Patents by Inventor Julie Straub
Julie Straub 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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Publication number: 20060093677Abstract: 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 16, 2005Publication date: May 4, 2006Inventors: Donald Chickering, Shaina Reese, Sridhar Narasimhan, Julie Straub, Howard Bernstein, David Altreuter, Eric Huang
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Publication number: 20050271591Abstract: Clinical studies have been conducted and specific dosage formulations developed using polymeric microparticles having incorporated therein perfluorocarbon gases that provide significantly enhanced images of long duration. The dosage formulation includes microparticles formed of a biocompatible polymer, preferably including a lipid incorporated therein, and containing a perfluorocarbon that is a gas at body temperature. The microparticles are provided to a patient in an amount effective to enhance ultrasound imaging in the ventricular chambers for more than 5 minutes or in the mycocardium for more than a minute, in a dose ranging from 0.025 to 8.0 mg microparticles/kg body weight. Preferably the dose ranges from 0.05 to 4.0 mg microparticles/kg body weight. The dosage formulation typically is provided in a vial.Type: ApplicationFiled: June 2, 2005Publication date: December 8, 2005Inventors: Richard Walovitch, Howard Bernstein, Donald Chickering, Julie Straub
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Patent number: 6962006Abstract: 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: GrantFiled: December 19, 2002Date of Patent: November 8, 2005Assignee: Acusphere, Inc.Inventors: Donald E. Chickering, III, Sridhar Narasimhan, David Altreuter, Paul Kopesky, Mark Keegan, Julie A. Straub, Howard Bernstein
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Publication number: 20050209099Abstract: 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: June 2, 2005Publication date: September 22, 2005Inventors: Donald Chickering, Sridhar Narasimhan, David Altreuter, Paul Kopesky, Mark Keegan, Julie Straub, Howard Bernstein
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Patent number: 6932983Abstract: 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: November 3, 2000Date of Patent: August 23, 2005Assignee: Acusphere, Inc.Inventors: Julie Straub, Howard Bernstein, Donald E. Chichering, III, Sarwat Khattak, Greg Randall
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Patent number: 6921458Abstract: 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: GrantFiled: January 7, 2004Date of Patent: July 26, 2005Assignee: Acusphere, Inc.Inventors: Donald E. Chickering, III, Sridhar Narasimhan, David Altreuter, Paul Kopesky, Mark Keegan, Julie A. Straub, Howard Bernstein
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Patent number: 6918991Abstract: 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: GrantFiled: January 7, 2004Date of Patent: July 19, 2005Assignee: Acusphere, Inc.Inventors: Donald E. Chickering, III, Sridhar Narasimhan, David Altreuter, Paul Kopesky, Mark Keegan, Julie A. Straub, Howard Bernstein
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Publication number: 20050079138Abstract: Methods are provided for making a dry powder blend pharmaceutical formulation, comprising the steps of: (a) providing microparticles which comprise a pharmaceutical agent; (b) blending the microparticles with at least one excipient in the form of particles to form a powder blend; and (c) jet milling the powder blend to form a dry powder blend pharmaceutical formulation having improved dispersibility, suspendability, or wettability as compared to the microparticles of step (a) or the powder blend of step (b). The method can further include dispersing the dry powder blend pharmaceutical formulation in a liquid pharmaceutically acceptable vehicle to make an formulation suitable for injection. Alternatively, the method can further include processing the dry powder blend pharmaceutical formulation into a solid oral dosage form. In one embodiment, the microparticles of step (a) are formed by a solvent precipitation or crystallization process.Type: ApplicationFiled: September 30, 2004Publication date: April 14, 2005Inventors: Donald Chickering, Shaina Reese, Sridhar Narasimhan, Julie Straub, Howard Bernstein, David Altreuter, Eric Huang, Luis Brito, Rajeev Jain
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Publication number: 20050069591Abstract: Pharmaceutical formulations and methods are provided for the sustained delivery of a pharmaceutical agent to a patient by injection, by oral administration or by topical administration. The injectable formulation includes porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein upon injection of the formulation a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles for at least 24 hours. The oral formulation includes porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles for at least 2 hours following oral administration.Type: ApplicationFiled: September 27, 2004Publication date: March 31, 2005Inventors: Howard Bernstein, Donald Chickering, Eric Huang, Sridhar Narasimhan, Shaina Reese, Julie Straub
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Publication number: 20050058710Abstract: 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 hydrophilic or hydrophobic excipients that stabilize the drug and inhibit crystallization, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of drug. Hydrophobic or hydrophilic excipients may be selected to stabilize the drug in crystalline form by inhibiting crystal growth or to stabilize the drug in amorphous form by preventing crystallization.Type: ApplicationFiled: August 27, 2004Publication date: March 17, 2005Inventors: Julie Straub, David Altreuter, Howard Bernstein, Donald Chickering, Sarwat Khattak, Greg Randall
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Publication number: 20050048116Abstract: 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 hydrophilic or hydrophobic excipients that stabilize the drug and inhibit crystallization, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of drug. Hydrophobic or hydrophilic excipients may be selected to stabilize the drug in crystalline form by inhibiting crystal growth or to stabilize the drug in amorphous form by preventing crystallization.Type: ApplicationFiled: August 24, 2004Publication date: March 3, 2005Inventors: Julie Straub, David Altreuter, Howard Bernstein, Donald Chickering, Sarwat Khattak, Greg Randall
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Patent number: 6800297Abstract: 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: GrantFiled: May 19, 2003Date of Patent: October 5, 2004Assignee: Acusphere, Inc.Inventors: David Altreuter, Julie Straub, Howard Bernstein, Donald E. Chickering, III, Paul Kopesky, Greg Randall
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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: 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: 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: 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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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