Impact of Silica Dry Coprocessing with API and Blend Mixing Time on Blend Flowability and Drug Content Uniformity
Document Type
Article
Publication Date
8-1-2023
Abstract
This paper considers two fine-sized (d50 ∼10 µm) model drugs, acetaminophen (mAPAP) and ibuprofen (Ibu), to examine the effect of API dry coprocessing on their multi-component medium DL (30 wt%) blends with fine excipients. The impact of blend mixing time on the bulk properties such as flowability, bulk density, and agglomeration was studied. The hypothesis tested is that blends with fine APIs at medium DL require good blend flowability to have good blend uniformity (BU). Moreover, the good flowability could be achieved through dry coating with hydrophobic (R972P) silica, which reduces agglomeration of not only fine API, but also of its blends while using fine excipients. For uncoated APIs, the blend flowability was poor, i.e. cohesive regime at all mixing times, and the blends failed to achieve acceptable BU. In contrast, for dry coated APIs, their blend flowability improved to easy-flow regime or better, improving with mixing time, and as hypothesized, all blends consequently achieved desired BU. All dry coated API blends exhibited improved bulk density and reduced agglomeration, attributed to mixing induced synergistic property enhancements, likely due to silica transfer. Despite coating with hydrophobic silica, tablet dissolution was improved, attributed to the reduced agglomeration of fine API.
Identifier
85160687192 (Scopus)
Publication Title
Journal of Pharmaceutical Sciences
External Full Text Location
https://doi.org/10.1016/j.xphs.2023.05.016
e-ISSN
15206017
ISSN
00223549
PubMed ID
37230252
First Page
2124
Last Page
2136
Issue
8
Volume
112
Grant
IIP- 2137209
Fund Ref
National Science Foundation
Recommended Citation
Kim, Sangah S.; Seetahal, Ameera; Amores, Nicholas; Kossor, Christopher; and Davé, Rajesh N., "Impact of Silica Dry Coprocessing with API and Blend Mixing Time on Blend Flowability and Drug Content Uniformity" (2023). Faculty Publications. 1532.
https://digitalcommons.njit.edu/fac_pubs/1532