Oral Contraceptive Spray
The subject invention provides a liquid contraceptive formulation for oral transmucosal administration. The formulation comprises etonogestrel, optionally together with ethinyl estradiol but does not contain a matrix former or a percutaneous absorption promoter, which is a hydroxy acid or a salt thereof.
1 - 32 . (canceled)
33 . A liquid contraceptive formulation for oral mucosal administration comprising etonogestrel provided that the formulation does not contain a matrix former or a percutaneous absorption promoter which is a hydroxy acid or a salt thereof.
34 . The formulation of claim 33 , further comprising ethinyl estradiol.
35 . The formulation of claim 33 , wherein the contraceptively effective daily dose of etonogestrel is between 0.04 mg and 0.08 mg.
36 . The formulation of claim 35 , wherein the contraceptively effective daily dose of etonogestrel is between 0.04 and 0.075 mg.
37 . The formulation of claim 35 , wherein the contraceptively effective daily dose of etonogestrel is between 0.045 and 0.08 mg.
38 . The formulation of claim 35 , wherein the contraceptively effective daily dose of etonogestrel is between 0.045 mg and 0.075 mg.
39 . The formulation of claim 34 , wherein the contraceptively effective daily dose of etonogestrel is between 0.08 and 0.16 mg and of ethinyl estradiol is between 0.015 and 0.03 mg.
40 . The formulation of claim 39 , wherein the contraceptively effective daily dose of etonogestrel is between 0.09 and 0.145 mg and of ethinyl estradiol is between 0.02 and 0.03 mg.
41 . The formulation of claim 33 , wherein the liquid formulation is a spray formulation.
42 . A method of female contraception comprising administering to an oral mucosal surface of a female a contraceptively effective metered spray dose of a formulation of claim 33 .
43 . The method of claim 42 , wherein the contraceptively effective metered spray dose is administered daily in a continuous regimen.
44 . The method of claim 42 , wherein the contraceptively effective metered spray dose is administered daily for at least 21 days.
45 . The method of claim 42 , wherein the spray dose is administered sublingually.
46 . A contraceptive kit comprising a device comprising a liquid composition for oral mucosal administration by spraying, the composition comprising a contraceptively effective amount of etonogestrel for at least 7 daily metered doses.
47 . The contraceptive kit according to claim 46 , wherein the composition comprises a contraceptively effective amount of etonogestrel for at least 21 daily metered doses.
48 . The contraceptive kit of claim 46 , wherein the composition comprises a contraceptively effective amount of etonogestrel for at least 28, 29, 30 or 31 daily metered doses.
49 . The contraceptive kit of claim 46 , wherein the composition further comprises ethinyl estradiol.
50 . A drug delivery system for female contraception comprising a device comprising a liquid composition for oral mucosal administration by spraying comprising at least 7 metered daily doses each comprising between 0.04 mg and 0.08 mg of etonogestrel.
51 . The drug delivery system of claim 50 , wherein each metered dose comprises between 0.045 and 0.08 mg of etonogestrel.
52 . The drug delivery system of claim 50 , wherein each metered dose comprises between 0.04 and 0.075 mg of etonogestrel.
53 . The drug delivery system of claim 50 , wherein each metered dose comprises between 0.045 and 0.075 mg of etonogestrel.
54 . A drug delivery system for female contraception comprising a device comprising a liquid composition for oral mucosal administration by spraying comprising at least 7 metered daily doses each comprising between 0.08 and 0.16 mg etonogestrel and between 0.015 and 0.03 mg of ethinyl estradiol.
55 . The drug delivery system of claim 54 , wherein each metered dose comprises between 0.09 and 0.145 mg etonogestrel and between 0.02 and 0.03 mg of ethinyl estradiol.