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Title of Journal: Pharm Res

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Abbravation: Pharmaceutical Research

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Springer US

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10.1016/0921-8696(94)92430-9

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1573-904X

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ATR/Raman and Fractal Characterization of HPBCD/Pr

Authors: Adamo Fini Francesca Ospitali Giorgio Zoppetti Nadia Puppini
Publish Date: 2008/07/03
Volume: 25, Issue: 9, Pages: 2030-2040
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Abstract

Characterization of hydroxypropylβcyclodextrin/progesterone HPBCD/P complex solid particles obtained from an aqueous solution by three different technological processes with the aim of preparing readytodissolve powders for injectable as well as solid oral formulations in progestinic therapyHPBCD/P complex in the 21 molar ratio was prepared in aqueous solution and obtained as dry solid particles by freezedrying by spraydrying and by fluidbed evaporation of the solvent The particles were characterized by μFTIR μRaman and Xray spectroscopy by thermal analysis differential scanning calorimetryDSC and thermogravimetryTGA by Karl Fischer KF titration by image and fractal analysis and by BET specific surface area analysis The structure of the complex was also defined by comparison of FTIR and Raman spectra of progesterone with those of pregnenolone and testosterone structurally related Dissolution tests were also performedPowders of the complex obtained by the three different methods are different in size and shape Particles obtained by freezedrying are flat and angular irregularly shaped without any relation to known geometrical solid figures Particles obtained by spraydrying are spherically shaped and display a very small size 510 μm with evident deformations and depression of the external surface due to the rapid evaporation of the solvent Particles obtained by fluid bed technique have intermediate sizes display a tridimensional structure and irregular surface with small and rounded protuberances Fractal dimension of the particle contour was found close to one unit for the microspheres obtained by spraydrying FTIR and Raman spectra confirm the occurrence of the complexation by the shift of representative bands of the two carbonyl groups in positions 3 and 20 of the complexed progesterone Xray diffractograms indicate the amorphous nature of all the types of particles also suggested by the absence of any melting peak of the drug in DSC thermograms The samples contain different amounts of humidity particles obtained by fluidbed method demonstrated nonporous in BET analysis Dissolution of different types of particles is complete after 3 min and only negligible differences could be appreciated among the three powders– μFTIR μRaman and Xray spectroscopy and the dissolution test did not reveal defined differences among the three different types of particles confirming occurrence of the complex in the solid state The spherical shape the very small size and the low value of the contour fractal dimension allows better technological performance of the particles obtained by spraydrying this drying process appears the most promising one to prepare dry particles of the HPBCD/P complex in view of its formulation in the fast preparation of extemporaneous injectable solutions and solid oral formulations intended for sublingual delivery

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