"Impact of Silica Dry Coprocessing with API and Blend Mixing Time on Bl" by Sangah S. Kim, Ameera Seetahal et al.
 

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

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