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General Interest: Implementing QbD in Pharmaceutical Salt Selection: Predicting Disproportionation

Scale-up Systems

Wednesday, January 23, 2013 from 9:00 AM to 10:00 AM (EST)

General Interest: Implementing QbD in Pharmaceutical Salt...

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Presented by Dr Jeremy Merritt of Eli Lilly.

Salts of active pharmaceutical ingredients are often used to enhance solubility, dissolution rate, or take advantage of other improved solid-state properties. The selected form must be maintained during processing and shelf-life to ensure quality. 

We aimed to develop a model to quantify risk of disproportionation, where the salt dissociates back to the freebase form. A mechanistic model based on thermodynamics was built to predict disproportionation. 

13 pharmaceutical compounds were screened in 4 formulations containing different combinations of excipients. The test set spanned molecules which did and did not disproportionate and also formulations which did and did not induce disproportionation. Model predictions were in qualitative agreement with the experimental data, recovering trends of how disproportionation varies with humidity, formulation excipients, base pKa and solubility of the API.

The model can predict the balance between different driving forces for disproportionation with limited experimental data resulting in a tool to aid in early-phase risk assessment and formulation design with respect to disproportionation.

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