Process Development • Scale up • Technology Transfer • Process Validation • QbD • Project Management • Leading Cross-Functional Teams • Pharmaceutical Manufacturing • NDA and IND authoring and submission • Drug Product Development • API Attributes • Crystallization • Polymorphism • Micronization • Membrane Separations • Solvent Recovery
Us Patents
Antisolvent Crystallization In Porous Hollow Fiber Devices And Methods Of Use Thereof
Kamalesh K. Sirkar - Bridgewater NJ, US Dimitrios Zarkadas - Fanwood NJ, US
International Classification:
C30B 7/14
US Classification:
117 68, 117 69, 117 70
Abstract:
Antisolvent crystallization systems and methods are provided that employ porous hollow fiber membranes. The porous hollow fiber membrane includes a plurality of porous hollow fibers positioned within a shell, each porous hollow fiber defining a lumen side and shell side. A crystallizing solution is introduced to one side of the hollow fibers and an antisolvent is introduced to the other side of the fibers, in either cocurrent or countercurrent flow. One of the antisolvent and the crystallizing solution permeates in part through the porous hollow fiber membrane to the other side and crystals are formed thereby. Permeation of the antisolvent or the crystallizing solution establishes advantageous radial mixing that facilitates crystal formation of a desired size distribution. Downstream mixing, e. g. , a completely stirred tank or a static mixer, may be employed to further improve crystallization operations.
Xinafoate Salt Of A Substituted 5-Oxazol-2-Yl-Quinoline Compound
Pauline C. Ting - New Providence NJ, US Joe F. Lee - Brooklyn NY, US Kung-I Feng - Basking Ridge NJ, US Michael R. Reeder - Skillman NJ, US Scott T. Trzaska - Raritan NJ, US Man Zhu - Clark NJ, US Chen Mao - New Providence NJ, US Dimitar L. Filipov - Elizabeth NJ, US Dimitrios N. Zarkadas - Fanwood NJ, US
Assignee:
Schering Corporation - Kenilworth NJ
International Classification:
C07D 215/38 A61K 31/04
US Classification:
514312, 546159, 546163
Abstract:
The present invention relates to the compound of the formula.
Process For The Precipitation And Isolation Of 6,6-Dimethyl-3-Aza-Bicyclo [3.1.0] Hexane-Amide Compounds By Controlled Precipitation And Pharmaceutical Formulations Containing Same
Dimitrios Zarkadas - Fanwood NJ, US Vincenzo Liotta - Glen Ridge NJ, US Christopher Stanley Pridgen - Union City NJ, US Wing-Kee Philip Cho - Princeton NJ, US Zhihui Qiu - Bridgewater NJ, US
Assignee:
Merck Sharp & Dohme Corp. - Rahway NJ
International Classification:
A61K 9/16 A61K 31/403 C07D 209/52
US Classification:
424489, 514412, 548515
Abstract:
The present invention provides a method of continuous precipitation and isolation of an amorphous solid particulate form of 3-[2-(3-tert-Butyl-ureido)-3,3-dimethyl-butyryl]-6,6-dimethyl-3-aza-bicyclo[3. 1. 0]hexane-2-carboxylic acid (2-carbamoyl-1-cyclobutylmethyl-2-oxo-ethyl)-amide having controlled physical properties. The present invention provides also pharmaceutical formulations comprising the precipitated compound.
Solid Hollow Fiber Cooling Crystallization Systems And Methods
Kamalesh Sirkar - Bridgewater NJ, US Dimitrios Zarkadas - Kearny NJ, US
International Classification:
H01L 21/322 C30B 11/00
US Classification:
117200000, 117206000, 117002000
Abstract:
A solid hollow fiber cooling crystallizer and method for crystallizing aqueous and organic solutions are provided. The solid hollow fiber crystallizer (SHFC) for carrying out cooling crystallization of inorganic/organic microsolutes/macrosolutes from solution generally includes a bundle of non-porous hollow fibers mounted within a shell where a feed solution for crystallization flows through the lumen side of the hollow fibers and a cooling solution flows through the shell side to form nuclei and subsequently crystals in the feed solution at a temperature below its saturation temperature. The solid hollow fiber crystallizer may be combined with a mixing device, such as a completely stirred tank or static mixer, to further effectuate crystallization. The solid hollow fiber crystallizer may be operated in a number of modes including feed recycle mode, once through mode, SHFC-in-line static mixer in series mode, and SHFC-CST in series mode. The advantages of solid hollow fiber cooling crystallization in comparison to conventional crystallization processes include improved temperature control between crystallizing solution and coolant, higher nucleation rates, improved control of crystal size and crystal size distribution, smaller crystal size, capability for decoupling crystal nucleation and crystal growth, decreased fouling of process equipment, and improved process scale-up.
