EA202191597A1 - Лекарственный препарат с отсроченным высвобождением, содержащий внешний слой с ферментативно разлагаемым полимером, его состав и способ его получения - Google Patents

Лекарственный препарат с отсроченным высвобождением, содержащий внешний слой с ферментативно разлагаемым полимером, его состав и способ его получения

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Publication number
EA202191597A1
EA202191597A1 EA202191597A EA202191597A EA202191597A1 EA 202191597 A1 EA202191597 A1 EA 202191597A1 EA 202191597 A EA202191597 A EA 202191597A EA 202191597 A EA202191597 A EA 202191597A EA 202191597 A1 EA202191597 A1 EA 202191597A1
Authority
EA
Eurasian Patent Office
Prior art keywords
preparation
delayed release
degradable polymer
core
composition
Prior art date
Application number
EA202191597A
Other languages
English (en)
Inventor
Фелипе Варум
Летиция Фон Рохов
Карстен Маркус Фюллер
Роберто Карлос Браво Гонсалес
Original Assignee
Тиллоттс Фарма АГ
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 Тиллоттс Фарма АГ filed Critical Тиллоттс Фарма АГ
Publication of EA202191597A1 publication Critical patent/EA202191597A1/ru

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • A61K31/606Salicylic acid; Derivatives thereof having amino groups
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/4816Wall or shell material
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Способ получения ядра с покрытием для лекарственного препарата с отсроченным высвобождением для перорального введения для доставки лекарственного средства в толстую кишку. Способ включает формирование ядра, содержащего лекарственное средство. Препарат для внешнего слоя покрытия получают путем смешивания первого водного препарата ферментативно разлагаемого полимера, который разлагается бактериальными ферментами толстой кишки; второго водного препарата пленкообразующего энтеросолюбильного полимера, имеющего пороговое значение pH примерно 6 или выше; и органического агента, препятствующего прилипанию. Затем ядро покрывают препаратом для внешнего слоя покрытия с формированием ядра с внешним слоем покрытия.
EA202191597A 2018-12-07 2019-12-05 Лекарственный препарат с отсроченным высвобождением, содержащий внешний слой с ферментативно разлагаемым полимером, его состав и способ его получения EA202191597A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18211152.6A EP3662901A1 (en) 2018-12-07 2018-12-07 Delayed release drug formulation comprising an outerlayer with an enzymaticyaaly degradable polymer, its composition and its method of manufacturing
PCT/EP2019/083910 WO2020115255A1 (en) 2018-12-07 2019-12-05 Delayed release drug formulation comprising an outerlayer with an enzymaticyally degradable polymer, its composition and its method of manufacturing

Publications (1)

Publication Number Publication Date
EA202191597A1 true EA202191597A1 (ru) 2021-08-30

Family

ID=64661233

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202191597A EA202191597A1 (ru) 2018-12-07 2019-12-05 Лекарственный препарат с отсроченным высвобождением, содержащий внешний слой с ферментативно разлагаемым полимером, его состав и способ его получения

Country Status (22)

Country Link
US (1) US20220023222A1 (ru)
EP (2) EP3662901A1 (ru)
JP (1) JP7391966B2 (ru)
KR (1) KR20210100663A (ru)
CN (1) CN113226292A (ru)
AR (1) AR117681A1 (ru)
AU (1) AU2019392854A1 (ru)
BR (1) BR112021010914A2 (ru)
CA (1) CA3122013A1 (ru)
CL (1) CL2021001472A1 (ru)
CO (1) CO2021008683A2 (ru)
CR (1) CR20210366A (ru)
EA (1) EA202191597A1 (ru)
GE (1) GEP20247608B (ru)
IL (1) IL283718A (ru)
JO (1) JOP20210136A1 (ru)
MA (1) MA54374A (ru)
MX (1) MX2021006603A (ru)
SG (1) SG11202105691RA (ru)
TW (1) TW202038968A (ru)
WO (1) WO2020115255A1 (ru)
ZA (1) ZA202103676B (ru)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024006539A1 (en) * 2022-07-01 2024-01-04 Vitakey Inc. Nutraceutical particles

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GB8812490D0 (en) 1988-05-26 1988-06-29 Agricultural & Food Res Delayed release formulations
GB8926639D0 (en) 1989-11-24 1990-01-17 Agricultural & Food Res Delayed release formulations
US5422121A (en) 1990-11-14 1995-06-06 Rohm Gmbh Oral dosage unit form
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FI20000780A (fi) 2000-04-03 2001-10-04 Novasso Oy Peroraalinen lääkemuoto lääkeaineen hallituksi vapauttamiseksi
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GB0203421D0 (en) 2002-02-13 2002-04-03 Alizyme Therapeutics Ltd Composition
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DE102005032806A1 (de) 2005-07-12 2007-01-18 Röhm Gmbh Verwendung eines teilneutralisierten, anionischen (Meth)acrylat-Copolymers als Überzug für die Herstellung einer Arzneiform mit einer Wirkstofffreisetzung bei erniedrigten pH-Werten
GB0607534D0 (en) * 2006-04-13 2006-05-24 Univ London Pharmacy Colonic drug delivery formulation
AU2012247013B2 (en) * 2006-04-13 2016-01-14 University College London Colonic drug delivery formulation
SI2152250T1 (sl) 2007-05-07 2020-06-30 Evonik Operations Gmbh Trdne dozirne oblike, ki vsebujejo enterično oplaščenje s pospešenim sproščanjem zdravila
RU2486917C2 (ru) * 2008-02-19 2013-07-10 МакНЕЙЛ-ППС, ИНК. Композиции для нанесения покрытия способом погружения, включающие крахмал с высоким содержанием амилозы
EP2659881B1 (en) 2012-04-30 2017-11-29 Tillotts Pharma Ag A delayed release drug formulation
MA38847B2 (fr) * 2013-10-29 2021-02-26 Tillotts Pharma Ag Formulation médicamenteuse à libération retardée
CA3011565C (en) 2016-02-09 2024-01-02 Albireo Ab Oral cholestyramine formulation and use thereof
EP3257501A1 (en) 2016-06-14 2017-12-20 Tillotts Pharma AG Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material, and an enteric core coating
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Also Published As

Publication number Publication date
CN113226292A (zh) 2021-08-06
IL283718A (en) 2021-07-29
TW202038968A (zh) 2020-11-01
MX2021006603A (es) 2021-08-24
AR117681A1 (es) 2021-08-25
BR112021010914A2 (pt) 2021-08-24
KR20210100663A (ko) 2021-08-17
SG11202105691RA (en) 2021-06-29
WO2020115255A1 (en) 2020-06-11
EP3662901A1 (en) 2020-06-10
JP7391966B2 (ja) 2023-12-05
CA3122013A1 (en) 2020-06-11
JOP20210136A1 (ar) 2023-01-30
CR20210366A (es) 2021-11-23
GEP20247608B (en) 2024-03-11
JP2022511119A (ja) 2022-01-28
CO2021008683A2 (es) 2021-08-19
CL2021001472A1 (es) 2021-12-24
US20220023222A1 (en) 2022-01-27
EP3890710A1 (en) 2021-10-13
ZA202103676B (en) 2022-10-26
AU2019392854A1 (en) 2021-07-08
MA54374A (fr) 2022-03-16

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