Differential scanning calorimetry as a screening technique in compatibility studies of DHEA extended release formulations.

摘要

Differential scanning calorimetry (DSC) was used as a screening technique for assessing the compatibility of DHEA as ternary complex with alpha-cyclodextrin and glycine (c-DHEA) with some excipients suitable for preparation of sustained-release matrix tablets by direct compression. The effect of sample mechanical treatment due to the compression process was also evaluated. In order to investigate the possible interactions between the components, the DSC curves of c-DHEA and each selected excipient were compared with those of their 1:1 w/w physical mixtures, before and after compression, in order to evaluate any possible solid state modification. FT-IR spectroscopy and X-ray powder diffractometry were used as complementary techniques to adequately implement and assist in interpretation of the DSC results. On the basis of DSC results, c-DHEA was found to be compatible with xanthan gum, hydroxypropylmethylcellulose, sodium starch glycolate (Explotab), polyvinylacetate-polyvinylpirrolidone (Kollidon SR) and sodium chloride. Some drug-excipient interaction was observed with dextrate hydrate (Emdex), mannitol and Magnesium stearate. Finally, the behaviour of the complete formulation, in the presence of all the excipients selected by means of the compatibility study, was investigated, in order to verify the absence of reciprocal interactions among the components.