公开(公告)号：US20240317773A1

公开(公告)日：2024-09-26

申请号：US18546049

申请日：2021-09-06

申请人： AURISCO PHARMACEUTICAL CO., LTD.

发明人： Wancheng GUO ,  Fuchang ZHANG ,  Yongli DUAN ,  Xiongpeng DUAN ,  Guoping WANG

IPC分类号： C07D495/04 ,  G01N33/15

CPC分类号： C07D495/04 ,  G01N33/15

摘要： A thienopyrimidine compound (a compound of formula N) and a preparation method therefor are provided. Specifically, the preparation method includes the steps of: (a) in a solvent A, reacting, in the presence of an organic base and acyl chloride, a compound of formula N-2 with 3-amino-6-methoxypyridazine to obtain a compound of formula N-1; and (b) in a solvent B, converting, in the presence of a base, the compound of formula N-1 into the compound of formula N. The preparation method does not require toxic and expensive reagents, has mild reaction conditions and a high product purity, and is suitable for industrial production.

公开(公告)号：US12061160B2

公开(公告)日：2024-08-13

申请号：US18170114

申请日：2023-02-16

申请人： UNIVERSITY OF MARYLAND, BALTIMORE ,  ACCESS TO ADVANCED HEALTH INSTITUTE

发明人： Yihua (Bruce) Yu ,  Marc Taraban ,  Christopher Fox

IPC分类号： G01N24/08 ,  G01N33/15

CPC分类号： G01N24/082 ,  G01N33/15

摘要： A method of using the transverse relaxation rate (R2) of solvent NMR signal to noninvasively assess if an alum-containing product, such as a vaccine, has been acceptably resuspended for use following transport and/or storage. This technique allows for the manufacturer and/or distributor and/or end user to monitor for unexpected stressors associated with transport and/or storage including, but not limited to, temperature fluctuations, pH changes, vigorous shaking during transportation, exposure to sunlight, and freezing.

公开(公告)号：US20240264072A1

公开(公告)日：2024-08-08

申请号：US18614181

申请日：2024-03-22

申请人： Truvian Sciences, Inc.

发明人： Ian Kleinemolen ,  Jeffrey A. Hawkins ,  Dena Marrinucci ,  Kameel Michael Abi-Samra

IPC分类号： G01N21/03 ,  B01L3/00 ,  G01N21/07 ,  G01N21/76 ,  G01N33/02 ,  G01N33/15 ,  G01N33/18 ,  G01N33/49 ,  G01N33/493

CPC分类号： G01N21/0303 ,  B01L3/502 ,  B01L3/502715 ,  G01N21/07 ,  G01N21/76 ,  G01N33/02 ,  G01N33/15 ,  G01N33/1893 ,  G01N33/4915 ,  G01N33/493 ,  B01L3/50273 ,  B01L3/5085 ,  B01L2300/0663 ,  B01L2300/0858 ,  B01L2300/0861 ,  B01L2300/087 ,  B01L2400/0409 ,  G01N2021/0325

摘要： A device includes a lower reservoir surface, an upper reservoir surface, and a reservoir sidewall extending between the upper and lower reservoir surfaces which together define a reservoir. The reservoir is configured to be completely filled by a liquid such that the liquid forms a column contacting the upper reservoir surface, the lower reservoir surface, and the reservoir sidewall, with a meniscus of the liquid being outside of the reservoir. At least one of the upper reservoir surface and the lower reservoir surface is configured to transmit light.

公开(公告)号：US20240245779A1

公开(公告)日：2024-07-25

申请号：US18420955

申请日：2024-01-24

申请人： Regeneron Pharmaceuticals, Inc.

发明人： Douglas E. KAMEN ,  Kenneth S. GRAHAM ,  Caterina RICCARDI

IPC分类号： A61K47/26 ,  A61J1/10 ,  A61K39/395 ,  A61K47/68 ,  G01N33/15

CPC分类号： A61K47/26 ,  A61K39/395 ,  A61K47/68 ,  G01N33/15 ,  A61J1/10

摘要： The disclosure provides methods of determining an initial amount of surfactant to include in a liquid pharmaceutical composition comprising a protein, intended for administration to a subject as an IV admixture. The methods comprise determining the degradation rate of the surfactant, the minimum amount of surfactant whereby stability of the protein is maintained in IV admixture the end of shelf-life of the liquid pharmaceutical composition, and, based on the degradation rate, shelf-life, and minimum amount of surfactant, determining a target amount of surfactant to include in the composition at the time of formulation.

公开(公告)号：US12007376B2

公开(公告)日：2024-06-11

申请号：US17122496

申请日：2020-12-15

申请人： Trace-Ability, Inc.

发明人： Artem Y. Lebedev ,  Arkadij M. Elizarov

IPC分类号： G01N33/15 ,  C12M1/34 ,  C12Q1/02 ,  G01N21/78 ,  G01N21/82 ,  A61B6/03 ,  G01N21/25 ,  G01N21/51 ,  G01N21/75 ,  G01N33/00

CPC分类号： G01N33/15 ,  C12M41/36 ,  C12Q1/02 ,  G01N21/78 ,  G01N21/82 ,  A61B6/037 ,  G01N21/253 ,  G01N21/51 ,  G01N2021/752 ,  G01N2033/0093

摘要： A method for determining a concentration of a synthesis component in a radiopharmaceutical sample comprises providing an indicator, a metal or a metal complex, contacting the radiopharmaceutical sample with the indicator, metal or metal complex for a period of time sufficient to obtain an interaction, measuring an optical characteristic of the interacted components, and determining a concentration of the synthesis component in the radiopharmaceutical sample based on the measured optical characteristic.

