Generic Success Story

Challenge

A generic company wanted to determine if they could match the stability of the originator drug product (a tablet) in its cold-form, aluminum-aluminum (foil-foil) blister packaging using a less expensive thermoformed blister packaging option.

 

FreeThink’s Approach

FreeThink carried out an extensive ASAPprime® study on both the originator product and the sponsor’s product.

 

Results

The ASAPprime® study revealed that there were three degradants over the conditions of the study.  While ASAPprime® modeling was carried out for each of these degradants, one was clearly shelf-life limiting, consistent with prior history on the product.  Modeling showed that the degradation was very moisture sensitive (B = 0.97).  Nonetheless, the modeling of this degradant showed that thermoformed blisters would be indeed successful.  Moreover, accelerated conditions (40°C/75%RH/6 months) will require the greatest barrier protection. This means that a lower barrier/less expensive film would pass for long-term (two years, 25°C/60%RH), while accelerated conditions need a much higher barrier.

 

Recommendations

It was advised to launch the generic product using accelerated data with higher barrier film, while setting up long-term storage conditions with less expensive film for a rapid post-launch switch.

 

 

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