P
USRE39264EExpiredUtilityPatentIndex 86

Pharmaceutical combination

Assignee: MEDIVIR ABPriority: Feb 6, 1995Filed: Feb 2, 1996Granted: Sep 5, 2006
Est. expiryFeb 6, 2015(expired)· nominal 20-yr term from priority
Inventors:HARMENBERG JOHANKRISTOFFERSON ANN HARRIET MARG
A61P 31/12A61P 43/00A61P 31/22A61K 9/0014A61K 31/675A61K 31/70A61K 31/57A61P 27/02A61K 31/58A61K 31/66A61K 31/56A61K 31/52
86
PatentIndex Score
19
Cited by
37
References
37
Claims

Abstract

The invention relates to pharmaceutical compositions for topical administration comprising a topically acceptable antiviral substance and an antiinflammatory glucocorticoid in a pharmaceutically acceptable carrier. The pharmaceutical composition can be used in the prophylactic and curative treatment of herpesvirus infections in mammals including man. The invention also relates to the use of a combination of a topically acceptable antiviral substance and an antiinflammatory glucocorticoid for the manufacture of a medicament for said prophylactic and curative treatment.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
       1. A pharmaceutical composition for topical administration comprising a synergistic combination of a topically acceptable antiviral substance which is 1) a herpes-specific nucleoside analogue or an ester, salt or solvate thereof that is preferentially phosphorylated in virus-infected cells or 2) selected from the group consisting of cidofovir, PMEA, PAA and PFA or an ester, salt or solvate thereof, and an antiinflammatory glucocorticoid in a pharmaceutically acceptable carrier. 
     
     
       2. A pharmaceutical composition for topical administration to treat recurrent herpes infections comprising, as sole active drug substances, a synergistic combination of an topically acceptable antiviral substance ingredient selected from the group consisting of foscarnet, acyclovir, cidofovir, desciclovir, famciclovir, ganciclovir, lobucavir, penciclovir, PMEA, valacyclovir, 2242, PAA, PFA and  9 -[   4   - hydroxy -   2   -( hydroxymethyl ) butyl]guanine  (H2G), or an ester, a salt or solvate thereof and an antiinflammatory glucocorticoid ingredient selected from the group consisting of hydrocortisone and esters thereof, in a pharmaceutically acceptable carrier, wherein said combination of antiviral and glucocorticoid is more effective in treating said herpes infections than either ingredient alone. 
     
     
       3. A pharmaceutical composition according to  claim 1 , wherein the antiinflammatory glucocorticoid is selected from the group consisting of hydrocortisone, alclometasone, desonide, fluprednidene, flumethasone, hydrocortisone butyrate, clobetasone, triamcinolone acetonide, betamethasone, budesonide, desoximethasone, diflorosane, fluocinolone, fluocortolone, fluticasone, methylprednisolone aceponate, mometasone and rofleponide or an ester, salt or solvate thereof. 
     
     
       4. A The pharmaceutical composition according to  claim 2 , wherein the antiinflammatory glucocorticoid is selected from the group consisting of  hydrocortisone, alclometasone, desonide, fluprednidene, flumethasone, hydrocortisone butyrate, clobetasone, triamcinolone acetonide, betamethasone, budesonide, desoximethasone, diflorosane, fluocinolone, fluocortolone, fluticasone, methylprednisolone aceponate, mometasone and rofleponide or an ester, salt or solvate thereof . 
     
     
       5. A The pharmaceutical composition according to claim  1   2 , wherein the antiviral substance is foscarnet and the antiinflammatory glucocorticoid is hydrocortisone, or an ester thereof . 
     
     
       6. A pharmaceutical composition according to  claim 1 , wherein the antiviral substance is foscarnet and the antiinflammatory glucocorticoid is budesonide, or an ester thereof. 
     
     
       7. A pharmaceutical composition according to claim  1   2 , wherein the antiviral substance is acyclovir, or an ester, salt or solvate thereof, and the antiinflammatory glucocorticoid is hydrocortisone, or an ester thereof . 
     
     
       8. The pharmaceutical composition according to  claim 5  comprising wherein said foscarnet is contained in an amount of 0.1-10% foscarnet (w/w) and said hydrocortisone is contained in an amount of 0.005-3% hydrocortisone (w/w)  based on the weight of the pharmaceutical composition . 
     
     
       9. The pharmaceutical composition according to  claim 8  comprising wherein said foscarnet is contained in an amount of 1-5% foscarnet (w/w) based on the weight of the pharmaceutical composition. 
     
     
       10. The pharmaceutical composition according to  claim 8  comprising wherein said foscarnet is contained in an amount of 0.3-3% foscarnet (w/w) and said hydrocortisone is contained in an amount of 0.25-1% hydrocortisone (w/w) based on the weight of the pharmaceutical composition. 
     
     
       11. The pharmaceutical composition according to  claim 6  comprising 0.1-10% foscarnet and 0.005-3% budesonide. 
     
     
       12. The pharmaceutical composition according to  claim 11  comprising 1-5% foscarnet . 
     
     
       13. The pharmaceutical composition according to  claim 7  comprising wherein said acyclovir is contained in an amount of 0.1-10% acyclovir (w/w) and said hydrocortisone is contained in an amount of 0.005-3% hydrocortisone (w/w) based on the weight of the pharmaceutical composition. 
     
     
       14. The pharmaceutical composition according to  claim 13  comprising wherein said acyclovir is contained in an amount of 1-5% acyclovir (w/w) based on the weight of the pharmaceutical composition. 
     
