Transcript Bioavailability of Dietary Supplements: Key Issues in

Bioavailability of Dietary
Supplements: Key Issues in
Defining the Research Agenda
Impact of Formulation on
Bioavailability?
Discussion Leader:
Stephen W. Hoag Ph.D.
University of Maryland
Rapporteur:
Ajaz S. Hussain, Ph.D.
CDER, FDA
Preface
 Introductions
 Background
– Pharmaceutical Sciences
– Nutritional Sciences
– Nutraceuitical Sciences
– Pharmaceutical formulations, bioavailability
and bioequivalence
– Food and Dietary Supplements – formulations,
bioavailability, and bioequivalence
Questions for considerations
 Key issues in defining the research agenda?
– What is the question?
• Do two different pharmaceutical products containing the same
drug provide the same “safety” and “efficacy” profile?
– What are we willing to assume?
• Drug concentration time profile in plasma is a reliable
surrogate for safety and efficacy profile
– How sure do we want to be?
• The 90% confidence interval of the ratio of the peak
concentration of drug in plasma, time to reach the peak
concentration, and the area under the curve are within 80125%
Key Topics Discussed
 Product Classification System
 Identification of “Critical Variables”
– Interactions
– Modulation of Bioavailability
– In vitro methods for assessing dissolution &
absorption
– Product Comparison
– Optimal Product Use
Goals and Objectives
 Improving Public Health
– Better products
– Safety
 Enhance Scientific Knowledge
 Develop General Methods for:
– Formulation
– Testing
 Define Quality Standards
 Prioritization
– Health Issues
– Market Prevalence
Identification of “Critical
Formulation Variables”
 For a given class
– Critical Process and formulation variables that
significantly impact
• Bioavaiable
• Stability
 General strategies and/or methods need to be
developed for formulation optimization of
nutritional supplements
 Data for Public Domain use
– Improve quality and safety through better practices
In vitro methods for assessing
dissolution & Absorption
 USP Dissolution
 Caco2
 Etc.
Product Comparison
 “Bioequivalence”
 Comparison of bioavailability of different
product types (including food)
– Information for consumers and clinicians
 Example
– Natural vs. synthetic
• Ca supplements
– Units of activity measurement