Martínez ÁLO; Montes PM

Language: Spanish
References: 9
Page: 43-49
PDF size: 59.27 Kb.

ABSTRACT

As part of the pre-stability study of the Auranofin tablet pre-formulation, a chemical compatibility study was conducted using thermal analysis techniques such as the differential scanning calorimetry and the thermogravimetry. Prior to these studies, the active principle and each of the excipients were thermally characterized with the aid of the differential scanning calorimetry. Then, there proceeded to carry out the chemical compatibility study by preparing binary physical mixtures between the active principle and each of the excipients. Both methods showed that the active principle had a melting physical transition, not reported in the literature, which allowed calculating its purity aided by the differential scanning calorimetry. It was possible to infer from the calorimetry technique that there was not chemical incompatibility between the active principle and the studied excipients. By means of the activation energy estimation, the following order of thermal stability was set: Auranofin:PVP> Auranofin: lactose> Auranofin:explotab> Auranofin:estearate> Auranofin:aerosil> Auranofin:celullose. The use of these excipients was recommended for the preparation of the pharmaceutical formulation.

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