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Pharmaceutical Dissolution Testing: Practical Training

21, 22 & 23 June 2023 | Live Online Course

£895.00

The price is for all 3-days

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

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Register for the full course before | 12 May to save £400 | 2 June to save £200

Discount is applied to the price above. VAT, if applicable, will be added.

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 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. 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. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.

Key Learning Objectives

 

  • 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

 

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. 

 

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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?)

Training Information

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.

 

The course is held in the following venue:

Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

 

Link to the Google Map

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

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

17 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

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. 

Leave this field blank

By clicking submit, you agree to our Privacy Policy

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

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.

 

The course is held in the following venue:

Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

 

Link to the Google Map

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.
• The dates and venue are subject to change.