Use of isothermal microcalorimetry in pharmaceutical preformulation studies - Part II. Amorphous phase quantification in a predominantly crystalline phase

摘要

Low amounts of amorphous phase present in predominantly crystalline powders were quantified by using various analytical techniques with an emphasis on the use of Isothermal Perfusion Microcalorimetry. The amorphous phase was plasticized using ethanol vapor and enthalpy of re-crystallization of amorphous phase was used for generation of a calibration curve. Amorphous content as low as 5% was quantified using this technique. Although baseline noise was very low, additional processes occurring during re-crystallization confounded quantification of lower amorphous fractions.