Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone
View Patent ↗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. A coated dosage form comprising a compressed tablet comprising 5-methyl-1-phenyl-2-(1H)-pyridone as an active ingredient; and a coating comprising a light shielding agent disposed on the compressed tablet.
2. The dosage form of claim 1 , wherein the light shielding agent is selected from the group consisting of titanium oxide, ferric oxide, and any mixture thereof.
3. The dosage form of claim 1 , 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.
4. The dosage form of claim 1 , wherein the coating further comprises a coating basis.
5. The dosage form of claim 4 , wherein the coating basis is selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylcellulose, and any mixture thereof.
6. The dosage form of claim 4 , wherein the coating basis is 2 to 6 wt % based on the weight of the active ingredient.
7. The dosage form of claim 1 , wherein the coating further comprises 0.01 to 1 wt % plasticizer based on the weight of the active ingredient.
8. The dosage form of claim 7 , wherein the plasticizer is selected from the group consisting of triethyl citrate, triacetin, and any mixture thereof.
9. The dosage form of claim 1 , wherein the amount of 5-methyl-1-phenyl-2-(1H)-pyridone is about 200 mg to 400 mg.
10. The dosage form of claim 1 , wherein the active ingredient comprises 50 to 85 wt % based on the weight of the dosage form.
11. The dosage form of claim 1 , comprising intragranular and extragranular components, wherein the intragranular component comprises the 5-methyl-1-phenyl-2-(1H)-pyridone and the extragranular component comprises a disintegrator.
12. The dosage form of claim 11 , wherein the disintegrator is selected from the group consisting of carmellose calcium, carmellose sodium, croscarmellose sodium, low substituted hydroxypropylcellulose, cross-linked polyvinylpyrrolidone, and any mixture thereof.
13. The dosage form of claim 11 , wherein the disintegrator is provided in an amount of 5 to 40 wt % based on the weight of the active ingredient.
14. The dosage form of claim 11 , wherein the intragranular component further comprises an excipient and a binder.
15. The dosage form of claim 14 , wherein the excipient is selected from the group consisting of lactose, corn starch, crystalline cellulose, and any mixture thereof.
16. The dosage form of claim 14 , wherein the binder is selected from the group consisting of hydroxypropylcellulose, polyvinylpyrrolidone, and any mixture thereof.
17. The dosage form of claim 11 , wherein the extragranular component further comprises a lubricant.
18. The dosage form of claim 17 , wherein the lubricant is selected from the group consisting of magnesium stearate, talc, and any mixture thereof.
19. The dosage form of claim 18 , wherein the lubricant is included in an amount of 0.5 to 5 wt % based on the weight of the active ingredient.
20. The dosage form of claim 1 , further comprising an excipient, a disintegrator, a binder, and a lubricant.