Pharmaceutical Dissolution Testing: Practical Training

Available for Group Training

Practical training so you have the skill to perform dissolution testing with confidence 

This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

We Can Deliver This Course for Your Team

 

No scheduled dates for this course right now — but we can deliver it exclusively for your team.

 

Follow the link below and complete the short form to receive a tailored course outline and clear, transparent pricing. Share your focus areas, objectives, timelines, and group size, and we’ll come back to you with a draft programme, estimated investment, and recommended next steps.

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Dissolution testing is crucial in the development and manufacture of many innovator and generic pharmaceuticals. Data obtained during development helps support formulation and equivalence decisions as well as monitoring product quality at release and over the shelf life. Dissolution testing is a challenge to the pharmaceutical sector in terms of method development and regulatory compliance.

 

This highly practical and interactive course will explain the theory, benefits, importance and role of dissolution testing in drug development today. The course covers the factors affecting solubility and dissolution rate, and how to approach dissolution method development and validation.

 

Working on dissolution testing apparatus, our expert team will demonstrate how to set up, conduct and troubleshoot dissolution testing so you have the knowledge to perform your own tests with confidence. All practical sessions are conducted by our partners Omicron Research Ltd.

 

Learn more about how we deliver both online and classroom training courses.

Key Learning Objectives

 

  • Practical Learning – Watch live demonstrations so you know how to set up and run dissolution testing.
  • Dissolution Process – Gain a practical introduction to the intricacies of dissolution testing with an emphasis on problems and problem solving.
  • Optimise Test Conditions – Select optimum test conditions and during method development.
  • Method Validation – Ensure your test methods are properly validated.
  • Troubleshooting – understand how to investigate anomalous and OOS results.
  • Biorelevant Dissolution – Understand how and when to use dissolution testing to de-risk bioequivalence/bioavailability.

Who Should Attend?

 

This course is applicable to professionals of all experience levels. It is carefully designed for people new to dissolution testing and requiring an intensive introduction to the topic. It is also ideal for professionals more experienced in dissolution testing. It is suited to those working in:

  • Analytical Development
  • Project Management
  • Quality Control
  • Quality Assurance
  • Regulatory Affairs
  • Pharmaceutical Development
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form
Introductory Module
FREE to Attend | Live & Recorded

Delivered Online

Overview of dissolution testing?

  • Why do we perform dissolution testing?
  • Uses of dissolution testing
  • Overview of dissolution testing in the context of drug development and manufacturing
  • Review dissolution theory, sink conditions and intrinsic dissolution rate
Day 1

21 June 2023

12:00 to 4:30 PM UK

Why do we perform dissolution testing?

  • Overview of dissolution testing in the context of drug development and manufacturing
  • Uses of dissolution testing
  • Review dissolution theory, sink condistions and intrinsic dissolution rate

Dissolution and drug release testing apparatus

  • Examine the various testing apparatus used during dissolution/drug release testing.
  • Rotating basket (USP Apparatus 1)
  • Rotating paddle (USP Apparatus 2)
  • Reciprocating cylinder (USP Apparatus 3)
  • Flow-through cell (USP Apparatus 4)
  • Paddle over disc (USP Apparatus 5)
  • Rotating cylinder (USP Apparatus 6)
  • Reciprocating holder (USP Apparatus 7)
  • Franz cell
  • Non-compendial approaches (including small-volume apparatus and peak vessels)
  • Approaches for novel dosage forms

Practical Demo Session 1

Omicron Research will demonstrate the set up of dissolution testing equipment with basket and paddle apparatus. The trainer will highlight common mistakes to avoid so your testing runs efficiently.

Day 2

22 June 2023

12:00 to 4:30 PM UK

Requirements for different dosage form types

You will examine the regulatory requirements and data interpretation for the following:

  • Immediate release
  • Extended release
  • Delayed release
  • Transdermal delivery systems

Dissolution equipment qualification

  • US FDA vs USP approach

Troubleshooting dissolution results

  • Gain knowledge to overcome common problems
  • Examine a logical stepwise approach for troubleshooting

Practical Demo Session 2

Following on from the first practical session, Omicron will perform a dissolution test on an immediate release drug product. The session will include correct sample introduction and sampling techniques. During the demonstration you will learn techniques and skills so you perform your dissolution tests with confidence.

Day 3

23 June 2023

12:00 to 4:30 PM UK

Dissolution method development

  • General requirements
  • Selection of dissolution medium (including uses of biorelevant media)
  • Apparatus and agitation rate
  • Sampling (time points & filtration)
  • Special requirements for gelatin capsules
  • Assay requirements

Dissolution method validation

  • Setting acceptance criteria with reference to drug product specifications
  • Specificity
  • Linearity/range
  • Accuracy/recovery
  • Precision
  • Robustness
  • Solution stability

Case study
Developing a dissolution method for a poorly soluble drug.

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. He is a former Honorary Secretary and Honorary Treasurer of the Royal Society of Chemistry’s Analytical Division and led a working group on continuing professional development during his time in office. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development.

 

In 2013, he set up his own company which offers consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in a variety of areas supporting organisations in drug development, manufacture, and regulations.

 

Mark is an expert in dissolution testing providing both consultancy and training to clients. He therefore brings a large amount of knowledge and experience to his dissolution workshops providing guidance and solutions to common challenges.

Presenters – Practical Sessions
Sam Stringer and Nicola Robinson – Omicron Ltd
Sam and Nicola have spent a number of years in service and technical support roles. They both have extensive experience supporting clients in the field and remotely to resolve analytical and technical enquiries, as well as having provided on-site dissolution apparatus maintenance and qualification services.

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