Pharmaceutical Amorphous Solid Dispersions by Ann Newman

By Ann Newman

Delivering a roadmap from early to past due levels of drug improvement, this publication overviews amorphous reliable dispersion know-how – a number one platform to convey poorly water soluble medicines, an immense hurdle in today’s pharmaceutical industry.

• Helps readers comprehend amorphous good dispersions and observe suggestions to specific pharmaceutical systems
• Covers actual and chemical houses, screening, scale-up, formula, drug product manufacture, highbrow estate, and regulatory considerations
• Has an appendix with constitution and estate info for polymers accepted in drug improvement and with advertised medicines built utilizing the amorphous offered dispersion approach
• Addresses worldwide regulatory concerns together with united states laws, ICH guidelines, and patent issues world wide

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Extra resources for Pharmaceutical Amorphous Solid Dispersions

Example text

If the rate of dissolution of the added amorphous API, upon contact with the aqueous medium, is slow relative to solid-state crystallization rates, it is also possible that solid API would undergo crystallization due to the plasticizing effects of the water and not attain significant supersaturation because of reduced amounts of amorphous API. As we have already seen, many polymers can form amorphous dispersions with an API and significantly inhibit solid-state crystallization by reducing molecular mobility and by direct interaction at nucleation sites.

Various details of the processing of amorphous dispersions and the ingredients used on a practical scale will be discussed throughout this book. Here, we wish to introduce some general concepts and issues that build on the principles discussed above. Depending on the physical and chemical characteristics of the API and polymer, amorphous solid dispersions are primarily prepared by either hot melt extrusion (HME) of a mixture of powdered API and polymer, or by the spray drying of a solution of API and polymer from a suitable volatile solvent.

The most widely used polymers include vinyl-pyrrolidone-based polymers, such as poly(vinyl pyrrolidone) (PVP) and the poly(vinyl pyrrolidone)-poly (vinyl acetate) copolymer (PVP-VA); cellulose-based polymers such as hydroxypropyl methylcellulose (HPMC) and hydroxyl propyl methylcellulose acetate-succinate; and methacrylate-based enteric coating polymer systems such as the Eudragits. The monographs in Chapter 14 and the Appendix A tables list various grades of these and other useful polymers with their corresponding Tg values.

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