Pharmaceutical formulation for administration by inhalation comprising an androstane derivative and a beta-2-adrenoreceptor for the treatment of inflammatory and allergic conditions

• US 20050164997A1
• Filed: 02/04/2003
• Published: 07/28/2005
• Est. Priority Date: 08/05/2000
• Status: Abandoned Application

• Current Assignee: Glaxo Group Limited (Glaxosmithkline Holdings Ltd.)
• Original Assignee: Glaxo Group Limited (Glaxosmithkline Holdings Ltd.)
• Inventors: Biggadike, Keith
• Application Number:
  US10/503,417
• Publication Number:
  US 20050164997A1
• Time in Patent Office: Days
• US Class Current: 514/172
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

A pharmaceutical formulation for administration by inhalation comprising a compound of formula (I),
or a solvate thereof, together with a long-acting β₂-adrenoreceptor agonist which formulation has a therapeutically useful effect in the treatment of inflammatory disorders of the respiratory tract over a period of 24 hours or more.

Claims

1. A pharmaceutical formulation for administration by inhalation comprising a compound of formula (I),

2. A pharmaceutical formulation according to claim 1 wherein the compound of formula (I) or a solvate thereof and the long-acting β

₂-adrenoreceptor agonist are both present in particulate form.

3. A pharmaceutical formulation according to claim 2 further comprising a particulate carrier.

4. A pharmaceutical formulation according to claim 3 wherein the carrier is lactose.

5. A pharmaceutical formulation according to claim 1 further comprising a liquified propellant gas.

6. A pharmaceutical formulation according to claim 1 wherein the inflammatory disorder of the respiratory tract is asthma.

8. A method of treatment of an inflammatory disorder of the respiratory tract once-per-day which comprises administration of a pharmaceutical formulation according to claim 1.

9. A method of treatment according to claim 8 wherein the inflammatory disorder of the respiratory tract is asthma.

20. A method for the treatment of a human or animal subject with an anti-inflammatory and/or allergic condition, which method comprises administering to said human or animal subject an effective amount of a formulation as claimed in claim 1.

7. (canceled)

10. An inhaler containing a plurality of doses of a pharmaceutical formulation comprising a compound of formula (I)

11. An inhaler according to claim 10 wherein the compound of formula (I) or a solvate thereof and the long-acting β

₂-adrenoreceptor agonist are both present in particulate form.

12. An inhaler according to claim 10 wherein the formulation further comprises a particulate carrier.

13. An inhaler according to claim 12 wherein the carrier is lactose.

14. An inhaler according to claim 10 wherein the formulation further comprises a liquefied propellant gas.

16. An inhaler according to claim 10 wherein the inflammatory disorder of the respiratory tract is asthma.

15. (canceled)

17-19. -19. (canceled)