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AssigneeCatalent Ontario Limited
InventorsJohn Lopez, Peter Draper, Sankalp Vashishtha, Nancy Klassen, Christina Armstrong
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This invention relates to a naproxen formulation suitable for encapsulation into a soft gel dosage unit by increasing the stability, concentration, and bioavailability of naproxen. Fill formulations of the invention may include other active pharmaceutical ingredients and combinations of two or more active pharmaceutical ingredients. This invention also provides for adjusting pH values of fill formulations without additional process steps. A process for increasing the achievable concentration of an active NSAID pharmaceutical ingredient, such as naproxen, relative to fill composition for dosage units is also provided. The highly concentrated formulation of this invention permits a reduction in the fill volume or dosage unit size, or an increase in concentration of the active pharmaceutical ingredient per dosage form. The invention also relates to a formulation of optimal stability suitable for supporting a fill composition compatible with the soft gel dosage unit.
1-19. (canceled)
A pharmaceutical fill formulation of a non-steroidal anti-inflammatory drug (NSAID) suitable for encapsulation in a soft gel, comprising:
The formulation according to claim 1, wherein the polyethylene glycol is PEG 400.
The formulation according to claim 1, wherein the povidone is povidone K12.
The formulation according to claim 1, wherein the pH of the composition ranges from about 2 to about 8.
The formulation according to claim 1, further comprising an additional active pharmaceutical ingredient,
The formulation according to claim 1, wherein the ratio of naproxen to naproxen sodium ranges from about 9:1 to about 3:7.
The formulation according to claim 1, wherein the ratio of naproxen to naproxen sodium ranges from about 3:2 to about 2:3.
The formulation according to claim 1, wherein the ratio of naproxen to naproxen sodium is about 1:1.
A dosage form for oral administration of naproxen, comprising:
The formulation according to claim 1, wherein the formulation is free of hydroxide ion.
The formulation according to claim 1, comprising a mass of not greater than about 900 mg.
A dosage form, comprising:
A soft gel capsule, comprising:
The soft gel capsule of claim 37, wherein the soft gel capsule has a size of not greater than 14 oblong.
The formulation according to claim 1, wherein the formulation is free of hydroxide ion.
Dependencies are inferred from the claim text.