INHALATION DRUG PRODUCTS, SYSTEMS AND USES
Various embodiments of the present invention provide drug products, inhalation systems and methods of treating respiratory diseases. Several embodiments provide an inhalation system including a pressurized metered dose inhaler and a chamber. The chamber may be an anti-static chamber with a chamber volume of about 145 milliliters (ml) to about 200 ml.
1 . A drug product comprising a pressurized metered dose inhaler comprising at least one non-CFC propellant, at least one active pharmaceutical agent and optional at least one excipient; wherein the at least one active pharmaceutical agent is selected from the group consisting of mometasone furoate, formoterol fumarate and pharmaceutically acceptable salts, isomers and combinations thereof; and an anti-static chamber having a chamber volume from about 145 ml to about 200 ml.
2 . The drug product of claim 1 , wherein the drug product delivers a fine particle fraction which is within about 25% of a fine particle fraction delivered from a second drug product comprising a pressurized metered dose inhaler comprising at least one non-CFC propellant, at least one active pharmaceutical agent and optional at least one excipient; wherein the at least one active pharmaceutical agent is selected from the group consisting of mometasone furoate, formoterol fumarate and pharmaceutically acceptable salts, isomers and combinations thereof; wherein the second drug product does not have a chamber.
3 . The drug product of claim 2 , wherein the drug product and the second drug product deliver a fine particle fraction within about 20% of each other.
4 . The drug product of claim 2 , wherein the drug product and the second drug product deliver a fine particle fraction within about 10% of each other.
5 . The drug product of claim 2 , wherein the drug product and the second drug product deliver a fine particle fraction within about 5% of each other.
6 . The drug product of claim 1 , wherein the drug product is capable of delivering a dose with at least about 30% fine particle fraction.
7 . The drug product of claim 1 , wherein the drug product is capable of delivering a dose with at least about 40% fine particle fraction.
8 . The drug product of claim 1 , wherein the at least one non-CFC propellant consists of 1,1,1,2,3,3,3 heptafluoropropane.
9 . The drug product of claim 1 , wherein the chamber has a volume of about 148 ml.
10 . (canceled)
11 . A method for treating asthma or chronic obstructive pulmonary disease in a patient in need thereof comprising administering to said patient a formulation comprising 1,1,1,2,3,3,3 heptafluoropropane, mometasone furoate, formoterol fumarate, oleic acid and ethanol; wherein the administered formulation delivers at least about a 30% fine particle fraction and the formulation is administered from a pressurized metered dose inhaler attached to an anti-static chamber.
12 . The method of claim 11 , wherein a dose of about 5 μg of formoterol fumarate and about 50 to about 200 μg of mometasone furoate is administered to the patient.
13 . The method of claim 11 , wherein the formulation is administered twice daily.
14 . The method of claim 11 , wherein the formulation is administered once daily.
15 . The method of claim 11 , wherein the anti-static chamber has a chamber volume from about 145 ml to about 200 ml.
16 . (canceled)
17 . (canceled)
18 . The method of claim 11 , wherein the administered formulation comprises at least about 40% fine particle fraction.
19 . An inhalation system comprising a pressurized metered dose inhaler comprising a suspension formulation comprising 1,1,1,2,3,3,3 heptafluoropropane, formoterol fumarate, mometasone furoate, ethanol, oleic acid; and an antistatic chamber.
20 . The inhalation system of claim 19 , wherein the formulation when administered has at least about 30% of a fine particle fraction.
21 . (canceled)
22 . The inhalation system of claim 19 , wherein the inhalation system delivers a fine particle fraction which is within about 25% of a fine particle fraction delivered from a second inhalation system comprising a pressurized metered dose inhaler comprising at least one non-CFC propellant, at least one active pharmaceutical agent and optional at least one excipient; wherein the at least one active pharmaceutical agent is selected from the group consisting of mometasone furoate, formoterol fumarate and pharmaceutically acceptable salts, isomers and combinations thereof; wherein the second drug product does not have a chamber.
23 . The inhalation system of claim 19 , wherein the inhalation system and the second inhalation system deliver a fine particle fraction within about 5% of each other.