US 9,549,918 B2 | STABILIZED TACROLIMUS COMPOSITION

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US 9,549,918 B2

STABILIZED TACROLIMUS COMPOSITION

Tech Center:

1600 Biotechnology and Organic Chemistry

Examiner:

Mark V Stevens

Art Unit:

1613 Organic Compounds: Bio-affecting, Body Treating, Drug Delivery, Steroids, Herbicides, Pesticides, Cosmetics, and Drugs

Agent:

Blank Rome LLP

Inventors:

Nikolaj Skak; Per Holm

Assignee:

VELOXIS PHARMACEUTICALS INC.

Priority:

02/17/11

Filed:

02/17/11

Granted:

01/24/17

Expiration:

05/30/28

Abstract

The invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.

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