Executive Summary:

“FreeThink Technologies, Inc., Aptar CSP Technologies, and PCI Pharma Services compared the efficacy of Activ-Blister™ packaging configurations with cold-form foil in maintaining the stability of a model tableted drug product. An Accelerated Stability Assessment Program (ASAP) study was carried out and growth of the main degradant of the active ingredient was quantified. The data were modeled using the ASAPprime® software and included four different packaging configurations: cold-form foil blisters, thermoform incorporating Activ-Blister™ technology with molecular sieve, thermoform incorporating Activ-Blister™ technology with silica gel and thermoform blisters alone. Four typical ICH storage conditions were also evaluated: 25°C/60% RH, 30°C/65% RH, 30°C/75% RH and 40°C/75% RH. Two different initial relative humidities were modeled to assess the impact of starting water content on shelf-life. To confirm the modeling results, tablets were packaged and stored under these conditions for up to 6 months prior to analysis. As predicted from the ASAP study, the packaging configurations can be ranked from most protective to least protective towards degradation in the following way: Activ-Blister™ technology with molecular sieve > Activ-Blister™ technology with silica gel > coldform foil > thermoform blister alone. The advantage of Activ-Blister™ solutions over cold-form foil was particularly pronounced when the drug product had a high initial water content. ASAPprime® predictions of degradant growth within packaging agreed with the data generated from the stressed blistered tablets at all packaging, storage and initial water conditions. ASAPprime® can effectively model packaging configurations incorporating molecular sieve and silica gel versions of Activ-Blister™ packaging and predict the shelf-life of a product using Activ-Blister™ technology.”

“Case study: Activ-Blister™ solutions provide superior protection of a model drug product over cold-form foil” M. Krisch, et al. (PharmaChem, March/April 2020)

 

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