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Pharmaceutical Dissolution Testing: Practical Training
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Practical training so you have the skill to perform dissolution testing with confidence
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.
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.
Learn more about how we deliver both online and classroom training courses.
Register for the Free to Attend Module
There are limited spaces on the free online session. 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. rmat. For information click here.
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.
Practical Training
View the set up of dissolution appratus and understand how to perform optimal studies with support and guidance from our experts.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Training Information
The training starts at 12:00 PM UK time and finishes approximately 4:30 PM on each day. There will be plenty of breaks. You will receive joining instructions.
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
19 May 2023 | 2:00 PM (UK)
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.
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
Omicron Research Ltd
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 Ltd are 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.
| * | • The training course is delivered either as a practical hands on classroom course or a practical online course. It contains both theory and hands on sessions. |
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