Applications of ASAPprime®

Shelf-Life


ASAPprime® employs isoconversion (time to failure) with designed temperature/RH conditions to statistically fit a humidity-corrected Arrhenius equation based on chemical or physical changes such as:

  • Degradant formation
  • Potency loss
  • Color change
  • Dissolution
  • Disintegration
  • Hardness


Wide Application

The ASAP protocols have been found to accurately determine shelf-life for drug products/substances, API, OTC products, household products, nutraceuticals, cosmetics and other types of products undergoing degradation or potency change.


Fast and Accurate

Even with complicated kinetics, ASAPprime® provides accurate assessments of stability. ASAPprime® software considers the effects of packaging by using program-generated or user-entered moisture vapor transmission rates (MVTR) and moisture sorption isotherms. With as little as four weeks of experimental data, ASAPprime® enables better predictions than even long-term (six to twelve month) standard testing.

 

 

Package Selection


ASAPprime® optimizes packaging selection, and eliminates the need for package screening entirely. Instead of wasting time and money screening multiple package types and configurations, simply use ASAPprime® to design your product’s optimal packaging and then confirm it. With ASAPprime® modeling, package confirmation can be completed in as little as four weeks versus six to twelve months for traditional package screening efforts.

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 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.

 

 

Regulatory Support 


ASAPprime® helps make regulatory submission packages more robust by providing scientific rationale for decisions. In some cases, ASAPprime® study data has been successfully used in place of traditional long-term ICH studies for regulatory filings. While some countries have refused to consider the Accelerated Stability Assessment Program (ASAP), others have been more receptive. In general, this approach has been used to help speed new drug candidates into clinical trials more quickly. In many cases, contingency samples of clinical supplies were placed in chambers for analysis with data available for regulatory queries.

FreeThink successfully works with both large and small companies to increase the initially granted shelf-life at the time of registration for new products. In fact, one international pharmaceutical company recently reported that it was granted a three-year shelf-life at launch for a new drug product in the EU, using ASAPprime® analysis and just three months of traditional ICH data (with commitment for ongoing monitoring).

ASAPprime® data can also be used to:

  • Contribute to regulatory filings as part of product understanding and QbD filings
  • Justify acceptance after shipment or storage excursions
  • Validate acceptability of generic versus originator drug products

Whether you are a first-time ASAPprime® user or a long-time customer, FreeThink can help with your regulatory strategy, and ensure a scientifically robust submission package based on ASAPprime® studies and data analysis.

 

 

Contact FreeThink Technologies, Inc. to learn more about licensing options, request a demo version of the software, or to schedule a live demonstration via WebEx®.