公开(公告)号：US12007366B2

公开(公告)日：2024-06-11

申请号：US17269675

申请日：2019-08-20

申请人： Gamlen Tableting Limited

发明人： Henry David Kafeman ,  Michael Gamlen

IPC分类号： G01N3/08 ,  G01N33/15 ,  G01N33/00

CPC分类号： G01N3/08 ,  G01N33/15 ,  G01N2033/0091 ,  G01N2203/0019 ,  G01N2203/0284

摘要： There is disclosed a system and method for identifying a powder material. A powder press has a die for receiving a powder to be compacted. A press member is arranged to be moveable so as to compact the powder within the die. A load sensor senses a load applied by the press member to the powder so as to generate multiple load readings during movement of the press member. A processor is arranged to receive the load readings from the load sensor and to compare the load readings during movement of the die with predetermined load data. The processor outputs an identification signal for the compacted powder based on said comparison.

公开(公告)号：US20240167926A1

公开(公告)日：2024-05-23

申请号：US18552768

申请日：2022-04-08

申请人： ASTRAZENECA AB

发明人： Farhan ALHUSBAN ,  Brian CLARK

IPC分类号： G01N3/303 ,  G01N33/15

CPC分类号： G01N3/303 ,  G01N33/15 ,  G01N2203/001 ,  G01N2203/0033 ,  G01N2203/0087 ,  G01N2203/0218 ,  G01N2203/0234 ,  G01N2203/0676

摘要： A solid pharmaceutical dosage form testing apparatus and a method are presented. The solid pharmaceutical dosage form testing apparatus includes a striker component, an impact platform, a sensor data acquisition system, and a solid dosage form placement mechanism. The solid dosage form placement mechanism has first and second push components that are movable toward each other to position a solid dosage form at an impact site. The method includes performing an impact strike test on a first plurality of solid dosage forms, and measuring a plurality of peak impact force values. The method may include performing a drop test on a second plurality of solid dosage forms, and measuring a plurality of physical defect rates. The method may include determining a model that describes a relationship between peak impact force values and physical defect rates, and determining, based on the model, a predicted physical defect rate.

公开(公告)号：US11944590B2

公开(公告)日：2024-04-02

申请号：US16975094

申请日：2018-02-22

申请人： MITSUBISHI CHEMICAL ENGINEERING CORPORATION

发明人： Akihiro Matsuki ,  Nobuhiro Tanaka ,  Katsuhiro Murata ,  Hironobu Takeda

IPC分类号： B65G53/56 ,  A61J3/10 ,  G01N21/85 ,  G01N33/15

CPC分类号： A61J3/10 ,  G01N21/85 ,  G01N33/15 ,  G01N2021/8592

摘要： A continuous manufacturing system continuously manufactures a product from a powder of a raw material. The system includes a first processing device that performs first processing on the powder of the raw material; a second processing device that performs second processing on the powder on which the first processing device has performed the first processing; and an inspection and sorting device including an inspection chamber into which powder sent from the first processing device flows. When a prescribed amount of the powder has accumulated in the inspection chamber, the inspection and sorting device inspects the powder inside the inspection chamber after blocking a path connecting the first processing device to the inspection chamber. When the inspection ends, the inspection and sorting device removes the blocking after discharging the powder from inside the inspection chamber.

公开(公告)号：US20240100058A1

公开(公告)日：2024-03-28

申请号：US17767742

申请日：2020-12-25

申请人： Chugai Seiyaku Kabushiki Kaisha

发明人： Tadanobu NAKAYAMA ,  Yoshiko KURE ,  Takuro SASAYAMA

IPC分类号： A61K31/5377 ,  A61K47/20 ,  G01N33/15

CPC分类号： A61K31/5377 ,  A61K47/20 ,  G01N33/15

摘要： The present invention provides a method for determining a sodium lauryl sulfate having a desired quality as a pharmaceutical raw material for a formulation by detecting a slight difference in quality of sodium lauryl sulfate to be used as a pharmaceutical raw material for a formulation.
The present invention relates to a method for sorting a raw material for a formulation which can provide a pharmaceutical formulation excellent in stability by pretreating the material for a formulation under a predetermined accelerated condition and detecting an impurity. According to the method of the present invention, it is possible to determine the quality of sodium lauryl sulfate of a pharmaceutical raw material for a formulation having no effect on the quality of a pharmaceutical formulation containing alectinib or a salt thereof. A pharmaceutical composition produced by using a pharmaceutical raw material for a formulation (SLS) and sorted out by the method of the present invention can provide a high-quality pharmaceutical formulation having excellent stability.

公开(公告)号：US11898959B2

公开(公告)日：2024-02-13

申请号：US17543401

申请日：2021-12-06

申请人： Harry Owen

发明人： Harry Owen

IPC分类号： G01N21/65 ,  G01N33/15

CPC分类号： G01N21/658 ,  G01N33/15 ,  G01N2201/06113

摘要： Raman systems and methods use advantages offered by increased laser mobility/path length and photon migration to analyze diffusively scattering solids, including pharmaceuticals. A collimated laser excitation beam having a first diameter induces from a sample a backscattered collimated Raman collection beam with a second diameter. The collimated laser excitation beam and the collimated Raman collection beam form a counter-propagating collimated optical path, and the collimated laser excitation beam is preferably smaller in diameter than the diameter of the backscattered collimated Raman beam. The collection beam to a spectrograph for Raman analysis of the sample. A Raman calibration standard may be placed in the collimated optical path, and/or the sample may be supported in a reflective holder that may be at least partially spherical and/or may form part of a multi-well plate. The counter-propagating collimated optical path may be contained within a Raman microscope.