Ani Pharmaceuticals, Inc.

Phyton Holdings, LLC

Edward M Desimone, Iii

Weijun Cheng

Zachary Holcomb

Barry Joseph Hand

Rex T Gallagher

Roland R Franke

John S Juchum

Brian A Bucher

Dong S Yang

Christopher D Howe

Marc A Plante

James Harvey Johnson

T G Sambandam

Tg Sambandam

James A Johnson

A kit and sterile preparation of purified corticotropin and methods relating thereto in which the preparation includes corticotropin extracted from a whole porcine pituitary gland including both anterior and posterior portions, and having proteins or peptides having a molecular weight higher than 4.6 kDa removed. Methods of manufacturing, testing, increasing stability, storage, and use of the purified corticotropin are also provided.

Kits for preparing and delivering purified corticotropin

A method of storing a sterile corticotropin composition at a temperature of 2° to 8° C., warming the sterile corticotropin composition to a temperature of 18° to 26° C., injecting 80 United States Pharmacopeia (USP) units of the sterile corticotropin composition into a human subject, wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units, or wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2.

Methods for storing and warming purified corticotropin compositions

A sterile preparation of purified corticotropin and methods relating thereto in which the preparation includes corticotropin extracted from a whole porcine pituitary gland including both anterior and posterior portions, and having proteins or peptides having a molecular weight higher than 4.6 kDa removed. Methods of manufacturing, testing, increasing stability, storage, and use of the purified corticotropin are also provided.

A method of warming a vial containing a sterile corticotropin composition from a temperature of 2° to 8° C. to a temperature of 18° to 26° C., withdrawing the sterile corticotropin composition from the vial with a first needle having a first gauge size with a first diameter, replacing the first needle with a second needle having a second gauge size with a second diameter that is different from the first diameter, and injecting 80 (United States Pharmacopeia) USP units of the sterile corticotropin composition into a human subject.

A method of storing and warming a sterile corticotropin composition by storing the sterile corticotropin composition in a multiple-dose vial comprising 80 USP units/mL of the sterile corticotropin composition, wherein the vial comprises a rubber stopper coated with cross-linked silicones, at a temperature of 2° to 8° C.; and warming the vial to a temperature of 18° to 26° C., wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units.

A method of crystallizing docetaxel is disclosed. The method comprises (a) combining docetaxel and at least one solubilizing solvent to obtain a solution, wherein the solubilizing solvent is selected from the group consisting of acetone, methyl-tert-butyl ether, tetrahydrofuran (THF), and acetonitrile and (b) adding an anti-solvent to the solution to obtain a crystalline docetaxel, wherein the anti-solvent is water.

Purification of taxanes

Disclosed is a method of crystallizing docetaxel comprising combining docetaxel and at least one solubilizing solvent to obtain a solution, wherein the solubilizing solvent is methylene chloride and adding an anti-solvent to the solution to obtain a crystalline docetaxel, wherein the anti-solvent is water.

Disclosed is a method of crystallizing a taxane comprising combining the taxane and methylene chloride to obtain a solution and adding an anti-solvent to the solution to obtain a crystalline taxane, wherein the anti-solvent is selected from the group consisting of hexane and heptane.

This invention is directed to a method for isolating and/or purifying one or more taxanes from materials comprising taxanes. In one embodiment, the method comprises the steps of: (a) treating a taxane containing material with an amino containing material attached to a solid matrix, such as a polyethyleneimine-bonded silica chromatographic resin; (b) eluting the desired taxane compound from the resin; and (c) recovering the eluted taxane compound.

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Indianapolis, IN, United States of America

Edward M Desimone, Iii