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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, this hands-on practical course will also demonstrate how to set up, conduct and troubleshoot dissolution testing so you have the knowledge to perform your own tests with confidence.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development.
Practical Learning – Gain hands on training on setting up and running 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
Register for the Free to Attend Module
Complete the form below to receive the agenda in pdf format. By completing the form, you will also be registered on to the free to attend module, delivered live online in July. For information click here.
Practical Hands-On Training
Set up dissolution appratus and conduct studies with support and guidance from our experts.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. The final day may start and finish earlier to accommodate peoples travel arrangements.
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
Action Plan
At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge
Reinforcement Session
Delivered 3 to 4 weeks after the training
It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Module
FREE to Attend | Live & Recorded
14 July | 2:00 PM (UK)
Delivered Online
Uses of biorelevant dissolution media (Register free)
Overview of the Biopharmaceutics Classification System (BCS)
Types of biorelevant dissolution media
Using biorelevant dissolution media to derisk bioavailability and bioequivalence
Register for the Module | Free
There are limited spaces on the free module. If demand is high, you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations. When you complete the form, you will also be sent the agenda for the full practical course.
Day 1
10 October 2022
Why do we perform dissolution testing?
Overview of dissolution testing in the context of drug development and manufacturing
Dissolution theory, sink conditions 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 Session 1
You will work on dissolution testing equipment with support and guidance from our expert team. In the first session you will set up a dissolution tester with basket and paddle apparatus. The trainer will highlight common mistakes to avoid so your testing runs efficiently.
Day 2
11 October 2022
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 Session 2
Following on from the first practical session, you will perform a dissolution test on an immediate release drug product. The session will include correct sample introduction and sampling techniques. With support from our expert team, you will learn techniques and skills so you perform your dissolution tests with confidence.
Day 3
12 October 2022
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.
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
Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.
We have partnered with Omicron Research Ltd to provide this hands-on practical training course. Omicron supply all the practical equipment for the course.
Omicron Research Ltdare UK based distributors specialising in, amongst other things, oral solid dose testing. With over 30 years’ experience in the UK pharmaceutical OSD testing marketplace, Omicron has the technical expertise and product range to support our clients in all aspects of their testing requirements. Omicron represent Distek Inc, Dissolution Accessories and Pharmag Instruments, as well as providing comprehensive service and support to all dissolution manufacturers and models.
Could your team benefit from this course?
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
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• The training course is delivered as a practical hands on classroom course. It contains both theory and hands on sessions.
• The dates and venue are subject to change.
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