     
       15. The pharmaceutical composition according to  claim 14  comprising wherein said hydrocortisone is contained in an amount of 0.25-1% hydrocortisone (w/w) based on the weight of the pharmaceutical composition. 
     
     
       16. A cream, lotion, gel, ointment, plaster, stick or pen containing a pharmaceutical composition according to any one of claims  2 ,  4 ,  5 ,  7 - 10  and    13     1  - 15 . 
     
     
       17. A method for the prophylaxis and/or treatment of herpesvirus infections of the skin or mucous membranes in mammals comprising topical administration, in combination or in sequence, of a therapeutically synergistic dose of a topically acceptable antiviral substance which is 1) a herpes-specific nucleoside analogue or an ester, salt or solvate thereof that is preferentially phosphorylated in virus-infected cells or 2) selected from the group consisting of cidofovir, PMEA, PAA and PFA or an ester, salt or solvate thereof and an antiinflammatory glucocorticoid. 
     
     
       18. A method for the prophylaxis and/or treatment of treating recurrent herpesvirus infections of the skin or mucous membranes in mammals having or identified as being at risk of developing said infections comprising topically administration ring thereto, as sole active drug substances and in combination or in sequence, of a therapeutically synergistic dose of a topically acceptable an antiviral substance ingredient selected from the group consisting of foscarnet, acyclovir, cidofovir, desciclovir, famciclovir, ganciclovir, lobucavir, penciclovir, PMEA, valacyclovir, 2242, PAA, PFA and  9 -[   4   - hydroxy -   2   -( hydroxymethyl ) butyl]guanine  (H2G), or an ester, a salt or solvate  thereof and an antiinflammatory glucocorticoid ingredient selected from the group consisting of hydrocortisone and esters thereof, in a pharmaceutically acceptable carrier, wherein said antiviral and glucocorticoid are more effective in treating said herpesvirus infections than either ingredient alone. 
     
     
       19. A method according to  claim 17 , wherein the antiinflammatory glucocorticoid is selected from the group consisting of hydrocortisone, alclometasone, desonide, fluprednidene, flumethasone, hydrocortisone butyrate, clobetasone, triamcinolone acetonide, betamethasone, budesonide, desoximethasone, diflorosane, fluocinolone, fluocortolone, fluticasone, methylprednisolone aceponate, mometasone and rofleponide or an ester, salt or solvate thereof. 
     
     
       20. A The method according to  claim 18 , wherein the antiinflammatory glucocorticoid is selected from the group consisting of hydrocortisone, alclometasone, desonide, fluprednidene, flumethasone, hydrocortisone butyrate, clobetasone, triamcinolone acetonide, betamethasone, budesonide, desoximethasone, diflorosane, fluocinolone, fluocortolone, fluticasone, methylprednisolone aceponate, mometasone and rofleponide or an ester, salt or solvate thereof . 
     
     
       21. A method according to claim  17   18 , wherein the antiviral substance is foscarnet and the antiinflammatory glucocorticoid is hydrocortisone, or an ester thereof. 
     
     
       22. A method according to  claim 17 , wherein the antiviral substance is foscarnet and the antiinflammatory glucocorticoid is budesonide, or an ester thereof. 
     
     
       23. A method according to claim  17   18 , wherein the antiviral substance is acyclovir, or an ester, salt or solvate thereof , and the antiinflammatory glucocorticoid is hydrocortisone, or an ester thereof. 
     
     
       24. A method for the prophylaxis and/or treatment of treating recurrent herpes virus infections of the skin or mucous membranes in mammals having or identified as being at risk of developing said infections comprising topically administration ring thereto a therapeutic dose of a topically acceptable composition according to anyone of claims  1 -  2 ,  4 ,  5 ,  7 - 10  and  13 - 15 . 
     
     
       25. A method according to  claim 24  wherein the composition is contained in a cream, lotion, gel, ointment, plaster, stick or pen. 
     
     
       26. A method according to anyone of claims  17 - 23 , wherein the herpesvirus infection is a recurrent herpesvirus infection. 
     
     
       27. A method according to any one of claims  17 -  18 ,  20 ,  21  and  23 , wherein the antiviral substance and the glucocorticoid are administered 1 to 10 times per day. 
     
     
       28. A method according to  claim 27 , wherein the antiviral substance and the glucocorticoid are administered 3 to 4 times per day. 
     
     
       29. A method according to claim  26   40 , wherein the antiviral substance  and the glucocorticoid are administered 1 to 10 times per day. 
     
     
       30. A method according to  claim 29 , wherein the antiviral substance and the glucocorticoid are administered 3 to 4 times per day. 
     
     
       31. A method according to anyone of claims  17 -  18 ,  20 ,  21  and  23  wherein the antiviral substance and the glucocorticoid are administered in combination and are contained in a cream, lotion, gel, ointment, plaster, stick or pen. 
     
     
       32. A method according to  claim 24 , wherein the herpesvirus infection is a recurrent herpesvirus infection. 
     
     
       33. A method according to  claim 24 , wherein the antiviral substance and the glucocorticoid are administered 1 to 10 times per day. 
     
     
       34. A method according to  claim 33 , wherein the antiviral substance and the glucocorticoid are administered 3 to 4 times per day. 
     
     
       35. A method according to  claim 31 , wherein the antiviral substance  and the glucocorticoid are administered 1 to 10 times per day. 
     
     
       36. A method according to  claim 35 , wherein the antiviral substance  and the glucocorticoid are administered 3 to 4 times per day. 
     
     
       37. The method according to  claim 18 , wherein said antiviral is acyclovir and said anti- inflammatory glucocorticoid is hydrocortisone.

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