Patents Assigned to Durect Corporation
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Patent number: 10758623Abstract: The present disclosure generally provides complexes including a pharmaceutically active agent and a functionalized polymer, wherein the functionalized polymer includes repeat units, the repeat units including ionizable repeat units having at least one ionizable side group and/or ionizable end group, a plurality of the at least one ionizable groups forming non-covalent bonds with the pharmaceutically active agent. Polymers which may be used to form such complexes as well as methods of making and using the complexes and related compositions are also provided.Type: GrantFiled: February 2, 2018Date of Patent: September 1, 2020Assignee: DURECT CORPORATIONInventors: Michael Sekar, Felix Theeuwes, Keith E Branham, John Gibson, James Matriano, Whitney Moro, John Tipton, William Van Osdol, Su Il Yum
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Patent number: 10682340Abstract: Pharmaceutical compositions comprising an active pharmaceutical ingredient, a high viscosity liquid carrier material, a hydrophobic solvent, and a hydrophilic solvent are disclosed. Also disclosed are methods of manufacturing and using the compositions. The compositions are suitable for use, e.g., as depot formulations.Type: GrantFiled: December 28, 2017Date of Patent: June 16, 2020Assignees: DURECT CORPORATION, SANTEN PHARMACEUTICAL CO., LTD.Inventors: Wilma Tamraz, Huey-Ching Su, WeiQi Lin, Kazuhito Yamada, Naoki Matsumoto, Sreenivasu Mudumba, Komei Okabe
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Patent number: 10668011Abstract: Pharmaceutical compositions comprising an active pharmaceutical ingredient, a high viscosity liquid carrier material, a hydrophobic solvent, and a hydrophilic solvent are disclosed. Also disclosed are methods of manufacturing and using the compositions. The compositions are suitable for use, e.g., as depot formulations.Type: GrantFiled: June 29, 2017Date of Patent: June 2, 2020Assignees: DURECT CORPORATION, SANTEN PHARMACEUTICAL CO., LTD.Inventors: Wilma Tamraz, Huey-Ching Su, WeiQi Lin, Kazuhito Yamada, Naoki Matsumoto, Sreenivasu Mudumba, Komei Okabe
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Publication number: 20200101073Abstract: Disclosed are formulations and related methods that comprise a non-polymeric, non-water soluble high viscosity liquid carrier material having a viscosity of at least 5,000 cP at 37° C. that does not crystallize neat under ambient or physiological conditions; a specified linear polymer comprising lactide repeat units; and one or more solvents that have a solvent capacity.Type: ApplicationFiled: September 3, 2019Publication date: April 2, 2020Applicant: DURECT CORPORATIONInventors: Jeremy C. Wright, Felix Theeuwes, John W. Gibson, Keith E. Branham, Stefania Sjobeck
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Publication number: 20200101021Abstract: Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.Type: ApplicationFiled: September 3, 2019Publication date: April 2, 2020Applicant: DURECT CORPORATIONInventors: Su Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael Zamloot
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Patent number: 10603312Abstract: The invention pertains to methods that include administering to a subject a transoral dosage form comprising a pharmaceutical carrier and sufentanil, and maintaining a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test. Related dosage forms are also disclosed. Also disclosed are transoral dosage forms and related methods, wherein a transoral dosage form may comprise: (1) about 5 to about 1000 micrograms of sufentanil; (2) about 50 micrograms to about 100 milligrams of naloxone; and (3) acidifying material in an amount sufficient to provide a mean pH ranging from about 3.5 to about 5.Type: GrantFiled: January 12, 2018Date of Patent: March 31, 2020Assignee: Durect CorporationInventors: Su Il Yum, Jaymin Shah, Sung Yun Kwon, Xiaoping Song
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Publication number: 20200085829Abstract: Compositions may include a pharmaceutical active agent, a high viscosity liquid carrier material (HVLCM), a lactic acid-based polymer, and an organic solvent. Related compositions and methods are also disclosed.Type: ApplicationFiled: August 19, 2019Publication date: March 19, 2020Applicant: DURECT CORPORATIONInventors: Jeremy C. WRIGHT, Wilma TAMRAZ, John J. LEONARD, John W. GIBSON, Keith E. BRANHAM, Stefania SJOBECK, Brooks BOYD, Christopher M. RUBINO
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Patent number: 10471001Abstract: Methods and compositions for systemically or locally administering by implantation a beneficial agent to a subject are described, and include, for example, depot gel compositions that can be injected into a desired location and which can provide controlled release of a beneficial agent over a short duration of time. The compositions include a low molecular weight biocompatible polymer, a biocompatible solvent having low water miscibility that forms a viscous gel with the polymer and limits water uptake by the implant, and a beneficial agent.Type: GrantFiled: December 28, 2018Date of Patent: November 12, 2019Assignee: Durect CorporationInventors: Guohua Chen, David T. Priebe
