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45 - PHR - Pharmaceutical Sciences

PHR 102 - Dissolution Testing: Importance and Principles

Code Start Date Duration Venue
PHR 102 16 October 2023 5 Days Istanbul Registration Form Link
PHR 102 11 December 2023 5 Days Istanbul Registration Form Link
Please contact us for fees


Course Description

Dissolution testing poses a major challenge to the pharmaceutical, biotech and generics industries both in terms of method development and regulatory compliance.

This course is devised to cover the benefits, importance and role of dissolution testing in drug development today. Intricacies of dissolution testing with an emphasis on common problems and methods for enhancing dissolution and bioavailability of compounds will be covered. Using practical examples and case studies throughout the program, delegates will gain a thorough understanding of setting and establishing specifications for optimum dissolution testing.


Course Objectives

  • Identifying the factors affecting dissolution
  • Understanding the relationship between dissolution testing and drug adsorption
  • Designing optimum method development strategies
  • Conducting Product performance tests and Quality Control
  • Selecting optimum test conditions and method development
  • Ensuring test methods are properly validated
  • Clarifying global regulatory requirements
  • Assessing new scientific developments and trends

Who Should Attend?

This course is designed for professionals working in the following areas:

  • Regulatory Affairs
  • Pharmaceutical Development
  • Analytical Development
  • Project Management
  • Quality Control and Assurance
  • Anyone who is involved in dissolution test

Course Details/Schedule

Day 1

  • Overview
  • The need for dissolution testing
  • Historical perspective
  • Theories of dissolution
  • Intrinsic dissolution
  • ISO standards 

Day 2

  • Drug adsorption dynamics
  • An overview of drug adsorption and how it relates to dissolution testing
  • Effects of gastric motility and pH on the drug adsorption process
  • Sink conditions-a regulatory requirement or a physiological fact?
  • Pharmacopial status of dissolution testing

Day 3

  • Regulatory aspects of dissolution testing
  • Official guidance of the FDA and the EMEA
  • The role of dissolution in the regulatory submission
  • The role of dissolution in the regulatory process
  • Quality control aspects of dissolution testing
  • Level 1,2 and 3 testing; what is it and what does it mean?
  • OODS-Out of Dissolution Specification

Day 4

  • Setting specifications
  • The regulatory view
  • The formulation development view
  • Stability issues
  • Development of Dissolution Tests
  • Simple formulations
  • Modified release formulations
  • Test requirements for hydroalcohol media to control burst effects
  • Poorly soluble drugs
  • Combination products
  • Dissolution For Non-Conventional Dosage Forms
  • Performance Verification Testing 

Day 5

  • Validation of dissolution tests
  • Equipment qualification
  • Chemical and mechanical calibration 
  • Dissolution testing validation requirements
  • Automation
  • Analytical procedures 
  • Dissolution and Bioavailabity/Bioequivalence
  • Dissolution testing as a surrogate marker
  • Biomimetic methods
  • In vivo/in vitro correlations