Patents by Inventor Howard Bernstein
Howard Bernstein has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Patent number: 6780434Abstract: This invention relates to a composition, and method of forming said composition, for the controlled release of interferon. The controlled release composition of this invention comprises a biocompatible polymer and particles of metal cation-stabilized interferon, wherein the particles are dispersed within the biocompatible polymer. The method of the invention, for producing a composition for the controlled release of interferon, includes dissolving a polymer in a polymer solvent to form a polymer solution, dispersing particles of metal cation stabilized-interferon particles in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of the interferon particles.Type: GrantFiled: March 6, 2002Date of Patent: August 24, 2004Assignee: Alkermes Controlled Therapeutics, Inc.Inventors: Mark A. Tracy, Howard Bernstein, M. Amin Khan
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Publication number: 20040139624Abstract: Methods and apparatus are provided for making particles comprising: (a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material (e.g., a pharmaceutical agent), through an atomizer and into a primary drying chamber, having a drying gas flowing therethrough, to form droplets comprising the solvent and bulk material dispersed in the drying gas; (b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in drying gas; and (c) flowing the particles and at least a portion of the drying gas through a jet mill to deagglomerate or grind the particles. By coupling spray drying with “in-line” jet milling, a single step process is created from two separate unit operations, and an additional collection step is advantageously eliminated. The one-step, in-line process has further advantages in time and cost of processing.Type: ApplicationFiled: January 7, 2004Publication date: July 22, 2004Inventors: Donald E. Chickering, Sridhar Narasimhan, David Altreuter, Paul Kopesky, Mark Keegan, Julie A. Straub, Howard Bernstein
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Publication number: 20040134091Abstract: Methods and apparatus are provided for making particles comprising: (a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material (e.g., a pharmaceutical agent), through an atomizer and into a primary drying chamber, having a drying gas flowing therethrough, to form droplets comprising the solvent and bulk material dispersed in the drying gas; (b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in drying gas; and (c) flowing the particles and at least a portion of the drying gas through a jet mill to deagglomerate or grind the particles. By coupling spray drying with “in-line” jet milling, a single step process is created from two separate unit operations, and an additional collection step is advantageously eliminated. The one-step, in-line process has further advantages in time and cost of processing.Type: ApplicationFiled: January 7, 2004Publication date: July 15, 2004Inventors: Donald E. Chickering, Sridhar Narasimhan, David Altreuter, Paul Kopesky, Mark Keegan, Julie A. Straub, Howard Bernstein
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Publication number: 20040121005Abstract: One or more COX-2 inhibitors are provided in a porous matrix form wherein the dissolution rate of the drug is enhanced when the matrix is contacted with an aqueous medium. The porous matrix yields upon contact with an aqueous medium nanoparticles and microparticles of COX-2 inhibitors having a mean diameter between about 0.01 and 5 &mgr;m and a total surface area greater than about 0.5 m2/mL. The dry porous matrix preferably is in a dry powder form having a TAP density less than or equal to 1.0 g/mL. The porous COX-2 inhibitor matrices preferably are made using a process that includes (i) dissolving one or more COX-2 inhibitors in a volatile solvent to form a drug solution, (ii) combining at least one pore forming agent with the drug solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the dry porous matrix of COX-2 inhibitors.Type: ApplicationFiled: May 19, 2003Publication date: June 24, 2004Applicant: Acusphere, Inc.Inventors: David Altreuter, Julie Straub, Howard Bernstein, Donald E. Chickering, Paul Kopesky, Greg Randall
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Publication number: 20040118007Abstract: Methods and apparatus are provided for making particles comprising: (a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material (e.g., a pharmaceutical agent), through an atomizer and into a primary drying chamber, having a drying gas flowing therethrough, to form droplets comprising the solvent and bulk material dispersed in the drying gas; (b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in drying gas; and (c) flowing the particles and at least a portion of the drying gas through a jet mill to deagglomerate or grind the particles. By coupling spray drying with “in-line” jet milling, a single step process is created from two separate unit operations, and an additional collection step is advantageously eliminated. The one-step, in-line process has further advantages in time and cost of processing.Type: ApplicationFiled: December 19, 2002Publication date: June 24, 2004Applicant: ACUSPHERE, INC.Inventors: Donald E. Chickering, Sridhar Narasimhan, David Altreuter, Paul Kopesky, Mark Keegan, Julie A. Straub, Howard Bernstein
