Claims for Patent: 10,265,265

Summary for Patent: 10,265,265

Title:	Topical composition
Abstract:	A composition suitable for topical application comprising a continuous phase and at least one discontinuous phase, said composition comprising at least one polyaphron dispersion, at least one vitamin D or vitamin D analog and at least one corticosteroid.
Inventor(s):	Wheeler; Derek (Leatherhead, GB), Steele; David F. (Leatherhead, GB), Georgiou; Michelle (Leatherhead, GB), Sindet-Pedersen; Steen (Leatherhead, GB)
Assignee:	DRUG DELIVERY SOLUTIONS LIMITED (Leatherhead, Surrey, GB)
Application Number:	12/076,248
Patent Claims:	1. An aqueous composition suitable for topical application comprising: a polyaphron dispersion comprising one or more surfactant, a continuous phase, and a discontinuous phase, wherein the continuous phase comprises water and the discontinuous phase comprises a pharmaceutically acceptable oil that is immiscible or substantially immiscible with the continuous phase, wherein the discontinuous phase comprises droplets, and wherein the droplets are dispersed in the continuous phase; wherein the polyaphron dispersion further comprises (i) at least one of calcipotriol or calcipotriol monohydrate, and (ii) at least one of betamethasone or ester of betamethasone; wherein the (i) at least one of calcipotriol or calcipotriol monohydrate, and the (ii) at least one of betamethasone or the ester of betamethasone are present in the droplets; wherein the aqueous composition comprises from 5% to 90% by weight of the water based on the total weight of the aqueous composition; wherein the pH of the composition is from 7.0 to 8.5; and wherein the composition is constructed to provide no more than a 5% reduction in the amount of the calcipotriol or the calcipotriol monohydrate and no more than a 5% reduction in the amount of the betamethasone or the ester of betamethasone with respect to the original amounts after three months of storage in a sealed glass container at 40.degree. C. 2. An aqueous composition according to claim 1, wherein the oil comprises a monoglyceride, a diglyceride, a triglyceride, isopropyl myristate or a mixture thereof. 3. An aqueous composition according to claim 1, wherein the continuous phase comprises xanthane gum, or isopropyl alcohol and neutralized polyacrylic acid. 4. An aqueous composition according to claim 1, wherein the aqueous composition comprises from 15% to 90% by weight of water, based on the total weight of the composition. 5. An aqueous composition according to claim 1, wherein the aqueous composition comprises from 5% to 50% by weight of water, based on the total weight of the composition. 6. An aqueous composition according to claim 1, wherein the continuous phase comprises a compound of formula R.sub.1--OH where R.sub.1 is C.sub.1-C.sub.10 alkyl and/or a compound of formula HO--R.sub.2--H where R.sub.2 is (C.sub.2H.sub.4)n or (C.sub.3H6) n where n is 1 to 100. 7. An aqueous composition according to claim 6, wherein the continuous phase comprises propylene glycol, glycerol, ethanol, isopropyl alcohol or a mixture thereof. 8. An aqueous composition according to claim 1, wherein the pH of the aqueous composition is 7.25 to 7.75. 9. An aqueous composition according to claim 1, further comprising a gelling agent. 10. An aqueous composition according to claim 1, further comprising a permeation enhancer. 11. An aqueous composition according to claim 1, wherein the aqueous composition comprises from 60 to 95% by weight of the at least one discontinuous phase. 12. An aqueous composition according to claim 1, wherein the aqueous composition comprises from 5 to 40% by weight of the continuous phase. 13. An aqueous composition suitable for topical application comprising: a polyaphron dispersion comprising one or more surfactant, a continuous phase, and a discontinuous phase, wherein the continuous phase comprises water and the discontinuous phase comprises a pharmaceutically acceptable oil that is immiscible or substantially immiscible with the continuous phase, wherein the discontinuous phase comprises droplets, and wherein the droplets are dispersed in the continuous phase; wherein the polyaphron dispersion further comprises (i) at least one of calcipotriol or calcipotriol monohydrate, and (ii) at least one of betamethasone or ester of betamethasone; wherein the (i) at least one of calcipotriol or calcipotriol monohydrate, and the (ii) at least one of betamethasone or ester of betamethasone are present in the same droplets or are present in separate droplets; wherein the aqueous composition comprises from 5% to 90% by weight of the water based on the total weight of the aqueous composition; wherein the pH of the composition is from 7.0 to 8.5; and wherein the calcipotriol, the calcipotriol monohydrate, the betamethasone, and the ester of betamethasone are the sole pharmacologically active compounds in the aqueous composition. 14. An aqueous composition according to claim 13, wherein the oil comprises a monoglyceride, a diglyceride, a triglyceride, isopropyl myristate or a mixture thereof. 15. An aqueous composition according to claim 13, wherein the continuous phase comprises xanthane gum, or isopropyl alcohol and neutralized polyacrylic acid. 16. An aqueous composition according to claim 13, wherein the aqueous composition comprises from 15% to 90% by weight of water, based on the total weight of the composition. 17. An aqueous composition according to claim 13, wherein the aqueous composition comprises from 5% to 50% by weight of water, based on the total weight of the composition. 18. An aqueous composition according to claim 13, wherein the continuous phase comprises a compound of formula R.sub.1--OH where R.sub.1 is C.sub.1-C.sub.10 alkyl and/or a compound of formula HO--R.sub.2--H where R.sub.2 is (C.sub.2H.sub.4)n or (C.sub.3H6) n where n is 1 to 100. 19. An aqueous composition according to claim 18, wherein the continuous phase comprises propylene glycol, glycerol, ethanol, isopropyl alcohol or a mixture thereof. 20. An aqueous composition according to claim 13, wherein the pH of the aqueous composition is 7.25 to 7.75. 21. An aqueous composition according to claim 13, further comprising a gelling agent. 22. An aqueous composition according to claim 13, further comprising a permeation enhancer. 23. An aqueous composition according to claim 13, wherein the aqueous composition comprises from 60 to 95% by weight of the discontinuous phase. 24. An aqueous composition according to claim 13, wherein the aqueous composition comprises from 5 to 40% by weight of the continuous phase. 25. An aqueous composition according to claim 13, wherein the composition is constructed to provide no more than a 5% reduction in the amount of the calcipotriol or the calcipotriol monohydrate and no more than a 5% reduction in the amount of the betamethasone or the ester of betamethasone with respect to the original amounts after three months of storage in a sealed glass container at 40.degree. C. 26. An aqueous composition according to claim 1, wherein the aqueous composition comprises from 10% to 90% by weight of water, based on the total weight of the composition. 27. An aqueous composition according to claim 13, wherein the aqueous composition comprises from 10% to 90% by weight of water, based on the total weight of the composition. 28. An aqueous composition according to claim 1, wherein the aqueous composition comprises the calcipotriol and the ester of betamethasone. 29. An aqueous composition according to claim 28, wherein the ester of betamethasone comprises betamethasone dipropionate. 30. An aqueous composition according to claim 13, wherein the aqueous composition comprises the calcipotriol and the ester of betamethasone. 31. An aqueous composition according to claim 29, wherein the ester of betamethasone comprises betamethasone dipropionate.