公开(公告)号：US20240115463A1

公开(公告)日：2024-04-11

申请号：US18235256

申请日：2023-08-17

申请人： Durect Corporation

发明人： ANDREW R. MIKSZTAL ,  JUDY JOICE ,  SUSAN AUTIO ,  MARK P. DAVIS

IPC分类号： A61J1/20 ,  A61K31/445 ,  A61K47/10 ,  A61K47/26

CPC分类号： A61J1/2089 ,  A61K31/445 ,  A61K47/10 ,  A61K47/26

摘要： The present disclosure relates to sustained release drug delivery systems. In some cases, a composition comprises an active pharmaceutical agent; at least one of sucrose acetate isobutyrate and a polyorthoester; an organic solvent; and 2,6-dimethylaniline, wherein the 2,6-dimethylaniline is present at a level less than 500 ppm. In some cases, a composition comprises N-oxide of active pharmaceutical agent at a level less than 1 wt %, based on weight of the composition. In some case, a composition comprises metal present at a level less than 5 ppm. Dosage forms and methods are also provided.

公开(公告)号：US11771624B2

公开(公告)日：2023-10-03

申请号：US17581665

申请日：2022-01-21

申请人： DURECT CORPORATION

发明人： Andrew R. Miksztal ,  Judy Joice ,  Susan Autio ,  Mark P. Davis

IPC分类号： A61J1/20 ,  A61K31/445 ,  A61K47/10 ,  A61K47/26

CPC分类号： A61J1/2089 ,  A61K31/445 ,  A61K47/10 ,  A61K47/26

摘要： The present disclosure relates to sustained release drug delivery systems. In some cases, a composition comprises an active pharmaceutical agent; at least one of sucrose acetate isobutyrate and a polyorthoester; an organic solvent; and 2,6-dimethylaniline, wherein the 2,6-dimethylaniline is present at a level less than 500 ppm. In some cases, a composition comprises N-oxide of active pharmaceutical agent at a level less than 1 wt %, based on weight of the composition. In some case, a composition comprises metal present at a level less than 5 ppm. Dosage forms and methods are also provided.

公开(公告)号：US20230146925A1

公开(公告)日：2023-05-11

申请号：US18093240

申请日：2023-01-04

申请人： DURECT CORPORATION

发明人： Jeremy C. WRIGHT ,  Felix THEEUWES ,  John W. GIBSON ,  Keith E. BRANHAM ,  Stefania SJOBECK

IPC分类号： A61K31/519 ,  A61K9/00 ,  A61K9/08 ,  A61K9/10 ,  A61K47/26 ,  A61K47/34 ,  A61K47/22

CPC分类号： A61K31/519 ,  A61K9/0019 ,  A61K9/0024 ,  A61K9/08 ,  A61K9/10 ,  A61K47/26 ,  A61K47/34 ,  A61K47/22

摘要： 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.

公开(公告)号：US20220280646A1

公开(公告)日：2022-09-08

申请号：US17671447

申请日：2022-02-14

申请人： DURECT CORPORATION

发明人： Jeremy C. WRIGHT ,  Wilma TAMRAZ ,  John J. LEONARD ,  John W. GIBSON ,  Keith E. BRANHAM ,  Stefania SJOBECK ,  Brooks Boyd ,  Christopher M. RUBINO

IPC分类号： A61K47/22 ,  A61K9/00 ,  A61K31/519 ,  A61K47/20 ,  A61K47/26 ,  A61M5/20 ,  A61M5/24 ,  A61M5/30 ,  A61M5/315

摘要： 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.

公开(公告)号：US20220265830A1

公开(公告)日：2022-08-25

申请号：US17627512

申请日：2020-07-17

申请人： DURECT CORPORATION

发明人： Susan AUTIO ,  Keith Edward BRANHAM ,  James A. FILICE ,  John W. GIBSON ,  John J. LEONARD ,  James MATRIANO ,  Whitney MORO ,  Michael SEKAR ,  Chelsea Alexandra SNYDER ,  Robert G. STRICKLEY ,  Raju SUBRAMANIAN ,  Felix THEEUWES ,  Monica TIJERINA ,  Jeremy C. WRIGHT ,  Su II YUM ,  Faye XU

IPC分类号： A61K47/26 ,  A61K45/06 ,  A61K47/22 ,  A61K47/34 ,  A61K9/08

摘要： The present disclosure provides long-acting formulations and vehicles, methods of making the same and methods of using the same.

