Download Amorphous Solid Dispersions: Theory and Practice by Navnit Shah, Harpreet Sandhu, Duk Soon Choi, Hitesh Chokshi, PDF

By Navnit Shah, Harpreet Sandhu, Duk Soon Choi, Hitesh Chokshi, A. Waseem Malick

This quantity bargains a accomplished consultant at the idea and perform of amorphous stable dispersions (ASD) for dealing with demanding situations linked to poorly soluble medications. In twenty-three inclusive chapters, the e-book examines thermodynamics and kinetics of the amorphous country and amorphous reliable dispersions, ASD applied sciences, excipients for stabilizing amorphous good dispersions resembling polymers, and ASD production applied sciences, together with spray drying, scorching soften extrusion, fluid mattress layering and solvent-controlled micro-precipitation expertise (MBP). every one expertise is illustrated via particular case experiences. moreover, committed sections conceal analytical instruments and applied sciences for characterization of amorphous reliable dispersions, the prediction of long term balance, and the improvement of appropriate dissolution equipment and regulatory facets. The e-book additionally highlights destiny applied sciences at the horizon, reminiscent of supercritical fluid processing, mesoporous silica, KinetiSol®, and using non-salt-forming natural acids and amino acids for the stabilization of amorphous systems.

Amorphous sturdy Dispersions: concept and perform is a helpful connection with pharmaceutical scientists attracted to constructing bioavailable and therapeutically powerful formulations of poorly soluble molecules on the way to increase those applied sciences and strengthen larger medicinal drugs for the future.

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Extra info for Amorphous Solid Dispersions: Theory and Practice

Example text

In that case, Eq. 30) can describe surface limited dissolution, as opposed to diffusion-limited dissolution. 7 Implications for Physical Stability Amorphous forms show a tendency toward crystallization as the means to reduce the total energy content. The rate of conversion must be slow enough to provide an intended shelf life for amorphous forms to be commercially viable. In a pure substance, crystallization may occur after short translational motions; whereas in ASD, longer diffusion motions are required.

In the L-J model, which is one-dimensional in r, switching locations would require molecules going through zero separation, which would require infinite energy in theory. ) With these considerations in mind, a hypothetical behavior of a neat API sample is shown in Fig. 8, which plots the potential energy versus the average distance as a dotted-solid line combination (through e-a-b-d-f ). This line will not be exactly proportional to any L-J curve because the relative positions of the molecules in 3d will change as a result of thermal expansion.

When the eutectic is exposed to water or the gastrointestinal (GI) fluids, the carrier will dissolve 2 Theoretical Considerations in Developing Amorphous Solid Dispersions 37 Fig. 1 Phase diagram of a simple eutectic system rapidly and release fine crystals of the drug. Through the large surface area and the improved wettability from the carrier, the dissolution rate of theAPI will be enhanced. 2 Solid Solutions Solid solutions are formed when a solute is nonstoichiometrically incorporated into the crystal lattice of the solvent (Moore and Wildfong 2009).

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