Abstract: Spray dried particles having specified aerodynamic characteristics are produced by atomizing a liquid feed and contacting the liquid feed with a drying gas, such as, for example, air or nitrogen. The humidity of the drying gas is controlled to a value, expressed, for instance, as dew point, which is known to produce particles having a specified tap density or aerodynamic diameter. Particles having a volume median geometric diameter greater than about 5 microns and a tap density less than about 0.4 g/cm3 are preferred.
Type:
Grant
Filed:
October 29, 2004
Date of Patent:
December 30, 2008
Assignees:
Alkermes, Inc., The Penn State Research Foundation
Inventors:
Donghao Chen, Richard P. Batycky, Lloyd Johnston, Jeffrey Mintzes
Abstract: The present invention provides coacervation methods forming compositions for the sustained release water soluble active agents, including biologically active polypeptides. The invention further relates to the discovery of improved non-aqueous quench liquids and washing systems, which enable a reduction in the amount and concentration of hardening agents such as heptane used to produce microparticles, while providing acceptable product yields and residual solvent levels.
Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Type:
Grant
Filed:
April 13, 2005
Date of Patent:
November 25, 2008
Assignee:
Alkermes, Inc.
Inventors:
Steven G. Wright, Troy Christenson, Thean Y. Yeah, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Henry R. Costantino
Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Type:
Application
Filed:
April 15, 2004
Publication date:
October 23, 2008
Applicant:
Alkermes, Inc.
Inventors:
Steven G. Wright, Troy Christensen, Thean Yeoh, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Henry R. Costantino
Abstract: Methods of forming compositions for the sustained release of water soluble active agents, including biologically active polypeptides and products produced by the process are described. Improved product characteristics and ease of scale-up can be achieved using a novel coacervation process wherein at least one coacervation agent is added to the mixture comprising the active agent and the polymer in at least two distinct stages.
Type:
Application
Filed:
March 19, 2008
Publication date:
September 25, 2008
Applicant:
Alkermes, Inc.
Inventors:
Rajesh Kumar, Gregory Troiano, J. Michael Ramstack, Paul Herbert, Michael Figa
Abstract: This invention relates to the discovery of novel polymorphic forms of naltrexone, including solvates, hydrates, anhydrous and other crystalline forms and combinations thereof. These novel forms of naltrexone impart advantages in pharmaceutical formulations incorporating them, including sustained release, or long acting, formulations.
Type:
Application
Filed:
September 25, 2007
Publication date:
September 18, 2008
Applicant:
ALKERMES, INC.
Inventors:
Harry G. Brittain, David A. Dickason, Joyce Hotz, Shawn L. Lyons, J. Michael Ramstack, Steven G. Wright
Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Type:
Application
Filed:
July 16, 2007
Publication date:
May 29, 2008
Applicant:
Alkermes, Inc.
Inventors:
Steven G. Wright, Troy Christensen, Thean Y. Yeah, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Henry R. Costantino
Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Type:
Application
Filed:
July 20, 2007
Publication date:
May 29, 2008
Applicant:
Alkermes, Inc.
Inventors:
Steven G. Wright, Troy Christensen, Thean Yeoh, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Henry R. Costantino
Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Type:
Application
Filed:
July 16, 2007
Publication date:
May 29, 2008
Applicant:
Alkermes, Inc.
Inventors:
Steven G. Wright, Troy Christensen, Thean Yeah, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Henry R. Costantino
Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Type:
Application
Filed:
July 20, 2007
Publication date:
May 22, 2008
Applicant:
Alkermes, Inc.
Inventors:
Steven G. Wright, Troy Christensen, Thean Yeoh, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Mark Fineman, Christine Smith, John Ong, David M. Lokensgard, Henry R. Costantino
Abstract: Method and apparatus for producing dry particles. Two liquid components are combined in a static mixer, atomized into droplets, and the droplets dried to form dry particles. Use of the static mixer enables incompatible liquid components to be rapidly and homogeneously combined. The present invention optimizes process conditions for increasing and controlling particle porosity. The present invention also allows for optimization of particle size in real-time during particle production.
