The Impact of Formulation on Dissolution Coning: Supporting Development of a Classification System and Predictive Tool

Abstract

Coning is a phenomenon that is specific to dissolution tests using USP Apparatus 2 due to the hydrodynamics of the system, resulting in the reduced dissolution of API. Experiments were conducted using design of experiment principles on various tabletted blends to investigate factors impacting coning. It was observed that the brittle filler used impacts the extent of coning present for the APIs studied. Particle size was found to have less of an impact than the brittle filler type. To resolve coning problems, it could be recommended that the brittle filler type is changed rather than the grade. Work with low solubility APIs is required to confirm this. This work has the potential to form the basis for a classification system to provide early warning if a formulation is likely to have coning issues.

Keywords

Dissolution, Coning, USP 2, Formulation

How to Cite

Arnold-Lockwood, E., Sproston, K. E., Kraus, D. & Brady, A. S., (2023) “The Impact of Formulation on Dissolution Coning: Supporting Development of a Classification System and Predictive Tool”, British Journal of Pharmacy 8(2). doi: https://doi.org/10.5920/bjpharm.1348

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Authors

Evanthe Arnold-Lockwood (Pfizer)
Kieran Ellis Sproston (Pfizer)
Debbie Kraus (Pfizer)
Aaron Sean Brady (Pfizer)

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Creative Commons Attribution 4.0

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