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Patent number: 10471002Abstract: Methods and compositions for systemically or locally administering by implantation a beneficial agent to a subject are described, and include, for example, depot gel compositions that can be injected into a desired location and which can provide controlled release of a beneficial agent over a short duration of time. The compositions include a low molecular weight biocompatible polymer, a biocompatible solvent having low water miscibility that forms a viscous gel with the polymer and limits water uptake by the implant, and a beneficial agent.Type: GrantFiled: March 8, 2019Date of Patent: November 12, 2019Assignee: Durect CorporationInventors: Guohua Chen, David T. Priebe
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Publication number: 20190255179Abstract: Compositions may include a pharmaceutical active agent, a high viscosity liquid carrier material (HVLCM), a lactic acid-based polymer, and an organic solvent. Related compositions and methods are also disclosed. For instance, a carrier formulation for controlled release of injectable drugs is disclosed. The formulation may include a non-water soluble high viscosity liquid which may be sucrose acetate isobutyrate, a lactic-acid based polymer which may be a poly(lactic acid)(glycolic acid), and an organic solvent which maintains the composition in a monophasic form at 25° C. in one atmosphere. Drug in the formulation may be released upon administration such that less than 10% (e.g. 2-8%) of drug is released in the first 5 hours; 10% to 80% of the drug is released during a period of 5 hours to 7 days after administration; and 10% to 40% of the drug is released gradually over a period of 7 days to 28 days from initial administration. The drug may be an anti-schizophrenia agent delivered by injection.Type: ApplicationFiled: January 17, 2019Publication date: August 22, 2019Applicant: DURECT CORPORATIONInventors: Jeremy C. WRIGHT, Wilma TAMRAZ, John J. LEONARD, John W. GIBSON, Keith E. BRANHAM, Stefania SJOBECK, Brooks Boyd, Christopher M. RUBINO
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Publication number: 20190231678Abstract: A composition includes a salt; a polymer; and an antioxidant. A dispenser includes a flexible container having a closed end and an opposed open end; an osmotically-effective solute composition encapsulating at least a portion of the container, the solute composition including antioxidant in an amount of at least 0.5 wt %, based on weight of the solute composition; a semipermeable membrane encapsulating the osmotically-effective solute composition; a cap having a sealing surface adapted for sealing engagement with the open end of the container; and a port extending from an interior of the container and through the cap. Also disclosed are methods of making and using the composition and osmotic pumps.Type: ApplicationFiled: December 18, 2018Publication date: August 1, 2019Applicant: Durect CorporationInventors: Xiaoping Song, Clarisa Peer, Su Il Yum
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Publication number: 20190209654Abstract: The present disclosure provides a biodegradable drug delivery composition including a vehicle and an insoluble component comprising beneficial agent dispersed in the vehicle. Typically, the composition is not an emulsion, but has a low viscosity and further provides for minimized initial burst and sustained release of the beneficial agent over time. Also provided, are kits including the biodegradable drug delivery composition or components thereof, as well as methods of making and using the biodegradable drug delivery composition.Type: ApplicationFiled: November 2, 2018Publication date: July 11, 2019Applicant: Durect CorporationInventors: William Van Osdol, SuIl Yum, Felix Theeuwes, Michael Sekar, John W Gibson, Keith Edward Branham, Huey Ching Su
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Patent number: 10328068Abstract: Controlled release oral dosage forms suitable for administration of methylphenidate are provided. Abuse-resistant controlled release oral dosage forms suitable for administration of methylphenidate are also provided. Methods of treating ADD and ADHD using the oral dosage forms are also provided.Type: GrantFiled: December 22, 2017Date of Patent: June 25, 2019Assignee: Durect CorporationInventors: Jan J. Scicinski, William W. van Osdol, Huey-Ching Su, Michael H. Arenberg, Jaymin Shah
