IP Library › Patent Application 17105316
Patent Application
App. No. 17/105,316

METHODS OF SIZING 6B,7B:15B,16B-DIMETHYLENE-3-OXO-17A-PREGN-4-ENE-21,17-CARBOLACTONE PARTICLES AND COMPOSITIONS COMPRISING THE SAME

Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US None
App. No.
17/105,316
Abstract

Described herein are methods to size particles of 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone, as well as compositions comprising 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone particles having defined particle size distributions. Also described are methods of use of the resulting particles.

Claims (27)

1 .- 3 . (canceled)

4 . A composition comprising:

6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone in the form of particles that have a median particle size ranging from 10 micrometers (μm) to 60 μm, the 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone being present in an amount ranging from 2 milligrams (mg) to 6 mg;

wherein the composition does not comprise estrogen;

wherein the composition does not comprise a significant amount of a surfactant;

wherein the composition is formulated such that no more than 50% of the 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone initially present in the composition is dissolved within 30 minutes if subjected to an in vitro dissolution test according to the USP XXIII Paddle Method; and

wherein the composition is formulated such that at least 50% of the 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone initially present in the composition is dissolved within 4 hours if subjected to the in vitro dissolution test according to the USP XXIII Paddle Method.

5 . The composition of claim 4 , further comprising one or more excipients.

6 . The composition of claim 5 , wherein the one or more excipients comprises a filler.

7 . The composition of claim 4 , wherein the one or more excipients comprises a lubricant.

8 . The composition of claim 4 , wherein the one or more excipients comprises a binder.

9 . The composition of claim 4 , wherein the one or more excipients comprises a glidant.

10 . The composition of claim 4 , wherein the composition further comprises one or more additional excipients.

11 . The composition of claim 10 , wherein the one or more additional excipients are present in an amount ranging from 0.1% to 10%, by weight, of the composition.

12 . The composition of claim 4 , wherein the composition is formulated as a tablet or a capsule.

13 . The composition of claim 12 , wherein the composition further comprises a coating.

14 . (canceled)

15 . The composition of claim 4 , wherein the 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone is in the form of particles that have a median particle size ranging from 10 μm to 30 μm.

16 . The composition of claim 4 , wherein the particles have:

(i) a d 90 particle size of less than 100 μm; and

(ii) a d 10 particle size of more than 3 μm.

17 .- 19 . (canceled)

20 . The composition of claim 4 , wherein the composition does not comprise the surfactant.

21 . (canceled)

22 . The composition of claim 4 , wherein the amount of 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone present ranges from 3.0 mg to 3.5 mg.

23 . The composition of claim 4 , wherein the amount of 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone present is about 3.5 mg or about 4.0 mg.

24 . (canceled)