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Last Updated: September 21, 2021

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Claims for Patent: 9,561,217


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Summary for Patent: 9,561,217
Title: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.
Inventor(s): Kiyonaka; Gakuji (Amagasaki, JP), Furuya; Yoshihiro (Amagasaki, JP), Suzuki; Yusuke (Amagasaki, JP)
Assignee: INTERMUNE, INC. (Brisbane, CA)
Application Number:14/951,313
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,561,217
Patent Claims: 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.

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