Rapid assessment of homogeneity and stability of amorphous solid dispersions by atomic force microscopy--from bench to batch.

ABSTRACT:

Purpose

To verify the robustness and fundamental value of Atomic Force Microscopy (AFM) and AFM-based assays to rapidly examine the molecular homogeneity and physical stability of amorphous solid dispersions on Hot-Melt-Extrudates.

Methods

Amorphous solid dispersions were prepared with a Hot-Melt Extruder (HME) and profiled by Raman Microscopy and AFM following a sequential analytical routine (Multi-Scale-Imaging-of-Miscibiliy (MIMix)). Extrudates were analyzed before and after incubation at elevated temperature and humidity. The data were compared with published results as collected on miniaturized melt models. The value of molecular phase separation rates for long term stability prediction was assessed.

Results

Data recorded on the extrudates are consistent with tho

SUBMITTER: Lauer ME 

PROVIDER: S-EPMC3695673 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature