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Process-induced crystal surface anisotropy and the impact on the powder properties of Odanacatib
File(s)
pharmaceutics-16-00883.pdf (5.71 MB)
Published version
Author(s)
Bade, Isha
Karde, Vikram
Schenck, Luke
Solomos, Marina
Figus, Margaret
Type
Journal Article
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.
Date Issued
2024-07
Date Acceptance
2024-06-18
Citation
Pharmaceutics, 2024, 16 (7)
URI
URL
DOI
ISSN
1999-4923
Publisher
MDPI AG
Journal / Book Title
Pharmaceutics
Volume
16
Issue
7
Copyright Statement
© 2024 by the authors.
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https://
creativecommons.org/licenses/by/
4.0/).
License URL
Identifier
http://dx.doi.org/10.3390/pharmaceutics16070883
Publication Status
Published
Article Number
883
Date Publish Online
2024-06-30