Granted Patent
B2
US 12,440,499 · App. 18/123,828 · Granted Oct 14, 2025
Topical composition
Inventors:
Nigel Crutchley (Guildford, GB); Michelle Georgiou (Guildford, GB); Stephen Lenon (Guildford, GB); Morten Praestegaard (Guildford, GB)
Assignee:
MC2 Therapeutics Limited
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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, and wherein the composition has a pH of 7.75±0.5.
Claims (29)
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 polyaphron dispersion comprises calcipotriol, betamethasone dipropionate, alpha-tocopherol and butylated hydroxyanisole,
wherein said at least one discontinuous oil phase comprises caprylic capric triglycerides and isopropyl myristate, wherein the isopropyl myristate and caprylic capric triglycerides are present in a weight ratio of from 4:1 to 8:1, 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 0.001 to 0.01 wt % of the calcipotriol; and/or
from 0.02 to 0.1 wt % of the betamethasone dipropionate; and/or
from 0.001 to 0.005 wt % of the alpha-tocopherol; and/or
from 0.05 to 0.5 wt % of the butylated hydroxyanisole.
4. A composition according to claim 1 wherein:
at least 60 wt % of the calcipotriol is in said at least one discontinuous oil phase; and/or
at least 60 wt % of the betamethasone dipropionate is in said at least one discontinuous oil phase; and/or
at least 60 wt % of the alpha-tocopherol is in said at least one discontinuous oil phase; and/or
at least 60 wt % of the butylated hydroxyanisole is in said at least one discontinuous oil phase.
5. A composition according to claim 1 , wherein the polyaphron dispersion further comprises a discontinuous phase comprising a non-solvent oil.
6. A composition according to claim 1 , wherein said at least one discontinuous oil phase comprises a first discontinuous phase, a second discontinuous phase and, optionally a third discontinuous phase comprising mineral oil,
wherein at least 60 wt % of the calcipotriol is in the first discontinuous phase,
wherein at least 60 wt % of the betamethasone dipropionate is in the second discontinuous phase, and
wherein at least 60 wt % of the alpha-tocopherol and the butylated hydroxyanisole are in the first discontinuous phase, or in the first and second discontinuous phases collectively.
7. A composition according to claim 1 , wherein the continuous aqueous phase comprises at least 4 wt % isopropanol by weight of the composition.
8. 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%.
9. 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 and betamethasone dipropionate,
wherein said at least one of discontinuous oil phase comprises caprylic capric triglycerides and isopropyl myristate, and
wherein the isopropyl myristate and caprylic capric triglycerides are present in a weight ratio of from 4:1to 8:1.
10. A composition accordingly to claim 9 , further comprising alpha-tocopherol.
11. A method of treating psoriasis in a human or animal subject comprising administering to a subject in need thereof an effective amount of a composition accordingly to claim 1 .
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 8, 2025
From: CRUTCHLEY, NIGEL; GEORGIOU, MICHELLE; LENON, STEPHEN; PRAESTEGAARD, MORTEN
To: MC2 THERAPEUTICS LIMITED
Reel/Frame 072185/0807 →
CHANGE OF ADDRESS
Recorded Sep 8, 2025
From: MC2 THERAPEUTICS LIMITED
To: MC2 THERAPEUTICS LIMITED
Reel/Frame 072851/0565 →
Priority Claims (1)
EP 18162664
· Mar 19, 2018
· regional
Continuity (2)
Continuation
16982281
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