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The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Patent No.:

US 9757362 B1

PDFFull Text
Date of Patent:
Sep. 12, 2017

Filed:

Sep. 16, 2015

Modified release compositions comprising tacrolimus

Applicant:

Veloxis Pharmaceuticals A/s, Hørsholm, DK;

Inventors:

Per Holm, Vanlose, DK;

Tomas Norling, Lyngby, DK;

Assignee:

VELOXIS PHARMACEUTICALS A/S, Copenhagen, DK;

Attorney:

Blank Rome LLP

Primary Examiner:

Micah-Paul Young

Int. Cl.
CPC ...
A61K 9/22 (2006.01); A61K 31/436 (2006.01); A61K 9/28 (2006.01); A61K 31/00 (2006.01); A61K 31/4745 (2006.01); A61K 9/10 (2006.01); A61K 31/439 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 9/20 (2006.01);
U.S. Cl.
CPC ...
A61K 31/436 (2013.01); A61K 9/0053 (2013.01); A61K 9/10 (2013.01); A61K 9/1617 (2013.01); A61K 9/1623 (2013.01); A61K 9/1641 (2013.01); A61K 9/1652 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2031 (2013.01); A61K 9/2054 (2013.01); A61K 9/2077 (2013.01); A61K 9/2846 (2013.01); A61K 31/00 (2013.01); A61K 31/439 (2013.01); A61K 31/4745 (2013.01); A61K 9/1611 (2013.01); A61K 9/2009 (2013.01); A61K 9/2095 (2013.01); A61K 9/2893 (2013.01); Y10S 514/885 (2013.01);
Abstract

A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

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