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

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%DegradantExample 1: Very Unstable (WhenUnprotected) Drug Product (B = 0.068)4321PVC blister(open bottle)15 tablets/60-ccbottle2 tablets/60-cc bottle15 tablets +desiccant/60-cc bottle00 10 20 30 40 50 60 70DaysLines: predicted (<strong>ASAP</strong> + calculated RH)Diamonds: experimentalCP-481,715 in 60-cc HDPE Bottles (40C/75%RH)34
Example 2: More Stable Drug Product(B = 0.015)Real time<strong>ASAP</strong>Varenicline tablets (500 0.5 mg in 180-cc bottle);30C/65%RH35
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 and 30: Moisture Vapor Transmission Rateper
Page 31 and 32: %RHEmpty Bottle/Blister Equilibrati
Page 33: %RHPredicted (Lines) vs. Measured R
Page 37 and 38: Bridging Science and Regulations•
Page 39 and 40: Acknowledgments• Pfizer scientist

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