Rtu Pharmaceuticals, LLC

Virginia Commonwealth University

Nacuity Pharmaceuticals, Inc.

Douglas Giles Johnson

Joseph V Pergolizzi

Alexander Mironov

Chad James Pickens

Jeffrey B Etter

G Michael Wall

Anja Rubenstein

Rodney Tucker

Josh Bolger

Al Quick

Antonio M Santos

Alexandre J G G Carvalho

Christopher Murray

Joseph Pergolizzi

The present invention includes methods for making and isolating N-acetylcysteine amide, (2R,2R')-3,3&#x2032;-disulfanediyl bis(2-acetamidopropanamide, diNACA), intermediates and derivatives thereof comprising: contacting cystine with an alcohol and a chlorinating reagent to form an organic solution containing L-cystine dimethylester dihydrochloride; combining dried or undried L-cystine dimethylester dihydrochloride with a triethylamine, an acetic anhydride, and an acetonitrile to form a di-N-acetylcystine dimethylester; mixing dried di-N-acetylcystine dimethylester with ammonium hydroxide to form a di-N-acetylcystine amide (diNACA); and separating dried di-N-acetylcystine dimethylester into N-acetylcysteine amide with dithiothreitol, triethylamine and an alcohol.

Method for preparation of n-acetyl cysteine amide and derivatives thereof

Disclosed in certain embodiments is a pharmaceutical composition for parenteral administration comprising:

Ready to use ketorolac formulations

The present invention provides novel compositions of allosteric hemoglobin modifiers which are substantially free of impurities, specifically polymeric impurities. In one embodiment, the novel compositions contain an allosteric hemoglobin modifier compound and less than 100 ppm of the polymeric impurities generated during the preparation of this compound. Included in the present invention are novel methods for preparing allosteric hemoglobin modifiers that are substantially free of polymeric impurities. Also included in the present invention are improved methods for the purification of the product formed by the method of this invention. The novel methods of purification comprise extracting the crude composition with a water immiscible or partially immiscible solvent such as methylisobutyl ketone (MIBK) to lower amounts of impurities, specifically polymeric impurities. Also included are methods to reduce impurities by recrystallization of the crude synthesized product, followed by filtration of the recrystallized product. The present invention also includes the products made by the processes of the invention and methods for analyzing compositions comprised of these products.

Compositions of allosteric hemoglobin modifiers and methods of making the same

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Arvada, CO, United States of America

Douglas Giles Johnson