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.
Claims20
A method of treating pain, inflammation or a combination thereof, comprising:
- administering to a subject in need thereof, a pharmaceutical composition consisting essentially of:
- about 2% to about 25% of naproxen;
- about 25% to about 2% of naproxen sodium, wherein the weight ratio of naproxen to naproxen sodium is about 9:1 to about 3:7;
- about 40% to about 70% polyethylene glycol;
- about 1% to about 5% propylene glycol;
- about 1% to about 6% povidone;
- about 1% to about 10% water,
- wherein the total amount of naproxen and naproxen sodium ranges from about 22% to about 30% by weight of the total composition,
- wherein the pharmaceutical composition is free of a neutralizing agent, and
- wherein a volume of the fill formulation is less than a volume of a neutralized naproxen fill composition containing an equivalent dose of naproxen and naproxen sodium.
A method of treating pain, inflammation or a combination thereof, and cough, cold, allergy, congestion or combinations thereof, comprising:
- administering to a subject in need thereof, a pharmaceutical composition consisting essentially of:
- about 2% to about 25% of naproxen;
- about 25% to about 2% of naproxen sodium, wherein the weight ratio of naproxen to naproxen sodium is about 9:1 to about 3:7;
- about 40% to about 70% polyethylene glycol;
- about 1% to about 5% propylene glycol;
- about 1% to about 6% povidone;
- about 1% to about 10% water,
- wherein the total amount of naproxen and naproxen sodium ranges from about 22% to about 30% by weight of the total composition,
- wherein the pharmaceutical composition is free of a neutralizing agent, and
- wherein a volume of the fill formulation is less than a volume of a neutralized naproxen fill composition containing an equivalent dose of naproxen and naproxen sodium.
Dependencies are inferred from the claim text.