ODD2009: Strategies for Oral Drug Delivery


Presented By

The Drug Delivery Foundation, Ann Arbor, MI

Location

Garmisch-Partenkirchen, Germany

Topics Covered

  • GI Physiological Variables and Drug Absorption
  • Dissolution and Oral Absorption Evaluation
  • Intestinal and Hepatic Transport and Metabolism
  • Oral Delivery Systems: Formulation and Regulatory Standards
  • Biopharmaceutics: From Discovery to Regulation

Speakers

  • Gordon L. Amidon, United States
  • Peter Langguth, Germany
  • Hans Lennernas, Sweden
  • James Polli, United States
  • Shinji Yamashita, Japan

Agenda

SUNDAY. Registration

  • 06:00-07:00pm: Registration
  • 07:00-09:00pm: Reception, Faculty

MONDAY. GI Physiological Variables & Drug Absorption

  • 07:30-08:30am: Breakfast
  • 08:30-09:20am: Oral Drug Delivery: A Mechanistic Approach, Amidon
  • 09:20-10:30am: Gastrointestinal Physiological Variables, Bermejo
  • 10:30-10:50am: Break
  • 10:50am-12:00pm: GI Permeability and Transit: Oral Fraction Absorbed, Amidon
  • 12:00-01:30pm: Lunch
  • 01:30-02:20pm: Mechanisms of Intestinal Membrane Permeation, Lennernas
  • 02:20-03:10pm: Fraction Dose Absorbed: Soluble and Insoluble Drugs, BCS, Amidon
  • 03:10-03:30pm: Break
  • 03:30-04:20pm: Cellular/Molecular Mechanisms of Transport Across Epithelium, KD Lee
  • 04:20-05:00pm: Panel Discussions, Amidon, Bermejo, Lennernas, Lee

TUESDAY. Methods for Evaluation of Oral Drug Absorption

  • 07:00-08:00am: Breakfast
  • 08:00-08:50am: Overview - Permeability Methods from In Vitro to In Vivo human, Lennernas
  • 08:50-09:40am: Cell Culture Methods and Permeability, Polli
  • 09:40-10:30am: In Vitro Approaches to Drug Absorption Screening, Yamashita
  • 10:30-10:45am: Break
  • 10:45-11:35am: Biophysical Predictive Absorption Models & Applications, Bermejo
  • 11:35-12:25am: Development of BCS Class 2 to 4 Compounds – Recommendations and Experiences from a Company Consortium, Yamashita
  • 12:30-02:00pm: Lunch
  • 02:00-02:50pm: In vivo Dissolution and IVIVC, Cook        
  • 02:50-03:40pm: Analysis of Drug Absorption from PK Studies, Langguth
  • 03:40-04:00pm: Break
  • 04:00-04:45pm: Dissolution of Water Insoluble Drugs: Ex Vivo Fluids, Abrahamsson
  • 04:45-05:30pm: Panel Discussion, Abrahamsson, Cook, Langguth, Yamashita, Bermejo, Lennernas

WEDNESDAY. Intestinal and Hepatic Transport and Metabolism

  • 07:30-08:30am: Breakfast 
  • 08:30-09:20am: Role of Transporters in Drug Absorption, Tamai
  • 09:20-10:10am: Liver Transport: Uptake and Excretion, Lennernas
  • 10:10–10:30am: Break
  • 10:30-11:15am: Access Path to the Site of Action: Predictability and Relevance Of Apparent Transporter Affinities, Spahn-Langguth
  • 11:15–12:00pm: Simulation of the Non-linear Dose Dependence for Substrates of Influx and Efflux Transporters in the Human Small Intestine, Bolger
  • 12:00pm: Lunch (Box Lunch)
  • **Wednesday Afternoon Free** 
  • 07:00-10:00pm: Computational Approaches: In Silico Predictions of Drug Absorption and Bioavailability & Computer Demonstrations – software provided – please bring laptops    
  • The “Bottom-Up” Approach to Predicting Population PK - Simcyp, Tucker
  • Computer Simulations: GastroPlus, Woltosz
  • Computer Simulations: PK-Sim, Willmann

THURSDAY. Oral Delivery Systems: Formulation & Regulatory Standards

  • 07:30-08:30am: Breakfast
  • 08:30-09:20am: Nanoparticles of Poorly Soluble Drugs, Lindfors
  • 09:20-10:10am: Formulation Approaches for Water Insoluble Drugs, Langguth
  • 10:10-10:30am: Break
  • 10:30–11:20am: Regulatory Assessment of Pharmaceutical Quality, Yu
  • 11:20-12:10pm: The 100 mg Approach – Maximizing Information in Early Development, TBA
  • 12:10-01:30pm: Lunch
  • 01:30-02:20pm: Dissolution Absorption and IVIVC, Polli
  • 02:20-03:10pm: Prodrug Approaches to Enhancing Absorption, Tamai
  • 03:10-03:25pm: Break
  • Oral Delivery Challenges
  • 03:25-04:05pm: Enhancement of Oral Absorption of Polar Drugs, Hilfinger
  • 04:05-04:45pm: Mucosal Immune Systems and Vaccine Delivery, KD Lee
  • 04:45-05:30pm: Panel Discussions, Polli, Lindfors, Langguth, Lee, Hilfinger, Yu, Tamai
  • 06:30-10:00pm: Dinner and Social Event

FRIDAY. Biopharmaceutics: From Discovery to Regulation

  • 07:30-08:30pm: Breakfast
  • 08:30-09:40am: Formulations Development BA/BE: An Industrial Perspective, Cook      
  • 09:40-10:30am: BE Requirements: Regulatory Assessment, Yu
  • 10:30-11:00am: Biopharmaceutics: Discovery, Development, Regulation, Amidon