Claims for Patent: 10,849,847

Summary for Patent: 10,849,847

Title:	Compositions and methods for treating rosacea and acne
Abstract:	Provided are compositions and methods for treating rosacea and acne. Specifically, a gel or foam composition having a tetracycline antibiotic and uses thereof for treating rosacea and acne are provided.
Inventor(s):	Tamarkin; Dov (Ness Ziona, IL), Eini; Meir (Ness Ziona, IL), Hazot; Yohan (Rehovot, IL), Shirvan; Mitchell (Kfar Saba, IL), Kedem; Tal Hetzroni (Rehovot, IL), Keynan; Rita (Rehovot, IL)
Assignee:	Foamix Pharamaceuticals Ltd. (Rehovot, IL)
Application Number:	16/508,611
Patent Claims:	1. A method for treating acne vulgaris in a subject in need thereof, comprising topically administering to the subject a therapeutically effective amount of a breakable foam obtained from a foamable composition once daily for at least seven consecutive days, wherein the foamable composition comprises: (a) a hydrophobic vehicle comprising: (i) about 70% to about 90% by weight of a hydrophobic solvent comprising: about 35% w/w to about 65% w/w of soybean oil; about 16.5% w/w to about 30.7% w/w of coconut oil; about 3.5% w/w to about 6.5% w/w of cyclomethicone; and about 1% w/w to about 6% w/w of light mineral oil; and (ii) about 10% to about 22% by weight of a foamer complex comprising: about 2.5% w/w to about 4.6% w/w of cetostearyl alcohol; about 2% w/w to about 4% w/w of stearic acid; about 1.8% w/w to about 3.3% w/w of myristyl alcohol; about 1% w/w to about 3% w/w of hydrogenated castor oil; about 1% w/w to about 3% w/w of beeswax; about 1% w/w to about 2% w/w of stearyl alcohol; and about 0.5% w/w to about 1.5% w/w of behenyl alcohol; (iii) minocycline in an amount ranging from about 1% w/w to about 4% w/w; and (b) a propellant in an amount ranging from about 3% to about 25% w/w; wherein the subject is between 15 years old and 16 years and 11 months old, wherein the foamable composition does not comprise silicon dioxide (SiO.sub.2), and wherein the minocycline is present in plasma from the subject at a concentration of at most 1.9 ng/mL before applying the seventh day of treatment with the therapeutically effective amount of the breakable foam. 2. The method of claim 1, wherein the minocycline is present in plasma from the subject at a concentration of about 1.8 ng/mL 3 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam. 3. The method of claim 1, wherein the minocycline is present in plasma from the subject at a concentration of about 1.8 ng/mL 12 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam. 4. The method of claim 1, wherein the minocycline is present in plasma from the subject at a concentration of about 1.6 ng/mL 16 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam. 5. The method of claim 1, wherein the minocycline is present in plasma from the subject at a concentration of about 1.5 ng/mL 24 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam. 6. The method of claim 1, wherein a maximum measured plasma concentration in the subject is reached about 6 hours after a daily topical administration. 7. The method of claim 1, wherein the concentration of minocycline present in plasma from the subject at day 8 is about the same or less than the concentration before applying the seventh day of treatment. 8. The method of claim 1, wherein the plasma concentration is a mean concentration. 9. A method of treating acne vulgaris in a subject in need thereof, comprising topically administering to the subject a therapeutically effective amount of a breakable foam obtained from a foamable composition once daily for at least seven consecutive days, wherein the foamable composition comprises: (a) a hydrophobic vehicle comprising: (i) about 70% to about 90% by weight of a hydrophobic solvent comprising: about 35% w/w to about 65% w/w of soybean oil; about 16.5% w/w to about 30.7% w/w of coconut oil; about 3.5% w/w to about 6.5% w/w of cyclomethicone; and about 1% w/w to about 6% w/w of light mineral oil; and (ii) about 10% to about 22% by weight of a foamer complex comprising: about 2.5% w/w to about 4.6% w/w of cetostearyl alcohol; about 2% w/w to about 4% w/w of stearic acid; about 1.8% w/w to about 3.3% w/w of myristyl alcohol; about 1% w/w to about 3% w/w of hydrogenated castor oil; about 1% w/w to about 3% w/w of beeswax; about 1% w/w to about 2% w/w of stearyl alcohol; and about 0.5% w/w to about 1.5% w/w of behenyl alcohol; (iii) minocycline in an amount ranging from about 1% w/w to about 4% w/w; and (b) a propellant in an amount ranging from about 3% to about 25% w/w; wherein the subject is between 15 years old and 16 years and 11 months old, wherein the foamable composition does not comprise silicon dioxide (SiO.sub.2), wherein the minocycline is present in plasma from the subject, and wherein an area under a concentration-time curve of the amount of minocycline in the plasma from the subject is 40.8 (ng/mL)*hour or less, as determined during a 24 hour period following a topical administration of the therapeutically effective amount of the breakable foam. 10. The method of claim 9, wherein the area is a mean area.