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Pharmaceutical Dissolution Testing: Practical Training
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Pharmaceutical Dissolution Testing: Practical Training

Register Your Interest

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

Register Your Interest

 

Register your interest in the course. When we schedule dates, we will be in touch.

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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. 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.

 

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.

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.

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

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.
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