Introduction to Dissolution Method Development
[Pages:46]Transferring Dissolution Methods Session 1 ? Building a Robust Dissolution Method
Ken Boda Applications Engineer Agilent Technologies
Overview
?What is Robustness? ?Key Elements of Dissolution ?Media Selection ?Agitation Speed/Type ?Sampling ?Filtration ?Cleaning and Carryover ?SOP Wording
Dissolution Method Goals
A successful dissolution method will be: ?Discriminatory ?Robust ?Correlated to In Vivo ?Transferrable ?Controlled Variability
Discrimination
Discrimination in Dissolution simply
means being able to tell the
difference between good and bad
formulations
120
100
80 Good
60
40 Bad
20
0
0
15
30
45
60
75
Robustness
While discrimination is important, your method should not be so sensitive that minor differences in the test lead to different results ?Analyst to analyst ?Lab to lab ?Vendor differences ?Overly sensitive method parameters
Find a Balance
Blender
Stagnant Water
Key Elements of Dissolution
Dissolution is made up of 3 components: ? Inert vessel ? Rotating Shaft ? Dissolution Media
Proper Alignment is key to ensuring consistency
Key Elements of Dissolution
Dissolution Systems used for method development and testing must be: ? Qualified by PVT or MQ ? Not have significant vibration ? Components should be in proper
condition
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