Pharmaceutical composition comprising palmitoylethanolamide and l-acetylcarnitine

Abstract

A pharmaceutical composition, for use in humans or animals, containing N-palmitoylethanolamide for the control of the inflammatory and/or neuropatic pain of various origin. In particular, the present invention relates to a pharmaceutical composition comprising palmitoylethanolamide (PEA) and L-acetylcarnitine (LAC), optionally in addition with an antioxidant compound, such as a polyphenol, alpha-lipoic acid, and L-acetylcysteine.

1 - 10 . (canceled) 
     
     
         11 . A pharmaceutical composition comprising:
 palmitoylethanolamide (PEA), and   L-acetylcarnitine (LAC).   
     
     
         12 . The pharmaceutical composition according to  claim 11 , wherein said palmitoylethanolamide is in non-micronized form with a particle size ranging between 50.0 and 100.0 μm, in micronized form (PEA-m) with a particle size ranging between 2.0 and 10.0 μm, or in ultra-micronized form (PEA-um) with a particle size ranging between 0.8 and 6.0 μm, or in a mixture of such forms. 
     
     
         13 . The pharmaceutical composition according to  claim 11 , wherein said L-acetylcarnitine is in a finely pulverized form. 
     
     
         14 . The pharmaceutical composition according to  claim 12 , wherein said L-acetylcarnitine is in a finely pulverized form. 
     
     
         15 . The pharmaceutical composition according to  claim 11 , further comprising palmitoylethanolamide in weight percentages ranging between 20 and 35%, L-acetylcarnitine in weight percentages between 20 and 55%, and one or more compounds with antioxidant activity in total weight percentages ranging between 0 and 20%. 
     
     
         16 . The pharmaceutical composition according to  claim 12 , further comprising palmitoylethanolamide in weight percentages ranging between 20 and 35%, L-acetylcarnitine in weight percentages between 20 and 55%, and one or more compounds with antioxidant activity in total weight percentages ranging between 0 and 20%. 
     
     
         17 . The pharmaceutical composition according to  claim 13 , further comprising palmitoylethanolamide in weight percentages ranging between 20 and 35%, L-acetylcarnitine in weight percentages between 20 and 55%, and one or more compounds with antioxidant activity in total weight percentages ranging between 0 and 20%. 
     
     
         18 . The pharmaceutical composition according to  claim 15 , wherein the compound with antioxidant activity is selected from the group comprising polyphenols, alpha-lipoic acid, and L-acetylcysteine. 
     
     
         19 . The pharmaceutical composition according to  claim 16 , wherein the compound with antioxidant activity is selected from the group comprising polyphenols, alpha-lipoic acid, and L-acetylcysteine. 
     
     
         20 . The pharmaceutical composition according to  claim 17 , wherein the compound with antioxidant activity is selected from the group comprising polyphenols, alpha-lipoic acid, and L-acetylcysteine. 
     
     
         21 . The pharmaceutical composition according to  claim 18 , wherein, when the antioxidant compound is or comprises a polyphenol, and is preferably selected from polydatin, resveratrol, luteolin, quercetin, and rutin. 
     
     
         22 . The pharmaceutical composition according to  claim 19 , wherein, when the antioxidant compound is or comprises a polyphenol, and is preferably selected from polydatin, resveratrol. luteolin, quercetin, and rutin. 
     
     
         23 . The pharmaceutical composition according to  claim 20 , wherein, when the antioxidant compound is or comprises a polyphenol, and is preferably selected from polydatin, resveratrol, luteolin, quercetin, and rutin. 
     
     
         24 . The pharmaceutical composition according to  claim 15 , wherein the compound with antioxidant activity is co-micronized with palmitoylethanolamide. 
     
     
         25 . The pharmaceutical composition according to  claim 18 , wherein the compound with antioxidant activity is co-micronized with palmitoylethanolamide. 
     
     
         26 . The pharmaceutical composition according to  claim 19 , wherein the compound with antioxidant activity is co-micronized with palmitoylethanolamide. 
     
     
         27 . The pharmaceutical composition according to  claim 23 , wherein the compound with antioxidant activity is co-micronized with palmitoylethanolamide. 
     
     
         28 . The pharmaceutical composition according to  claim 11 , wherein said composition is for oral or buccal use. 
     
     
         29 . The pharmaceutical composition according to  claim 11 , for use in the treatment of a disease selected from:
 both acute and chronic painful peripheral neuropathies of dysmetabolic, compressive, traumatic, toxic, infectious, iatrogenic origin;   pain associated with vertebral column and spinal cord diseases of traumatic, dysmetabolic, degenerative, infectious, iatrogenic origin;   pain associated with small fibre diseases of infectious, traumatic, dysmetabolic, iatrogenic origin.   acute and/or chronic pain associated with diseases in the pelvic area, such as Endometriosis, Interstitial Cystitis, Recurrent Cystitis, Irritable Bowel Syndrome, Prostatites, Vaginites, Vulvovaginites, primary and secondary Dysmenorrhoea, Vulvodynias, Vestibulodynias;   pain associated with traumatic and degenerative joint diseases;   pain associated with arthritic diseases.   
     
     
         30 . The pharmaceutical composition according to  claim 29 , wherein the pharmaceutical composition is for human or veterinary use.