Topical composition comprising tacrolimus

1. A composition for topical application comprising: a first discontinuous phase comprising diisopropyl adipate and tacrolimus;

a second discontinuous phase comprising mineral oil; and a continuous aqueous phase;

wherein the tacrolimus is substantially soluble in the diisopropyl adipate and substantially insoluble in the mineral oil;

wherein the phases are physically and chemically distinct;

wherein the composition comprises less than 1 wt % surfactant by weight of the composition;

wherein the composition comprises less than 5 wt % by weight of the composition of C 1 -C 4 alcohols, polyethylene glycol, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, glycerol, diethylene glycol mono ethyl ether, propylene carbonate and mixtures of two or more thereof; and

wherein the composition is in the form of a lotion or cream.

2. The composition according to claim 1 , wherein the composition has a weight ratio of the second discontinuous phase to the first discontinuous phase of from 1:3 to 3:1.

3. The composition according to claim 1 , wherein the composition comprises from 10 to 30 wt % of the second discontinuous phase by weight of the composition.

4. The composition according to claim 1 , wherein the composition comprises at least 10 wt % water by weight of the composition.

5. The composition according to claim 1 , wherein the composition comprises at most two discontinuous phases.

6. The composition according to claim 1 , wherein the composition has a mean droplet diameter of from 1 to 30 μm.

7. The composition according to claim 1 , wherein the composition has a pH of from 3.5 to 6.

8. The composition according to claim 1 , wherein the composition is stable for at least 12 months at 25° C.±2° C., as measured at 60% RH±5%; and/or wherein the composition is stable for at least 6 months at 40° C.±3° C., as measured at 60% RH±5%.

9. The composition according to claim 1 for use in the treatment of human and/or animal skin by topical application.

10. A method of manufacturing a composition for topical application, the method comprising:

(i) providing a first oil comprising diisopropyl adipate and tacrolimus;

(ii) providing a second oil comprising mineral oil;

(iii) providing an aqueous component; and

(iv) dispersing the first oil and the second oil in the aqueous component to form a composition for topical application;

wherein the first oil is different from the second oil;

wherein the composition comprises a first discontinuous phase comprising the first oil, a second discontinuous phase comprising the second oil, and a continuous phase comprising the aqueous component;

wherein the tacrolimus is substantially soluble in the first oil and substantially insoluble in the second oil; and

wherein the phases are physically and chemically distinct;

wherein the composition comprises less than 1 wt % surfactant by weight of the composition;

wherein the composition comprises less than 5 wt % by weight of the composition of C 1 -C 4 alcohols, polyethylene glycol, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, glycerol, diethylene glycol mono ethyl ether, propylene carbonate and mixtures thereof; and

wherein the composition is in the form of a lotion or cream.

11. The composition according to claim 1 , having a total surfactant content of less than 0.5 wt % by weight of the composition.

12. The composition according to claim 1 , comprising less than 1 wt % by weight of the composition of C 1 -C 4 alcohols, polyethylene glycol, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, glycerol, diethylene glycol mono ethyl ether, propylene carbonate and mixtures thereof.

13. The composition according to claim 1 , comprising less than 0.5 wt % by weight of the composition of C 1 -C 4 alcohols, polyethylene glycol, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, glycerol, diethylene glycol mono ethyl ether, propylene carbonate and mixtures thereof.

14. The composition according to claim 1 , wherein the composition has a weight ratio of the second discontinuous phase to the first discontinuous phase of from 2:3 to 3:2.

15. The composition according to claim 1 , wherein the composition comprises from 15 to 25 wt % of the second discontinuous phase by weight of the composition.

16. The composition according to claim 1 , wherein the composition comprises at least 50 wt % water by weight of the composition.

17. The composition according to claim 1 , wherein the composition has a mean droplet diameter of from 1 to 20 μm.

18. The composition according to claim 1 , wherein the composition has a pH of from 4 to 5.5.