Use of Adelmidrol in the Treatment of Epithelial Dysfunctions

Abstract

The described herein is the use of Adelmidrol in the treatment of epithelial dysfunctions. In particular, described herein is Adelmidrol for use in the treatment of epithelial tissue dysfunctions in a human being or animal, wherein said Adelmidrol causes an increase of the endogenous levels of Palmitoylethanolamide without inhibiting the activity of the Palmitoylethanolamide-degrading FAAH and NAAA enzymes.

What is claimed is: 
     
         1 . Adelmidrol for use in the treatment of epithelial tissue dysfunctions in a human being or animal, wherein said Adelmidrol causes an increase of the endogenous levels of palmitoylethanolamide without inhibiting the activity of the palmitoylethanolamide-degrading FAAH and NAAA enzymes. 
     
     
         2 . Adelmidrol for use according to  claim 1 , wherein said epithelial tissue dysfunctions in a human being or animal are selected from the group consisting of oropharyngeal and esophageal Dysphagia with different etiology; gastroesophageal reflux; Cricopharyngeal Achalasia; esophageal Achalasia; stomatites with different etiology; Presbiphagia in the elderly; feline gingivostomatitis; periodontal disease also related to endodontics/orthodontics and dental implantology interventions; Burning Mouth Syndrome (BMS); Eyelid Edema; Blepharitis, Blepharoconjunctivitis; inward turning (entropion) and eversion (ectropion) of the eyelid; keratitis and keratitoconjunctivitis with different etiology (e.g., superficial punctate keratitoconjunctivitis); corneal lesions with different etiology; quali-quantitative alterations of the tear film; Dacryocystitis; Uveitis; Glaucoma; diseases of the ceruminous glands of the ear; ear hematomas in dog and cat; fly strike irritations in dog and cat; Pododermatites; Rhinites, Rhinotracheites, acute and chronic rhinopharyngites; acute and chronic Pharyngites; acute and chronic bronchites; Sinusites, Rinosinusites; bronchial asthma; Alopecia; nasal dermatoses in dog and cat; Acute and chronic sialadenites; neuropathic itch; bladder pain syndrome with different etiology attributable to alterations of the urothelium and in particular interstitial cystitis, cystitis due to systemic chemotherapeutics, cystitis due to bladder instillation of local chemotherapeutics, such as Epirubicin or Mitomycin, cystitis due to pelvic radiotherapy; chronic and/or recurrent Cystites; Gastrointestinal disorders attributable to alterations of the epithelium; Diseases of the ano-rectal segment, particularly posterior rectocele, proctites, muco-rectal prolapse, hemorrhoids, anal rhagades, perianal itching, diseases of the anal sacs in dog, and other perineal dysfunctions; small and medium vessel Vasculites and particularly granulomatous Vasculites, Vasculites due to immunocomplexes; Inflammations of the secondary sexual glands and particularly of the seminal vesicles and the seminal ducts; orofacial pain syndromes in the human and veterinary field; synovites associated to rheumatoid arthritis and osteoarthrosis. 
     
     
         3 . Adelmidrol for use according to  claim 1 , wherein said Adelmidrol is administered in a combined, sequential, or separate manner in combination with at least one active ingredient selected from the group consisting of an oxazoline derivative of palmitoylethanolamide, an anti-microbial agent, trans-traumatic acid and hyaluronic acid or derivatives thereof. 
     
     
         4 . Adelmidrol for use according to  claim 3 , wherein said anti-microbial agent is selected from  Echinacea purpurea  extract,  Usnea barbata  extract, usnic acid, phytosphingosine, bronopol and mixtures thereof. 
     
     
         5 . Adelmidrol for use according to  claim 4 , wherein hyaluronic acid and trans-traumatic acid are present in sodium hyaluronate trans-traumatate double salt form. 
     
     
         6 . Adelmidrol for use according to  claim 1 , wherein the amount of Adelmidrol to be administered in the form of solutions intended to the epithelia ranges between 0.5 and 20 mg/Kg body weight. 
     
