Claims for Patent: 11,191,740

Summary for Patent: 11,191,740

Title:	Methods for treating inflammatory skin conditions
Abstract:	The present application relates to a method of treating an inflammatory skin condition by administering a pharmaceutical composition comprising a reduced dose of minocycline to a subject in need thereof, wherein said administration provides an effective plasma or interstitial fluid concentration of minocycline for treating the inflammatory skin condition.
Inventor(s):	Swati KULKARNI, Bijay Kumar Padhi, Shanvas ALIKUNJU, Rajeev Singh Raghuvanshi, Srinivas Ramchandra SIDGIDDI, Anirudh GAUTAM
Assignee:	Journey Medical Corp
Application Number:	US16/241,754
Patent Claims:	1. A method of treating rosacea in a subject in need thereof, comprising administering an oral pharmaceutical composition comprising a body-weight independent dose of about 10 mg to about 40 mg of minocycline to a subject in need thereof, wherein the said composition results in a maximum plasma concentration (CmaxP) of about 55 ng/ml to about 450 ng/ml of minocycline, wherein said composition provides equivalent or improved efficacy as compared to the oral doxycycline composition comprising 40 mg of doxycycline, wherein said composition reduces the IGA score of the subject by at least one grade compared to the IGA score before treatment and wherein said composition reduces the number of inflammatory lesions of the subject by at least about 60% as compared to the number of inflammatory lesions before treatment. 2. The method of claim 1, wherein said composition comprises about 20 mg of minocycline. 3. The method of claim 1, wherein said composition comprises about 40 mg of minocycline. 4. The method of claim 1, wherein said rosacea is selected from the group consisting of: a papulopustular rosacea, an erythematotelangiectatic rosacea, a phymatous rosacea, an ocular rosacea, acne rosacea, a pyoderma faciale, a rosacea conglobata, a mild rosacea, a moderate rosacea, a severe rosacea, a mild to moderate rosacea, and a moderate to severe rosacea. 5. The method of claim 1, wherein said administration reduces the IGA score to an equal or greater extent as compared to administration of an oral doxycycline composition comprising 40 mg of doxycycline. 6. The method of claim 1, wherein said administration reduces the number of inflammatory lesions to an equal or greater extent as compared to administration of an oral doxycycline composition comprising 40 mg of doxycycline. 7. The method of claim 1, wherein said composition, upon oral administration for about 3 weeks or less, exhibits a fluctuation index (FISSP) of about 0.9 to about 1.3 in plasma. 8. The method of claim 1, wherein said composition upon oral administration for about 3 weeks or less, exhibits at least one of the following pharmacokinetic parameters, when measured in plasma samples: a) CmaxSSP/D of about 5 ng/ml/mg to about 12 ng/ml/mg; and b) AUC0-tSSP/D of about 60 ng/ml/mg to about 114 ng/ml/mg. 9. The method of claim 1, wherein said composition upon oral administration for about 3 weeks or less, exhibits a ratio of minocycline exposure in interstitial fluid to plasma (AUC0-tSSIF/AUC0-tSSP) of at least about 10% higher, as compared to oral administration of a doxycycline composition comprising 40 mg of doxycycline. 10. The method of claim 1, wherein said composition, upon oral administration for about 3 weeks or less, exhibits at least about a 30% lower fluctuation index (FISSP) [(CmaxSSP−CminSSP)/CavgSSP] in plasma, as compared to oral administration of a doxycycline composition comprising 40 mg of doxycycline. 11. The method of claim 1, wherein said composition, upon oral administration for about 3 weeks or less, exhibits a CmaxSSP of at least about 10% lower, as compared to oral administration of a doxycycline composition comprising 40 mg of doxycycline. 12. The method of claim 1, wherein said composition, upon oral administration for about 3 weeks or less, exhibits at least about a 10% reduction in a coefficient of variance (CV %) of CmaxSSP, as compared to oral administration of a doxycycline composition comprising 40 mg of doxycycline. 13. The method of claim 1, wherein said composition, upon oral administration for about 3 weeks or less, exhibits at least about a 10% reduction in a coefficient of variance (CV %) of minocycline exposure (AUC0-tSSP) in plasma, as compared to oral administration of a doxycycline composition comprising 40 mg of doxycycline. 14. The method of claim 1, wherein said composition, upon oral administration for about 3 weeks or less, exhibits a plasma concentration ratio (CmaxSSP:CmaxP) of at least about 30% lower, as compared to oral administration of a doxycycline composition comprising 40 mg of doxycycline. 15. The method of claim 1, wherein said composition, upon oral administration for about 3 weeks or less, exhibits a plasma concentration ratio (CmaxSSP:CmaxP) of at least about 0.9. 16. The method of claim 1, wherein said composition, upon oral administration for about 3 weeks or less, exhibits a CavgSSP of at least about 20% lower, as compared to oral administration of a doxycycline composition comprising 40 mg of doxycycline. 17. The method of claim 1, wherein said composition exhibits a Cmax in the subject's plasma at about 1.75 hours after administration. 18. The method of claim 1, wherein said composition upon administration exhibits a CmaxSSP of minocycline of not more than about 500 ng/ml.