EA033537B1 - Инъекционная композиция с контролируемым высвобождением, содержащая жидкий носитель с высокой вязкостью - Google Patents

Инъекционная композиция с контролируемым высвобождением, содержащая жидкий носитель с высокой вязкостью

Info

Publication number
EA033537B1
EA033537B1 EA201591560A EA201591560A EA033537B1 EA 033537 B1 EA033537 B1 EA 033537B1 EA 201591560 A EA201591560 A EA 201591560A EA 201591560 A EA201591560 A EA 201591560A EA 033537 B1 EA033537 B1 EA 033537B1
Authority
EA
Eurasian Patent Office
Prior art keywords
lactic acid
composition
poly
glycolic acid
acid
Prior art date
Application number
EA201591560A
Other languages
English (en)
Other versions
EA201591560A1 (ru
Inventor
Jeremy C Wright
Wilma Tamraz
John J Leonard
John W Gibson
Keith E Branham
Stefania Sjobeck
Brooks Boyd
Christopher M Rubino
Original Assignee
Durect Corp
Zogenix Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Durect Corp, Zogenix Inc filed Critical Durect Corp
Publication of EA201591560A1 publication Critical patent/EA201591560A1/ru
Publication of EA033537B1 publication Critical patent/EA033537B1/ru

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2046—Media being expelled from injector by gas generation, e.g. explosive charge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated

Abstract

Предлагается композиция, представляющая собой раствор или суспензию, для доставки лекарственного средства, содержащая фармацевтический активный агент, содержащий по меньшей мере один агент, выбранный из пептида, белка и молекулы небольшого размера, от 25 до 80 мас.%, в пересчете на общую массу композиции, сахарозы ацетата изобутирата, полимер на основе молочной кислоты, который представляет собой поли(молочную кислоту)(гликолевую кислоту), содержащую концевую алкоксигруппу. Молярное соотношение молочной кислоты к гликолевой кислоте в поли(молочной кислоте)(гликолевой кислоте) варьирует от 95:5 до 60:40, а средневзвешенная молекулярная масса поли(молочной кислоты)(гликолевой кислоты) варьирует в диапазоне от 4000 до 15000 Да. Композиция также содержит органический растворитель, выбранный из N-метилпирролидона, диметилсульфоксида и пропиленкарбоната. Соотношение массы сахарозы ацетата изобутирата, полимера на основе молочной кислоты и органического растворителя варьирует в пределах 1:0,066-1,3:0,3-1,7. Также предлагается применение такой композиции, содержащей фармацевтический активный агент против шизофрении, для производства лекарственного средства для лечения шизофрении и/или биполярного расстройства.
EA201591560A 2013-03-11 2014-03-11 Инъекционная композиция с контролируемым высвобождением, содержащая жидкий носитель с высокой вязкостью EA033537B1 (ru)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361776336P 2013-03-11 2013-03-11
US201361798874P 2013-03-15 2013-03-15
US201361824827P 2013-05-17 2013-05-17
PCT/US2014/023397 WO2014164754A1 (en) 2013-03-11 2014-03-11 Injectable controlled release composition comprising high viscosity liquid carrier

Publications (2)

Publication Number Publication Date
EA201591560A1 EA201591560A1 (ru) 2016-07-29
EA033537B1 true EA033537B1 (ru) 2019-10-31

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EA201591560A EA033537B1 (ru) 2013-03-11 2014-03-11 Инъекционная композиция с контролируемым высвобождением, содержащая жидкий носитель с высокой вязкостью

Country Status (10)

Country Link
US (5) US9737605B2 (ru)
EP (1) EP2986278A1 (ru)
JP (2) JP2016512523A (ru)
CN (3) CN109602692B (ru)
AU (2) AU2014249008B2 (ru)
BR (1) BR112015022023B1 (ru)
CA (1) CA2903769A1 (ru)
EA (1) EA033537B1 (ru)
HK (1) HK1220628A1 (ru)
WO (1) WO2014164754A1 (ru)

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CN109602692B (zh) 2013-03-11 2022-11-04 度瑞公司 包含高粘度液体载体的可注射控制释放组合物
WO2015088990A1 (en) 2013-12-09 2015-06-18 Durect Corporation Pharmaceutically active agent complexes, polymer complexes, and compositions and methods involving the same
CN104007070B (zh) * 2014-06-19 2015-04-15 中国石油大学(华东) 用于矿物样品检测的自动观测装置
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