US 11,911,398 B2
Treating Vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
Charles W. Bishop, Miami, FL (US); Keith H. Crawford, Parker, CO (US); and Eric J. Messner, Lake Forest, IL (US)
Assigned to OPKO RENAL, LLC, Miami, FL (US)
Filed by OPKO RENAL, LLC, Miami, FL (US)
Filed on Apr. 22, 2021, as Appl. No. 17/237,889.
Application 13/848,982 is a division of application No. 12/278,053, granted, now 8,426,391, previously published as PCT/US2007/061521, filed on Feb. 2, 2007.
Application 17/237,889 is a continuation of application No. 16/171,100, filed on Oct. 25, 2018, granted, now 11,007,204.
Application 16/171,100 is a continuation of application No. 15/722,757, filed on Oct. 2, 2017, granted, now 10,213,442.
Application 15/722,757 is a continuation of application No. 14/548,275, filed on Nov. 19, 2014, granted, now 9,943,530.
Application 14/548,275 is a continuation of application No. 13/848,982, filed on Mar. 22, 2013, granted, now 8,906,410.
Claims priority of provisional application 60/764,665, filed on Feb. 3, 2006.
Prior Publication US 2021/0236517 A1, Aug. 5, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/593 (2006.01); A61K 9/00 (2006.01); A61K 9/48 (2006.01); A61K 31/592 (2006.01); A61K 9/16 (2006.01); A61K 47/26 (2006.01)
CPC A61K 31/593 (2013.01) [A61K 9/00 (2013.01); A61K 9/0019 (2013.01); A61K 9/16 (2013.01); A61K 9/48 (2013.01); A61K 9/4808 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 9/4875 (2013.01); A61K 31/592 (2013.01); A61K 47/26 (2013.01)] 20 Claims
 
1. A soft gelatin capsule dosage form, consisting of:
a) a soft gelatin shell optionally treated with a cross linking agent and which gradually dissolves after oral administration, and
b) a pharmaceutical composition disposed in the soft gelatin shell and consisting essentially of
(1) (a) an active ingredient selected from 25(OH) vitamin D
(b) a matrix material comprising one or more compounds in the group of a glyceride, a fatty acid, a fatty alcohol, and a fatty acid ester; and
(c) ethanol; or
(2) (a) an active ingredient selected from 25(OH) vitamin D;
(b) an insoluble polymer comprising one or more selected from the group of swellable methacrylic acid esters, polyvinyl esters, polyvinyl acetal esters, polyacrylic acid esters and butadiene styrene copolymers; and
(c) ethanol.