Patents Assigned to Alkermes, Inc.
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Publication number: 20100240691Abstract: The instant application relates to morphinan derivatives of formula I with enhanced oral bioavailability for the treatment of diseases associated with opioid receptor activity or blockade including alcohol and opiate addiction.Type: ApplicationFiled: March 19, 2010Publication date: September 23, 2010Applicant: Alkermes, Inc.Inventors: Ryan Turncliff, Daniel Deaver, Derrick Arnelle
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Patent number: 7754242Abstract: The present invention is based, in part, on the unexpected discovery that particles for pulmonary delivery of a therapeutic, prophylactic or diagnostic agent that comprise a phospholipid and a sufficient amount of leucine can produce sustained effect of the agent. Specifically, particles for pulmonary delivery of a therapeutic, prophylactic or diagnostic agent that contain a phospholipid or combination of phospholipids, wherein the phospholipid or combination of phospholipids is present in the particles in an amount of about 1 to 46 weight percent; and leucine, wherein leucine is present in the particles in an amount of at least 46 weight percent, can contribute to sustained effect of the agent. Particles that comprise at least 46 weight percent leucine but that do not contain phospholipids do not exhibit these same sustained effect properties.Type: GrantFiled: March 19, 2003Date of Patent: July 13, 2010Assignee: Alkermes, Inc.Inventors: Sujit K. Basu, Giovanni Caponetti, Robert Clarke, Katharina J. Elbert
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Publication number: 20100152111Abstract: 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: ApplicationFiled: September 17, 2009Publication date: June 17, 2010Applicant: Alkermes, Inc.Inventors: Steven G. Wright, Troy Christensen, Thean Yeoh, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Henry R. Costantino
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Publication number: 20100152097Abstract: 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: ApplicationFiled: February 25, 2010Publication date: June 17, 2010Applicant: Alkermes, Inc.Inventors: Steven G. Wright, Troy Christensen, Thean Y. Yeah, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Henry R. Costantino
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Patent number: 7678364Abstract: The invention generally relates to a method for pulmonary delivery of therapeutic, prophylactic and diagnostic agents to a patient wherein the agent is released in a sustained fashion, and to particles suitable for use in the method. In particular, the invention relates to a method for the pulmonary delivery of a therapeutic, prophylactic or diagnostic agent comprising administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of particles comprising a multivalent metal cation which is complexed with a therapeutic, prophylactic or diagnostic agent or any combination thereof having a charge capable of complexing with the cation upon association with the agent, a pharmaceutically acceptable carrier and optionally, a multivalent metal cation-containing component wherein the total amount of multivalent metal cation present in the particles is more than 1% weight/weight of the total weight of the agent (% w/w).Type: GrantFiled: March 30, 2001Date of Patent: March 16, 2010Assignee: Alkermes, Inc.Inventors: David A. Edwards, Jeffrey S. Hrkach
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Patent number: 7612176Abstract: 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: GrantFiled: July 16, 2007Date of Patent: November 3, 2009Assignee: Alkermes, Inc.Inventors: Steven G. Wright, Troy Christensen, Thean Yeoh, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Henry R. Costantino
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Publication number: 20090247463Abstract: 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: ApplicationFiled: June 12, 2009Publication date: October 1, 2009Applicants: Alkermes, Inc., Amylin Pharmaceuticals, Inc.Inventors: Steven G. Wright, Troy Christensen, Thean Yeoh, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Mark Fineman, Christine Smith, John Ong, David Lokensgard, Henry R. Costantino
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Publication number: 20090214650Abstract: The current invention provides methods of treating alcohol related disorders by providing a sustained release oral drug dosage form comprising a plurality of solid state drugs i.e., baclofen and naltrexone, dispersed in a solid state unitary matrix formed from a combination of swellable polymers. The combination of swellable polymers in a single oral drug dosage form is beneficial in terms of release rate control for combination therapies.Type: ApplicationFiled: February 1, 2007Publication date: August 27, 2009Applicant: Alkermes, Inc.Inventor: Elliot Ehrich
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Publication number: 20090209569Abstract: The present invention relates to compounds of Formula I or II, or pharmaceutically acceptable salts, esters, or prodrugs thereof: which relates to morphinan compounds useful as ?, ?, and/or ? receptor opioid compounds and pharmaceuticals containing same that may be useful for mediating analgesia, combating drug addiction, alcohol addiction, drug overdose, mental illness, bladder dysfunctions, neurogenic bladder, interstitial cystitis, urinary incontinence, premature ejaculation, inflammatory pain, peripherally mediated and neuropathic pain, cough, lung edema, diarrhea, cardiac disorders, cardioprotection, depression, and cognitive, respiratory, diarrhea, irritable bowel syndrome and gastro-intestinal disorders, immunomodulation, and anti-tumor agents.Type: ApplicationFiled: February 13, 2009Publication date: August 20, 2009Applicant: Alkermes, Inc.Inventors: Derrick Arnelle, Daniel Deaver, Reginald L. Dean, III, Mark Todtenkopf
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Publication number: 20090194894Abstract: 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: ApplicationFiled: March 20, 2009Publication date: August 6, 2009Applicant: Alkermes, Inc.Inventors: Michael E. Rickey, J. Michael Ramstack, Rajesh Kumar
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Patent number: 7563871Abstract: 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: GrantFiled: September 14, 2006Date of Patent: July 21, 2009Assignees: Alkermes, Inc., Amylin Pharmaceuticals, Inc.Inventors: Steven G. Wright, Troy Christensen, Thean Yeoh, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Mark Fineman, Christine Smith, John Ong, David Lokensgard, Henry R. Costantino
