The impact of formulation on dissolution coning: Supporting development of a classification system and predictive tool

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...

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Bibliographic Details
Published inBritish Journal of Pharmacy Vol. 8; no. 2; pp. S1 - S2
Main Authors Evanthe Arnold-Lockwood, Aaron Brady, Debbie Kraus, Kieran Sproston
Format Journal Article
LanguageEnglish
Published Huddersfield, United Kingdom University of Huddersfield Press 01.12.2023
Subjects
Calcium carbonate
coning
dissolution
Evaluation
Experimental design
formulation
Packaging
Solid dosage forms
Solubility
Tablets (Medicine)
usp 2
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Summary: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.
Bibliography:British Journal of Pharmacy, Vol. 8, No. 2, Dec 2023, S1-S2
Informit, Melbourne (Vic)
ISSN:2058-8356
2058-8356
DOI:10.5920/bjpharm.1348