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Last Updated: November 28, 2020

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Claims for Patent: 10,028,925

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Summary for Patent: 10,028,925
Title:Liquid dosage forms of sodium naproxen
Abstract: Described herein are oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules. In one embodiment, the pharmaceutical composition comprises sodium naproxen, 0.2-1.0 mole equivalents of a de-ionizing agent per mole of naproxen, polyethylene glycol, and one or more solubilizers such as propylene glycol, polyvinyl pyrrolidone or a combination thereof.
Inventor(s): Chidambaram; Nachiappan (Sandy, UT), Fatmi; Aqeel A (High Point, NC)
Assignee: Patheon Softgels, Inc. (High Point, NC)
Application Number:15/591,512
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,028,925
Patent Claims: 1. A pharmaceutical composition comprising a soft gelatin capsule encapsulating a liquid matrix comprising: (a) naproxen sodium; (b) about 5% lactic acid by weight of the matrix; (c) one or more polyethylene glycols; and (d) one or more solubilizers.

2. The composition of claim 1, wherein the solubilizer comprises polyvinylpyrrolidone, propylene glycol, or a combination thereof.

3. The composition of claim 1, wherein the polyethylene glycol comprises from about 10% to about 80% by weight of the matrix.

4. The composition of claim 1, wherein the polyethylene glycol comprises one or more polyethylene glycols with a molecular weight between 300 and 1500.

5. The composition of claim 1, wherein the polyethylene glycol comprises polyethylene glycol 600.

6. The composition of claim 1, wherein the solubilizer comprises from about 1% to 10% by weight of the matrix.

7. The composition of claim 1, wherein the solubilizer comprises about 2% polyvinylpyrrolidone and about 2% propylene glycol by weight of the matrix.

8. The composition of claim 1, further comprising one or more excipients comprising plasticizers, crystallization inhibitors, wetting agents, bulk filling agents, bioavailability enhancers, solvents, dyes, preservatives, surfactants, or combinations thereof.

9. A pharmaceutical composition comprising a soft gelatin capsule encapsulating a liquid matrix comprising: (a) about 25% naproxen sodium by weight of the matrix; (b) about 5% lactic acid by weight of the matrix; (c) about 10% to about 80% of polyethylene glycol by weight of the matrix; and (d) about 1% to about 10% of one or more solubilizers.

10. The composition of claim 9, wherein the solubilizer comprises polyvinylpyrrolidone, propylene glycol, or a combination thereof.

11. The composition of claim 9, wherein the solubilizer comprises polyvinylpyrrolidone and propylene glycol.

12. The composition of claim 9, wherein the matrix comprises a mole ratio of lactic acid to naproxen sodium of about 0.6.

13. The composition of claim 9, wherein the solubilizer comprises about 2% polyvinylpyrrolidone and about 2% propylene glycol by weight of the matrix.

14. The composition of claim 9, wherein the matrix further comprises one or more excipients selected from plasticizers, crystallization inhibitors, wetting agents, bulk filling agents, bioavailability enhancers, solvents, dyes, preservatives, surfactants, or combinations thereof.

15. The composition of claim 9, wherein the matrix comprises a pH is from about 2.5 to about 7.5.

16. The composition of claim 9, wherein the soft gelatin capsule comprises: (a) gelatin; (b) plasticizer; and (c) purified water.

17. A method for making the pharmaceutical composition of claim 9, the method comprising: (a) mixing together the components of 9(a) to 9(d) to form a mixture; and (b) encapsulating the mixture in a soft gelatin capsule using rotary die encapsulation.

18. An oral dosage form produced by the method of claim 17.

19. A pharmaceutical composition comprising a soft gelatin capsule encapsulating a liquid matrix comprising: (a) about 25% naproxen sodium by weight of the matrix; (b) about 5% lactic acid by weight of the matrix; (c) quantum sufficit (q.s.) of polyethylene glycol; and (d) about 1% to about 10% of one or more solubilizers.

20. The composition of claim 19, wherein the solubilizer comprises about 2% polyvinylpyrrolidone and about 2% propylene glycol by weight of the matrix.

21. The composition of claim 19, wherein the matrix comprises a mole ratio of lactic acid to naproxen sodium of about 0.6.

22. The composition of claim 9, wherein the polyethylene glycol comprises polyethylene glycol 600.

23. The composition of claim 19, wherein the polyethylene glycol comprises polyethylene glycol 600.

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