Recent Progress in Solid Dispersion Technology

Dear Colleagues,

Amorphous solid dispersion (ASD) has been recognized as a powerful formulation technology to improve oral absorption of poorly soluble drugs for more than half century. Despite such a long history, novel important findings on ASD is still being reported every year. One of the great findings recently is that supersaturation created by ASDs may not be a simple solution but may involve colloidal structure. This knowledge is inevitable to design superior ASD, which can maintain supersaturated state effectively.

Another topic which is actively discussed recently to understand performance of ASD is crystallization behavior of active pharmaceutical ingredients. Solid state stability of ASD, especially the physical stability, is one of the concerns for industrial formulators when ASD is employed, as it cannot be predicted from conventional accelerated testing protocol. General understanding on crystallization of small organic compounds is of great challenge, as their dynamics is affected by both strong (covalent) and weak (noncovalent) interactions, unlike inorganic glasses.

ASDs are mainly manufactured using spray-drying (SD) and hot-melt extrusion (HME). Many requirements exist for both drugs and excipients including high solubility in organic solvents (SD), high (SD) and low (HME) glass transition temperatures, and high thermal stability (HME). Thus, development of a novel manufacturing method and excipient are also grand challenges.

This special issue welcomes any topics regarding recent progress in ASD technology as exampled above but not limited to.

Dr. Kohsaku Kawakami
Guest Editor

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