Type:
Application
Filed:
January 4, 2008
Publication date:
May 8, 2008
Applicant:
Alkermes, Inc.
Inventors:
Blair Jackson, Lloyd Johnston, Ernest Penachio, Charles Blizzard, Marie Chung, Jean Sung
Abstract: Sustained-release microparticle composition. The microparticle composition can be formulated to provide extended release and a duration of action of from about 7 days to about 200 days. The microparticles may be formulated with a biodegradable and biocompatible polymer, and an active agent, such as risperidone, 9-hydroxy-risperidone, and pharmaceutically acceptable acid addition salts of the foregoing.
Abstract: Sustained-release microparticle composition. The microparticle composition can be formulated to provide extended release over a period of from about 7 days to about 200 days. The microparticles may be formulated with a biodegradable and biocompatible polymer, and an active agent, such as risperidone, 9-hydroxy-risperidone, and pharmaceutically acceptable acid addition salts of the foregoing.
Abstract: A method for preparing microparticles having a selected polymer molecular weight. The hold time and temperature of a solution containing a nucleophilic compound and a polymer having a starting molecular weight are controlled in order to control the molecular weight of the polymer in the finished microparticle product. In this manner, a selected polymer molecular weight in the finished microparticle product can be achieved from a variety of starting material molecular weights.
Type:
Application
Filed:
July 17, 2007
Publication date:
March 6, 2008
Applicant:
Alkermes, Inc.
Inventors:
Steven Wright, Michael Rickey, J. Ramstack, Shawn Lyons, Joyce Hotz
Abstract: Apparatus and method for preparing microparticles using in-line solvent extraction. An emulsion is formed by combining two phases in a static mixer. The emulsion is combined with an extraction liquid in a blending static mixer. The outflow of the blending static mixer is combined with additional extraction liquid. The additional extraction liquid and the outflow of the blending static mixer can be combined in a vessel, or through the use of a static mixer manifold that includes a plurality of static mixers.
Abstract: Apparatus and method for preparing microparticles using in-line solvent extraction. An emulsion is formed by combining two phases in a static mixer. The emulsion is combined with an extraction liquid in a blending static mixer. The outflow of the blending static mixer is combined with additional extraction liquid. The additional extraction liquid and the outflow of the blending static mixer can be combined in a vessel, or through the use of a static mixer manifold that includes a plurality of static mixers.
Abstract: Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.
Type:
Application
Filed:
July 13, 2007
Publication date:
February 28, 2008
Applicant:
Alkermes, Inc.
Inventors:
Michael Rickey, J. Ramstack, Rajesh Kumar
Abstract: Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.
Type:
Application
Filed:
July 13, 2007
Publication date:
February 28, 2008
Applicant:
Alkermes, Inc.
Inventors:
Michael Rickey, J. Ramstack, Rajesh Kumar
Abstract: Apparatus and method for preparing microparticles using in-line solvent extraction. An emulsion is formed by combining two phases in a static mixer. The emulsion is combined with an extraction liquid in a blending static mixer. The outflow of the blending static mixer is combined with additional extraction liquid. The additional extraction liquid and the outflow of the blending static mixer can be combined in a vessel, or through the use of a static mixer manifold that includes a plurality of static mixers.
Abstract: Methods for preparing microparticles having improved flowability to facilitate processing in automated equipment. Microparticles are conditioned so that a flowability index of the microparticles is greater than about 60. The conditioning preferably includes maintaining the microparticles at a conditioning temperature for a period of time. The conditioning can be used with microparticles containing an active agent, and with placebo microparticles, and it is reversible.
Type:
Application
Filed:
June 21, 2007
Publication date:
November 8, 2007
Applicant:
Alkermes, Inc.
Inventors:
J. Michael Ramstack, Steven Wright, David Dickason