Resources


Error Estimation in Accelerating Stability Modeling

December 20, 2016
#FreeThink White Papers

Methods of predicting the uncertainty in ambient shelf-life (probability of passing a specification limit at a given storage time) from accelerated data using a two-step process (estimation of isoconversion then Arrhenius fitting) were evaluated.  by Kenneth C. Waterman*, Jon T. Swanson, Blake L. Lippold, FreeThink Technologies, Inc. Branford, CT      

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Pfizer: Lean Stability: Global Regulatory Reception—Successes and Challenges of Recent Case Studies

December 8, 2016
#Customer Presentation/ Publications using ASAPprime®

Presentation by Dr. Freed, AAPS Stability Workshop 2016 (Washington)    

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Collaboration to offer predictive modeling for drug stability

November 28, 2016
#FreeThink in the News

“Clariant Healthcare Packaging has entered into a joint promotion agreement with FreeThink Technologies to support pharmaceutical predictive calculation and modeling” Hughes, E. “Collaboration to offer predictive modelling for drug stability,” Epm News (2015) Click hear to view article.

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Building a Barrier in Solid-Dosage Drug Packaging

November 28, 2016
#FreeThink in the News

“New materials and software modeling streamline the blister-package design process.” H. Forcinio, “Building a Barrier in Solid-Dosage Drug Packaging,” Pharmaceutical Technology 39 (12) 2014. Click here to read article.    

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Bayer Health Care: Application of the Accelerated Stability Assessment Program (ASAP) to a Liquid Dosage Form Containing Multiple Active Ingredients: A Case Study

November 28, 2016
#Customer Presentation/ Publications using ASAPprime®

Poster by Dr. Foyeke Badejo, AAPS 2016 (Denver) ASAP study conducted in three weeks was used successfully to predict liquid drug product shelf-lives (25oC/60%RH). Moreover, the mechanistic insight gained helped to rationalize the impact of flavor components on the product. Click here to view poster description.                   […]

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GSK Consumer: Accelerated Stability Modeling for Nicotine Patch

November 28, 2016
#Customer Presentation/ Publications using ASAPprime®

Poster by Dr. Chen, AAPS 2016 (Denver) The study result indicated that it was possible to conduct accelerated stability study in just two weeks and use various stability modeling software and methods to project the shelf life of nicotine patch packed in a foil pouch under ICH conditions. To conduct ASAP studies and perform stability […]

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Eli Lilly: Implementing an Accelerated Stability Assessment Program: Case Study

November 28, 2016
#Customer Presentation/ Publications using ASAPprime®

Presentation by Dr. Hyzer at IVT’s Third Annual Forum on Stability Programs, 2012 (San Diego) Click here to view presentation.

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Vertex: Prediction of the Changes in Drug Dissolution from an Immediate-Release Tablet Containing Two Active Pharmaceutical Ingredients Using an Accelerated Stability Assessment Program (ASAPprime®)

November 28, 2016
#Customer Presentation/ Publications using ASAPprime®

The computer program ASAPprime® has been used successfully for some time to predict the stability of active pharmaceutical ingredients (APIs) in solid-dosage forms. In this study, we have demonstrated that the ASAPprime® program can also be used to predict the slow-down in dissolution of two APIs in an immediate release tablet. The tablets were pre-equilibrated […]

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Predictive Dissolution/Disintegration Stability Modeling: Case Studies

November 28, 2016
#ASAPprime® and Stability Modeling

For two immediate release tabletted products, short-term accelerated stability studies were used to determine dissolution and disintegration failure times at a range of stress conditions, which then was propagated back to ambient storage conditions based on the moisture-modified Arrhenius equation.  The onset of dissolution failures appears to be sudden and directly correlated to changes in […]

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Science of Temperature Impact on Degradation Rates

November 28, 2016
#ASAPprime® and Stability Modeling #FreeThink White Papers

The nature of the temperature dependence on reaction rates is reviewed. The Arrhenius equation is discussed with special attention paid to the two key terms: the activation energy Ea, and collision frequency A. While the latter term is usually considered temperature-independent, we examine this assumption in more detail for gas, liquid and solid states.  In liquid state, collision frequency […]

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