Drug excipient interaction study with polymorphic forms of tibolone.
Powder mixtures (1:1) of tibolone polymorphic forms I (monoclinic) and II (triclinic) and excipients have been prepared and compacted. The samples were stored at 50 °C and 90% RH for one month and subsequently were evaluated using differential scanning calorimetry (DSC) and high-performance liquid...
Guardado en:
| Autores principales: | , , , |
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| Formato: | Articulo Comunicacion |
| Lenguaje: | Inglés |
| Publicado: |
2010
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| Materias: | |
| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/7936 http://www.latamjpharm.org/resumenes/29/3/LAJOP_29_3_2_6.pdf |
| Aporte de: |
| Sumario: | Powder mixtures (1:1) of tibolone polymorphic forms I (monoclinic) and II (triclinic) and excipients have been prepared and compacted. The samples were stored at 50 °C and 90% RH for one month and subsequently were evaluated using differential scanning calorimetry (DSC) and high-performance
liquid chromatography (HPLC). The results indicate that during the compaction, the applied pressure
reduced the chemical stability of tibolone in both polymorph forms. The triclinic form was more chemically unstable, both pure and in contact with excipients, than the monoclinic form. Lactose monohydrate
was shown to reduce chemical degradation for both forms. Ascorbyl palmitate was shown to affect
the tibolone stability differently depending on the polymorphic form used. |
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