US 11,896,566 B2
Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
John Lopez, Windsor (CA); Peter Draper, Amherstburg (CA); Sankalp Vashishtha, Mississauga (CA); Nancy Klassen, Windsor (CA); and Christina Armstrong, Windsor (CA)
Assigned to Catalent Ontario Limited, Windsor (CA)
Filed by Catalent Ontario Limited, Windsor (CA)
Filed on Sep. 26, 2019, as Appl. No. 16/583,903.
Application 15/285,968 is a division of application No. 13/574,159, granted, now 9,480,667, issued on Nov. 1, 2016, previously published as PCT/CA2011/000059, filed on Jan. 29, 2011.
Application 16/583,903 is a continuation of application No. 15/285,968, filed on Oct. 5, 2016, granted, now 10,463,637.
Claims priority of application No. 2690488 (CA), filed on Jan. 19, 2010.
Prior Publication US 2020/0046662 A1, Feb. 13, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/192 (2006.01); A61K 31/4402 (2006.01); A61K 31/405 (2006.01); A61K 9/48 (2006.01); A61K 45/06 (2006.01); A61K 9/00 (2006.01)
CPC A61K 31/192 (2013.01) [A61K 9/0053 (2013.01); A61K 9/48 (2013.01); A61K 9/4833 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 45/06 (2013.01)] 23 Claims
 
1. A softgel dosage form, comprising:
a pharmaceutical fill formulation, 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, wherein the polyethylene glycol is PEG 400;
about 1% to about 5% propylene glycol;
about 1% to about 6% povidone;
about 1% to about 10% water; and
phenylephrine hydrochloride,
wherein the total amount of naproxen and naproxen sodium ranges from about 22% to about 30% by weight of the total composition,
wherein the pH of the fill formulation is from about 4 to about 6,
wherein the fill formulation is free of a neutralization 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.