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Introduction to Dissolution Method Development & Validation

Dissolution testing is used to demonstrate the performance of drug products throughout the product lifecycle. This highly interactive course is designed to assist both new and seasoned professionals with an interest in dissolution to design, develop, and validate dissolution methods, with your particular needs in mind. The course begins with a review of the various reasons you might need a dissolution method and moves to establishing the requirements using the Analytical Target Profile. Next on the agenda comes determining the important parameters for a dissolution  method: medium, apparatus, speed and time, and discussion on some of the other parameters that can make or break a dissolution method, such as sinkers, deaeration and sample clarification. After discussion on validation, attendees will have a hands on opportunity to perform a dissolution test, and witness recommended laboratory techniques.

Who Should Attend?

Chemists (Research, Quality Control, and CRO; Human, Veterinary or Generic) involved with dissolution method development or testing and their managers, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution.

Course Overview

  1. Assessment of attendees goals
  2. Rationale and expectations (regulatory, compendial) for dissolution methods
  3. Review of USP monograph dissolution methods and FDA dissolution database
  4. General approach to dissolution development:
    1. Establishing requirements (Analytical Target Profile)
    2. Identifying critical parameters: medium, apparatus, speed, timepoints
    3. Analytical finish
  5. Discussion on some important details
    1. Sinkers, deaeration, filtering, solution stability
  6. Validation of dissolution methods
    1. ICH and USP requirements
    2. Robustness
    3. Discriminating ability
  7. Setting specifications
  8. Hands on experience: Dissolution tablet testing
  9. Attendee challenges and questions

Learning Objectives

  • Learn about regulatory and compendial expectations for dissolution methods, and the reasons behind them
  • Learn strategies for selecting dissolution conditions, including medium, apparatus and time points
  • Learn how to examine robustness and discriminating power of a dissolution method, and how to execute validation
  • Learn how to propose and justify dissolution specifications

Course Accomplishments

Upon completion of this course the attendee will be able to:

  1. Understand regulatory and compendial drivers for dissolution methods
  2. Develop a dissolution method for a pharmaceutical dosage form, using the analytical target profile and drug substance solubility data
  3. Evaluate robustness and discriminating power of a dissolution method, and execute validation to meet regulatory and compendial requirements
  4. Run a dissolution test with confidence
10 /2019
Fee $495.00
Length One Day Course
Category Lecture & Hands-On
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