JP2018536007A - 胃保持性装置 - Google Patents

胃保持性装置 Download PDF

Info

Publication number
JP2018536007A
JP2018536007A JP2018529014A JP2018529014A JP2018536007A JP 2018536007 A JP2018536007 A JP 2018536007A JP 2018529014 A JP2018529014 A JP 2018529014A JP 2018529014 A JP2018529014 A JP 2018529014A JP 2018536007 A JP2018536007 A JP 2018536007A
Authority
JP
Japan
Prior art keywords
hours
subject
enteric polymer
gastric
hpmcas
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2018529014A
Other languages
English (en)
Japanese (ja)
Other versions
JP2018536007A5 (enExample
Inventor
ザリット、イラン
メナケム、アヴシャロム ベン
メナケム、アヴシャロム ベン
Original Assignee
クレキシオ バイオサイエンシーズ エルティーディー.
クレキシオ バイオサイエンシーズ エルティーディー.
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 クレキシオ バイオサイエンシーズ エルティーディー., クレキシオ バイオサイエンシーズ エルティーディー. filed Critical クレキシオ バイオサイエンシーズ エルティーディー.
Publication of JP2018536007A publication Critical patent/JP2018536007A/ja
Publication of JP2018536007A5 publication Critical patent/JP2018536007A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833Encapsulating processes; Filling of capsules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/0001Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor characterised by the choice of material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2207/00Methods of manufacture, assembly or production
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1053Stomach
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2001/00Use of cellulose, modified cellulose or cellulose derivatives, e.g. viscose, as moulding material
    • B29K2001/08Cellulose derivatives
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0005Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
    • B29K2105/0035Medical or pharmaceutical agents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0005Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
    • B29K2105/0038Plasticisers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0094Condition, form or state of moulded material or of the material to be shaped having particular viscosity

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Hematology (AREA)
  • Physiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Manufacturing & Machinery (AREA)
  • Medicinal Preparation (AREA)
JP2018529014A 2015-12-01 2016-12-01 胃保持性装置 Pending JP2018536007A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562261752P 2015-12-01 2015-12-01
US62/261,752 2015-12-01
PCT/US2016/064439 WO2017096054A1 (en) 2015-12-01 2016-12-01 Gastric retentive devices

Publications (2)

Publication Number Publication Date
JP2018536007A true JP2018536007A (ja) 2018-12-06
JP2018536007A5 JP2018536007A5 (enExample) 2019-12-26

Family

ID=57681728

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2018529014A Pending JP2018536007A (ja) 2015-12-01 2016-12-01 胃保持性装置

Country Status (8)

Country Link
US (2) US11147766B2 (enExample)
EP (1) EP3383365A1 (enExample)
JP (1) JP2018536007A (enExample)
CN (1) CN108601724A (enExample)
AU (1) AU2016365321A1 (enExample)
CA (1) CA3006999A1 (enExample)
IL (1) IL259584A (enExample)
WO (1) WO2017096054A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106535878B (zh) * 2014-06-02 2022-11-01 科莱西奥生物科技有限公司 可张开的胃内滞留剂型
CN118975972A (zh) 2015-10-23 2024-11-19 林德拉治疗公司 用于治疗剂缓释的胃驻留系统及其使用方法
EP3383365A1 (en) * 2015-12-01 2018-10-10 Clexio Biosciences Ltd. Gastric retentive devices
BR112018011636B1 (pt) 2015-12-08 2024-03-12 Lyndra Therapeutics, Inc Sistema de residência gástrico para liberação sustentada de um agente terapêutico
CN119925721A (zh) 2016-05-27 2025-05-06 林德拉治疗公司 用于胃驻留系统的材料结构
CN110022861B (zh) 2016-09-30 2024-06-28 林德拉治疗公司 用于金刚烷类药物缓释的胃驻留系统
AU2018279853B2 (en) 2017-06-09 2024-07-04 Lyndra Therapeutics, Inc. Gastric residence systems with release rate-modulating films
WO2020230089A1 (en) 2019-05-14 2020-11-19 Clexio Biosciences Ltd. Treatment of nocturnal symptoms and morning akinesia in subjects with parkinson's disease
WO2022195476A1 (en) 2021-03-15 2022-09-22 Clexio Biosciences Ltd. Gastroretentive devices for assessment of intragastric conditions
IL320492A (en) 2022-10-25 2025-06-01 Veradermics Incorporated Compositions and methods of use for modified release minoxidil

