Pharmaceutical composition comprising palmitoylethanolamide and l-acetylcarnitine

Abstract

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

What is claimed: 
     
         1 . A pharmaceutical composition, comprising:
 palmitoylethanolamide (PEA) and L-acetylcarnitine (LAC).   
     
     
         2 . The pharmaceutical composition according to  claim 1 , 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. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein said L-acetylcarnitine is in finely pulverized form. 
     
     
         4 . The pharmaceutical composition according to  claim 1 , 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%. 
     
     
         5 . The pharmaceutical composition according to  claim 4 , wherein the compound with antioxidant activity is selected from the group comprising polyphenols, alpha-lipoic acid, and L-acetylcysteine. 
     
     
         6 . The pharmaceutical composition according to  claim 5 , wherein, when the antioxidant compound is or comprises a polyphenol, preferably selected from polydatin, resveratrol, luteolin, quercetin, and rutin. 
     
     
         7 . The pharmaceutical composition according to  claim 5 , wherein the compound with antioxidant activity is co-micronized with palmitoylethanolamide. 
     
     
         8 . The pharmaceutical composition according to  claim 1 , wherein said composition is for oral or buccal use. 
     
     
         9 . The pharmaceutical composition according to  claim 1 , 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, Prostatitis, Vaginitis, Vulvovaginitis, primary and secondary Dysmenorrhea, Vulvodynia, Vestibulodynia;   pain associated with traumatic and degenerative joint diseases; and   pain associated with arthritic diseases.   
     
     
         10 . The pharmaceutical composition according to  claim 9 , for human or veterinary use.