By Navnit Shah, Harpreet Sandhu, Duk Soon Choi, Hitesh Chokshi, A. Waseem Malick
This quantity deals a finished consultant at the concept and perform of amorphous reliable dispersions (ASD) for dealing with demanding situations linked to poorly soluble medicinal drugs. In twenty-three inclusive chapters, the booklet examines thermodynamics and kinetics of the amorphous kingdom and amorphous strong dispersions, ASD applied sciences, excipients for stabilizing amorphous good dispersions reminiscent of polymers, and ASD production applied sciences, together with spray drying, sizzling soften extrusion, fluid mattress layering and solvent-controlled micro-precipitation know-how (MBP). every one expertise is illustrated by way of particular case experiences. furthermore, committed sections hide analytical instruments and applied sciences for characterization of amorphous sturdy dispersions, the prediction of long term balance, and the advance of appropriate dissolution tools and regulatory points. The ebook additionally highlights destiny applied sciences at the horizon, corresponding to supercritical fluid processing, mesoporous silica, KinetiSol®, and using non-salt-forming natural acids and amino acids for the stabilization of amorphous systems.
Amorphous strong Dispersions: thought and perform is a necessary connection with pharmaceutical scientists drawn to constructing bioavailable and therapeutically potent formulations of poorly soluble molecules with the intention to develop those applied sciences and strengthen larger medicinal drugs for the future.
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Extra info for Amorphous Solid Dispersions: Theory and Practice
29) Applying Eq. 26) leads to m ≈ 684 which can be applied to many typical materials. From Eq. 29), it can be said that strong glass formers are associated with strength factors D > 25–30 and weak ones with D < 10–12. Numerous publications refer to the association between strong glass formers and Arrhenius-like behavior, as opposed to weak glass formers and non-Arrhenius behaviors (Angell 1995; Yu 2001). While this distinction is not critical for understanding the temperature effects, it is of interest and warrants a short discussion.
In an amorphous solid, it can be expected that nucleation will follow a pattern analogous to Eq. 34), in which γ would represent the interfacial tension between the crystalline and amorphous forms of the drug. This reflects the notion that a pure API is not microscopically homogeneous when nucleation and crystallization are occurring, so on a microscopic scale, there are regions with different molecular packing, density, and energy patterns. These regions create interfaces and interfacial tensions, based on the different molecular packing of the regions.
While these are equivalent in theory, each view provides different insights and advantages for explaining certain behaviors. In particular, the microscopic viewpoint allows a fundamental interpretation in terms of molecular interactions and packing, while thermodynamics allows material-independent equations to be developed based on macroscopic energy content arguments. From the standpoint of dissolution, the microscopic viewpoint allows a simple but useful picture to be constructed that gives a clear and intuitive way to think of the properties of amorphous systems with regard to dissolution.