Kamalesh Sirkar - Bridgewater NJ, US Alexander Korikov - Uniondale NY, US Praveen Kosaraju - Harrison NJ, US Dimitrios Zarkadas - Fanwood NJ, US
International Classification:
F28F 13/18
US Classification:
165133000, 165158000
Abstract:
Heat exchange systems are provided that include one or more polymeric hollow fibers. Exemplary hollow fibers are asymmetric and include a microporous wall and a dense skin formed thereon, thereby preventing liquid transmission and/or contamination through the wall of the hollow fiber while simultaneously enhancing heat transfer based on the presence of liquid molecules within the porous substructure of the hollow fiber. The hollow fibers may be employed in a variety of heat transfer-related commercial/industrial applications, including solvent-aqueous systems, organic-aqueous systems, organic-organic systems, desalination applications, solar heating applications, applications in the chemical industry, applications in the biomedical industry, and applications in the biotechnology or pharmaceutical industry, e.g., extracorporeal blood oxygenation systems. Heat transfer systems wherein steam is advantageously condensed on a first side of a polymeric, hollow fiber-based heat exchanger are also provided. The condensed steam provides energy that may be used to heat water and/or other liquids that flow on a second side of the polymeric, hollow fibers.
Process For The Precipitation And Isolation Of 6,6-Dimethyl-3-Aza Bicyclo [3.1.0] Hexane-Amide Compounds By Controlled Precipitation And Pharmaceutical Formulations Containing Same
Dimitrios Zarkadas - Fanwood NJ, US Vincenzo Liotta - Glen Ridge NJ, US Christopher Stanley Pridgen - Union City NJ, US Wing-Kee Philip Cho - Princeton NJ, US Zhihui Qiu - Bridgewater NJ, US
The present invention provides a method of continuous precipitation and isolation of an amorphous solid particulate form of 3-[2-(3-tert-Butyl-ureido)-3,3-dimethyl-butyryl]-6,6-dimethyl-3-aza-bicyclo[3.1.0]hexane-2-carboxylic acid (2-carbamoyl-1-cyclobutylmethyl-2-oxo-ethyl)-amide having controlled physical properties. The present invention provides also pharmaceutical formulations comprising the precipitated compound.
Solid Hollow Fiber Cooling Crystallization Systems And Methods
Kamalesh K. Sirkar - Bridgewater NJ, US Dimitrios Zarkadas - Kearny NJ, US
Assignee:
NEW JERSEY INSTITUTE OF TECHNOLOGY - Newark NJ
International Classification:
B01D 9/02
US Classification:
23301, 23295 R
Abstract:
A solid hollow fiber cooling crystallizer and method for crystallizing aqueous and organic solutions are provided. The solid hollow fiber crystallizer (SHFC) for carrying out cooling crystallization of inorganic/organic microsolutes/macrosolutes from solution generally includes a bundle of non-porous hollow fibers mounted within a shell where a feed solution for crystallization flows through the lumen side of the hollow fibers and a cooling solution flows through the shell side to form nuclei and subsequently crystals in the feed solution at a temperature below its saturation temperature. The solid hollow fiber crystallizer may be combined with a mixing device, such as a completely stirred tank or static mixer, to further effectuate crystallization. The solid hollow fiber crystallizer may be operated in a number of modes including feed recycle mode, once through mode, SHFC-in-line static mixer in series mode, and SHFC-CST in series mode. The advantages of solid hollow fiber cooling crystallization in comparison to conventional crystallization processes include improved temperature control between crystallizing solution and coolant, higher nucleation rates, improved control of crystal size and crystal size distribution, smaller crystal size, capability for decoupling crystal nucleation and crystal growth, decreased fouling of process equipment, and improved process scale-up.
Process For The Production Of Substituted 5-Quinolyl-Oxazoles And Pharmaceutically Acceptable Salts Thereof
Timothy D. Cutarelli - Clinton NJ, US Dimitar L. Filipov - San Francisco CA, US Christopher Stanley Pridgen - Union City NJ, US Michael R. Reeder - Skillman NJ, US Kelvin H. Yong - Lyndhurst NJ, US Dimitrios N. Zarkadas - Fanwood NJ, US
International Classification:
C07D 413/14 C07D 413/02
US Classification:
546176
Abstract:
The present invention relates a process for the preparation of a compound of the formula:wherein R, R, R, Rand Rare as described herein. The compounds are inhibitors of phosphodiesterase 4 (PDE4).
Resumes
Associate Principal Scientist At Schering-Plough Research Institute Associate Principal Scientist At Merck Associate Principal Scientist At Schering-Plough See Less...
Schering-Plough Research Institute (Public Company; 10,001 or more employees; SGP; Pharmaceuticals industry): Associate Principal Scientist, (-) Merck (Pharmaceuticals industry): Associate Principal Scientist, (2006-Present) Schering-Plough ...
Aug 2012 to 2000 Associate DirectorMerck & Co, Inc. Rahway, NJ Nov 2009 to Aug 2012 Principal Scientist/Associate Principal ScientistSchering Plough Research Institute Union, NJ Jan 2007 to Nov 2009 Associate Principal ScientistSchering Plough Research Institute Union, NJ Jan 2005 to Jan 2007 Engineer
Education:
New Jersey Institute of Technology Newark, NJ 1999 to 2005 PhD in Chemical EngineerAristotle University of Thessaloniki 1990 to 1997 BS in Chemical Engineering
Military:
Rank: Sergeant Major Mar 1997 to Sep 1998 Branch: InfantryL.i.location.original
Skills:
Process Development, Scale up, Technology Transfer, Process Validation, QbD, Project Management, Leading Cross-Functional Teams, Pharmaceutical Manufacturing, NDA and IND authoring and submission, Drug Product Development, API Attributes, Crystallization, Polymorphism, Micronization, Membrane Separations, Solvent Recovery