Shelf life prediction software finds application with ethical drugs

Applications for approval of new ethical drugs require that st ability stud ies be completed prior to submission to the FDA. If the company chooses pac kaging which is found (by conventional storage testing) to provide insuffic ient barrier protection, new packaging must be identified and storage tests re-run. This iterative process must be repeated until packages are found w hich provide adequate protection. If the chosen package is over-protective, stability studies show adequacy, but do not identify over-protection. A th ird option is to employ a myriad of test packs which impacts negatively on facilities and personnel, and is expensive and time-consuming Package optim ization requires additional testing and re-submission of the New Drug Appli cation (NDA). A combination of analysis and computer shelf life predictions can be utilized to develop optimal packaging without such repetitive testi ng. A study was initiated with Searle to apply analytical evaluations and shelf life simulations to identify appropriate packaging for new drugs prior to the initiation of conventional stability testing. The procedure used analyt ical evaluations of two ethical drugs (without package protection) to ident ify the susceptibilities of the product to storage-induced changes. The ana lytical results were then plugged into a computer shelf life modelling prog ram which identified barrier requirements which would provide the protectio n found to be required for the drug product. This then defined the packagin g needs. The efficacy of this modelling approach was confirmed for one prod uct by conducting conventional stability studies with packaging materials w hich satisfied the barrier requirements which had been specified by the com puter simulations. Storage studies for the second product are in process, a nd performance to date supports the predicted values. Copyright (C) 1999 Jo hn Wiley & Sons, Ltd.