Polymorph Form II of Tanaproget
AssigneeWyeth
InventorsMarc Sadler Tesconi, Mannching Sherry Ku, Yan Xu
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Abstract
Tanaproget polymorph Form II, processes for preparing tanaproget polymorph Form II, pharmaceutical compositions including tanaproget polymorph Form II, micronized tanaproget polymorph Form II, and processes for converting Form II to tanaproget Form I are provided. Also provided are methods of contraception, hormone replacement therapy, stimulation of food intake and treating or preventing uterine myometrial fibroids, benign prostatic hypertrophy, benign and malignant neoplastic disease, dysfunctional bleeding, uterine leiomyomata, endometriosis, polycystic ovary syndrome, or carcinomas and adenocarcinomas comprising administering polymorph Form II to a mammalian subject.
Claims14
A process for preparing polymorph Form I of tanaproget, said process comprising heating polymorph Form II of tanaproget.
A process for preparing polymorph Form I of tanaproget, said process comprising combining polymorph Form II of tanaproget with acetone and water.
A method of preparing a pharmaceutical composition comprising polymorph Form II of tanaproget, comprising combining polymorph Form II of tanaproget and one of more of:
- (i) a metal chelator;
- (ii) a pH adjuster;
- (iii) a surfactant;
- (iv) at least one filler;
- (v) a binder;
- (vi) a disintegrant;
- and
- (vii) a lubricant.
A method of contraception comprising administering polymorph Form II of tanaproget to a female of child bearing age.
A method of hormone replacement therapy comprising administering polymorph Form II of tanaproget to a female.
A method of stimulating food intake or treating or preventing uterine myometrial fibroids, benign prostatic hypertrophy, benign and malignant neoplastic disease, dysfunctional bleeding, uterine leiomyomata, endometriosis, polycystic ovary syndrome, or carcinomas and adenocarcinomas comprising administering polymorph Form II of tanaproget to a mammalian subject.
Dependencies are inferred from the claim text.