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Publication number: 20190167801Abstract: An injectable, nonaqueous suspension including at least one therapeutic agent suspended in a single component vehicle. The single component vehicle is a single amphiphilic material, such as a polyethoxylated castor oil or derivative thereof, a polyoxyethylene alkyl ether, a polyoxyethylene sorbitan fatty acid ester, a polyoxyethylene stearate, a block copolymer of polyethylene oxide-polypropylene oxide-polyethylene oxide, a block copolymer of polypropylene oxide-polyethylene oxide-polypropylene oxide, a tetra-functional block copolymer of polyethylene oxide-polypropylene oxide, or a tetra-functional block copolymer of polypropylene oxide-polyethylene oxide. A dosage kit that includes the injectable, nonaqueous suspension and a method of administering the injectable, nonaqueous suspension are also disclosed.Type: ApplicationFiled: October 29, 2018Publication date: June 6, 2019Applicant: Durect CorporationInventors: Paul R. Houston, Guohua Chen, Andrew Sheung-King Luk
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Patent number: 10300142Abstract: The present disclosure provides compositions (e.g., extended release compositions) which exhibit a desirable pharmacokinetic profile of an active agent while providing reduced dissolution sample variability, e.g., in the form of reduced inter-capsule variability and/or a reduction in storage-time dependent change in mean release of the active agent from the composition. Related methods of making and administering the disclosed compositions are also provided.Type: GrantFiled: November 29, 2017Date of Patent: May 28, 2019Assignee: Durect CorporationInventors: Su Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael S. Zamloot, Karl Bratin, Ravi M. Shanker
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Patent number: 10272097Abstract: Methods of preventing and/or treating ischemia, organ dysfunction and/or organ failure, including multiple organ dysfunction syndrome (MODS), and necrosis and apoptosis associated with organ dysfunction/failure, are provided. For instance, the methods involve contacting organ(s) with an oxygenated cholesterol sulfate (OCS), e.g. 5-cholesten-3,25-diol, 3-sulfate (25HC3S). The organ(s) may be in vivo (e.g. in a patient that is treated with the OCS) or ex vivo (e.g. an organ that has been harvested from a donor and is to be transplanted).Type: GrantFiled: December 23, 2014Date of Patent: April 30, 2019Assignees: Virginia Commonwealth University, Durect CorporationInventors: Shunlin Ren, Felix Theeuwes, James E. Brown, WeiQi Lin
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Patent number: 10226532Abstract: Compositions may include a pharmaceutical active agent, a high viscosity liquid carrier material (HVLCM), a lactic acid-based polymer, and an organic solvent. Related compositions and methods are also disclosed. For instance, a carrier formulation for controlled release of injectable drugs is disclosed. The formulation may include a non-water soluble high viscosity liquid which may be sucrose acetate isobutyrate, a lactic-acid based polymer which may be a poly(lactic acid)(glycolic acid), and an organic solvent which maintains the composition in a monophasic form at 25° C. in one atmosphere. Drug in the formulation may be released upon administration such that less than 10% (e.g. 2-8%) of drug is released in the first 5 hours; 10% to 80% of the drug is released during a period of 5 hours to 7 days after administration; and 10% to 40% of the drug is released gradually over a period of 7 days to 28 days from initial administration. The drug may be an anti-schizophrenia agent delivered by injection.Type: GrantFiled: July 18, 2017Date of Patent: March 12, 2019Assignee: DURECT CORPORATIONInventors: Jeremy C. Wright, Wilma Tamraz, John J. Leonard, John W. Gibson, Keith E. Branham, Stefania Sjobeck, Brooks Boyd, Christopher M. Rubino
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Patent number: 10206883Abstract: Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.Type: GrantFiled: December 12, 2017Date of Patent: February 19, 2019Assignee: Durect CorporationInventors: Su Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael Zamloot
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Patent number: 10201496Abstract: Methods and compositions for systemically or locally administering by implantation a beneficial agent to a subject are described, and include, for example, depot gel compositions that can be injected into a desired location and which can provide controlled release of a beneficial agent over a short duration of time. The compositions include a low molecular weight biocompatible polymer, a biocompatible solvent having low water miscibility that forms a viscous gel with the polymer and limits water uptake by the implant, and a beneficial agent.Type: GrantFiled: September 15, 2016Date of Patent: February 12, 2019Assignee: Durect CorporationInventors: Guohua Chen, David T. Priebe
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Publication number: 20190030032Abstract: Disclosed are formulations and related methods that comprise a non-polymeric, non-water soluble high viscosity liquid carrier material having a viscosity of at least 5,000 cP at 37° C. that does not crystallize neat under ambient or physiological conditions; a specified linear polymer comprising lactide repeat units; and one or more solvents that have a solvent capacity.Type: ApplicationFiled: June 25, 2018Publication date: January 31, 2019Applicant: DURECT CORPORATIONInventors: Jeremy C. WRIGHT, Felix THEEUWES, John W. GIBSON, Keith E. BRANHAM, Stefania SJOBECK