Patents Assigned to Durect Corporation
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Publication number: 20180256553Abstract: The present invention relates to novel anesthetic compositions containing a non-polymeric carrier material and an anesthetic, where the compositions are suitable for providing a sustained local anesthesia without an initial burst and having a duration for about 24 hours or longer. Certain compositions are also provided that include a first anesthetic and a second anesthetic. In such compositions, the second anesthetic is a solvent for the first anesthetic and provides an initial anesthetic effect upon administration to a subject. The non-polymeric carrier may optionally be a high viscosity liquid carrier material such as a suitable sugar ester. The compositions can further include one or more additional ingredients including active and inactive materials. Methods of using the compositions of the invention to produce a sustained anesthetic effect at a site in a subject are also provided.Type: ApplicationFiled: January 12, 2018Publication date: September 13, 2018Applicant: DURECT CORPORATIONInventor: Adrian Neil Verity
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Publication number: 20180256727Abstract: 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: ApplicationFiled: February 2, 2018Publication date: September 13, 2018Applicant: 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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Publication number: 20180228792Abstract: 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: ApplicationFiled: January 12, 2018Publication date: August 16, 2018Applicant: Durect CorporationInventors: Su Il Yum, Jaymin Shah, Sung Yun Kwon, Xiaoping Song
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Patent number: 10028957Abstract: 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: GrantFiled: March 8, 2013Date of Patent: July 24, 2018Assignee: DURECT CORPORATIONInventors: Jeremy C. Wright, Felix Theeuwes, John W. Gibson, Keith E. Branham, Stefania Sjobeck
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Publication number: 20180140605Abstract: 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: January 16, 2018Publication date: May 24, 2018Applicant: 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: 20180117016Abstract: 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: ApplicationFiled: December 28, 2017Publication date: May 3, 2018Applicants: 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: 20180110739Abstract: Disclosed are bupivacaine transdermal delivery systems, and related methods.Type: ApplicationFiled: September 5, 2017Publication date: April 26, 2018Applicant: Durect CorporationInventors: Su Il Yum, Sung Yun Kwon, Xiaoping Song, James E Brown
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Patent number: 9918982Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.Type: GrantFiled: November 3, 2016Date of Patent: March 20, 2018Assignee: Durect CorporationInventors: Su Il Yum, Grant Schoenhard, Arthur J. Tipton, John W. Gibson, John C. Middleton, Roger Fu, Michael S. Zamloot
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Patent number: 9907851Abstract: 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 and formulations are also provided.Type: GrantFiled: December 15, 2016Date of Patent: March 6, 2018Assignee: Durect CorporationInventors: Su Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael S. Zamloot, Karl Bratin, Ravi M. Shanker
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Publication number: 20180036412Abstract: 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: July 18, 2017Publication date: February 8, 2018Applicant: 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: 9884056Abstract: 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: February 16, 2017Date of Patent: February 6, 2018Assignee: Durect CorporationInventors: Jan J. Scicinski, William W. van Osdol, Huey-Ching Su, Michael H. Arenberg, Jaymin Shah
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Publication number: 20180000729Abstract: 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: ApplicationFiled: June 29, 2017Publication date: January 4, 2018Applicants: 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: 9855333Abstract: 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: January 4, 2017Date of Patent: January 2, 2018Assignee: Durect CorporationInventors: Su Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael S. Zamloot, Karl Bratin, Ravi M. Shanker
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Publication number: 20170319702Abstract: 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: May 1, 2017Publication date: November 9, 2017Applicant: Durect CorporationInventors: Paul R. Houston, Guohua Chen, Andrew Luk
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Publication number: 20170239252Abstract: An injectable depot formulation includes a biocompatible polymer, an organic solvent combined with the biocompatible polymer to form a viscous gel, and a small molecule drug incorporated in the viscous gel such that the formulation exhibits an in vivo release profile having Cmax to Cmin ratio less than 200 and lag time less than 0.2.Type: ApplicationFiled: February 2, 2017Publication date: August 24, 2017Applicant: DURECT CORPORATIONInventors: Andrew S. LUK, Gunjan H. JUNNARKAR, Guohua CHEN
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Patent number: 9737605Abstract: 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: March 11, 2014Date of Patent: August 22, 2017Assignee: 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: 20170216267Abstract: The present invention relates to novel anesthetic compositions containing a non-polymeric carrier material and an anesthetic, where the compositions are suitable for providing a sustained local anesthesia without an initial burst and having a duration for about 24 hours or longer. Certain compositions are also provided that include a first anesthetic and a second anesthetic. In such compositions, the second anesthetic is a solvent for the first anesthetic and provides an initial anesthetic effect upon administration to a subject. The non-polymeric carrier may optionally be a high viscosity liquid carrier material such as a suitable sugar ester. The compositions can further include one or more additional ingredients including active and inactive materials. Methods of using the compositions of the invention to produce a sustained anesthetic effect at a site in a subject are also provided.Type: ApplicationFiled: January 9, 2017Publication date: August 3, 2017Applicant: DURECT CORPORATIONInventor: Adrian Neil Verity
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Publication number: 20170196989Abstract: The present disclosure is directed to a method of making a composition by combining a vehicle, e.g., a single phase vehicle, and an insoluble component comprising a beneficial agent, and sterilizing the composition using ionizing radiation prior to use, wherein the beneficial agent is stable following exposure to a sterilizing dose of ionizing radiation. Related compositions and methods are provided.Type: ApplicationFiled: December 19, 2016Publication date: July 13, 2017Applicant: Durect CorporationInventors: Michael Sekar, Su Il Yum, Felix Theeuwes, William W. van Osdol
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Publication number: 20170143721Abstract: 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: January 5, 2017Publication date: May 25, 2017Applicants: DURECT CORPORATION, ZOGENIX INC.Inventors: 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: 9655861Abstract: Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.Type: GrantFiled: July 13, 2015Date of Patent: May 23, 2017Assignee: DURECT CORPORATIONInventors: Su Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael Zamloot