Claims for Patent: 11,696,919

Summary for Patent: 11,696,919

Title:	Topical composition
Abstract:	The present invention relates to a composition for topical application comprising a polyaphron dispersion, the polyaphron dispersion comprising a continuous aqueous phase and at least one discontinuous oil phase,wherein the polyaphron dispersion comprises calcipotriol, betamethasone dipropionate, alpha-tocopherol and butylated hydroxyanisole, andwherein the composition has a pH of 7.75±0.5.
Inventor(s):	Nigel Crutchley, Michelle Georgiou, Stephen Lenon, Morten Praestegaard
Assignee:	MC2 Therapeutics Ltd
Application Number:	US16/982,281
Patent Claims:	1. A composition for topical application comprising a polyaphron dispersion, the polyaphron dispersion comprising a continuous aqueous phase and at least one discontinuous oil phase, wherein the composition comprises, by weight of the composition, from 0.001 to 0.01 wt % calcipotriol, betamethasone dipropionate, from 0.001 to 0.005 wt % alpha-tocopherol, and from 0.05 to 0.5 wt % butylated hydroxyanisole, and wherein the composition has a pH of 7.75±0.5. 2. A composition according to claim 1, wherein the composition has a pH of 7.75±0.25. 3. A composition according to claim 1 wherein the composition comprises, by weight of the composition: from 0.02 to 0.1 wt % betamethasone. 4. A composition according to claim 1 wherein: the at least 60 wt % of the calcipotriol is in at least one of said discontinuous oil phase(s); and/or the at least 60 wt % of the betamethasone dipropionate is at least 60 wt % of the betamethasone dipropionate is in at least one of said discontinuous oil phase(s); and/or the at least 60 wt % of the alpha-tocopherol is in at least one of said discontinuous oil phase(s); and/or the at least 60 wt % of the butylated hydroxyanisole is in at least one of said discontinuous oil phase(s). 5. A composition according to claim 1, wherein at least one of said discontinuous oil phase(s) comprises medium chain triglycerides and isopropyl myristate, wherein the isopropyl myristate and medium chain triglycerides are present in a weight ratio of from 3:1 to 12:1. 6. A composition according to claim 1, wherein the polyaphron dispersion further comprises a discontinuous phase comprising a non-solvent oil. 7. A composition according to claim 1, wherein said discontinuous oil phase(s) comprises a first discontinuous phase, a second discontinuous phase and, optionally a third discontinuous phase comprising mineral oil, at least 60 wt % of the calcipotriol is in the first discontinuous phase, at least 60 wt % of the betamethasone dipropionate is in the second discontinuous phase, and at least 60 wt % of the the alpha-tocopherol and the butylated hydroxyanisole are in the first discontinuous phase, or predominantly in the first and second discontinuous phases collectively. 8. A composition according to claim 7, wherein the first discontinuous phase and the second discontinuous phase each comprise the same pharmaceutically acceptable oil, wherein the pharmaceutically acceptable oil is a blend of caprilic capric triglycerides (CCT) and isopropyl myristate, and wherein the isopropyl myristate and caprilic capric triglycerides are present in a weight ratio of from 3:1 to 12:1. 9. A composition according to claim 1, wherein the continuous aqueous phase comprises at least 4 wt % isopropanol by weight of the composition. 10. A composition according to claim 1, wherein the composition is chemically stable for at least 6 months at 25° C.±2° C., as measured at 60% RH±5%; and/or wherein the composition is chemically stable for at least 12 months at 5° C.±3° C., as measured at 60% RH±5%. 11. A composition according to claim 6, wherein the non-solvent oil comprises mineral oil.