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0229268A (ja) * 1988-05-31 1990-01-31 Pfizer Inc 薬剤徐放のための胃内停滞システム
WO2007010847A1 (ja) * 2005-07-15 2007-01-25 Kissei Pharmaceutical Co., Ltd. 徐放製剤
JP2012500230A (ja) * 2008-08-18 2012-01-05 北京天衡▲薬▼物研究院 胃内滞留薬物放出システム及びその製造方法と使用

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU449029B2 (en) 1969-08-28 1974-04-17 Commonwealth Scientific And Industrial Research Organisation Device for administration to ruminants
US4735804A (en) 1985-05-10 1988-04-05 Merck & Co., Inc. Drug delivery device which can be retained in the stomach for a controlled period of time
US4767627A (en) 1985-05-29 1988-08-30 Merck & Co., Inc. Drug delivery device which can be retained in the stomach for a controlled period of time
IL133196A0 (en) * 1999-11-29 2001-03-19 Yissum Res Dev Co Gastroretentive controlled release pharmaceutical dosage forms
EP1945189A4 (en) * 2005-11-03 2012-08-15 Sun Pharmaceutical Ind Ltd CONTROLLED RELEASE COATED TABLETS CHARACTERIZED BY PROLONGED GASTRIC RETENTION
US8298574B2 (en) 2006-01-18 2012-10-30 Intec Pharma Ltd. Method and apparatus for forming delivery devices for oral intake of an agent
ES2606395T3 (es) * 2008-04-18 2017-03-23 Intec Pharma Ltd. Administración de fármacos gastrorretentivos para carbidopa/levodopa
US20110066175A1 (en) * 2009-05-07 2011-03-17 Rainbow Medical Ltd. Gastric anchor
CN106535878B (zh) * 2014-06-02 2022-11-01 科莱西奥生物科技有限公司 可张开的胃内滞留剂型
JP6666858B2 (ja) * 2014-06-11 2020-03-18 マサチューセッツ インスティテュート オブ テクノロジー 滞留構造体および関連方法
EP3383365A1 (en) * 2015-12-01 2018-10-10 Clexio Biosciences Ltd. Gastric retentive devices
JP2018537201A (ja) * 2015-12-02 2018-12-20 クレキシオ バイオサイエンシーズ エルティーディー. 胃保持型投与形態を調整する装置および方法
IL266377B2 (en) * 2016-12-02 2023-10-01 Clexio Biosciences Ltd Gastric residence system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0229268A (ja) * 1988-05-31 1990-01-31 Pfizer Inc 薬剤徐放のための胃内停滞システム
WO2007010847A1 (ja) * 2005-07-15 2007-01-25 Kissei Pharmaceutical Co., Ltd. 徐放製剤
JP2012500230A (ja) * 2008-08-18 2012-01-05 北京天衡▲薬▼物研究院 胃内滞留薬物放出システム及びその製造方法と使用

Also Published As

Publication number Publication date
AU2016365321A1 (en) 2018-06-21
WO2017096054A1 (en) 2017-06-08
EP3383365A1 (en) 2018-10-10
CA3006999A1 (en) 2017-06-08
US20220008334A1 (en) 2022-01-13
WO2017096054A9 (en) 2017-09-08
US20180369138A1 (en) 2018-12-27
US11147766B2 (en) 2021-10-19
CN108601724A (zh) 2018-09-28
IL259584A (en) 2018-07-31

Similar Documents

Publication Publication Date Title
US20220008334A1 (en) Gastric retentive devices
US20230080008A1 (en) Gastric residence system
US11648198B2 (en) Expandable gastroretentive dosage form
US11964120B2 (en) Long acting gastric residence system
JP4533531B2 (ja) 制御放出組成物
US9314430B2 (en) Floating gastric retentive dosage form
HK1186095B (en) Dosage form
HK1186095A (en) Dosage form

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20191115

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20191115

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20200929

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20210427