RIBAVIRIN PERFLUBRON EMULSION COMPOSITION FOR TREATING VIRAL DISEASES

Abstract

The present invention is a novel method using a MegaRibavirin aerosol or a MegaRibavirin combination of therapeutics for the treatment of viral disease particularly the pandemic influenza strains swine 2009 HI N1 and H5N1. This invention utilizes Ribavirin in an aerosol Mega Dose (61-161 mg/ml) alone or combined with or without other antivirals, a perfluorocarbon emulsion and anti-inflammatory/anti-oxidants. Where applicable, the perfluorocarbon emulsion may dissolve these agents enabling a depot effect and possible protracted delivery. In addition, perfluorocarbon emulsions have the possible added benefit of oxygen carrying capacity and alveolar nitric oxide sequestration, which may reduce peroxynitrite formation and decrease Influenza severity.

Claims

1. A method of treatment for a patient with influenza comprising delivering to the patient via a nebulizer (a) aerosolized ribavirin at a concentration greater than 61 and less than 161 mg/ml and (b) aerosolized perflubron.

2. The method of claim 1 further comprising delivering to the patient via a nebulizer zanamivir.

3. The method of claim 1 further comprising delivering to the patient via a nebulizer oseltamivir.

4. The method of claim 1 wherein said perflubron is a perflubron emulsion.

5. The method of claim 3 wherein said ribavirin is combined with the perflubron emulsion.

6. The method of claim 1 further comprising delivering to the patient via a nebulizer N acetylcysteine.

7. The method of claim 1 further comprising delivering to the patient via a nebulizer dismutase.

8. The method of claim 1 further comprising the step of administering oxygen simultaneously with said aerosolized perflubron.

9. The method of claim 1 comprising administering the aerosolized ribavirin and aerosolized perflubron to the patient via the nebulizer for about 30 minutes once or twice daily for 4-7 days, wherein said aerosolized composition comprises 1000 mg ribavirin diluted in 10 mL sterile saline and perflubron emulsion at 60% w/v.

10. The method of claim 9 further comprising administering aerosolized 150 mg zanamivir diluted in 10 mL sterile saline, aerosolized 2 mL of 20% w/v N-acetylcysteine, and aerosolized 0.5 mL of 20 mg/mL superoxide dismutase to the patient via the nebulizer.

11. A pharmaceutical composition consisting of aerosolized particles comprising ribavirin and perflubron in sterile saline.

12. The pharmaceutical composition of claim 12 further comprising 15 mg/mL zanamivir.

13. The pharmaceutical composition of claim 12 further comprising N-acetylcysteine.

14. The pharmaceutical composition of claim 12 further comprising superoxide dismutase.

15. The pharmaceutical composition of claim 12, wherein the ribavirin is present at a concentration of 100 mg/mL or 61-161 mg/mL.

16. The pharmaceutical composition of claim 12, wherein the perflubron is a 60% emulsion.

17. A pharmaceutical composition comprising 61 mg/mL-161 mg/mL ribavirin and a 60% perflubron emulsion.

18. The pharmaceutical composition of claim 17 further comprising one or more additional antiviral drugs selected from the group consisting of zanamivir and oseltamivir.

19. The pharmaceutical composition of claim 17 further comprising one or more additional drugs selected from the group consisting of superoxide dismutase and N-acetylcysteine.

20. The pharmaceutical composition of claim 17, wherein the composition is an aerosol.

Description

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0022] Embodiments are described more fully below with reference to the accompanying figures, which form a part hereof and show, by way of illustration, specific exemplary embodiments. These embodiments are disclosed in sufficient detail to enable those skilled in the art to practice the invention. However, embodiments may be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. The following detailed description is, therefore, not to be taken in a limiting sense in that the scope of the present invention is defined only by the appended claims.

[0023] Ribavirin has a long history of efficacy against viruses notably Influenza, Respiratory Syncytial Virus and Hepatitis.

[0024] Example Pandemic Influenza treatments could be exemplified by an aerosol treatment combination such as Ribavirin 1000 mg and Zanamivir 150 mg diluted in 10 ml of sterile saline and given over 30 minutes once or twice daily for 4-7 days. This combination could also include a perflubron emulsion 60% w/v, NAC 20% 2 ml and SOD 20 mg/ml 0.5 ml alone or separate.

[0025] By using drugs with different mechanisms and anti-inflammatory agents this may have a substantial advantage over using any drug alone (Ghezzi and Ungheri, 2003 Intern J of Imm and Pharm p 99-101;). However doses of Ribavirin may be used alone 61-161 mg/ml and given over 4 days. Zanamivir 5-20 mg/ml and may be with or without a perfluorocarbon emulsion 1-100% w/v given for 5120 minutes up to every 4 hours for up to 2 weeks. Further NAC may be given as 5-20% solution 1-3 ml and SOD 5-25 mg/ml 0.1-3 ml may also be included.

[0026] In addition to a new concentration and the use of a novel vehicle the present invention uses a new nebulizer, the Aerotech II, which provides a stable small particle size aerosol for deep deposition delivery, which is advantageous specifically for H5N1 Influenza. However this application is not restricted to any current brand of nebulizers as several Nebulizers are considered possible to use.

[0027] Although the invention has been described in language that is specific to certain structures and methodological steps, it is to be understood that the invention defined in the appended claims is not necessarily limited to the specific structures and/or steps described. Rather, the specific aspects and steps are described as forms of implementing the claimed invention. Since many embodiments of the invention can be practiced without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.