PRODUCT LITERATURE
Water soluble progesterone–hydroxypropyl-b-cyclodextrin complex for injectable formulations
The use of cyclodextrin to increase the water solubility of progesterone (P) was described by Pitha as a complex with b-cyclodextrin and derivates
to obtain a water soluble formulation (Pitha, J.: US patent n. 4,727,064). Hydroxypropyl-b-cyclodextrin (HPBCD) has a high water solubility which allows the
solubilization of high quantity of P. Considering a 1:2 guess/host complex stoichiometry it is possible to obtain up to 50 mg/ml of P concentration, which is a
considerable dosage for drug development in the progesterone therapy. In our drug development the P/ HPBCD complex in water showed the formation of a
light precipitate during stability ICH conditions.
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