Destabilization of Indomethacin-Paracetamol Co-Amorphous Systems by Mechanical Stress
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Destabilization of Indomethacin-Paracetamol Co-Amorphous Systems by Mechanical Stress. / Di, Rong; Grohganz, Holger; Rades, Thomas.
In: Pharmaceutics, Vol. 16, 67, 2024.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Destabilization of Indomethacin-Paracetamol Co-Amorphous Systems by Mechanical Stress
AU - Di, Rong
AU - Grohganz, Holger
AU - Rades, Thomas
PY - 2024
Y1 - 2024
N2 - Using co-amorphous systems (CAMS) has shown promise in addressing the challenges associated with poorly water-soluble drugs. Quench-cooling is a commonly used CAMS preparation method, often followed by grinding or milling to achieve a fine powder that is suitable for subsequent characterization or further down-stream manufacturing. However, the impact of mechanical stress applied to CAMS has received little attention. In this study, the influence of mechanical stress on indomethacin—paracetamol CAMS was investigated. The investigation involved thermal analysis and solid-state characterization across various CAMS mixing ratios and levels of mechanical stress. The study revealed a negative effect of mechanical stress on stability, particularly on the excess components in CAMS. Higher levels of mechanical stress were observed to induce phase separation or recrystallization. Notably, samples at the optimal mixing ratio demonstrated greater resistance to the destabilization caused by mechanical stress. These results showed the significance of careful consideration of processing methods during formulation and the significance of optimizing mixing ratios in CAMS.
AB - Using co-amorphous systems (CAMS) has shown promise in addressing the challenges associated with poorly water-soluble drugs. Quench-cooling is a commonly used CAMS preparation method, often followed by grinding or milling to achieve a fine powder that is suitable for subsequent characterization or further down-stream manufacturing. However, the impact of mechanical stress applied to CAMS has received little attention. In this study, the influence of mechanical stress on indomethacin—paracetamol CAMS was investigated. The investigation involved thermal analysis and solid-state characterization across various CAMS mixing ratios and levels of mechanical stress. The study revealed a negative effect of mechanical stress on stability, particularly on the excess components in CAMS. Higher levels of mechanical stress were observed to induce phase separation or recrystallization. Notably, samples at the optimal mixing ratio demonstrated greater resistance to the destabilization caused by mechanical stress. These results showed the significance of careful consideration of processing methods during formulation and the significance of optimizing mixing ratios in CAMS.
U2 - 10.3390/pharmaceutics16010067
DO - 10.3390/pharmaceutics16010067
M3 - Journal article
C2 - 38258078
VL - 16
JO - Pharmaceutics
JF - Pharmaceutics
SN - 1999-4923
M1 - 67
ER -
ID: 382370288