E13 – Dissolution: A Rational Approach

Dissolution: A Rational Approach to Developing and
Validating Methods for a Variety of Purposes

 One-Day Course E13-26, Tuesday, November 19th, 8:30am – 5:00pm

 Mr. Gregory Martin, Complectors Consulting, Pottstown, PA

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, validate and troubleshoot dissolution methods, with your particular needs in mind.  We will show how to create an Analytical Target Profile, which defines the expectations for the method, then build a Method Development Decision Tree to address the ATP in an INTERACTIVE SESSION.  Proceeding through Method Understanding and Validation, we’ll demonstrate how this Method Lifecycle concept can be used iteratively during the evolution of the product from early to late stage development, through changes and transfer, to compendial monograph and generic products.  Of course, this will also require discussion on establishing specifications and comparing dissolution data.  The course will also provide some very valuable, practical information on dissolution instrument qualification, resource-sparing approaches to validation and troubleshooting some issues commonly encountered with dissolution.

Scientists who develop or apply dissolution methods (e.g. research and development, stability, quality control) and those who need to understand dissolution testing and its implications for formulation selection, manufacturing and regulatory filings (both those at the bench and their managers) will benefit from this course.

1. Introductions
     * Dissolution testing for a variety of reasons
     * Analytical Target Profile – Defining the requirements for your particular method
2. Dissolution Method Development
     * Choosing the right dissolution apparatus and speed
     * Challenges with the dissolution medium, especially for poorly soluble compounds:  understanding BCS
     * Selecting the best times for a dissolution profile
     * UV-Vis or HPLC:  What’s best for you?
3. Dissolution Method Understanding
     * Is the method reproducible?
     * Is the method discriminating?
4. Validation of Dissolution Methods
5. Evolution of Dissolution Methods
     * Early development: formulation selection
     * Late development: reproducible vs discriminating
     * Marketed products: SUPAC and biowaivers
     * Methods for generic products
6. Specifications and Comparisons
     * Clinically relevant specifications
     * IVIVC
     * Evaluating your dataset
7. Dissolution Apparatus Qualification
     * Performance Verification Test or Mechanical Calibration?
8. Method Troubleshooting
     * Practical examples of some of the common issues encountered in dissolution testing:  how to diagnose them and how to address them
     * Discussion of attendees issues
9. Questions and discussion

Mr. Greg Martin is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry.  He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.  Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.  In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.  He is also Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.  Mr. Martin is co-author (with Vivian A. Gray) of the series “Dissolution Concepts and Applications” which has appeared in Journal of Validation Technology and Journal of GXP Compliance.