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Polymorphism of progesterone

Influence of the carrier and of the solid dispersion manufacturing processes. A calorimetric and radiocrystallographic study

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Abstract

Solid dispersions are used in pharmaceutical technology in order to improve solubility and/or dissolution kinetics of poorly water soluble drugs [1, 2, 3]. A preliminary study concerning progesterone structure after melting revealed the existence of a drug polymorphism after cooling, and gave the opportunity to specify the manufacturing conditions in order to obtain the stable form of this hormone [4]. In this work, two different types of progesterone solid dispersion have been compared. The first one is obtained by a slow cooling rate of the drug in the presence of polyoxyethylene glycol 6000 and the second one after quenching in the presence of saccharose distearate.

DSC and radiocrystallographic studies of the solid dispersions served to specify the nature of the compounds obtained and to characterize the physical structure of the hormone in the solidified melts.

Zusammenfassung

Dispersionen werden in der pharmazeutischen Technologie angewendet zur Erhöhung der Bioverfügbarkeit schlecht wasserlöslicher Wirksubstanzen. In einer Voruntersuchung konnte durch Schmelzen von Progesteron gezeigt werden, dass polymorphe Formen existieren. Unterschiedliche ProgesteronprÄparate wurden durch Mischungen einerseits mit Polyethylenglykol 6000 und andererseits mit Saccharosedistearat hergestellt, wobei verschiedene Erstarrungsprozesse angewendet wurden.

Die Methoden der DSC und der Röntgendiffraktion wurden zur Charakterisierung der erhaltenen Festkörper eingesetzt.

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Authors and Affiliations

  1. Laboratoire de Pharmacie Galenique, UFR de Medicine-Pharmacie de Rouen, Avenue de I'Universite, B.P. 97, 76803, Saint Etienne Rouvray Cedex, France

    R. Duclos & A. M. Orecchioni

  2. Laboratoire L. E. C. A. P., UFR des Sciences et Techniques de Rouen, B. P. 118, 76123, Mont-Saint-Aignan Cedex, France

    J. M. Saiter & J. Grenet

Authors
  1. R. Duclos
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  2. J. M. Saiter
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  3. J. Grenet
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  4. A. M. Orecchioni
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Additional information

The authors wish to express their thanks to Mrs. Odile Lopez and to Mr. Maurice Liziard for their technical assistance.

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Duclos, R., Saiter, J.M., Grenet, J. et al. Polymorphism of progesterone. Journal of Thermal Analysis 37, 1869–1875 (1991). https://doi.org/10.1007/BF01912217

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  • DOI: https://doi.org/10.1007/BF01912217

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