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Last Updated: November 19, 2019

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Claims for Patent: 10,022,344

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Summary for Patent: 10,022,344
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:15/817,471
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,022,344
Patent Claims: 1. A soft gelatin capsule comprising a fill material comprising: (a) naproxen sodium; (b) about 5% of a deionizing agent comprising acetic acid, propionic acid, pyruvic acid, or lactic acid; (c) polyethylene glycol; and (d) a solubilizer comprising glycerin, polyvinylpyrrolidone, propylene glycol, or combinations thereof.

2. The capsule of claim 1, wherein the deionizing agent is propionic acid or lactic acid.

3. The capsule of claim 1, wherein the deionizing agent is lactic acid.

4. The capsule of claim 1, wherein polyethylene glycol is present in an amount from 10% to 80% by weight.

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

6. The capsule of claim 1, wherein the fill material further comprises water in an amount from 1% to 18% by weight.

7. The capsule 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.

8. The capsule of claim 1, wherein the solubilizer is present in amount from 1% to 10% by weight.

9. The capsule of claim 1, wherein the fill material is liquid.

10. A method for treating pain, inflammation, or fever comprising administering the capsule of claim 1 to a patient in need thereof.

11. A method of making the capsule of claim 1 comprising (a) mixing components (a), (b), (c), and (d) as defined in claim 1; and (b) encapsulating the mixture in a softgel capsule.

12. The method of claim 11, wherein step (a) is conducted at a temperature of from 50.degree. C. to 70.degree. C.

13. A soft gelatin capsule comprising a fill material comprising: (a) naproxen sodium; (b) about 5% of a deionizing agent comprising acetic acid, propionic acid, pyruvic acid, or lactic acid; (c) polyethylene glycol; (d) a solubilizer comprising glycerin, polyvinylpyrrolidone, propylene glycol, or combinations thereof; and (e) water.

14. The capsule of claim 13, wherein polyethylene glycol is present in an amount from 10% to 80% by weight.

15. The capsule of claim 13, wherein the polyethylene glycol comprises one or more polyethylene glycols with a molecular weight between 300 and 1500.

16. The capsule of claim 13, wherein water is present in an amount from 1% to 18% by weight.

17. The capsule of claim 13, further comprising one or more excipients comprising plasticizers, crystallization inhibitors, wetting agents, bulk filling agents, bioavailability enhancers, solvents, dyes, preservatives, surfactants, or combinations thereof.

18. The capsule of claim 13, wherein the solubilizer is present in amount from 1% to 10% by weight.

19. The capsule of claim 13, wherein the fill material is liquid.

20. A method for treating pain, inflammation, or fever comprising administering the capsule of claim 13 to a patient in need thereof.

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