(32e) API Particle Engineering As a Strategy to Address Sticking/Picking During Drug Product Development

API
particle engineering as a strategy to address sticking/picking during drug
product development

Todd S. McDermott

Abbott Laboratories, Global Pharmaceutical Sciences

Ahmad Sheikh

Jorge Gandarilla

Abbott Laboratories,
Process Research & Development- Solid State Chemistry

Sticking of material to tablet punch surfaces is a common
problem encountered during tablet development. APIs that have sticking issues
also tend to have poor flow and density, which add to the formulation
challenges. For particularly difficult APIs, traditional strategies may not be
sufficient to address the severe sticking and flow issues. An alternative
approach is to fundamentally change the API properties by particle engineering.
Liquid-liquid phase separation crystallization (LLPS) was used to greatly
improve the solid-state properties of a model API. The process was optimized
and demonstrated on pilot-plant scale. The resulting material was formulated
and characterized in terms of flow, density, compaction properties, and sticking.
The resulting material shows significant improvement relative to the original
API.