公开(公告)号：US20220257619A1

公开(公告)日：2022-08-18

申请号：US17627000

申请日：2020-07-17

申请人： Gilead Sciences, Inc. ,  Durect Corporation

发明人： Susan Autio ,  Keith Edward Branham ,  James A. Filice ,  John W. Gibson ,  John J. Leonard ,  James Matriano ,  Whitney Moro ,  Michael Sekar ,  Chelsea Alexandra Snyder ,  Robert G. Strickley ,  Raju Subramanian ,  Felix Theeuwes ,  Monica Tijerina ,  Jeremy C. Wright ,  Su Il Yum ,  Faye Xu

IPC分类号： A61K31/675 ,  A61K47/26 ,  A61K47/34 ,  A61K47/22 ,  A61P31/18

摘要： The present disclosure provides long-acting formulations of tenofovir alafenamide, methods of making the same and methods of using the same.

公开(公告)号：US20220133595A1

公开(公告)日：2022-05-05

申请号：US17504913

申请日：2021-10-19

申请人： DURECT CORPORATION

发明人： ANDREW R. MIKSZTAL ,  JUDY JOICE ,  SUSAN AUTIO ,  MARK P. DAVIS

IPC分类号： A61J1/20 ,  A61K31/445 ,  A61K47/26 ,  A61K47/10

摘要： The present disclosure relates to sustained release drug delivery systems. In some cases, a composition comprises an active pharmaceutical agent; at least one of sucrose acetate isobutyrate and a polyorthoester; an organic solvent; and 2,6-dimethylaniline, wherein the 2,6-dimethylaniline is present at a level less than 500 ppm. In some cases, a composition comprises N-oxide of active pharmaceutical agent at a level less than 1 wt %, based on weight of the composition. In some case, a composition comprises metal present at a level less than 5 ppm. Dosage forms and methods are also provided.

公开(公告)号：US20220023424A1

公开(公告)日：2022-01-27

申请号：US17364519

申请日：2021-06-30

申请人： Durect Corporation

发明人： Gunjan Junnarkar ,  Michael A. Desjardin ,  John P. Carr

IPC分类号： A61K47/26 ,  A61K31/7024 ,  A61K9/00 ,  A61K9/10 ,  A61K38/21 ,  C07H1/06 ,  C07H13/04

摘要： 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.

公开(公告)号：US20210330582A1

公开(公告)日：2021-10-28

申请号：US17227236

申请日：2021-04-09

申请人： Durect Corporation

发明人： Xiaoping Song ,  Clarisa Peer ,  Su Il Yum

IPC分类号： A61K9/00 ,  A61K47/02 ,  A61K47/10 ,  A61K47/20 ,  A61K47/32 ,  A61K47/34 ,  A61K47/38

摘要： 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.

公开(公告)号：US20210169898A1

公开(公告)日：2021-06-10

申请号：US17094432

申请日：2020-11-10

申请人： Virginia Commonwealth University ,  Durect Corporation

发明人： Shunlin Ren ,  Leyuan Xu ,  Yanxia Ning ,  Jin Koung Kim ,  WeiQi Lin ,  Mee Jean Kim ,  Andrew R. Miksztal ,  Hongwei Wu ,  Min L. Lee ,  Wilma Tamraz

IPC分类号： A61K31/565 ,  A61Q19/00 ,  A61K9/19 ,  A61P31/04 ,  A61K47/10 ,  A61K31/575 ,  A61K8/63 ,  A61P17/06 ,  A61K31/724 ,  A61K9/00 ,  A61P3/06 ,  A61K47/40 ,  A61K8/73 ,  A61P1/16 ,  C07J31/00

摘要： Compositions comprising 5-cholesten-3, 25-diol, 3-sulfate (25HC3S) or pharmaceutically acceptable salt thereof and at least one cyclic oligosaccharide, e.g., a cyclodextrin (CD), are provided. The compositions may be used to prevent and/or treat a variety of diseases and conditions, including organ failure (e.g. acute liver failure), high cholesterol/high lipids, and various inflammatory diseases and conditions.