Chiesi Farmaceutici S.p.a.

The Medicines Company

Eagle Pharmaceuticals, Inc.

Hospira, Inc.

Scynexis, Inc.

Bristol-myers Squibb Holdings Ireland

Rajeshwar Motheram

Min Ding

Adel Rafai Far

Panna Dutta

Gopal Krishna

Gregory Charles Williams

Nagesh R Palepu

Monika Kanter

Akif Emre Tureli

Praful Shah

Glenn Sblendorio

Kornepati Ramakrishna

Keith Flood

David C Hanley, Sr

David Hanley

Julia Zh Gao

David C Hanley

Akif Emre TÜRELI

Ding Min

Flood Keith

Ramakrishna Kornepati

Provided is a pharmaceutical composition comprising clevidipine in a sterile, ready to use, physically stable, aqueous dispersion of nanoparticles that stabilizes clevidipine against formation of impurities and is suitable for parenteral administration.

Clevidipine nanoparticles and pharmaceutical compositions thereof

Pharmaceutical formulations comprising clevidipine in an oil-in-water formulation that is resistant to microbial growth and stable against the formation of impurities.

Clevidipine emulsion formulations containing antimicrobial agents

A composition having clevidipine as an active ingredient is described. The composition includes clevidipine as an active ingredient and an amount of the impurity H168/79 that is no greater than about 1.5%, or where the ratio between clevidipine and H168/79 is equal or above 60 to 1.

Pharmaceutical compositions and methods for producing low impurity concentrations of the same

The present invention relates to high purity cangrelor, pharmaceutical formulations comprising high purity cangrelor as an active ingredient, methods for preparing such compounds and formulations, and methods for using the pharmaceutical formulations in the inhibition of platelet activation and aggregation.

Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same

Pharmaceutical formulations comprising clevidipine and an antimicrobial agent exhibit a reduced propensity for microbial growth and provide increased convenience to health care workers administering clevidipine-containing formulations to patients.

The invention provides intravenous formulations of propofol in an oil-in-water emulsion, having a combination of preservatives.

Antimicrobial preservation of propofol emulsions

A method for preventing the formation of a bivalirudin precipitate during preparation of a pharmaceutical drug product comprising about 250 mg of bivalirudin, a dried bivalirudin drug product, and a concentrated liquid bivalirudin drug product. The method for preventing the formation of a bivalirudin precipitate comprises (i) preparing an aqueous solution comprising a buffer and a pH greater than the isoelectric point of bivalirudin; (ii) adding bivalirudin salt to the aqueous solution to form a bulk solution; (iii) transferring the bulk solution to one or more vessels; and (iv) drying the bulk solution. The buffer may have a pKof about 4 to less than 7, and a pH greater than the isoelectric point of bivalirudin. The pH of the bulk solution may be maintained at a level greater than the isoelectric point of bivalirudin. Further, the bulk solution may have a final pH of about 4 to about 7.

Buffer-based method for preparing bivalirudin drug product

Ready-to-use bivalirudin compositions, methods of using the ready-to-use bivalirudin compositions, and methods of preparing the ready-to-use bivalirudin compositions. The ready-to-use bivalirudin compositions comprise bivalirudin and one or more stabilizing agents. The one or more stabilizing agents may be buffering agents having a pKa of about 2.5 to about 6.5, pH-adjusting agents, polymers, preservatives, antioxidants, sugars or polyols, or a combination thereof. The ready-to-use bivalirudin compositions may also comprise [9-10]-cycloimido bivalirudin, [11-12]-cycloimido bivalirudin, or a combination thereof. The method of using the ready-to-use bivalirudin compositions comprises administering the ready-to-use compositions to a patient in need thereof. Further, the method of preparing the ready-to-use bivalirudin compositions comprises mixing bivalirudin with one or more stabilizing agents.

Ready-to-use bivalirudin compositions

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Dayton, NJ, United States of America

Rajeshwar Motheram