Pharmaceutical Dissolution Testing - a Hands-on course

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Tutor : Mark Powell
DateLocationFee 
23 - 26 October 2018
London
London£1,850
£1,665 + Vat
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Before 7 September 2018
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Before 7 September 2018

Description

Dissolution and drug release tests are directly relevant to the safety and efficacy of many common pharmaceutical dosage forms. To achieve reliable and reproducible results, analysts must understand the importance correct equipment set-up, sample introduction and sampling. In addition to use of dissolution testers, this three-day course will also cover equipment qualification, data evaluation and development and validation of dissolution procedures.

An optional half day will deal with use of dissolution testing in the assessment of bioavailability and bioequivalence.

Delegates will have the opportunity to set up and run dissolution tests using a USP I/II dissolution tester during the course and the course will include case studies and individual/group exercises.

Overview

After completing this course, trainees will be familiar with the different types of pharmaceutical dissolution testing equipment, understand the factors that must be considered when developing a test, and be able to perform a dissolution test.

This course has been approved by the Royal Society of Chemistry for Continuing Professional Development (CPD)

Who Should Attend?

This 3 day hands-on course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas:

  • Regulatory Affairs
  • Pharmaceutical Development
  • Analytical Development
  • Project Management
  • Quality Control
  • Quality Assurance

Course Programme

Day 1

Why do we perform dissolution testing

Dissolution theory, sink conditions and intrinsic dissolution rate

Dissolution and drug release testing apparatus

  • 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)

Practical session: setting up a dissolution tester with basket and paddle apparatus

Day 2

Requirements for different dosage form types (including data interpretation)

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

Dissolution equipment qualification

Practical session: delegates will perform a dissolution test on an immediate release drug product

Day 3

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

Day 4 (half-day - optional) - advise when booking if not attending

Dissolution and the assessment of bioavailability/bioequivalence

  • Bioavailability and bioequivalence - definitions and in vivo evaluation
  • In vitro biowaivers
  • In vitro-in vivo correlation
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