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Publication number: 20040121003Abstract: Methods are provided for making a dry powder blend pharmaceutical formulation comprising (i) forming microparticles which comprise a pharmaceutical agent; (ii) providing at least one excipient in the form of particles having a volume average diameter that is greater than the volume average diameter of the microparticles; (iii) blending the microparticles with the excipient to form a powder blend; and (iv) jet milling the powder blend to deagglomerate at least a portion of any of the microparticles which have agglomerated, while substantially maintaining the size and morphology of the individual microparticles. Jet milling advantageously can eliminate the need for more complicated wet deagglomeration processes, can lower residual moisture and solvent levels in the microparticles (which leads to better stability and handling properties for dry powder formulations), and can improve wettability, suspendability, and content uniformity of dry powder blend formulations.Type: ApplicationFiled: December 19, 2002Publication date: June 24, 2004Applicant: ACUSPHERE, INC.Inventors: Donald E. Chickering, Shaina Reese, Sridhar Narasimhan, Julie A. Straub, Howard Bernstein, David Altreuter, Eric K. Huang
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Patent number: 6749866Abstract: The present invention relates to a composition for the modulated release of a biologically active agent. The composition comprises a biocompatible polymeric matrix, a biologically active agent which is dispersed within the polymeric matrix, and a metal cation component which is separately dispersed within the polymeric matrix, whereby the metal cation component modulates the release of the biologically active agent from the polymeric matrix. The present invention also relates to a method for modulating the release of a biologically active agent from a biocompatible polymeric matrix, comprising the steps of dissolving a biocompatible polymer in a solvent to form a polymer solution and also separately dispersing a metal cation component and a biologically active agent within the polymer solution.Type: GrantFiled: January 3, 2002Date of Patent: June 15, 2004Assignee: Alkermes Controlled Therapeutics, Inc.Inventors: Howard Bernstein, Yan Zhang, M. Amin Khan, Mark A. Tracy
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Publication number: 20040105821Abstract: Pharmaceutical formulations and methods are provided for the sustained delivery of a pharmaceutical agent to the lungs of a patient by inhalation. The formulation includes porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein upon inhalation of the formulation a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles in the lungs for at least 2 hours. Preferably, a majority of the pharmaceutical agent is released from the microparticles by 24 hours following inhalation, for example where a majority of the pharmaceutical agent is released no earlier than about 2 hours and no later than about 24 hours following inhalation. Methods for delivering a pharmaceutical agent, such as a corticosteroid, to the lungs of a patient are also provided. For example, the method includes having the patient inhale a dry powder blend comprising the present microparticles and a pharmaceutically acceptable bulking agent.Type: ApplicationFiled: September 30, 2003Publication date: June 3, 2004Inventors: Howard Bernstein, Donald E. Chickering, Eric K. Huang, Shaina Reese, Sridhar Narasimhan, Julie A. Straub
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Patent number: 6730322Abstract: A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.Type: GrantFiled: March 6, 2003Date of Patent: May 4, 2004Assignee: Acusphere, Inc.Inventors: Howard Bernstein, Donald Chickering, Sarwat Khattak, Julie Straub
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Patent number: 6689390Abstract: A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.Type: GrantFiled: March 5, 2003Date of Patent: February 10, 2004Assignee: Acusphere, Inc.Inventors: Howard Bernstein, Donald Chickering, Sarwat Khattak, Julie Straub
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Publication number: 20030211153Abstract: A pharmaceutical composition for the sustained release of human growth hormone from a polymer matrix is disclosed. The pharmaceutical composition comprises a biocompatible polymer, particles of metal cation-complexed human growth hormone wherein said particles are dispersed within the biocompatible polymer and an aqueous injection vehicle.Type: ApplicationFiled: October 29, 2002Publication date: November 13, 2003Inventors: Olufunmi Lily Johnson, Medha M. Ganmukhi, Howard Bernstein, Henry Auer, M. Amin Khan
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Patent number: 6645528Abstract: Drugs, especially low aqueous solubility drugs, are provided in a porous matrix form, preferably microparticles, which enhances dissolution of the drug in aqueous media. The drug matrices preferably are made using a process that includes (i) dissolving a drug, preferably a drug having low aqueous solubility, in a volatile solvent to form a drug solution, (ii) combining at least one pore forming agent with the drug solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of drug. The pore forming agent can be either a volatile liquid that is immiscible with the drug solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent.Type: GrantFiled: October 23, 2000Date of Patent: November 11, 2003Assignee: Acusphere, Inc.Inventors: Julie Straub, Howard Bernstein, Donald E. Chickering, III, Sarwat Khattak, Greg Randall
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Patent number: 6610317Abstract: Paclitaxel is provided in a porous matrix form, which allows the drug to be formulated without Cremophor and administered as a bolus. The paclitaxel matrices preferably are made using a process that includes (i) dissolving paclitaxel in a volatile solvent to form a paclitaxel solution, (ii) combining at least one pore forming agent with the paclitaxel solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of paclitaxel. The pore forming agent can be either a volatile liquid that is immiscible with the paclitaxel solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent.Type: GrantFiled: March 2, 2001Date of Patent: August 26, 2003Assignee: Acusphere, Inc.Inventors: Julie Straub, Howard Bernstein, Donald E. Chickering, III, Sarwat Khattak, Greg Randall
