Pharmaceutical composition

Patent metadata

Field	Value
Publication number	US-10179139-B2
Application number	US-201113879145-A
Country	US
Kind code	B2
Filing date	Jul 25, 2011
Priority date	Oct 12, 2010
Publication date	Jan 15, 2019
Grant date	Jan 15, 2019

Abstract

Described herein is a pharmaceutical composition that includes a beta2-agonist selected from indacaterol and formoterol in combination with a corticosteroid selected from fluticasone and ciclesonide, and, optionally, one or more pharmaceutically acceptable excipients.

First claim

The invention claimed is:

1. A pressurized metered dose inhaler comprising a pharmaceutical composition consisting of:
a) a beta2-agonist selected from indacaterol maleate in an amount ranging from 20-1200 mcg and formoterol fumarate present in an amount ranging from 0.5-40 mcg;
b) a corticosteroid selected from fluticasone furoate in an amount ranging from 0.5-800 mcg and ciclesonide in an amount ranging from 20-800 mcg; and
c) solubilizer selected from ethanol, PEG, glycerol, polyvinyl pyrrolidone or combination thereof; and
d) propellant
wherein the composition is in a form suitable for once daily administration, and
wherein the composition further consists of a cosolvent, an antioxidant, a surfactant, a bulking agent, and a lubricant.

2. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , wherein the corticosteroid is fluticasone furoate.

3. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , wherein the corticosteroid is ciclesonide.

4. A pressurized metered dose inhaler comprising a pharmaceutical composition of claim 1 , wherein the beta-2 agonist is indacaterol maleate and the corticosteroid is fluticasone furoate.

5. A pressurized metered dose inhaler comprising a pharmaceutical composition of claim 1 , wherein the beta-2 agonist is indacaterol maleate and the corticosteroid is ciclesonide.

6. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , wherein pharmaceutical composition along with any excipients are formulated in a single pharmaceutical composition.

7. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , wherein the bulking agent is a saccharide and/or a sugar alcohol.

8. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , further consisting of an excipient selected from a wetting agent, osmotic agent, a pH regulator, a buffering agent, and a complexing agent, provided in a pharmaceutically acceptable vehicle.

9. A method of treatment of a respiratory, inflammatory or obstructive airway disease, comprising administering a therapeutically effective amount of a pharmaceutical composition according to claim 1 to a patient in need thereof, wherein the disease is COPD or asthma.

10. A dry powder inhalation composition consisting of:
a) indacaterol maleate in an amount ranging from 20-1200 mcg or formoterol fumarate in an amount ranging from 0.5-40 mcg;
b) fluticasone furoate in an amount ranging from 0.5-800 mcg or ciclesonide in an amount ranging from 20-800 mcg;
c) lactose;
and, one or more pharmaceutically acceptable excipients selected from a propellant and a surfactant,
wherein the composition is in a form suitable for once daily administration.

11. A method of treatment of a respiratory, inflammatory or obstructive airway disease, comprising administering a therapeutically effective amount of a composition according to claim 10 to a patient in need thereof, wherein the disease is COPD or asthma.

Assignees

• Malhotra Geena
• Purandare Shrinivas Madhukar
• Cipla Ltd

Inventors

• Malhotra Geena
• Purandare Shrinivas Madhukar

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61K31/573

  substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone · CPC title

• A61P11/06

  Antiasthmatics · CPC title

• A61K31/46

  8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine · CPC title