Pharmaceutical composition for neuropathic pain

Abstract

The present application describes a pharmaceutical composition/formulation for use in controlling neuropathic pain. The composition/formulation includes Palmitoylethanolamide (PEA) and one or more natural ingredients. The application also provides various formulations and methods of preparing the same.

We claim: 
     
         1 . A pharmaceutical composition comprising: Palmitoylethanolamide (PEA) and one or more naturally occurring Fatty Acid Amide Hydrolase (FAAH) Inhibitor. 
     
     
         2 . The pharmaceutical composition as claimed in  claim 1 , wherein the amount of PEA ranges from 35 to 80% by wt. of the composition. 
     
     
         3 . The pharmaceutical composition as claimed in  claim 1 , wherein the amount of naturally occurring FAAH inhibitor ranges from 0.5 to 40% by wt. of the composition. 
     
     
         4 . The pharmaceutical composition as claimed in  claim 1 , wherein the naturally occurring FAAH Inhibitor is selected from Myricetin, Isorhamnetin, Kaempferol, Pristimerin, Biochanin A, Genistein, Daidzein or a combination thereof. 
     
     
         5 . The pharmaceutical composition as claimed in  claim 4 , wherein the naturally occurring FAAH inhibitor is selected from Daidzein, Genistein or combination thereof. 
     
     
         6 . The pharmaceutical composition as claimed in  claim 1 , further comprising vitamins, coenzymes or a combination thereof. 
     
     
         7 . The pharmaceutical composition as claimed in  claim 6 , wherein the vitamins are selected from methylcobalamin, cyanocobalamin, benfotiamine or a combination thereof; and co-enzymes are selected from ubidecarenone, thiamine pyrophosphate, Flavin adenine dinucleotide or a combination thereof. 
     
     
         8 . The pharmaceutical composition as claimed in  claim 6 , wherein the amount of vitamins ranges from 0.01 to 30% by wt. of the composition. 
     
     
         9 . The pharmaceutical composition as claimed in  claim 6 , wherein the amount of coenzymes ranges from 10 to 40% by wt. of the composition. 
     
     
         10 . The pharmaceutical composition as claimed in  claim 1 , further comprising pharmaceutically acceptable excipients. 
     
     
         11 . The pharmaceutical composition as claimed in  claim 10 , wherein the pharmaceutically acceptable excipient is selected from a diluent, disintegrant, binder, solubilizing agent, lubricant, glidant, or solvent. 
     
     
         12 . The pharmaceutical composition as claimed in  claim 11 , wherein the amount of diluent ranges from 5% to 50% by wt. of the composition, disintegrant ranges from 0.5% to 10% by wt. of the composition, binder ranges from 0.1% to 10% by wt. of the composition, solubilizing agent ranges from 0.25% to 15% by wt. of the composition, lubricant ranges from 1.0% to 10% by wt. of the composition, glidant ranges from 1.0% to 10% by wt. of the composition, or amount of solvent is quantity sufficient. 
     
     
         13 . The pharmaceutical composition as claimed in  claim 1 , wherein the composition is in the form of a tablet, capsule, sachet, pill, hard capsule filled with liquid or solid, soft capsule, powder, granule, suspension solution or modified release formulation. 
     
     
         14 . A process for preparing a pharmaceutical composition as claimed in  claim 1  comprising:
 a. weighing accurately all the ingredients in separate containers, 
 b. sifting previously weighed PEA, Natural FAAH Inhibitor(s), diluent(s), and a disintegrating agent(s) separately, 
 c. mixing content of step b, 
 d. preparing binder solution in separate container and add it to step c and sieve the dough to obtain granules, 
 e. drying the obtained granulates until the level of dryness (LOD) is reduced to less than 1.5% w/w, 
 f. sifting semi dried granules through suitable sieve, 
 g. sifting previously weighed lubricant(s) or glidant(s) separately through suitable sieve and add to step f.