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Publication number: 20030147962Abstract: A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.Type: ApplicationFiled: March 5, 2003Publication date: August 7, 2003Applicant: Acusphere, Inc.Inventors: Howard Bernstein, Donald Chickering, Sarwat Khattak, Julie Straub
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Publication number: 20030133979Abstract: A device for the sustained release in vivo of a water soluble, biologically active agent wherein the agent is susceptible to aggregation comprising a drug delivery device and aggregation-stabilized, biologically active agent wherein the aggregation-stabilized agent is disposed within the drug delivery device.Type: ApplicationFiled: October 22, 2002Publication date: July 17, 2003Applicant: Alkermes Controlled Therapeutics, Inc.Inventors: Paul A. Burke, Stephen E. Zale, Mark A. Tracy, OluFunmi Lily Johnson, Howard Bernstein, M. Amin Khan, Avram Brickner, Henry E. Auer
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Patent number: 6589557Abstract: Celecoxib is provided in a porous matrix form wherein the dissolution rate of the drug is enhanced when the matrix is contacted with an aqueous medium. The porous matrix yields upon contact with an aqueous medium nanoparticles and microparticles of celecoxib having a mean diameter between about 0.01 and 5 &mgr;m and a total surface area greater than about 0.5 m2/mL. The dry porous matrix preferably is in a dry powder form having a TAP density less than or equal to 1.0 g/mL. The porous celecoxib matrices preferably are made using a process that includes (i) dissolving celecoxib in a volatile solvent to form a drug solution, (ii) combining at least one pore forming agent with the drug solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the dry porous matrix of celecoxib.Type: GrantFiled: June 14, 2001Date of Patent: July 8, 2003Assignee: Acusphere, Inc.Inventors: Julie Straub, Howard Bernstein, Donald E. Chickering, III, Greg Randall
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Patent number: 6560897Abstract: Improved spray drying apparati, and methods of use thereof, have been developed. The spray drying equipment includes a primary drying chamber and a secondary drying apparatus which includes tubing having a length sufficient to increase the contact time between the drying gas and the droplets/particles to dry the particles to the extent desired, at a drying rate and temperature which would be too low to provide adequate drying without the secondary drying apparatus. The secondary drying apparatus increases the drying efficiency of the spray dryer system without increasing the drying rate, while minimizing loss in yield. Te secondary drying apparatus can include multiple secondary apparati, which are independently controlled for temperature and/or have different dimensions (cross-sectional areas and/or lengths), to allow for optimization of drying conditions.Type: GrantFiled: October 26, 2001Date of Patent: May 13, 2003Assignee: Acusphere, Inc.Inventors: Donald E. Chickering, III, Mark J. Keegan, Greg Randall, Howard Bernstein, Julie Straub
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Publication number: 20030037459Abstract: Improved spray drying apparati, and methods of use thereof, have been developed. The spray drying equipment includes a primary drying chamber and a secondary drying apparatus which includes tubing having a length sufficient to increase the contact time between the drying gas and the droplets/particles to dry the particles to the extent desired, at a drying rate and temperature which would be too low to provide adequate drying without the secondary drying apparatus. The secondary drying apparatus increases the drying efficiency of the spray dryer system without increasing the drying rate, while minimizing loss in yield. Te secondary drying apparatus can include multiple secondary apparati, which are independently controlled for temperature and/or have different dimensions (cross-sectional areas and/or lengths), to allow for optimization of drying conditions.Type: ApplicationFiled: October 26, 2001Publication date: February 27, 2003Applicant: Acusphere, Inc.Inventors: Donald E. Chickering, Mark J. Keegan, Greg Randall, Howard Bernstein, Julie Straub
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Publication number: 20030035845Abstract: A composition, and methods of forming and using said composition, for the sustained release of non-aggregated, biologically active, erythropoietin (EPO). The sustained release composition of this invention comprises a polymeric matrix of a biocompatible polymer and particles of biologically active, aggregation-stabilized EPO, wherein said particles are dispersed within the biocompatible polymer.Type: ApplicationFiled: March 7, 2002Publication date: February 20, 2003Inventors: Stephen E. Zale, Paul A. Burke, Howard Bernstein, Avram Brickner
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Publication number: 20030031716Abstract: This invention relates to a composition, and method of forming said composition, for the controlled release of interferon. The controlled release composition of this invention comprises a biocompatible polymer and particles of metal cation-stabilized interferon, wherein the particles are dispersed within the biocompatible polymer. The method of the invention, for producing a composition for the controlled release of interferon, includes dissolving a polymer in a polymer solvent to form a polymer solution, dispersing particles of metal cation stabilized-interferon particles in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of the interferon particles.Type: ApplicationFiled: March 6, 2002Publication date: February 13, 2003Applicant: Alkermes Controlled Therapeutics, Inc.Inventors: Mark A. Tracy, Howard Bernstein, M. Amin Khan