Claims for Patent: 11,413,249

Summary for Patent: 11,413,249

Title:	Synthetic progestogens and pharmaceutical compositions comprising the same
Abstract:	Described herein are synthetic progestogens, such as 6.beta.,7.beta.:15.beta.,16.beta.-Dimethylene-3-oxo-17.alpha.-pregn-4-ene- -21,17-carbolactone, as well as pharmaceutical compositions comprising the same. Also described are methods of use.
Inventor(s):	Perrin; Philippe (Paris, FR), Velada; Jose Luis (Amersfoort, NL), Drouin; Dominique (Verrieres-le-Buisson, FR)
Assignee:	LABORATORIOS LEON FARMA SA (Leon, ES)
Application Number:	17/693,243
Patent Claims:	1. A method of providing effective contraception in a female patient, the method comprising: orally administering to the patient a daily pharmaceutical composition for 24 consecutive days, followed by orally administering to the patient a daily placebo dosage unit for 4 consecutive days, wherein the pharmaceutical composition comprises from 2 mg to 6 mg drospirenone and is formulated such that: (1) when orally administered under fasting conditions, the pharmaceutical composition provides a pharmacokinetic profile for the drospirenone comprising: (i) a mean T.sub.max ranging from 2.2 hours to 6 hours; (ii) a mean C.sub.max which is less than 30 ng/ml; and (iii) a mean AUC.sub.0h-tlast of at least 300 ng*h/ml; and (2) no more than 50% of the drospirenone initially present in the pharmaceutical composition is dissolved within 30 minutes if subjected to an in vitro dissolution test according to the USP XXIII Paddle Method; and wherein the pharmaceutical composition does not comprise estrogen. 2. The method of claim 1, wherein the mean T.sub.max ranges from 3 hours to 4 hours. 3. The method of claim 1, wherein the mean C.sub.max ranges from 15 ng/ml to less than 30 ng/ml. 4. The method of claim 1, wherein the mean AUC.sub.0h-tlast is at least 350 ng*h/ml. 5. The method of claim 1, wherein the pharmaceutical composition is formulated such that at least 55% of the drospirenone initially present in the pharmaceutical composition is dissolved within 4 hours if subjected to the in vitro dissolution test according to the USP XXIII Paddle Method. 6. The method of claim 1, wherein the amount of the drospirenone present is 3.5 mg. 7. The method of claim 1, wherein the amount of the drospirenone present is 4.0 mg. 8. The method of claim 1, wherein the amount of the drospirenone present ranges from 3.0 mg to 4.5 mg. 9. The method of claim 1, wherein the amount of the drospirenone present ranges from 3.0 mg to 3.5 mg. 10. The method of claim 1, wherein the amount of the drospirenone present ranges from 3.5 mg to 4.5 mg.