Dissolution testing is used to demonstrate the performance of drug products throughout the product lifecycle. This course is designed to provide an overview of dissolution testing, showing how the elements included in a USP monograph can be applied to the development of a dissolution test for a wide variety of products, including those containing soluble and poorly soluble drugs, immediate, modified and extended release products and generic products. In addition, we will cover troubleshooting techniques designed to quickly and easily identify the root cause for unexpected or failing dissolution results. Finally, we'll discuss the options available for qualification and calibration of the dissolution apparatus
Learning Objectives:
- Understand regulatory and compendial drivers for dissolution methods
- Establishing expectations for a dissolution method
- Sources of information for existing dissolution methods
- Develop a dissolution method for a pharmaceutical dosage form, using the analytical target profile and drug substance solubility data, including selection of apparatus, medium, sampling times and analysis technique.
- Learn to address various situations, such as highly soluble drugs, poorly soluble drugs, delayed release products, extended release products, generic products and topical products.
- Approaches to validation of dissolution methods
- Identify the options for dissolution apparatus qualification and calibration.
- Troubleshoot unexpected or failing dissolution results
Areas Covered:
- Rationale and expectations (regulatory, compendial) for dissolution methods
- Review of USP monograph dissolution methods and FDA dissolution database
- General approach to dissolution development: medium, apparatus, speed, timepoints, analytical finish
- Discussion on some important details: Sinkers, deaeration, filtering, solution stability
- Addressing Soluble Drugs (BCS Class 1 and 3)
- Addressing Poorly Soluble Drugs (BCS Class 2 and 4)
- Dissolution Methods for Generic Products
- Dissolution Methods for Modified or Extended Release Products
- Troubleshooting Unexpected or Failing Dissolution Results
- Options for Dissolution Apparatus Qualification and Calibration
- Attendee challenges and questions
Who will benefit:
- Supervisors and Managers in Pharmaceutical (Human or Veterinary)
- Chemists
- Generic, OTC or Contract Laboratories
- Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
- 8:30-9:00 Registration Meet & Greet
- 9:00-10:30
- Seminar objectives review, expectations and scope.
- Rationale and expectations (regulatory, compendial) for dissolution methods
- Developing an Analytical Target Profile
- Review of USP monograph dissolution methods and FDA dissolution database
- 10:30-10:45 Break
- 10:45-12:00
- General approach to dissolution development
- Selection of medium, apparatus, speed, timepoints, analytical finish
- WORKSHOP: Information gathering exercise for dissolution method development
- 12:00-1:00 Lunch
- 1:00-2:30
- Addressing Soluble Drugs (BCS Class 1 and 3)
- Addressing Poorly Soluble Drugs (BCS Class 2 and 4)
- CASE STUDIES: Medium selection based on solubility
- 2:30-2:45 Break
- 2:45-4:30
- Dissolution Methods for Generic Products
- Dissolution Methods for Modified or Extended Release Products
- WORKSHOP: Propose Methods for Generic and Extended Release Products based on examples provided
- 8:30-9:00 Meet & Greet Questions for the Instructor
- 9:00-10:30
- Dissolution profile comparisons and SUPAC
- Setting up a spreadsheet for f2 calculations
- CASE STUDIES: Profile comparisons
- 10:30-10:45 Break
- 10:45-12:00
- Responding to dissolution results in stability studies
- Impact of gelatin crosslinking on dissolution results and what to do about it
- WORKSHOP: Developing an SOP for responding to gelatin crosslinking
- 12:00-1:00 LUNCH
- 1:00-2:30
- Validation of dissolution methods
- Qualification of the Dissolution Apparatus
- 2:30-2:45 Break
- 2:45-4:30
- Discussion on some important details: Sinkers, deaeration, filtering, solution stability
- Some causes for unexpected or failing dissolution results
- HANDOUT: Dissolution Troubleshooting Flowchart
- Additional questions and discussion
Gregory Martin
President of Complectors Consulting LLC
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. 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 on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.
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 is author of several papers in the areas of dissolution and analytical method validation, and is past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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