Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib

Bade, Isha; Karde, Vikram; Schenck, Luke; Solomos, Marina; Figus, Margaret; Chen, Chienhung; Axnanda, Stephanus; Heng, Jerry Y. Y.

doi:10.3390/pharmaceutics16070883

Open AccessArticle

Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib

by

Isha Bade

¹

,

Vikram Karde

¹,

Luke Schenck

²,

Marina Solomos

²,

Margaret Figus

³,

Chienhung Chen

³,

Stephanus Axnanda

^3,*

and

Jerry Y. Y. Heng

^1,*

¹

Department of Chemical Engineering, South Kensington Campus, Imperial College London, London SW7 2AZ, UK

²

Oral Formulation Sciences, Merck & Co., Inc., Rahway, NJ 07065, USA

³

Analytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA

^*

Authors to whom correspondence should be addressed.

Pharmaceutics 2024, 16(7), 883; https://doi.org/10.3390/pharmaceutics16070883

Submission received: 7 May 2024 / Revised: 17 June 2024 / Accepted: 18 June 2024 / Published: 30 June 2024

(This article belongs to the Special Issue Pharmaceutical Solids: Advanced Manufacturing and Characterization)

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Abstract

Crystalline active pharmaceutical ingredients with comparable size and surface area can demonstrate surface anisotropy induced during crystallization or downstream unit operations such as milling. To the extent that varying surface properties impacts bulk powder properties, the final drug product performance such as stability, dissolution rates, flowability, and dispersibility can be predicted by understanding surface properties such as surface chemistry, energetics, and wettability. Here, we investigate the surface properties of different batches of Odanacatib prepared through either jet milling or fast precipitation from various solvent systems, all of which meet the particle size specification established to ensure equivalent biopharmaceutical performance. This work highlights the use of orthogonal surface techniques such as Inverse Gas Chromatography (IGC), Brunauer–Emmett–Teller (BET) surface area, contact angle, and X-ray Photoelectron Spectroscopy (XPS) to demonstrate the effect of processing history on particle surface properties to explain differences in bulk powder properties.

Keywords: particle properties; anisotropy; powder processing; crystalline API; characterization techniques

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MDPI and ACS Style

Bade, I.; Karde, V.; Schenck, L.; Solomos, M.; Figus, M.; Chen, C.; Axnanda, S.; Heng, J.Y.Y. Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib. Pharmaceutics 2024, 16, 883. https://doi.org/10.3390/pharmaceutics16070883

AMA Style

Bade I, Karde V, Schenck L, Solomos M, Figus M, Chen C, Axnanda S, Heng JYY. Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib. Pharmaceutics. 2024; 16(7):883. https://doi.org/10.3390/pharmaceutics16070883

Chicago/Turabian Style

Bade, Isha, Vikram Karde, Luke Schenck, Marina Solomos, Margaret Figus, Chienhung Chen, Stephanus Axnanda, and Jerry Y. Y. Heng. 2024. "Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib" Pharmaceutics 16, no. 7: 883. https://doi.org/10.3390/pharmaceutics16070883

APA Style

Bade, I., Karde, V., Schenck, L., Solomos, M., Figus, M., Chen, C., Axnanda, S., & Heng, J. Y. Y. (2024). Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib. Pharmaceutics, 16(7), 883. https://doi.org/10.3390/pharmaceutics16070883

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Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib

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