(+) naloxone and epinephrine combination therapy

• US 6,284,765 B1
• Filed: 04/27/2000
• Issued: 09/04/2001
• Est. Priority Date: 04/27/2000
• Status: Expired due to Fees

• Current Assignee: University of North Texas Health Science Center (University of North Texas)
• Original Assignee: University of North Texas Health Science Center (University of North Texas)
• Inventors: Caffrey, James L.
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US09/561,391
• Time in Patent Office: 495 Days
• Field of Search: 514/263, 514/289, 514/653
• US Class Current: 514/263.32
• 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 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 31/52 Purines, e.g. adenine
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system

Abstract

A composition formulated for dose-wise delivery to a breathing passageway of a human, the composition comprising a carrier solution containing (+)naloxone and a pharmacologically effective amount of at least one adrenergic agonist, the (+)naloxone and agonist forming a mixture in the carrier. The at least one adrenergic agonist is selected from the group consisting of epinephrine, isoproterenol, albuterol, aminophylline, beclomethasone, dyphylline, flunisolide, isoetharine, metaproterenol, oxtriphylline, terbutaline, theophylline, pseudoephedrine, phenylephrine, ephedrine and norepinephrine. That composition is delivered by an atomizer means such as a liquid sprayer or inhaler to treat nasal congestion and asthmatic attacks. Further provided by the invention is a cardiovascular and respiratory stimulating composition for administration to a patient in doses, the composition comprising a pharmacologically effective concentration of (+)naloxone in a carrier solution. If necessary, the composition may also contain a pharmacologically effective amount of at least one adrenergic agonist.

Claims

1. A composition formulated for dose-wise delivery to a breathing passageway of a human, the composition comprising:

a carrier solution, the solution containing (+)naloxone; and

the solution also including a pharmacologically effective amount of at least one adrenergic agonist, the (+)naloxone and agonist forming a mixture in the carrier solution.

2. The composition of claim 1, wherein a dose is metered to deliver between about 0.01 and 5 μ

g/mL of the adrenergic agonist.

3. The composition of claim 1, wherein a dose is metered to deliver between about 0.1 and 6 μ

g/mL of (+)naloxone.

4. The composition of claim 1, wherein the at least one adrenergic agonist is a catecholamine.

5. The composition of claim 1, wherein the at least one adrenergic agonist is selected from the group consisting of epinephrine, isoproterenol, albuterol, aminophylline, beclomethasone, dyphylline, flunisolide, isoetharine, metaproterenol, oxtriphylline, terbutaline, theophylline, pseudoephedrine, phenylephrine ephedrine and norepinephrine.

6. The composition of claim 1, comprising two adrenergic agonists.

7. The composition of claim 1, further comprising a preservative.

8. The composition of claim 1, wherein the carrier is a buffered saline solution of pH between about pH 5 and pH 7.

9. The composition of claim 1, wherein the mixture is placed within a liquid sprayer for administration to the nasal passageway of a human for treatment of nasal decongestion.

10. The composition of claim 1, wherein the mixture is placed within an inhaler for administration to the lungs of a human for treatment of asthmatic attacks.

11. A cardiovascular and respiratory stimulating composition for administration to a patient in doses, the composition comprising:

a pharmacologically effective concentration of (+)naloxone in a carrier solution; and

further comprising a pharmacologically effective amount of at least one adrenergic agonist selected from the group consisting of epinephrine, isoproterenol, albuterol, aminophylline, beclomethasone, dyphylline, flunisolide, isoetharine, metaproterenol, oxtriphylline, terbutaline, theophylline, pseudoephedrine, phenylephrine, ephedrine and norepinephrine.

12. The composition of claim 11, wherein a dose is metered to deliver between about 0.01 and 5 μ

g/mL of the adrenergic agonist.

13. A cardiovascular and respiratory stimulating composition for administration to a patient in doses, the composition comprising:

a pharmacologically effective concentration of (+)naloxone in a carrier solution; and

wherein a dose is metered to deliver between about 0.1 and 6 μ

g/mL of (+)naloxone.

14. A method of alleviating breathing passageway compromise in humans, the method comprising:

providing a carrier solution, the solution containing (+)naloxone and a pharmacologically effective concentration of at least one adrenergic agonist, the (+)naloxone and at least one agonist forming a mixture in the saline solution;

wherein the mixture is contained in an atomizer means to direct an atomized fog of the mixture directly into at least one breathing passageway of the human;

directing a atomized fog dose of the mixture into the at least one breathing passageway of the human.

15. The method of claim 14, wherein the at least one adrenergic agonist is a catecholamine.

16. The method of claim 14, wherein the at least one adrenergic agonist is selected from the group consisting of epinephrine, isoproterenol, albuterol, aminophylline, beclomethasone, dyphylline, flunisolide, isoetharine, metaproterenol, oxtriphylline, terbutaline, theophylline, pseudoephedrine, phenylephrine ephedrine and norepinephrine.

17. The method of claim 14, comprising two adrenergic agonists.

18. The method of claim 14, wherein a dose is metered to deliver between about 0.01 and 5 μ

g/mL of the adrenergic agonist.

19. The method of claim 14, wherein a dose is metered to deliver between about 0.1 and 6 μ

g/mL of (+)naloxone.

20. The method of claim 14, wherein the atomizing means is a liquid sprayer for delivering the mixture to the nasal passageway of the human.

21. The method of claim 14, wherein the atomizing means is an inhaler for delivering the mixture to the lungs of the human.

22. The method of claim 14, wherein the carrier is a buffered saline solution of pH between about pH 5 and pH 7.

23. A method of stimulating cardiovascular and respiratory output in a human during high-stress situations, the method comprising:

delivering a pharmacologically effective dose of (+)naloxone in a carrier solution, the (+) naloxone thus creating a first composition in the saline solution.

24. The method of claim 23, wherein further provided in the first composition is a pharmacologically effective amount of at least one adrenergic agonist selected from the group consisting of epinephrine, isoproterenol, albuterol, aminophylline, beclomethasone, dyphylline, flunisolide, isoetharine, metaproterenol, oxtriphylline, terbutaline, theophylline, pseudoephedrine, phenylephrine, ephedrine and norepinephrine.

25. The method of claim 23, wherein the first composition is administered via injection directly into the blood stream of the human.

26. The method of claim 23, wherein the first composition is taken into the lungs of the human.

27. The method of claim 24, wherein a dose is metered to deliver between about 0.01 and 5 μ

g/mL of the adrenergic agonist.

28. The method of claim 23, wherein a dose is metered to deliver between about 0.1 and 6 μ

g/mL of (+)naloxone.

29. The method of claim 23, wherein the carrier is a buffered saline solution of pH between about pH 3 and pH 7.

30. A method of enhancing local vasoconstriction and serve as an adjuvant administered with adrenergic agonists and other pharmaceuticals in order to contain those pharmaceuticals in a high therapeutically effective concentration at their site of administration, the method comprising:

delivering a pharmacologically effective dose of (+)naloxone in a carrier solution, the (+) naloxone thus creating a first composition in the saline solution.

31. The method of claim 30, wherein the effective dose of (+)naloxone is administered topically.

32. The method of claim 31, wherein the effective dose of (+)naloxone is administered by injection into a blood vessel.