Inhibitor of p38 map kinase
A dry powder pharmaceutical formulation for inhalation including a compound of formula (I): that is 1-(3-(tert-butyl)-1-(p-tolyl)-1H-pyrazol-5-yl)-3-(4-((2-((6-ethylpyrazin-2-yl)amino)pyridin-4-yl)methoxy)naphthalen-1-yl)urea or a pharmaceutically acceptable salt thereof, including all stereoisomers, tautomers and isotopic derivatives thereof; and lactose as a topically acceptable diluent. An inhaler device containing the dry powder pharmaceutical formulation is also described.
1. A dry powder pharmaceutical formulation for inhalation comprising: a compound of formula (I)
that is 1-(3-(tert-butyl)-1-(p-tolyl)-1H-pyrazol-5-yl)-3-(4-((2-((6-ethylpyrazin-2-yl)amino)pyridin-4-yl)methoxy)naphthalen-1-yl)urea or a pharmaceutically acceptable salt thereof, including all stereoisomers, tautomers and isotopic derivatives thereof; and
optionally, lactose as a topically acceptable diluent.
2. The dry powder pharmaceutical formulation according to claim 1 , wherein the compound of formula (I) has a mass median diameter (MMAD) of 1-10 μm.
3. The dry powder pharmaceutical formulation according to claim 1 , wherein the compound of formula (I) is micronized.
4. The dry powder pharmaceutical formulation according to claim 1 , wherein the formulation comprises magnesium stearate.
5. The dry powder pharmaceutical formulation according to claim 1 , wherein the compound of formula (I) in the form of its maleate salt.
6. The dry powder pharmaceutical formulation according to claim 2 , wherein the compound of formula (I) is in the form of its maleate salt.
7. The dry powder pharmaceutical formulation according to claim 3 , wherein the compound of formula (I) is in the form of its maleate salt.
8. The dry powder pharmaceutical formulation according to claim 4 , wherein the compound of formula (I) is in the form of its maleate salt.
9. The dry powder pharmaceutical formulation according to claim 1 , wherein the compound of formula (I) is in the form of its free base.
10. The dry powder pharmaceutical formulation according to claim 5 , wherein the compound of formula (I) is in the form of its Form 2 crystalline polymorph.
11. The dry powder pharmaceutical formulation according to claim 6 , wherein the compound of formula (I) is in the form of its Form 2 crystalline polymorph.
12. The dry powder pharmaceutical formulation according to claim 7 , wherein the compound of formula (I) is in the form of its Form 2 crystalline polymorph.
13. The dry powder pharmaceutical formulation according to claim 8 , wherein the compound of formula (I) is in the form of its Form 2 crystalline polymorph.