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Pharmaceutical Dissolution Testing - a Hands-on course

 
  February 08, 2015  
     
 
PharmCourses Ltd, London
2015-05-27


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, it is important that analysts understand the importance of correctly setting up and sampling from  the chosen apparatus.  In addition to use of dissolution testers, this three-day course will also cover equipment qualification, development and validation of dissolution procedures, and the 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.

Who should attend?

This course is aimed at those new to dissolution testing and analysts with previous experience seeking to improve their skills and knowledge.

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

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

· Apparatus and agitation

· Sampling (time points & filtration)

· Assay requirements

Dissolution method validation

· Setting acceptance criteria with reference to drug product specifications

· Specificity

· Linearity/range

· Accuracy/recovery

· Precision

· Robustness

· Solution stability

Dissolution and the assessment of bioavailability/bioequivalence

 

 

 
 
Organized by: PharmaCourses Ltd
Invited Speakers: Dr Mark Powell
 
Deadline for Abstracts: .
 
Registration:

Early-bird fee: £1080.00 if booked and paid by 27 March 2015

Full Fee: £1200.00

E-mail: info@pharma-training-courses.com
 
   
 
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