Therapeutic compositions comprising monoterpenes

Abstract

This invention provides a compositions for transport of a therapeutic agent. The compositions contain a therapeutic agent and a monoterpene or an analog thereof. In one aspect, the monoterpene is perillyl alcohol (POH) or an analog thereof. In one aspect, the therapeutic agent is provided in an amount effective to treat the disease or subject of choice.

What is claimed is: 
     
         1 . A composition for administration by one or more of inhalation, intranasally or ocularly, comprising: a therapeutic agent; from about 0.0001% to about 0.01% (v/v) of perillyl alcohol, perillaldehyde or a carboxylic acid ester of perillyl alcohol; and one or more components selected from the group consisting of polyols, permeation enhancers, co-solvents, and any combination thereof. 
     
     
         2 . The composition of  claim 1 , wherein the composition comprises perillyl alcohol. 
     
     
         3 . The composition of  claim 1 , wherein the therapeutic agent is a chemotherapeutic agent or a therapeutic antibody. 
     
     
         4 . The composition of  claim 1 , wherein the therapeutic agent is temozolomide or dimethylcelecoxib. 
     
     
         5 . The composition of  claim 1 , wherein the permeation enhancers comprise fatty acid esters of glycerin; fatty acid esters of isosorbide, sucrose, and polyethylene glycol; caproyl lactylic acid; laureth-2; laureth-2 acetate; laureth-2 benzoate; laureth-3 carboxylic acid; laureth-4; laureth-5 carboxylic acid; oleth-2; glyceryl pyroglutamate oleate; glyceryl oleate; N-lauroyl sarcosine; N-myristoyl sarcosine; N-octyl-2-pyrrolidone; lauraminopropionic acid; polypropylene glycol-4-laureth-2; polypropylene glycol-4-laureth-5dimethyllauramide; lauramide diethanolamine (DEA), lauryl pyroglutamate (LP), glyceryl monolaurate (GML), glyceryl monocaprylate, glyceryl monocaprate, glyceryl monooleate (GMO) and sorbitan monolaurate. 
     
     
         6 . The composition of  claim 1 , wherein at least one of the one or more polyols acts as a permeation enhancer or co-solvent. 
     
     
         7 . The composition of  claim 1 , wherein the co-solvents comprise glycerol, glycol, ethanol, methanol, propanol, isopropanol, and butanol. 
     
     
         8 . The composition of  claim 1 , formulated for pediatric administration. 
     
     
         9 . The composition of  claim 1 , wherein the therapeutic agent treats a neurological disorder or a cancer affecting the central nervous system. 
     
     
         10 . The composition of  claim 1 , wherein the perillyl alcohol, perillaldehyde or the carboxylic acid ester of perillyl alcohol is present in an amount from about 0.001% to about 0.01% (v/v). 
     
     
         11 . The composition of  claim 1 , wherein the perillyl alcohol, perillaldehyde or the carboxylic acid ester of perillyl alcohol is present in an amount of about 0.01% (v/v). 
     
     
         12 . A kit comprising the composition of  claim 1 , a device for administering the composition by inhalation, and instruction for use of the device. 
     
     
         13 . A composition for administration by one or more of inhalation, intranasally or ocularly, consisting essentially of: a therapeutic agent; from about 0.0001% to about 0.01% (v/v) of perillyl alcohol, perillaldehyde or a carboxylic acid ester of perillyl alcohol; and one or more components selected from the group consisting of polyols, permeation enhancers, co-solvents, and any combination thereof. 
     
     
         14 . The composition of  claim 13 , wherein the therapeutic agent is a chemotherapeutic agent or a therapeutic antibody. 
     
     
         15 . The composition of  claim 13 , wherein the therapeutic agent is temozolomide or dimethylcelecoxib. 
     
     
         16 . The composition of  claim 13 , wherein the permeation enhancers comprise fatty acid esters of glycerin; fatty acid esters of isosorbide, sucrose, and polyethylene glycol; caproyl lactylic acid; laureth-2; laureth-2 acetate; laureth-2 benzoate; laureth-3 carboxylic acid; laureth-4; laureth-5 carboxylic acid; oleth-2; glyceryl pyroglutamate oleate; glyceryl oleate; N-lauroyl sarcosine; N-myristoyl sarcosine; N-octyl-2-pyrrolidone; lauraminopropionic acid; polypropylene glycol-4-laureth-2; polypropylene glycol-4-laureth-5dimethyllauramide; lauramide diethanolamine (DEA), lauryl pyroglutamate (LP), glyceryl monolaurate (GML), glyceryl monocaprylate, glyceryl monocaprate, glyceryl monooleate (GMO) and sorbitan monolaurate. 
     
     
         17 . The composition of  claim 13 , wherein at least one of the one or more polyols acts as a permeation enhancer or co-solvent. 
     
     
         18 . The composition of  claim 13 , wherein the co-solvents comprise glycerol, glycol, ethanol, methanol, propanol, isopropanol, and butanol. 
     
     
         19 . The composition of  claim 13 , wherein the perillyl alcohol, perillaldehyde or the carboxylic acid ester of perillyl alcohol is present in an amount from about 0.001% to about 0.01% (v/v). 
     
     
         20 . The composition of  claim 13 , wherein the therapeutic agent treats a neurological disorder or a cancer affecting the central nervous system.