Pharmaceutical applications amorphous drugs

Thermal analysis is an extremely important analytical tool for the pharmaceutical industry. All transitions in materials involve the flow of heat (either into the sample during an endothermic event or out of the sample during an exothermic event) and DSC is the universal detector for measuring a wide variety of transitions in pharmaceutical materials. These include measurement of amorphous structure, crystallinity (and polymorphs), drug-excipient interaction and many other applications. 

Hancock BC, Shambhn 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 Oiiline. 2012. http //www.reuters.com/article/2012/12/31/us-pharmaceuticals-fda-approvals-idUSBRE8BU0EK20121231. 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. Dover, New York House JE (2007) Principles of chemical kinetics, 2nd edn. Elsevier, Amsterdam Khawam A, Flanagan DR (2006) Basics and applications of solid state kinetics a pharmaceutical perspective. J Pharm Sci 95 472 98... 

Through the HME process, one or more active pharmaceutical ingredients (API) are blended with at least one molten excipient in an extruder. The API in the extru-date (or HME product) may exist in its crystalline or amorphous state. Some of the applications of pharmaceutical HME include products designed to promote oral absorption, sustained release (either for oral delivery or implants Follonier et al. 1995), targeted release (Doelker 1993 Follonier et al. 1995 Andrews et al. 2008), and prevention of substance abuse (Oshlack et al. 2001 Arkenau-Maric and Bartholomaus 2008). Some of these applications are listed in Table 6.1, where the commercial status and the purpose of the HME process are summarized for several drug products. 

Loftsson T, Brewster ME (1996) Pharmaceutical applications of cyclodextrins. 1. Diug solubihza-tion and stabilization. J Pharm Sci 85(10) 1017-1025 MiUer MA, DiNunzio J, Matteucci ME, Ludher BS, Williams RO, Johnston KP (2012) Flocculated amorphous itraconazole nanoparticles for enhanced in vitro supersaturation and in vivo bioavailabUity. Drug Dev Ind Pharm 38(5) 557-570... 

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