Assessment of degree of disorder (amorphicity) of lyophilized formulations of growth hormone using isothermal microcalorimetry

Drug Development and Industrial Pharmacy
Mitra Mosharraf

Abstract

When determining the degree of disorder of a lyophilized cake of a protein, it is important to use an appropriate analytical technique. Differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD) are the most commonly used thermoanalytical techniques for characterizing freeze-dried protein formulations. Unfortunately, these methods are unable to detect solid-state disorder at levels < 10%. Also, interpretation of DSC results for freeze-dried protein formulations can be difficult, as a result of the more complex thermal events occurring with this technique. For example, proteins can inhibit the thermally induced recrystallization of the lyophilized cake, resulting in potential misinterpretation of DSC degree of disorder results. The aim of this investigation was to study the use of isothermal microcalorimetry (IMC) in the assessment of degree of solid-state disorder (amorphicity) of lyophilized formulations of proteins. For this purpose, two formulations of growth hormone were prepared by lyophilization. These formulations consisted of the same amounts of protein, mannitol, glycine, and phosphate buffer, but differed in the freeze-drying procedure. After lyophilization, the recrystallization of the samples was st...Continue Reading

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Citations

Oct 15, 2013·Journal of Pharmaceutical Sciences·Sharmila Devi, Daryl Williams
Jan 9, 2007·International Journal of Pharmaceutics·Mitra MosharrafJonas Fransson
Mar 19, 2005·Drug Development and Industrial Pharmacy·Sitaram P Velega, Johan Carlfors

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