Allaboard! AnalyticalInsightsfasttrack yourTime toMarket · Contact: Joke De Gelder,...
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Contact: Joke De Gelder, [email protected] presentation Tuesday June 19th, 3 pm Eddy Ruijter, [email protected] BOS CMC Basel, booth 27 Standardized approach Risk mitigation Knowledge GMP prospect Expectations Product Timelines Customise You typical DS track Validation Forced degradation Method optimisation Solubility Validation Forced degradation Method optimisation Solubility Stability modelling Pre-validation anacura DS track Time All aboard! Analytical Insights fast track your Time to Market Stability modelling: DP tablet example Applications • DS/DP stability indication • Formulation selection • Packaging selection (performance/cost) • Avoid reformulations • Extended shelf-life claim in filing Theory • Humidity corrected Arrhenius equation: a kinetic understanding of degradation ln k = ln A – (E a / RT) + (B * RH) • Isoconversion time = time needed to reach the specification limit • Identical pathways to failure Efficient and effective drug development starts with sharing goals, expected timelines, product information and with creating customized solutions. Stability of formulations is an important aspect throughout product development. The stability modelling using the ASAP technology is employed at several points throughout the drug development phases, supporting quick DS stability checks, formulation selection, packaging selection and extended shelf-life claims. At anacura we have developed a process with smart integration of forced degradation studies, solubility testing, method optimisation, stability modelling using ASAP studies and pre-validation. The integrated approach results in higher quality and avoids rework. An ASAP stability study takes 4-10 weeks from protocol design to report, which is significantly shorter than traditional development stability studies. The outcome is a shelf life prediction, which allows fast descisions on needed revisions in the production process. This risk mitigation pays off in the next phases of drug development. Creating the model In ASAPprime® software: Data of the major degradant: Model evaluation: R² > 0.9 Q² > 0.7 Study setup Early DS development track Predicted shelf-life • At 25°C/60%RH for 0.4 years with 97% probability at a degradant specification of 0.30%w_w • At 5°C for 2 year with 98% probability at a degradant specification of 0.30%w_w Excipients Predicted water uptake In ASAPdesign TM software: • Broad range of T and RH conditions (min. 5) • Determine ‘the plane’ Stress testing Packaging HDPE bottles selected as preferred packaging (cost-related) Excipient composition table combined with database information on excipient water uptake. • RH: use of saturated salt • Continous logging of T and RH in proximity of the samples • Immediate appearance evaluation after pulling • Storage of pulled samples at 5°C, protected from moisture • Comparative appearance of all conditions • Combined LC runs to minimize inter-day variability Packaging selection Humidity of the packaging headspace Water uptake of the formulation Development stability Viewpoint
Transcript of Allaboard! AnalyticalInsightsfasttrack yourTime toMarket · Contact: Joke De Gelder,...
Contact: Joke De Gelder, [email protected] presentation Tuesday June 19th, 3 pm
Eddy Ruijter, [email protected] BOS CMC Basel, booth 27
Standardized approach
Risk mitigation
Knowledge
GMP prospectExpectations
Product
Timelines Customise
You
typical DS trackValidation
Forced degradation
Method optimisation
Solubility
Validation
Forced degradation
Method optimisation
Solubility Stability modelling
Pre-validation
anacura DS track
Time
All aboard! Analytical Insights fast track your Time to Market
Stability modelling: DP tablet example
Applications
• DS/DP stability indication
• Formulation selection
• Packaging selection (performance/cost)
• Avoid reformulations
• Extended shelf-life claim in filing
Theory
• Humidity corrected Arrhenius equation: a
kinetic understanding of degradation
ln k = ln A – (Ea / RT) + (B * RH)
• Isoconversion time = time needed to reach
the specification limit
• Identical pathways to failure
Efficient and effective drug development starts with sharing goals, expected timelines, product
information and with creating customized solutions.
Stability of formulations is an important aspect throughout product development. The stability
modelling using the ASAP technology is employed at several points throughout the drug
development phases, supporting quick DS stability checks, formulation selection, packaging
selection and extended shelf-life claims.
At anacura we have developed a process with smart
integration of forced degradation studies, solubility testing,
method optimisation, stability modelling using ASAP studies
and pre-validation. The integrated approach results in higher
quality and avoids rework.
An ASAP stability study takes 4-10 weeks from protocol design
to report, which is significantly shorter than traditional
development stability studies. The outcome is a shelf life
prediction, which allows fast descisions on needed revisions
in the production process. This risk mitigation pays off in the
next phases of drug development.
Creating the model
In ASAPprime® software:
Data of the major degradant:
Model evaluation:
R² > 0.9
Q² > 0.7
Study setup
Early DS development track
Predicted shelf-life
• At 25°C/60%RH for 0.4 years with 97%
probability at a degradant specification of
0.30%w_w
• At 5°C for 2 year with 98% probability at a
degradant specification of 0.30%w_w
Excipients Predicted water uptake
In ASAPdesignTM software:
• Broad range of T and RH conditions
(min. 5)
• Determine ‘the plane’
Stress testing
Packaging HDPE bottles selected
as preferred packaging (cost-related)
Excipient composition table
combined with database
information on excipient water
uptake.
• RH: use of saturated salt
• Continous logging of T and RH
in proximity of the samples
• Immediate appearance
evaluation after pulling
• Storage of pulled samples at
5°C, protected from moisture
• Comparative appearance of all
conditions
• Combined LC runs to minimize
inter-day variability
Packaging selection
Humidity of the packaging headspace
Water uptake of the formulation
Development stability
Viewpoint
