Accelerated Stability Assessment Program (ASAP) - American ...

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MVTR Values• Vary with T inArrhenius manner• Proportional tosurface area• Bottles– 60-cc HDPE (75%RH)• 20C 0.198• 30C 0.534• 40C 1.352– 180-cc HDPE (75%RH)• 30C 1.061• Blisters (30C;75%RH)– Aclar 0.027– PVDC 0.14830
%RHEmpty Bottle/Blister Equilibration6560555045403530Aclar Blister60-cc bottle0 20 40 60 80Days25ºC/60%RH Oven31
Page 1 and 2: Accelerated Stability AssessmentPro
Page 3 and 4: Accelerated Stability AssessmentPro
Page 5 and 6: log kExcipient/API Interactions-0.6
Page 7 and 8: Stability at Different Temperatures
Page 9 and 10: 80CArrhenius Plot:Two Approaches70C
Page 11 and 12: Aspirin Tablet Degradation70C50C 40
Page 13 and 14: Effect of B Values on Shelf Life (C
Page 15 and 16: ASAP Screening-Protocol: Set to Gen
Page 17 and 18: Error Bars for Predicted Shelf-Life
Page 19 and 20: Error Bars for Predicted Shelf-Life
Page 21 and 22: Protocol ExampleFinal protocol may
Page 23 and 24: Protocol ExampleFinal protocol may
Page 25 and 26: Packaged-Product StabilityH 2 OH 2
Page 27 and 28: %H 2 OMoisture Sorption Isotherm—
Page 29: Moisture Vapor Transmission Rateper
Page 33 and 34: %RHPredicted (Lines) vs. Measured R
Page 35 and 36: Example 2: More Stable Drug Product
Page 37 and 38: Bridging Science and Regulations•
Page 39 and 40: Acknowledgments• Pfizer scientist

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