TY - JOUR
T1 - Comparison of three different dry coating devices for fine API bulk property enhancements
T2 - The effect of device intensities and processing parameters
AU - Tripathi, Siddharth
AU - Owasit, Anna
AU - Adham, Elzar
AU - Kossor, Christopher
AU - Davé, Rajesh
N1 - Publisher Copyright:
© 2025 The Author(s)
PY - 2025/11/10
Y1 - 2025/11/10
N2 - As predicted by the multi-asperity particle contact model, powder cohesion can be significantly reduced through dry coating of silica using a high-intensity vibratory mixer (HIVM). To promote industry adoption of dry coating, industry-relevant devices, a low-intensity V-blender and a medium-intensity comil, were evaluated against HIVM as a benchmarking control. Since low/medium intensity devices could lead to less effective silica dispersion, the contact model was extended to account for silica agglomeration. Three model APIs, belonging to very cohesive and cohesive flow category, were coated with two silica types (A200 and R972P) for enhancing flow (flow function coefficient − FFC) and conditioned bulk density (CBD). The V-blender exhibited least improvements in FFC and CBD. Corresponding SEM images revealed poor silica dispersion and presence of large porous agglomerates on coated API surfaces. Comil, at one and five passes with different-sized screens, performed better than V-blender. While FFC and CBD improved, some silica agglomeration on API surfaces was evident. HIVM, due to well-dispersed silica coating, achieved the most significant, 2–3 category enhancements in FFC and CBD at higher intensities. These results, in line with the extended model predictions, indicated that whereas V-blender would be unsuitable for dry coating due to excessive silica agglomeration, comil with finer screens would be a promising continuous manufacturing option for enhancing fine powder flowability. Device equivalence analysis identified lower intensity HIVM operating conditions that could achieve performance comparable to best outcomes from V-blender or comil; potentially enabling HIVM as a surrogate material sparing screening device.
AB - As predicted by the multi-asperity particle contact model, powder cohesion can be significantly reduced through dry coating of silica using a high-intensity vibratory mixer (HIVM). To promote industry adoption of dry coating, industry-relevant devices, a low-intensity V-blender and a medium-intensity comil, were evaluated against HIVM as a benchmarking control. Since low/medium intensity devices could lead to less effective silica dispersion, the contact model was extended to account for silica agglomeration. Three model APIs, belonging to very cohesive and cohesive flow category, were coated with two silica types (A200 and R972P) for enhancing flow (flow function coefficient − FFC) and conditioned bulk density (CBD). The V-blender exhibited least improvements in FFC and CBD. Corresponding SEM images revealed poor silica dispersion and presence of large porous agglomerates on coated API surfaces. Comil, at one and five passes with different-sized screens, performed better than V-blender. While FFC and CBD improved, some silica agglomeration on API surfaces was evident. HIVM, due to well-dispersed silica coating, achieved the most significant, 2–3 category enhancements in FFC and CBD at higher intensities. These results, in line with the extended model predictions, indicated that whereas V-blender would be unsuitable for dry coating due to excessive silica agglomeration, comil with finer screens would be a promising continuous manufacturing option for enhancing fine powder flowability. Device equivalence analysis identified lower intensity HIVM operating conditions that could achieve performance comparable to best outcomes from V-blender or comil; potentially enabling HIVM as a surrogate material sparing screening device.
KW - Coating devices
KW - Device equivalence
KW - Dry coating
KW - Mechanistic modeling
KW - Processing intensity
KW - Silica agglomeration
UR - https://www.scopus.com/pages/publications/105014779274
UR - https://www.scopus.com/pages/publications/105014779274#tab=citedBy
U2 - 10.1016/j.ijpharm.2025.126116
DO - 10.1016/j.ijpharm.2025.126116
M3 - Article
C2 - 40886808
AN - SCOPUS:105014779274
SN - 0378-5173
VL - 684
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
M1 - 126116
ER -