Shelf life prediction software finds application with ethical drugs
✍ Scribed by Kenneth S. Marsh; John Bitner; Paul David; Anju Rao
- Book ID
- 101288579
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 122 KB
- Volume
- 12
- Category
- Article
- ISSN
- 0894-3214
No coin nor oath required. For personal study only.
✦ Synopsis
Applications for approval of new ethical drugs require that stability studies be completed prior to submission to the FDA. If the company chooses packaging which is found (by conventional storage testing) to provide insuf®cient barrier protection, new packaging must be identi®ed and storage tests re-run. This iterative process must be repeated until packages are found which provide adequate protection. If the chosen package is over-protective, stability studies show adequacy, but do not identify over-protection. A third option is to employ a myriad of test packs which impacts negatively on facilities and personnel, and is expensive and time-consuming. Package optimization requires additional testing and re-submission of the New Drug Application (NDA). A combination of analysis and computer shelf life predictions can be utilized to develop optimal packaging without such repetitive testing.
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 analytical evaluations of two ethical drugs (without package protection) to identify the susceptibilities of the product to storage-induced changes. The analytical results were then plugged into a computer shelf life modelling program which identi®ed barrier requirements which would provide the protection found to be required for the drug product. This then de®ned the packaging needs. The ef®cacy of this modelling approach was con®rmed for one product by conducting conventional stability studies with packaging materials which satis®ed the barrier requirements which had been speci®ed by the computer simulations. Storage studies for the second product are in process, and performance to date supports the predicted values.