Topical pharmaceutical formulation
A composition for topical application of an NSAID comprises a solution or suspension of the NSAID in a carrier system comprising a polyhydric alcohol, a glycol ether and an ester of A higher fatty acid, the carrier system being present as a single phase at ambient temperatures. The NSAID may be diclofenac as diclofenac acid. The polyhydric alcohol may be a glycol such as isopropylene glycol and the glycol ether may be a diethylene glycol ether such as diethylene glycol monoethyl ether.
1. A composition for topical application of an NSAID, the composition comprising
a solution or suspension of the NSAID as active ingredient in a carrier system comprising
a polyhydric alcohol,
a glycol ether and
an ester of a higher fatty acid, wherein the composition is in a single phase at ambient temperatures, wherein water is essentially absent from the carrier system except in impurity amounts, and wherein the composition is not multiple phase.
2. The composition according to claim 1 , wherein the NSAID as the active ingredient is diclofenac.
3. The composition according to claim 2 , wherein diclofenac is present as diclofenac acid.
4. The composition according to claim 1 , wherein the polyhydric alcohol comprises a glycol.
5. The composition according to claim 1 , wherein the ester comprises a polar lipid.
6. The composition according to claim 5 , wherein the polar lipid comprises a branched-chain alkyl ester of a C 12 to C 20 saturated carboxylic acid.
7. The composition according to claim 1 , wherein the glycol ether comprises a diethylene glycol ether.
8. The composition according to claim 1 having the following amounts of the carrier system ingredients, percentages being given by weight:
polyhydric alcohol
5-70%
glycol ether
20-60%
ester
2-70%.
9. The composition according to claim 1 , wherein the amount of the NSAID is up to 10% by weight.
10. The composition according to claim 1 , wherein the ratio of polyhydric alcohol to glycol ether is in the range 80:20 to 30:70 with the ester ranging from 2 to 20% by weight.
11. The composition according to claim 10 , wherein the ratio of polyhydric alcohol to glycol ether is in the range 70:30 to 40:60 and the ester is in the range 3 to 10% by weight.
12. The composition according to claim 1 , further comprising a volatile solvent.
13. The composition according to claim 12 , wherein the volatile solvent comprises a lower alcohol containing up to 5 carbon atoms.
14. The composition according to claim 1 , further comprising an antinucleating agent.
15. The composition according to claim 1 , further comprising sensory signals.
16. The composition according to claim 4 , wherein the glycol is isopropylene glycol.
17. The composition according to claim 7 , wherein the diethylene glycol ether is diethylene glycol monoethyl ether.
18. The composition according to claim 9 wherein the amount of the NSAID is up to 5% by weight.
19. The composition according to claim 18 wherein the amount of the NSAID is up to 2.5% by weight.
20. The composition according to claim 13 , wherein the volatile solvent is ethanol or a liquid-phase ketone.
21. The composition according to claim 15 , wherein the sensory signals comprise menthol, eucalyptus oil or a mixture thereof.