Vaginally administratable progesterone-containing tablets and method for preparing same
OwnerVladimir Yankov, Azariah Jossifoffinventors
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Abstract
The present invention discloses a method for preparing a tablet for the vaginal administration of progesterone for systemic use. Tablets prepared by this method are also disclosed. Also disclosed are methods for vaginally administering such tablets three times a day to female patients being treated for infertility or other pregnancy-related conditions and disorders in an IVF program. In addition, disclosed are methods of administering a tablet containing 100 mg of natural progesterone at least three times per day to female patients who require stronger luteal support, e.g., older patients and overweight or obese patients, and patients in a donor oocyte program.
Claims25
A method of delivering progesterone to a female patient for hormone replacement therapy, which comprises placing in the vagina of said patient at least three times daily a tablet comprising progesterone as the active ingredient, pharmaceutically acceptable excipients or diluents, and an effervescent,
- and retaining said tablet in the vagina for a time efficacious to deliver said progesterone to said patient.
A method of delivering progesterone to a female patient, which comprises placing in the vagina of said patient at least three times daily a tablet comprising progesterone, a pharmaceutically acceptable excipient or diluent, and an effervescent, wherein said tablet is prepared by the steps of:
- (i) mixing water with progesterone to obtain wetted progesterone in the absence of pharmaceutically acceptable excipients or diluents;
- and drying said wetted progesterone to form dry progesterone;
- (ii) mixing said dry progesterone with
- (a) a pharmaceutically acceptable excipients or diluent and
- (b) an effervescent to form a mixture;
- and
- (iii) forming the tablet by direct compaction of said mixture, and retaining said tablet in said vagina until the tablet dissolves, wherein the tablet provides a Tmax upon dissolution of about six hours.
A method of delivering progesterone to a female patient, which comprises
- (a) placing in the vagina of the patient at least three times daily a vaginal tablet comprising micronized progesterone as the active ingredient, pharmaceutically acceptable excipients or diluents, and an effervescent;
- and
- (b) permitting the tablet to dissolve in the vagina, the tablet providing a Tmax of about six hours upon dissolution.
A method of delivering progesterone to a female patient, comprising placing in the vagina of said patient at least three times daily a tablet consisting essentially of progesterone as the active ingredient, pharmaceutically acceptable excipients or diluents, and an effervescent, and retaining said tablet in the vagina for a time efficacious to deliver said progesterone to said patient.
Dependencies are inferred from the claim text.