Pharmaceutical compositions based on benzilic acid esters and soluble TNF receptor fusion proteins

• US 20050186175A1
• Filed: 01/18/2005
• Published: 08/25/2005
• Est. Priority Date: 02/20/2004
• Status: Abandoned Application

• Current Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Pairet, Michel, Pieper, Michael P., Meade, Christopher John Montague
• Application Number:
  US11/038,649
• Publication Number:
  US 20050186175A1
• Time in Patent Office: Days
• US Class Current: 424/85.100
• 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 31/439 the ring forming part of a bridged ring system, e.g. quinuclidine 8-azabicyclo [3.2.1] octanes A61K31/46
• CPC Class Codes: A61K 38/191 Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 11/08 Bronchodilators
• 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 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to novel pharmaceutical compositions based on benzilic acid ester derived anticholinergics of formula 1 and soluble TNF receptor fusion proteins, processes for preparing them and their use in the treatment of respiratory diseases.

Claims

1. ). A pharmaceutical composition, comprising one or more anticholinergics of formula 1

2. ). The pharmaceutical composition according to claim 1, wherein the soluble TNF receptor fusion protein 2 is etanercept or lenercept.

3. ). The pharmaceutical composition according to claim 2, wherein the soluble TNF receptor fusion protein 2 is etanercept.

4. ). The pharmaceutical composition according to claim 1, wherein the active substances 1 and 2 are present either together in a single formulation or in two separate formulations.

5. ). The pharmaceutical composition according to claim 1, wherein the weight ratios of the active substances 1 to 2 are in the range from 1:

2000 to 1;

1.

6. ). The pharmaceutical composition according to claim 4 wherein a single administration corresponds to a dose of the active substance combination 1 and 2 of 1 to 10000 μ

g.

7. ). The pharmaceutical composition according to claim 1, which is in a form of a formulation suitable for inhalation.

8. ). The pharmaceutical composition according to claim 7, wherein the formulation selected from among inhalable powders and inhalable solutions or suspensions.

9. ). The pharmaceutical composition according to claim 8, wherein the inhalable powder comprises active substances 1 and 2 in admixture with suitable physiologically acceptable excipients selected from monosaccharides, disaccharides, oligo- and polysaccharides, polyalcohols, salts, or mixtures thereof.

10. ). The pharmaceutical composition according to claim 9, wherein the excipient has a maximum mass mean aerodynamic diameter of up to 250 μ

m.

11. ). The pharmaceutical composition according to claim 9, wherein the inhalable powder is comprised in a capsule.

12. ). The pharmaceutical composition according to claim 8, wherein the inhalable powder ontains only the active substances 1 and 2 as its ingredients.

13. ). The pharmaceutical composition according to claim 8, wherein the inhalable solution or suspension contains water, ethanol or a mixture of ethanol and water as solvent.

14. ). The pharmaceutical composition according to claim 13, wherein the inhalable solution or suspension has a pH of 2-7.

15. ). The pharmaceutical composition according to claim 11, wherein the inhalable powder comprised in a capsule is administered in an inhaler.

16. ). The pharmaceutical composition according to claim 13, wherein the inhalable solution or suspension is administered by nebulizing in a suitable inhaler.

17. ). A method of treating inflammatory or obstructive diseases of the respiratory tract comprising administering to a patient in need thereof the pharmaceutical composition according to claim 1.