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Physical stability studies of miscible amorphous solid dispersions.

Igor Ivanisevic¹

¹SSCI, A Division of Aptuit, W. Lafayette, Indiana 47906, USA. iigor@cs.wisc.edu

Journal of Pharmaceutical Sciences

|June 10, 2010

Summary

Amorphous solid dispersions that are miscible remain stable, while phase-separated systems and pure drugs crystallize quickly. Humidity affects local order but not phase separation in miscible dispersions.

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Area of Science:

Pharmaceutical Sciences
Materials Science

Background:

Amorphous solid dispersions (ASDs) are crucial for improving the solubility and bioavailability of poorly soluble drugs.
Understanding the physical stability of ASDs is essential for successful drug product development.

Purpose of the Study:

To evaluate the long-term physical stability of amorphous solid dispersions under ambient conditions.
To investigate the impact of miscibility and environmental factors on the crystallization behavior of ASDs.

Main Methods:

X-ray powder diffraction (XRPD) was used to assess the amorphous or crystalline state of 12 ASDs over 9-22 months.
Small-angle X-ray powder diffraction (SAXRPD) was employed to observe structural changes like pore formation.

Main Results:

Nine initially miscible drug-polymer systems remained X-ray amorphous throughout the study.
Three phase-separated systems and pure amorphous drugs crystallized within 1-2 months and a few days, respectively.
Changes in local order were observed in dispersions with polyvinylpyrrolidone, correlating with relative humidity (RH) fluctuations.

Conclusions:

Miscible amorphous solid dispersions exhibit superior physical stability compared to phase-separated systems and pure amorphous drugs.
Ambient relative humidity can influence the local order of ASDs but does not induce phase separation in miscible systems.
Crystallization can be accompanied by structural changes, such as pore formation, as evidenced by SAXRPD analysis.