Abstract: 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:
Grant
Filed:
July 2, 2015
Date of Patent:
April 11, 2017
Assignee:
Durect Corporation
Inventors:
Jan J. Scicinski, William W. van Osdol, Huey-Ching Su, Michael H. Arenberg, Jaymin Shah
Abstract: 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.
Abstract: 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:
Grant
Filed:
April 30, 2015
Date of Patent:
March 21, 2017
Assignee:
DURECT CORPORATION
Inventors:
Andrew S. Luk, Gunjan H. Junnarkar, Guohua Chen
Abstract: 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:
Grant
Filed:
March 14, 2014
Date of Patent:
February 21, 2017
Assignee:
Durect Corporation
Inventors:
Su Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael S. Zamloot, Karl Bratin, Ravi M. Shanker
Abstract: 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:
Grant
Filed:
January 14, 2016
Date of Patent:
February 21, 2017
Assignee:
DURECT CORPORATION
Inventors:
Jeremy C. Wright, Wilma Tamraz, John J. Leonard, John W. Gibson, Keith E. Branham, Stefania Sjobeck, Brooks Boyd, Christopher M. Rubino
Abstract: 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:
Grant
Filed:
March 14, 2014
Date of Patent:
January 31, 2017
Assignee:
Durect Corporation
Inventors:
Su Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael S. Zamloot, Karl Bratin, Ravi M. Shanker
Abstract: The present invention is related to methods for lowering peroxide levels in sucrose acetate isobutyrate formulations and to composition used in and formed by such methods.
Type:
Application
Filed:
August 29, 2016
Publication date:
December 15, 2016
Applicant:
DURECT CORPORATION
Inventors:
Gunjan Junnarkar, Michael A. Desjardin, John P. Carr
Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.
Type:
Grant
Filed:
December 2, 2015
Date of Patent:
December 13, 2016
Assignee:
DURECT CORPORATION
Inventors:
Su Il Yum, Grant Schoenhard, Arthur J. Tipton, John W. Gibson, John C. Middleton, Roger Fu, Michael S. Zamloot
Abstract: 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.
Abstract: 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:
Application
Filed:
December 8, 2014
Publication date:
October 20, 2016
Applicant:
Durect Corporation
Inventors:
Michael Sekar, Felix Theeuwes, Keith E Branham, John W Gibson, James Matriano, Whitney Moro, John Tipton, William Van Osdol, Su Il Yum
Abstract: 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:
Application
Filed:
February 26, 2016
Publication date:
September 29, 2016
Applicant:
DURECT CORPORATION
Inventors:
Jeremy C. WRIGHT, Felix THEEUWES, John W. GIBSON, Keith E. BRANHAM, Stefania SJOBECK
Abstract: 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:
Application
Filed:
January 14, 2016
Publication date:
July 21, 2016
Applicants:
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
Abstract: 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:
Application
Filed:
December 4, 2015
Publication date:
July 7, 2016
Applicant:
Durect Corporation
Inventors:
Paul R. Houston, Guohua Chen, Andrew Luk
Abstract: 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:
Application
Filed:
October 1, 2015
Publication date:
June 9, 2016
Applicant:
Durect Corporation
Inventors:
Su II Yum, Jaymin Shah, Sung Yun Kwon, Xiaoping Song
Abstract: 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:
Application
Filed:
July 16, 2015
Publication date:
February 18, 2016
Applicant:
DURECT CORPORATION
Inventors:
Jeremy C. WRIGHT, Felix Theeuwes, John W. GIBSON, Keith E. BRANHAM, Stefania SJOBECK
Abstract: 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:
Application
Filed:
March 11, 2014
Publication date:
February 11, 2016
Applicants:
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
Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.
Type:
Grant
Filed:
December 17, 2014
Date of Patent:
January 12, 2016
Assignee:
DURECT CORPORATION
Inventors:
Su Il Yum, Grant Schoenhard, Arthur J. Tipton, John W. Gibson, John C. Middleton, Roger Fu, Michael S. Zamloot
Abstract: 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:
Application
Filed:
April 30, 2015
Publication date:
August 20, 2015
Applicant:
DURECT CORPORATION
Inventors:
Andrew S. LUK, Gunjan H. JUNNARKAR, Guohua CHEN
Abstract: 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:
Grant
Filed:
March 8, 2013
Date of Patent:
June 2, 2015
Assignee:
DURECT CORPORATION
Inventors:
Andrew S. Luk, Gunjan H. Junnarkar, Guohua Chen