USE OF SALT OF AN ACETYLSALICYLIC ACID FOR THE TREATMENT OF VIRAL INFECTIONS

• US 20120017892A1
• Filed: 01/14/2009
• Published: 01/26/2012
• Est. Priority Date: 01/14/2008
• Status: Active Grant

• Current Assignee: AspiAir GmbH
• Original Assignee: Activaero GmbH
• Inventors: Ludwig, Stephan
• Granted Patent: US 9,492,413 B2
• Time in Patent Office: Days
• US Class Current: 128/200.14
• 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 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 31/616 by carboxylic acids, e.g. acetylsalicylic acid
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
• CPC Class Codes: A61K 51/088 conjugates with carriers being peptides, polyamino acids or proteins antibodies A61K51/10
• 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 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to a method of use of a composition comprising a salt of the o-acetylsalicylic acid with a basic amino acid for producing a pharmaceutical composition for the prophylaxis or treatment of viral infections of humans or of animals, in particular mammals and birds.

Claims

1. A method of use of a composition comprising a salt of the o-acetylsalicylic acid with a natural or non-natural basic amino acid for producing a pharmaceutical composition for the prophylaxis or treatment of viral infections of humans or of animals.

2. The method of use according to claim 1, wherein the basic amino acid is selected from the group consisting of lysine, arginine, ornithine, diaminobutyric acid, and mixtures of such amino acids, preferably a monoacetylsalicylate, and wherein optionally, in addition a salt of the o-acetylsalicylic acid with a natural or non-natural amino acid with a not-basic side chain, in particular with glycine, may be comprised.

3. The method of use according to claim 2, wherein the basic amino acid is D-lysine, L-lysine or a mixture of D-lysine and L-lysine.

4. The method of use according to claim 1 for the prophylaxis or treatment of infections with negative-strand RNA viruses, preferably with influenza A viruses, in particular with viruses of the H5 or H7 type.

5. The method of use according to claim 1 in a galenic preparation as a liquid, aqueous composition, in particular for the aerogenic, for instance nasal administration.

6. The method of use according to claim 5, wherein the aqueous composition is a 0.1 to 5 M, in particular 0.1 to 3 M, preferably 1 to 3 M, aqueous solution of the salt.

7. The method of use according to claim 5, wherein the aqueous composition is a 0.01 to 100 mM, in particular 0.1 to 10 mM, aqueous solution of the salt.

8. The method of use according to claim 1, wherein the composition is arranged in a pharmaceutically compatible tank with a vaporizer or nebulizer.

9. The method of use according to claim 8, wherein the tank is prepared for the adjustment of an inhalation flow of less than 1,000 ml/s, preferably less than 500 ml/s, in particular less than 300 ml/s, and of a breathing volume of at least 10%, in particular at least 30%, preferably at least 50%, up to 95%, referred to the inspiration capacity of a patient.

10. An aerosol formulation comprising a salt of the o-acetylsalicylic acid with a natural or non-natural basic amino acid, a propellant and optionally auxiliary and/or carrier substances.

11. The aerosol formulation according to claim 10, wherein the salt is comprised in an amount of 0.001 to 50 wt-%, 0.001 to 10 wt-%, in particular 0.1 to 10 wt-%, or in particular 10 to 50 wt-%, referred to the total formulation.

12. The aerosol formulation according to claim 10, wherein the salt is comprised in particle form or solution with an MMAD value of less than 10 μ

m, in particular less than 5 μ

m.

13. The A method of use of an aerosol formulation according to claim 10 for the prophylaxis or treatment of viral infections of humans or of animals, wherein a human, who is at risk to catch a viral infection or is affected therewith, or such an animal, is administered aerogenically for the inhalation through the nose or the mouth,. a physiologically effective amount of the aerosol formulation.

14. The method of use according to claim 13, wherein at least 10 mg, preferably at least 50 mg, most preferably at least 100 mg, up to more than 200 mg, of the aerosol formulation is administered aerogenically and preferably within a time of less than 5 min, preferably less than 2 min, most preferably less than 1 min.

15. The method of use according to claim 13, wherein the inhalation flow is adjusted to less than 1,000 ml/s, in particular less than 500 ml/s, in particular less than 300 ml/s is, and wherein the breathing volume is adjusted to at least 20%, in particular at least 30%, preferably at least 50%, up to 95%, referred to the inspiration capacity of a patient.

16. An inhalation device with a supply tank and an aerosol generator connected to the supply tank, wherein the supply tank comprises an aerosol formulation according to claim 10.

17. The inhalation device according to claim 16 with control and/or regulation means for the control and/or regulation of the inhalation flow and of the breathing volume, wherein the control and/or regulation means are preferably adjusted to less than 1,000 ml/s, in particular less than 500 ml/s, in particular less than 300 ml/s is, and wherein the breathing volume is adjusted to at least 20%, in particular at least 30%, preferably at least 50%, up to 95%, referred to the inspiration capacity of a patient.