Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy

Abstract

Vasoconstrictors are administered topically to provide protection against the adverse effects, e.g., alopecia, mucositis or dermatitis, induced by chemotherapy or radiotherapy. Appropriate dosages and formulations of topical vasoconstrictors are provided. Methods for the use of such compositions are also provided.

1 .- 42 . (canceled) 
     
     
         43 . A topical vasoconstrictor formulation comprising a vasoconstrictor that is an agonist of the α1 adrenergic receptor, but is not an agonist of the β2 adrenergic receptor, and a pharmaceutically-acceptable delivery vehicle that comprises at least 50% alcohol. 
     
     
         44 . The topical formulation of  claim 43  wherein the vasoconstrictor is norepinephrine, epinephrine, phenylephrine, methoxamine, zolmitriptan, tetrahydrozaline, naphazoline, or any combination thereof. 
     
     
         45 . The topical formulation of  claim 43  wherein the vasoconstrictor is norepinephrine. 
     
     
         46 . The topical formulation of  claim 45  wherein the norepinephrine is present at a concentration of about 200 to 800 mM. 
     
     
         47 . The topical formulation of  claim 45  wherein the norepinephrine is present at a concentration of about 450 to about 750 mM. 
     
     
         48 . The topical formulation of  claim 45  wherein the norepinephrine is present at a concentration of about 450 mM. 
     
     
         49 . The topical formulation according to  claim 43  wherein said delivery vehicle comprises 55% alcohol. 
     
     
         50 . The topical formulation according to  claim 43  wherein said delivery vehicle comprises 70% alcohol. 
     
     
         51 . The topical formulation according to  claim 43  wherein said alcohol is ethanol, propylene glycol, polyethylene glycol, isopropanol, methanol, butanediol, or any combination thereof. 
     
     
         52 . The topical formulation according to  claim 43  wherein said delivery vehicle comprises ethanol and water. 
     
     
         53 . The topical formulation according to  claim 43  wherein said delivery vehicle comprises alcohol and water in a ratio of 70-80:20-30. 
     
     
         54 . A topical vasoconstrictor formulation comprising phenylephrine at a concentration of about 150 mM to about 2500 mM and a pharmaceutically-acceptable delivery vehicle that comprises at least 50% alcohol. 
     
     
         55 . The topical formulation according to  claim 54  wherein the phenylephrine is present at a concentration of about 250 mM to about 2500 mM. 
     
     
         56 . The topical formulation according to  claim 54  wherein the phenylephrine is present at a concentration of about 300 mM, about 500 mM, or about 1000 mM. 
     
     
         57 . The topical formulation according to  claim 54  wherein said delivery vehicle comprises up to 90% alcohol. 
     
     
         58 . The topical formulation according to  claim 54  wherein said delivery vehicle comprises at least 55% alcohol. 
     
     
         59 . The topical formulation according to  claim 54  wherein said alcohol is ethanol, propylene glycol, polyethylene glycol, isopropanol, methanol, butanediol, or any combination thereof. 
     
     
         60 . The topical formulation according to  claim 54  wherein said delivery vehicle comprises ethanol, propylene glycol, and water.