Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1h)-pyridone

Abstract

A tablet characterized by comprising 5-methyl-1-phenyl-2-(1H)-pyridone as the main ingredient and, based on the main ingredient, 10 to 50 wt. % excipient, 5 to 40 wt. % disintegrator, 1 to 10 wt. % binder, 0.5 to 5 wt. % lubricant, 2 to 6 wt. % coating basis, and 0.05 to 3 wt. % light-shielding agent, wherein the odor or bitterness of the 5-methyl-1-phenyl-2-(1H)-pyridone is masked and the light stability is improved.

1 - 14 . (canceled) 
     
     
         15 . A coated dosage form comprising a pharmaceutical tablet comprising intragranular and extragranular components, wherein the intragranular component comprises 5-methyl-1-phenyl-2-(1H)-pyridone and a disintegrant, and the extragranular component comprises a disintegrant; and a coating disposed on the pharmaceutical tablet. 
     
     
         16 . The dosage form of  claim 15 . wherein the disintegrator is selected from carmellose calcium, carmellose sodium, croscarmellose sodium, low substituted hydroxypropylcellulose, cross-linked polyvinylpyrrolidone, or any mixture thereof. 
     
     
         17 . The dosage form of  claim 15 , wherein the disintegrator is provided in a total amount of 5 to 40 wt % based on the weight of the active ingredient. 
     
     
         18 . The dosage form of  claim 15 , wherein the intragranular component further comprises an excipient and a binder. 
     
     
         19 . The dosage form of  claim 18 , wherein the excipient is selected from lactose, corn starch, crystalline cellulose, or any mixture thereof. 
     
     
         20 . The dosage form of  claim 18 , wherein the binder is selected from hydroxypropylcellulose, polyvinylpyrrolidone, or any mixture thereof. 
     
     
         21 . The dosage form of  claim 15 , wherein the extragranular component further comprises a lubricant. 
     
     
         22 . The dosage form of  claim 21 , wherein the lubricant is selected from magnesium stearate, talc, or any mixture thereof. 
     
     
         23 . The dosage form of  claim 22 , wherein the lubricant is included in an amount of 0.5 to 5 wt % based on the weight of the active ingredient. 
     
     
         24 . The dosage form of  claim 15 , further comprising a light shielding agent. 
     
     
         25 . The dosage form of  claim 15 , wherein the amount of 5-methyl-1-phenyl-2-(1H)-pyridone ranges from 200 mg to 400 mg. 
     
     
         26 . The dosage form of  claim 15 , comprising 10 to 85% of the 5-methyl-1-phenyl-2-(1H)-pyridone by weight based on the total weight of the tablet. 
     
     
         27 . The dosage form of  claim 15 , comprising 10 wt % to 50 wt % lactose based on the weight of the main ingredient. 
     
     
         28 . A coated dosage form comprising a pharmaceutical tablet comprising 5-methyl-1-phenyl-2-(1H)-pyridone as a main ingredient and 10 wt % to 50 wt % lactose based on the weight of the main ingredient; and a coating disposed on the pharmaceutical tablet. 
     
     
         29 . The dosage form of  claim 28 , wherein the coating comprises a light shielding agent. 
     
     
         30 . The dosage form of  claim 29 , wherein the light shielding agent is selected from titanium oxide, ferric oxide, or any mixture thereof. 
     
     
         31 . The dosage form of  claim 29 , wherein the light-shielding agent is present in an amount ranging from 0.05 to 3 wt % based on the weight of the active ingredient. 
     
     
         32 . The dosage form of  claim 28 , wherein the active ingredient comprises 50 to 85 wt % based on the weight of the dosage form. 
     
     
         33 . The dosage form of  claim 28 , wherein the amount of 5-methyl-1-phenyl-2-(1H)-pyridone ranges from 200 mg to 400 mg. 
     
     
         34 . The dosage form of  claim 28 , further comprising 5 to 40 wt % disintegrant selected from carmellose calcium, carmellose sodium, croscarmellose sodium, low substituted hydroxypropylcellulose, cross-linked polyvinylpyrrolidone, or any mixture thereof, 1 to 10 wt % binder selected from hydroxypropylcellulose and polyvinylpyrrolidone, or any mixture thereof, and 0.5 to 5 wt. % lubricant selected from magnesium stearate, talc, or any mixture thereof, the wt. % being based on the weight of the 5-methyl-1-phenyl-2-(1H)-pyridone.