Pharmaceutical products and composition comprising specific anticholinergic agents, β-2 agonists and corticosteroids

Patent metadata

Field	Value
Publication number	US-9446054-B2
Application number	US-201414570679-A
Country	US
Kind code	B2
Filing date	Dec 15, 2014
Priority date	Aug 29, 2002
Publication date	Sep 20, 2016
Grant date	Sep 20, 2016

Abstract

This invention relates to pharmaceutical products and compositions for use in the treatment of asthma and related disorders, and especially but not exclusively for the treatment of chronic obstructive pulmonary disease (COPD). More particularly, the invention provides pharmaceutical products and compositions comprising specific anticholinergic agents, β-2 agonists and corticosteroids.

First claim

The invention claimed is:

1. A pharmaceutical composition comprising any one of the following corribinations of therapeutic agents in a form suitable for administration by inhalation:
(i) salmeterol, ciclesonide and tiotropium;
(ii) formoterol, budesonide and ipratropium;
(iv) formoterol, budesonide and oxitropium;
(v) salbutamol, beclornethasone and ipratropium;
(vi) salbutamol, budesonide and tiotropium;
(vii) terbutaline, fluticasone and tiotropium;
(viii) terbutaline, fluticasone and ipratropium;
(ix) salbutamol, budesonide and ipratropium;
(x) salmeterol, fluticasone and ipratropium;
(xi) salmeterol, budesonide and ipratropium;
(xii) sahrieterol, fluticasone and tiotropium; and
wherein the therapeutic agents are each provided in particulate form, each of the therapeutic agents individually has a particle size from nano-size up to about 12 μm, and approximately 95% of the therapeutic agent particles have a particle size of below 5 μm or 6 μm; and
wherein each of the therapeutic agents can optionally independently be present as a pharmaceutically acceptable salt or ester thereof, and each of the therapeutic agents can optionally independently be present in enantiornerically pure form or as a racemic mixture, together with a pharmaceutically acceptable carrier or excipient therefor.

2. A composition according to claim 1 , wherein each of the therapeutic agents of the composition is present in an amount 0.001 wt % to 5 wt % based on the weight of the total composition.

3. A composition according to claim 1 , which is an aerosol.

4. A composition according claim 3 , which is a propellant free inhalation solution or suspension.

5. A composition according to claim 1 , which is an inhalation powder.

6. A composition according to claim 5 , which comprises lactose as the excipient.

7. A composition according to claim 1 , in a form suitable for use with a nebuliser.

8. A metered dose inhaler which contains a composition as defined in claim 1 .

9. A dry powder inhaler which contains a composition as defined in claim 1 .

10. A nebuliser which contains a composition as defined in claim 1 .

Assignees

• Cipla Ltd

Inventors

• Lulla Amar
• Malhotra Geena

Classifications

• A61P29/00

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

• A61K31/46

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

• A61K31/58 Primary

  containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) · CPC title

• A61K31/135

  having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)} · CPC title

• A61K31/439

  the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46) · CPC title