ASAPprime® software provides a robust, science-based argument for choosing the optimal combination of packaging, formulation, ingredient supplier and manufacturing process without the need for repeated, lengthy and costly laboratory studies. Through accelerated stability modeling, ASAPprime® allows for better, more informed decision-making earlier in the development process, preventing costly reformulations and other changes throughout the product’s life-cycle.
Eliminate Package Screening
Now you can select packaging with sufficient confidence to eliminate package screening entirely. For many solid drug products, packaging provides protection from moisture; yet there is a trade-off between packaging cost and the degree of protection. With the Accelerated Stability Assessment Program (ASAP) and FreeThink’s ASAPprime® software, one can readily determine packaging that will provide an acceptable shelf-life for a product in any selected climate zone. The software can exactly predict the stability impact of the number and type of desiccants, number of unit dosage forms (i.e., number of tablets, capsules or amount of powder) and choice of excipients. In addition, the ASAPprime® software allows the user to balance moisture specifications with packaging choices. This provides a scientific basis for determining the impact of the initial moisture content and how it relates to the shelf-life in a QbD fashion.
No Surprise Reformulations
ASAP has proven to be a more accurate predictor of the true shelf-life for drug products and drug substances than real-time stability chambers. This is due to several factors, including the explicit accounting for moisture’s impact, and elimination of the assumption of linear degradation kinetics. ASAPprime® software eliminates the need for costly reformulations late in development, by providing confidence in the drug product stability.
When multiple lots of a drug substance or drug product are produced, stability variability can be determined with confidence using ASAPprime® software’s three-parameter fit. This comparison ability is especially useful when changes are made to the process, site, source material or excipients.
Insight into Manufacturing Issues
ASAPprime® can inform decisions on balancing the costs of drying to lower specifications versus using packaging with a higher degree of moisture protection. The software can also help companies confidently select packaging with different levels of moisture protection for different climate zones.