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Patent number: 7556798Abstract: A method for delivering an agent to the pulmonary system, in a single, breath-activated step or a single breath, comprises administering from a receptacle enclosing a mass of particles, to a subject's respiratory tract, particles which have a tap density of less than 0.4 g/cm3 and deliver at least about 50% of the mass of particles. The particles are capable of carrying agents. The agent is (1) part of the spray-drying pre-mixture and thereby incorporated into the particles, (2) added to separately-prepared particles so that the agent is in chemical association with the particles or (3) blended so that the agent is mixed with, and co-delivered with the particles. Respirable compositions comprising carrier particles having a tap density of less than 0.4 g/cm3 and a composition comprising an agent are also disclosed. Methods of delivering these respirable compositions are also included.Type: GrantFiled: June 8, 2001Date of Patent: July 7, 2009Assignee: Alkermes, Inc.Inventors: David A. Edwards, Richard P. Batycky, Lloyd Johnston
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Patent number: 7547452Abstract: 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.Type: GrantFiled: July 13, 2007Date of Patent: June 16, 2009Assignees: Alkermes, Inc., Janssen Pharmaceutica, N.VInventors: Thomas J. Atkins, Michael E. Rickey, Jean Mesens
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Publication number: 20090143403Abstract: The present invention relates, in part, to the discovery that a pharmaceutical composition comprising aripiprazole and a carrier administered in a bolus injection resulted in an extended release profile similar to that obtained by the injection of a poly lactide-co-glycolide microsphere formulation containing the active agent. This surprising result suggests that pharmacologically beneficial extended release formulations without the complexities and expense associated with the manufacture microspheres.Type: ApplicationFiled: October 15, 2008Publication date: June 4, 2009Applicant: Alkermes, Inc.Inventor: Josiah Brown
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Patent number: 7524530Abstract: 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: GrantFiled: April 19, 2007Date of Patent: April 28, 2009Assignee: Alkermes, Inc.Inventors: Michael E. Rickey, J. Michael Ramstack, Rajesh Kumar
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Publication number: 20090105201Abstract: The present invention provides improved pharmaceutical formulations for pulmonary delivery having improved chemical and physical stability of the therapeutic, prophylactic or diagnostic agent as compared to formulations known in the art. The improved pharmaceutical formulations of the invention for administration to the respiratory system of a patient for the treatment of a variety of disease conditions comprise a mass of biocompatible particles comprising an active agent, and a hydrogenated starch hydrosylate (HSH). The improvement over the prior art comprises the presence of HSH in the pharmaceutical formulation. The invention further relates to a method of treating diseases comprising administering the pharmaceutical formulations of the present invention to the respiratory system of a patient in need of treatment.Type: ApplicationFiled: August 21, 2008Publication date: April 23, 2009Applicant: Alkermes, Inc.Inventors: Charles D. Blizzard, Michael M. Lipp, Kevin L. Ward, Rachel Ryznal, Daniel Leblanc, Mark Tracy, Rebbeca Martin
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Patent number: 7510730Abstract: 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.Type: GrantFiled: July 16, 2007Date of Patent: March 31, 2009Assignee: Alkermes, Inc.Inventors: Shawn L. Lyons, Steven G. Wright
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Publication number: 20090068274Abstract: A method for delivering an agent to the pulmonary system, in a single, breath-activated step or a single breath, comprises administering from a receptacle enclosing a mass of particles, to a subject's respiratory tract, particles which have a tap density of less than 0.4 g/cm3 and deliver at least about 50% of the mass of particles. The particles are capable of carrying agents. The agent is (1) part of the spray-drying pre-mixture and thereby incorporated into the particles, (2) added to separately-prepared particles so that the agent is in chemical association with the particles or (3) blended so that the agent is mixed with, and co-delivered with the particles. Respirable compositions comprising carrier particles having a tap density of less than 0.4 g/cm3 and a composition comprising an agent are also disclosed. Methods of delivering these respirable compositions are also included.Type: ApplicationFiled: October 17, 2008Publication date: March 12, 2009Applicant: Alkermes, Inc.Inventors: David A. Edwards, Richard P. Batycky, Lloyd Johnston
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Publication number: 20090025721Abstract: An improved inhalation device is provided for facilitating inhalation by a patient of powder medicaments contained in a receptacle. The inhalation device includes a staple assembly comprising a plunger and staple that are securely and robustly coupled to one another. Embodiments of the inhalation device have a cap that prevents or reduces the amount of dust and grime entering into the device. The cap is additionally configured to prevent or reduce inadvertent and unintentional operation of the device. The body portion and first casing portion of certain embodiments of the inhalation device are sealably coupled, restricting or reducing undesirable flow pathways that have an adverse effect on the operation of the device.Type: ApplicationFiled: June 10, 2008Publication date: January 29, 2009Applicant: Alkermes, Inc.Inventors: Colleen Ellwanger, Brian Noble, Chuck Ganem, Jake Ganem, Kevin Stapleton
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Publication number: 20090022823Abstract: The present invention relates, in part, to the discovery that parenterally administered extended release formulations possess an unexpected advantage in treating patients possessing active CYP 3A4. This advantage is particularly beneficial where the individual is concomitantly administering a CYP 3A4 inhibitor or is in risk of doing so. Thus, the invention relates to a method for treating individuals possessing a functional CYP3A4 gene with an active agent metabolized by CYP3A4 comprising parenterally administering the active agent in a first extended release formulation in a first administration and the formulations for use in such methods. The invention further includes a method for preventing adverse drug reactions in individuals possessing a functional CYP3A4 gene with an active agent metabolized by CYP3A4 comprising parenterally administering the active agent in a first extended release formulation in a first administration.Type: ApplicationFiled: September 30, 2008Publication date: January 22, 2009Applicant: Alkermes, Inc.Inventors: Elliot Ehrich, Trevor Mundel