Abstract

AbstractDynamic mechanical analysis (DMA) offers several advantages over prevailing methods in the characterization of amorphous solid dispersions (ASDs) typically used for improving the delivery of poorly water-soluble drugs. This method of analysis, though underutilized in the study of pharmaceutical systems, is particularly attuned to rheological investigations of thermal and mechanical properties of solids such as ASDs. Its ability to determine the viscoelastic properties of systems across a wide range of temperatures and shear conditions provides useful insight for the development and processing of ASDs. The response of materials to an imposed stress, captured by DMA, can help identify proper conditions for preparing homogenous extrudates of the polymer and active pharmaceutical ingredient through hot melt extrusion (HME). As HME continues to gain utility within the pharmaceutical industry, the ability to tailor process conditions will become increasingly important for the efficient design and production of ASD products for poorly water-soluble drugs. Furthermore, DMA can be used to probe molecular mobility and its link to physical stability of ASDs. Establishing the link between molecular mobility and crystallization kinetics is central to predicting the physical stability of ASDs. Therefore, increasing the understanding of material properties through DMA will enable the successful development of more stable amorphous drug products. This review summarizes current characterization tools for ASDs and discusses the potential of utilizing DMA as a robust alternative to traditional methods.

Highlights

  • The formation of amorphous solid dispersions (ASDs) of a poorly soluble drug in suitable polymer carriers is an innovative and enabling technique for enhancing the dissolution and oral delivery of many poorly water-soluble active pharmaceutical ingredients (APIs).[1]

  • We have shown the utility of dynamic mechanical analysis (DMA) in determining the appropriate hot melt extrusion (HME) processing conditions for ASD preparation

  • Characterization with DMA offers insights that are essential for both process development and stability modelling

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Summary

Introduction

The formation of amorphous solid dispersions (ASDs) of a poorly soluble drug in suitable polymer carriers is an innovative and enabling technique for enhancing the dissolution and oral delivery of many poorly water-soluble active pharmaceutical ingredients (APIs).[1]. Thermal preparation of ASDs can be achieved by the hot melt extrusion (HME)

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