JP6855469B2 - 消化器標的療法のための処方物を調製するための工程 - Google Patents

消化器標的療法のための処方物を調製するための工程 Download PDF

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Publication number
JP6855469B2
JP6855469B2 JP2018519006A JP2018519006A JP6855469B2 JP 6855469 B2 JP6855469 B2 JP 6855469B2 JP 2018519006 A JP2018519006 A JP 2018519006A JP 2018519006 A JP2018519006 A JP 2018519006A JP 6855469 B2 JP6855469 B2 JP 6855469B2
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Prior art keywords
lyosphere
coating
enteric
therapeutic agent
sugar
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JP2018519006A
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Japanese (ja)
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JP2018534280A5 (enExample
JP2018534280A (ja
Inventor
バームバーニ，アクヒレシュ
エヴァンス，ロバート・ケイ
グプタ，プラナフ
スミス，ロナルド・エル
ウィリアムズ，ドナ・エム
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Merck Sharp & Dohme LLC
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Merck Sharp & Dohme LLC
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    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2018519006A 2015-10-16 2016-10-11 消化器標的療法のための処方物を調製するための工程 Active JP6855469B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562242718P 2015-10-16 2015-10-16
US62/242,718 2015-10-16
PCT/US2016/056322 WO2017066134A1 (en) 2015-10-16 2016-10-11 Processes for preparing formulations for gastrointestinal-targeted therapies

Publications (3)

Publication Number Publication Date
JP2018534280A JP2018534280A (ja) 2018-11-22
JP2018534280A5 JP2018534280A5 (enExample) 2019-11-14
JP6855469B2 true JP6855469B2 (ja) 2021-04-07

Family

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Family Applications (1)

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JP2018519006A Active JP6855469B2 (ja) 2015-10-16 2016-10-11 消化器標的療法のための処方物を調製するための工程

Country Status (4)

Country Link
US (1) US10617650B2 (enExample)
EP (1) EP3362052B1 (enExample)
JP (1) JP6855469B2 (enExample)
WO (1) WO2017066134A1 (enExample)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020525436A (ja) * 2017-06-21 2020-08-27 ミネルバ・ニューロサイエンシズ・インコーポレイテッド 胃耐性制御放出経口剤形
EP3503041B1 (en) 2017-12-24 2025-11-12 Dassault Systèmes Design of a 3d finite element mesh of a 3d part that comprises a lattice structure
CN112587507A (zh) * 2018-02-14 2021-04-02 浙江万方生物科技有限公司 用于掩味缓释替米考星预混剂的制备方法
EP3801469A4 (en) * 2018-06-07 2022-03-09 Merck Sharp & Dohme Corp. CRITICAL LYOSPHERE REAGENTS KIT
CN108904795B (zh) * 2018-08-29 2022-07-05 温氏食品集团股份有限公司 一种猪流行性腹泻病毒的口服疫苗的制备方法
CN110101678B (zh) * 2019-04-26 2021-04-30 安阳天助药业有限责任公司 改良的含硬脂酸镁的包衣预混剂及制作方法
CN109925294A (zh) * 2019-04-26 2019-06-25 安阳天助药业有限责任公司 一种软胶囊防渗包衣预混剂
AU2020407163A1 (en) 2019-12-16 2022-07-21 Minute Molecular Diagnostics, Inc. Lyophilized reagents
LT4243797T (lt) 2020-11-16 2026-06-10 Orcosa Inc. Greitos infuzijos platforma ir kompozicijos, skirtos žmonių terapiniam gydymui
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
US20260207509A1 (en) * 2022-12-15 2026-07-23 Merck Sharp & Dohme Llc Lyospheres containing programmed death receptor 1 (pd-1) antibodies and methods of use thereof

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NL295570A (enExample) * 1962-07-20
US3655838A (en) 1969-03-20 1972-04-11 Organon Method of pelletizing analytical or immunological reagents
US3767790A (en) 1972-02-11 1973-10-23 Nat Patent Dev Corp Microorganisms
US3860490A (en) 1972-02-11 1975-01-14 Nat Patent Dev Corp Process of subjecting a microorganism susceptible material to a microorganism
US4397844A (en) 1978-02-24 1983-08-09 Ciba-Geigy Corporation Antigen derivatives and processes for their preparation
US4377568A (en) 1981-08-12 1983-03-22 Merck Sharp & Dohme (I.A.) Corp. Preparation of aqueous alcoholic dispersions of pH sensitive polymers and plasticizing agents and a method of enteric coating dosage forms using same
IL78775A (en) 1985-05-15 1992-06-21 Biotech Australia Pty Ltd Oral vaccines
JP3249147B2 (ja) * 1990-06-01 2002-01-21 キリン−アムジエン・インコーポレーテツド 生理活性蛋白含有経口製剤
EP0695171B1 (en) * 1993-04-28 1996-12-18 Akzo Nobel N.V. Lyospheres comprising gonadotropin
JP2002514886A (ja) * 1994-10-24 2002-05-21 プロメガ コーポレーション クロストリジウム・ディフィシル疾患の治療及び予防のためのワクチン及び抗トキシン
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IL120202A (en) * 1996-03-07 2001-03-19 Akzo Nobel Nv Container with freeze-dried vaccine components
US6139875A (en) 1998-09-29 2000-10-31 Eastman Chemical Company Aqueous enteric coating composition and low gastric permeability enteric coating
KR20060115350A (ko) * 2003-09-02 2006-11-08 화이자 프로덕츠 인크. 지프라시돈의 지속 방출형 투여 형태
US20050233435A1 (en) * 2003-09-04 2005-10-20 Nyu Medical Center Plasmodium axenic liver stages as a noninfectious whole organism malaria vaccine
US7682796B2 (en) * 2003-09-12 2010-03-23 Kozel Thomas R Compositions and methods for detection, prevention, and treatment of anthrax and other infectious diseases
US20050165038A1 (en) * 2004-01-22 2005-07-28 Maxwell Gordon Analgetic dosage forms that are resistant to parenteral and inhalation dosing and have reduced side effects
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TWI471127B (zh) * 2009-04-29 2015-02-01 Intervet Int Bv 供人類使用之口服崩解錠劑的製備方法、所製得之口服崩解錠劑、以及含有該口服崩解錠劑的包裝物
EP2464341B1 (en) 2009-08-12 2022-07-06 Sublimity Therapeutics Limited Immunomodulatory compositions comprising a polymer matrix and an oil phase
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JP2014533240A (ja) * 2011-10-31 2014-12-11 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． 生物材料の凍結乾燥球形ペレットを調製する方法
US20140017318A1 (en) * 2012-07-10 2014-01-16 Kevin O'Connell Method to produce a medicinal product comprising a biologically active protein and the resulting product
US20160228371A1 (en) 2013-10-18 2016-08-11 Abbvie Inc. Stable solid units and methods of making the same

Also Published As

Publication number Publication date
US10617650B2 (en) 2020-04-14
EP3362052A1 (en) 2018-08-22
EP3362052A4 (en) 2019-06-19
WO2017066134A1 (en) 2017-04-20
US20180311172A1 (en) 2018-11-01
JP2018534280A (ja) 2018-11-22
EP3362052B1 (en) 2025-02-12

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