AEROSOL FORMULATION, CANISTER, AND INHALER CONTAINING THE FORMULATION, AND METHOD OF USE

1 . A pressurized canister comprising a formulation, the formulation comprising

one or more active pharmaceutical ingredients,

one or more propellants, and

PVP; wherein

the interior of the pressurized canister is coated with a coating selected from a poly(fluoroalkylene) polymer, a copolymer of poly(fluoralkylenes), and the condensation product of a first coating layer comprising a silane having one or more reactive silane groups and a second coating layer deposited on the first coating layer and comprising an at least partially fluorinated compound having at least one reactive silane group.

2 . The pressurized canister of claim 1 , wherein the one or more active pharmaceutical ingredients has at least one amine moiety and at least one alcohol moiety.

3 . The pressurized canister of claim 1 , wherein the one or more active pharmaceutical ingredients comprises umeclidinium or a pharmaceutically acceptable salt thereof, wherein the salt is optionally bromide, vilanterol or a pharmaceutically acceptable salt thereof, wherein the salt is optionally trifenatate, or a combination of the foregoing.

4 . The pressurized canister of claim 1 , wherein the PVP has a K-value of 10 and 95.

5 . The pressurized canister of claim 1 , wherein the PVP is about 0.005% to about 0.05% by weight of the formulation.

6 . The pressurized canister of claim 1 , wherein the coating comprises a copolymer of poly(fluoralkylenes).

7 . The pressurized canister of claim 6 , wherein the copolymer of poly(fluoroalkylenes) is a copolymer of a C2-C4 fluoroalkylene and a C3-C6 fluoroalkylene.

8 . The pressurized canister of claim 6 , wherein the copolymer of poly(fluoroalkylenes) is a copolymer of hexafluoropropylene and tetrafluoroethylene.

9 . The pressurized canister of claim 1 , wherein the coating comprises the condensation product of a second coating layer that is a perfluoropolyether silane according to Formula Ia in which R f comprises from 20 to 40 linked repeating units

Formula Ia:

R f [Q 1 -[C(R) 2 —Si(Y) 3−x (R 1a ) x ] y ] z

wherein:

R f is a monovalent or multivalent polyfluoropolyether moiety;

Q 1 is an organic divalent or trivalent linking group;

each R is independently hydrogen or a C1-4 alkyl group;

each Y is independently a hydrolysable group;

R 1a is a C1-8 alkyl or phenyl group;

x is 0 or 1 or 2;

y is 1 or 2; and

z is 1, 2, 3, or 4,

and a first coating layer comprising a silane having two or more reactive silane groups separated by an organic linker group.

10 . The pressurized canister of claim 1 , wherein the coating comprises the condensation product of a first coating layer comprising a silane polymer having one or more reactive silane groups and a second coating layer deposited on the first coating layer wherein the second coating layer comprises a polyfluoropolyether silane of the formula

R f Q 1 v [Q 2 w -[C(R 4 ) 2 —Si(X) 3−x (R 5 ) x ] y ] z

wherein:

R f is a polyfluoropolyether moiety;

Q 1 is a trivalent linking group;

each Q 2 is an independently selected organic divalent or trivalent linking group;

each R 4 is independently hydrogen or a C 1-4 alkyl group;

each X is independently a hydrolysable or hydroxyl group;

R 5 is a C 1-8 alkyl or phenyl group; and

v and w are independently 0 or 1, x is 0 or 1 or 2; y is 1 or 2; and z is 2, 3, or 4.

v and w are independently 0 or 1, x is 0 or 1 or 2; y is 1 or 2; and z is 2, 3, or 4.

11 . The pressurized canister of claim 9 , wherein Formula Ia is Formula Ib

Formula Ib

R f [Q 1 -[C(R) 2 —Si(O—) 3−x (R 1a ) x ] y ] z

wherein:

R f is a monovalent or multivalent polyfluoropolyether segment;

Q 1 is an organic divalent or trivalent linking group;

each R is independently hydrogen or a C1-4 alkyl group; and

R 1a is a C1-8 alkyl or phenyl group.

12 . The pressurized container of claim 1 , wherein the formulation contains no more than a trace amount of any component other than the one or more active pharmaceutical ingredients, the one or more propellants, and the PVP.

13 . The pressurized container of claim 12 , further comprising a trace amount of water, alcohol, or water and alcohol.

14 . An inhaler comprising the pressurized canister of claim 1 .

15 . The inhaler of claim 14 , wherein the inhaler further comprises a valve and an actuator in communication with the valve.

16 . The inhaler of claim 15 , wherein the valve is a metering valve

17 . The inhaler of claim 14 , wherein at least a portion of the metering valve is coated with the poly(fluoroalkylene) polymer or a copolymer of poly(fluoralkylenes).

18 . A method of actuating an inhaler comprising actuating the actuator of an inhaler of claim 15 for a sufficient time to release at least of a portion of the formulation from the pressurized canister.

19 . A method of administering a formulation comprising actuating the actuator of an inhaler of claim 15 for a sufficient time to release at least a portion of the formulation from the pressurized container; and inhaling at least a portion of the formulation.

20 . The method of claim 19 , wherein the method comprises administering a pharmaceutically acceptable amount of umeclidinium, vilanterol, or a combination thereof.

21 - 33 . (canceled)