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CCK Technical Groups – Session 1-A
Dissolution & Bioavailability Group
13 Jan 2019
Obaid Ali & Roohi B. Obaid
Reference:
Dissolution Method Development for Generic Drug Product
Banu Sizanli Zolnik, DOB, OPQ, CDER, FDA
To control consistency
To control the process
To assure the quality
Tool
Critical for formulation
development
Tool
To get waiver from bio-studies
Tool
To use as in-vitro
bioequivalence studies
Tool
Alcohol induced dose dumping
Tool
Post marketing approval
manufacturing change
Tool
Process Parameter
Material Attributes
Formulation Variables
Dissolution
Evaluation
Discrimination
Criteria
Method
Solubility
Apparatus
Media
Evaluation
Rotation speed
Sink conditions
Surfactant
Evaluation
Differentiates drug product
manufactured under target
conditions
VS
Formulation with meaningful
variations for the most relevant
manufacturing variablesDiscrimination
Particle Size
Clinical Batch
Multiple batches
Discrimination
Manufactured
product variants
with different
release
characteristics
1- Manufactured product variants with different release characteristics
1
Manufactured
product variants
with different
release
characteristics
Select optimal
dissolution
method with
adequate
discriminating
power
1
2
2- Select optimal dissolution method with adequate discriminating power
Manufactured
product variants
with different
release
characteristics
Select optimal
dissolution
method with
adequate
discriminating
power
Determine
bioavailability for
product variants
1
2
3- Determine bioavailability for product variants
3
Manufactured
product variants
with different
release
characteristics
Select optimal
dissolution
method with
adequate
discriminating
power
Determine
bioavailability for
product variants
Determine
dissolution rates
resulting in
similar in vivo
performance
1
2
4- Determine dissolution rates resulting in similar in vivo performance
3
4
Manufactured
product variants
with different
release
characteristics
Select optimal
dissolution
method with
adequate
discriminating
power
Determine
bioavailability for
product variants
Determine
dissolution rates
resulting in
similar in vivo
performance
Dissolution
specifications
chosen to ensure
similar (BE)
product
performance1
2
5- Dissolution specifications chosen to ensure similar (BE) product performance
3
4
5
Manufactured
product variants
with different
release
characteristics
Select optimal
dissolution
method with
adequate
discriminating
power
Determine
bioavailability for
product variants
Determine
dissolution rates
resulting in
similar in vivo
performance
Dissolution
specifications
chosen to ensure
similar (BE)
product
performance
Illustration of
dissolution profile
based on BE
batches/ reference
1
2
6- Illustration of dissolution profile based on BE batches/ reference
3
4
5
6
BE batches
85%
drug is dissolved
Time
Q = 80% of drug
Criteria
Application is not supported
with dissolution method
development data
Common Deficiencies
Failed to demonstrate that the
dissolution method is
discriminating
Information on critical material
attributes & process parameters
are missing
Common Deficiencies
Data do not support the
proposed acceptance criteria
Common Deficiencies
There is no dissolution data for
the lower strength waiver
Multi media testing for MR
products
Common Deficiencies
Method transfer report is not
available when method
validation is done at different
sites
Common Deficiencies
Dissolution data collected on
aged lots
Common Deficiencies
Individual dissolution data is
not submitted
Common Deficiencies
Remember
Dissolution method is product specific, nothing
cannot be assumed, everything has to be justified
Thanks

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CCK Technical Group Session 1 - A