By Navnit Shah, Harpreet Sandhu, Duk Soon Choi, Hitesh Chokshi, A. Waseem Malick
This quantity deals a entire consultant at the concept and perform of amorphous sturdy dispersions (ASD) for dealing with demanding situations linked to poorly soluble medications. In twenty-three inclusive chapters, the publication examines thermodynamics and kinetics of the amorphous kingdom and amorphous reliable dispersions, ASD applied sciences, excipients for stabilizing amorphous good dispersions corresponding to polymers, and ASD production applied sciences, together with spray drying, scorching soften extrusion, fluid mattress layering and solvent-controlled micro-precipitation expertise (MBP). each one expertise is illustrated through particular case stories. furthermore, devoted sections conceal analytical instruments and applied sciences for characterization of amorphous sturdy dispersions, the prediction of long term balance, and the advance of compatible dissolution equipment and regulatory elements. The e-book additionally highlights destiny applied sciences at the horizon, equivalent 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: concept and perform is a priceless connection with pharmaceutical scientists drawn to constructing bioavailable and therapeutically powerful formulations of poorly soluble molecules for you to enhance those applied sciences and boost greater medications for the future.
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Additional info for Amorphous Solid Dispersions: Theory and Practice
4 Solubility and Chemical Potential From thermodynamics, it is well established that materials will convert from a higher to lower chemical potential form. In this context, the chemical potentials of the drug in its dissolved and undissolved states are of primary interest. The chemical potential of a drug is the change in the Gibbs energy per changes in drug amount, holding all other factors (remaining chemical composition, temperature, and pressure) constant. 13) . T ,P ,n0 The change in chemical potential for the drug due to dissolution is given by μ1 = chemical potential of dissolved drug − chemical potential of undissolved drug .
J Pharm Sci 86:1–12 Hancock BC, Shamblin SL, Zografi G (1995) Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures. Pharm Res 12:799–806 Herschler B, Humer C (2012) FDA new drug approvals hit 16-year high in 2012. Reuters Online. 2012. com/article/2012/12/31/us-pharmaceuticals-fda-approvalsidUSBRE8BU0EK20121231. Accessed 31 Dec 2012 Hildebrand J, Scott R (1950) Solubility of non-electrolytes, 3rd edn. Rheinhold, New York Hill TL (1986) An introduction to statistical thermodynamics.
Any factor that makes the right-hand side of Eq. 17) more positive (or less negative) will work to increase the solubility of the drug. For a given drug and solvent, physical factors that influence the right-hand side include the heat of melting hM1 and the melting temperature TM1 of the “undissolved” solid form, both of which are different for the amorphous versus crystalline forms. The effect can be seen as follows. ” The solubility with respect to each form is given by Eq. 17), using the appropriate mole fraction, heat of melting, and melting temperature.