Liquid dosage forms of sodium naproxen
View Patent ↗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.
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° C. to 70° 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.