     
         7 . A pharmaceutical formulation for use in the treatment of epithelial and mucosal tissue dysfunctions in a human being or animal, wherein said pharmaceutical formulation contains Adelmidrol and one or more active ingredients selected from the group consisting of an oxazoline derivative of palmitoylethanolamide, an anti-microbial agent, trans-traumatic acid, and hyaluronic acid or derivatives thereof. 
     
     
         8 . The formulation for use according to  claim 7 , wherein said epithelial tissue dysfunctions in a human being or animal are selected from the group consisting of oropharyngeal and esophageal Dysphagia with different etiology; gastroesophageal reflux; Cricopharyngeal Achalasia; esophageal Achalasia; stomatites with different etiology; Presbiphagia in the elderly; feline gingivostomatitis; periodontal disease also related to endodontics/orthodontics and dental implantology interventions; Burning Mouth Syndrome (BMS); Eyelid Edema; Blepharitis, Blepharoconjunctivitis; inward turning (entropion) and eversion (ectropion) of the eyelid; keratitis and keratitoconjunctivitis with different etiology (e.g., superficial punctate keratitoconjunctivitis); corneal lesions with different etiology; quali-quantitative alterations of the tear film; Dacryocystitis; Uveitis; Glaucoma; diseases of the ceruminous glands of the ear; ear hematomas in dog and cat; fly strike irritations in dog and cat; Pododermatites; Rhinites, Rhinotracheites, acute and chronic rhinopharyngites; acute and chronic Pharyngites; acute and chronic bronchites; Sinusites, Rinosinusites; bronchial asthma; Alopecia; nasal dermatoses in dog and cat; Acute and chronic sialadenites; neuropathic itch; bladder pain syndrome with different etiology attributable to alterations of the urothelium and in particular interstitial cystitis, cystitis due to systemic chemotherapeutics, cystitis due to bladder instillation of local chemotherapeutics, such as Epirubicin or Mitomycin, cystitis due to pelvic radiotherapy; chronic and/or recurrent Cystites; Gastrointestinal disorders attributable to alterations of the epithelium; Diseases of the ano-rectal segment, particularly posterior rectocele, proctites, muco-rectal prolapse, hemorrhoids, anal rhagades, perianal itching, diseases of the anal sacs in dog, and other perineal dysfunctions; small and medium vessel Vasculites and particularly granulomatous Vasculites, Vasculites due to immunocomplexes; Inflammations of the secondary sexual glands and particularly of the seminal vesicles and the seminal ducts; orofacial pain syndromes in the human and veterinary field; synovites associated to rheumatoid arthritis and osteoarthrosis 
     
     
         9 . The formulation for use according to  claim 7 , wherein said formulation has the following weight composition, the balance being relative only to the active ingredients: 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Adelmidrol 
                   50-100%   
                 
                     
                   Oxazoline derivative of PEA 
                   0-5% 
                 
                     
                   Hyaluronic acid or derivative thereof 
                   0-5% 
                 
                     
                   Trans-traumatic acid 
                   0-5% 
                 
                     
                   Anti-microbial agent 
                    0-1%. 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
               
            
           
         
       
     
     
         10 . The formulation for use according to  claim 7 , wherein said anti-microbial agent is selected from  Echinacea purpurea  extract,  Usnea barbata  extract, usnic acid, phytosphingosine, bronopol and mixtures thereof. 
     
     
         11 . The formulation for use according to  claim 7 , wherein hyaluronic acid and trans-traumatic acid are present in the sodium hyaluronate trans-traumatate double salt form. 
     
     
         12 . The formulation for use according to  claim 7 , wherein the weight concentration of Adelmidrol in the pharmaceutical forms for topic application intended to the use in both human beings and animals ranges between 0.2% and 7.0%, and the weight concentration of Adelmidrol in the solutions for application on internal epithelia ranges between 0.3% and 5.0%.