Vaginally administrable progesterone containing tablets and method for preparing the same
AssigneeFerring Pharmaceuticals A/S
InventorAzariah Jossifoff
Life of this patent
Estimating the term…
Abstract
The present invention provides a method for preparing a tablet for the vaginal administration of progesterone for systemic use. The method comprises first mixing water with micronized progesterone, the total amount of water mixed with said micronized progesterone not exceeding the maximum wetting capacity of the micronized progesterone, drying the wetted, micronized progesterone; mixing the dry micronized progesterone with other pharmaceutically acceptable excipients or diluents; and; forming a tablet by direct compaction of the dry micronized progesterone. Tablets prepared by this method are also provided.
Claims25
A method for preparing a tablet for the vaginal administration of:
- progesterone for systemic use, comprising the steps of:
- (i) preparing a mixture consisting of water and micronized progesterone to obtain wetted micronized progesterone;
- (ii) drying the wetted micronized progesterone to obtain dry micronized progesterone;
- (iii) mixing the dried micronized progesterone with at least one pharmaceutically acceptable excipient or diluent to form a second mixture;
- and
- (iv) forming a tablet by direct compaction of the second mixture.
A method for preparing a tablet useful for vaginal administration of progesterone which comprises (i) mixing water with micronized progesterone, prior to adding any other ingredients, to obtain wetted micronized progesterone;
- (ii) drying the wetted micronized progesterone;
- (iii) mixing a pharmaceutically acceptable excipient or diluent with the micronized progesterone after the drying step to form a tabletting mixture;
- and
- (iv) directly compacting the tabletting mixture to form the tablet.
A method for preparing a tablet for the vaginal administration of progesterone for systemic use, comprising the following sequential steps:
- (i) first mixing water with micronized progesterone, in the absence of a pharmaceutically acceptable excipient or diluent, to obtain wetted micronized progesterone;
- (ii) drying said wetted micronized progesterone to form dry micronized progesterone;
- (iii) mixing said dry micronized progesterone with
- (a) a pharmaceutically acceptable non effervescent excipient or diluent;
- and
- (b) an effervescent to form a mixture;
- and
- (iv) forming a tablet by direct compaction of said mixture.
Dependencies are inferred from the claim text.