Topical composition
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, and wherein the composition has a pH of 7.75±0.5.
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.