Pharmaceutical composition comprising lidocaine and melatonin

Abstract

The present disclosure provides a pharmaceutical composition comprising Lidocaine or salt or hydrates or solvates thereof and Melatonin or salt or hydrates or solvates thereof. The compositions of the present disclosure may find utility in treatment of mucositis, oral mucositis, ulcers, ulcer mediated pain and the like conditions. Aspects of the present disclosure also relates to method of treating oral and gastrointestinal disease/conditions using the advantageous compositions of the present disclosure.

1 . A pharmaceutical composition comprising: Lidocaine or salt or hydrates or solvates thereof and Melatonin thereof. 
     
     
         2 . The composition of  claim 1 , wherein the composition comprises Lidocaine or salt or hydrates or solvates thereof and Melatonin thereof in a weight ratio ranging from 1:1 to 400:1. 
     
     
         3 . The composition of  claim 1 , wherein the composition comprises Lidocaine or salt or hydrates or solvates thereof and Melatonin thereof in a weight ratio ranging from 5:1 to 150:1. 
     
     
         4 . The composition of  claim 1 , wherein Lidocaine or salt or hydrates or solvates thereof is present in an amount ranging from 50 mg to 400 mg. 
     
     
         5 . The composition of  claim 1 , wherein Melatonin thereof is present in an amount ranging from 1 mg to 60 mg. 
     
     
         6 . The composition of  claim 1 , wherein the composition further comprises a pharmaceutically acceptable excipient. 
     
     
         7 . The composition of  claim 6 , wherein the pharmaceutically acceptable excipient is selected from any or a combination of: a diluent, an anti-oxidant, a preservative, an alkalizing agent, a buffering agent, a disintegrant, a binder, an antifoaming agent, a solvent, a glidant, a lubricant, a flavoring agent, a sweetener, a coating agent, a rate controlling polymer or non-polymer, a zinc salt, a fatty acid or derivative thereof, an amino acid or metabolites or derivative thereof, a bulking agent, an antitacking agent, an emulsifier, a surfactant, a plasticizer and a stabilizer. 
     
     
         8 . The composition of  claim 7 , wherein the fatty acid derivative comprises any or a combination of: diglyceryl lauryl fumarate, diglyceryl lauryl succinate, and diglyceryl capryl succinate. 
     
     
         9 . The composition of  claim 1 , wherein the composition comprises an intragranular portion and an extra-granular portion, wherein the intra-granular portion comprises Lidocaine or salt or hydrates or solvates thereof, Melatonin thereof and a pharmaceutically acceptable excipient, and the extra-granular portion comprises a pharmaceutically acceptable excipient. 
     
     
         10 . The composition of  claim 1 , wherein the composition comprises an intragranular portion and an extra-granular portion, wherein the intra-granular portion comprises a pharmaceutically acceptable excipient, and the extra-granular portion comprises Lidocaine or salt or hydrates or solvates thereof, Melatonin thereof and a pharmaceutically acceptable excipient. 
     
     
         11 . The composition of  claim 1 , wherein the composition comprises an intragranular portion and an extra-granular portion, wherein the intra-granular portion comprises Melatonin thereof and a pharmaceutically acceptable excipient, and the extra-granular portion comprises Lidocaine or salt or hydrates or solvates thereof and a pharmaceutically acceptable excipient. 
     
     
         12 . The composition of  claim 1 , wherein the composition comprises an intragranular portion and an extra-granular portion, wherein the intra-granular portion comprises Lidocaine or salt or hydrates or solvates thereof and a pharmaceutically acceptable excipient, and the extra-granular portion comprises Melatonin thereof and a pharmaceutically acceptable excipient. 
     
     
         13 . The composition of  claim 1 , wherein the composition comprises an intragranular portion and an extra-granular portion, and wherein the portions are compressed together to obtain any of a tablet dosage form and a Lozenge dosage form, optionally coated with a seal coat. 
     
     
         14 . The composition of  claim 1 , wherein the composition comprises an intragranular portion and an extra-granular portion, and wherein the intra-granular portion comprises a pharmaceutically acceptable excipient, and the extra-granular portion comprises Lidocaine hydrochloride monohydrate in an amount of 100 mg, Melatonin in an amount of 10 mg and a pharmaceutically acceptable excipient. 
     
     
         15 . The composition of  claim 1 , wherein the composition comprises Lidocaine hydrochloride monohydrate in an amount of 100 mg, Melatonin in an amount of 10 mg and a pharmaceutically acceptable excipient, said composition being a directly compressed lozenge formulation. 
     
     
         16 . The composition of  claim 1 , wherein the composition comprises Lidocaine hydrochloride monohydrate in an amount of 100 mg, Melatonin in an amount of 3 mg and a pharmaceutically acceptable excipient, said composition being a directly compressed lozenge formulation. 
     
     
         17 . The composition of  claim 1 , wherein the composition comprises Lidocaine hydrochloride monohydrate in an amount of 200 mg, Melatonin in an amount of 3 mg and a pharmaceutically acceptable excipient, said composition being a directly compressed lozenge formulation. 
     
     
         18 . A method of treating oral and gastrointestinal disorders in a patient in need thereof comprising administering to a subject a therapeutically effective amount of the pharmaceutical composition of  claim 1 . 
     
     
         19 . Use of the pharmaceutical composition of  claim 1  in preparation of a medicament for the treatment of oral and gastrointestinal diseases in patient in need thereof.