November 21, 2013: Pharmaceutical companies all share the same goal: Delivering safe and effective drugs to patients. One aspect of achieving this objective is conducting stability studies that demonstrate to regulatory organizations that a drug’s formulation is safe and effective. Stability studies are conducted on each drug and its package to assure that the drug will meet this goal for the shelf life indicated. Too often, pharmaceutical companies focus on stability studies with minimal consideration for package performance, not realizing that a stability test failure may have nothing to do with the drug itself, rather the failure can be attributed to its packaging. To avoid stability failure and gain understanding of the sensitivity of your dosage, the performance of the drug’s package should be studied at the same time the performance of the drug itself is being evaluated. Package integrity can be determined very early in the stability test’s timeline. In doing so, a potential cause for failure can be identified and corrected, allowing Pharma to prevent delays in the launch process due to package failures. This ensures that the drug’s packaging is performing as intended and will pass stability.
This white paper covers three guiding principles relevant to barrier films that pharmaceutical companies can employ to reduce the risk of failure, understand the barrier required to pass stability, avoid over-packaging and potential delay. CCI Newswire