Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
AssigneeCatalent Ontario Limited
InventorsJohn Lopez, Peter Draper, Sankalp Vashishtha, Nancy Klassen, Christina Armstrong
Life of this patent
Estimating the term…
Abstract
Disclosed are methods of using a naproxen fill formulation suitable for encapsulation into a soft gel dosage unit to treat inflammation and pain. Methods include administering naproxen to a subject in need thereof to treat pain and inflammation. Methods can include administering naproxen together with another medicament to a subject in need thereof to treat an additional condition such as a cough, cold, allergy, congestion, etc.
Claims18
-19. (canceled)
A pharmaceutical fill formulation for treating cold and flu symptoms, comprising:
- about 2% to about 25% by weight of naproxen;
- about 25% to about 2% by weight of naproxen sodium;
- about 40% to about 70% by weight of polyethylene glycol;
- about 1% to about 5% by weight of propylene glycol;
- about 1% to about 6% by weight of povidone;
- about 1% to about 10% by weight of water;
- about 0.01% to about 1% by weight of phenylephrine hydrochloride;
- wherein the total amount of naproxen and naproxen sodium ranges from about 22% to about 30% by weight of the total composition.
A soft gel capsule comprising:
- a fill formulation comprising:
- about 2% to about 25% by weight of naproxen;
- about 25% to about 2% by weight of naproxen sodium;
- about 40% to about 70% by weight of polyethylene glycol;
- about 1% to about 5% by weight of propylene glycol;
- about 1% to about 6% by weight of povidone;
- about 1% to about 10% by weight of water;
- about 0.01% to about 1% by weight of phenylephrine hydrochloride;
- wherein the total amount of naproxen and naproxen sodium ranges from about 22% to about 30% by weight of the total composition;
- and
- a shell formulation.
Dependencies are inferred from the claim text.