Variankaval
Merck Research Labs
NanoCrystal Technology for Poorly Water Soluble Drug Development
Christian Wertz
Elan Nanosystems
Nanosized Crystalline Drug in Dry/Polymer Systems-Synthesis, Characterization and Pharmaceutical Evaluation
Shawn Yin
Bristol-Myers Squibb
Dissolution Enhancement for Formulations Containing Salt of Poorly Soluble Compounds
Huailiang (Leon) Wu
Abbott Laboratories
Impact of Percolation Theory and Fractal Dimension on the Formulation of Low Water Soluble Drugs
Gabriele Betz
University of Basel
Scalable Manufacturing of Water-Insoluble Drug Products
Nitin Paphak
Pfizer (invited)
Conference Agenda:
Day 1 (July 19, 2005)
Biopharmaceutical Considerations of Water-Insoluble Drugs for Oral Drug Delivery
John Crison
Pfizer
Impact of GI Physiology on Oral Absorption
Sesha Neervannan
Amgen
Strategies in Deciphering the Pharmacokinetics of Water-Insoluble Drugs
Honghui Zhou
Centocor, Inc, Johnson & Johnson
Formulation Strategies and Practices Used for Water-Insoluble Drug Candidates at Early Phases of Drug Development
Lien-feng Huang
Johnson & Johnson
Use of Lipid-based Drug Delivery Systems to Enhance Solubilization and Bioavailability of Poorly Soluble Drugs
John Cannon
Abbott Labs
Liposomes in Solubilization
Rong (Ron) Liu
Bristol-Myers Squibb
Phospholipid Solid Dispersions: Physical Properties, Dissolution and Bioavailability
Muhammad Habib
Howard University
Amphiphilic Block Copolymer Micelles for Nanoscale Drug Delivery
Glen Kwon
University of Wisconsin
Day 2 (July 20, 2005)
Water-Insoluble Drug Delivery in Life Cycle Management
Rong (Ron) Liu
Bristol-Myers Squibb
Solubility Enhancement by Manipulation of the Solid State
Mike Joqwiakowski
3M Pharmaceuticals
Improving Delivery of Poorly Soluble Compounds by Designed Synthesis of Co-Crystalline Supramolecular Complexes
Narayan Variankaval
Merck Research Labs
NanoCrystal Technology for Poorly Water Soluble Drug Development
Christian Wertz
Elan Nanosystems
Nanosized Crystalline Drug in Dry/Polymer Systems-Synthesis, Characterization and Pharmaceutical Evaluation
Shawn Yin
Bristol-Myers Squibb
Dissolution Enhancement for Formulations Containing Salt of Poorly Soluble Compounds
Huailiang (Leon) Wu
Abbott Laboratories
Impact of Percolation Theory and Fractal Dimension on the Formulation of Low Water Soluble Drugs
Gabriele Betz
University of Basel
Scalable Manufacturing of Water-Insoluble Drug Products
Nitin Paphak
Pfizer (invited)