Sustained formulation for prevention or treatment of autoimmune disease containing low-dose naltrexone and method using the same

Abstract

The present disclosure provides a sustained formulation for prevention or treatment of autoimmune disease, comprising microparticles comprising naltrexone or pharmaceutically acceptable salts thereof, and biodegradable polymers, and a method using the same. Accordingly, it may be used to prevent or treat autoimmune diseases for a prolonged period of time with a single administration.

1 . A pharmaceutical composition for prevention or treatment of autoimmune diseases, comprising naltrexone or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is administered parenterally. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is an injection for subcutaneous administration or intramuscular administration. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition comprises 0.1 mg to 1 g of naltrexone or a pharmaceutically acceptable salt thereof per unit dosage form. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition comprises low-dose naltrexone or a pharmaceutically acceptable salt thereof. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is administered in a dose of 0.1 mg/kg body weight to 1 g/kg body weight. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is administered in a dose of 10 mg/kg body weight to 500 mg/kg body weight.