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AR109898A1 - Perlas multicapa para uso farmacéutico - Google Patents

Perlas multicapa para uso farmacéutico

Info

Publication number
AR109898A1
AR109898A1 ARP170102802A ARP170102802A AR109898A1 AR 109898 A1 AR109898 A1 AR 109898A1 AR P170102802 A ARP170102802 A AR P170102802A AR P170102802 A ARP170102802 A AR P170102802A AR 109898 A1 AR109898 A1 AR 109898A1
Authority
AR
Argentina
Prior art keywords
drug
polymer
layer
hept
difluoro
Prior art date
Application number
ARP170102802A
Other languages
English (en)
Original Assignee
Sucampo Ag
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 Sucampo Ag filed Critical Sucampo Ag
Publication of AR109898A1 publication Critical patent/AR109898A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • A61K31/558Eicosanoids, e.g. leukotrienes or prostaglandins having heterocyclic rings containing oxygen as the only ring hetero atom, e.g. thromboxanes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10Laxatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Se divulgan perlas multicapa para uso farmacéutico que tienen una capa de fármaco en polímero. Las perlas multicapa divulgadas para uso farmacéutico tienen (a) una partícula de núcleo; (b) una capa de barrera opcional que recubre la superficie de la partícula de núcleo; (c) una capa de fármaco en polímero que recubre la superficie del núcleo o la capa de barrera, (d) una capa selladora opcional que recubre la superficie de la capa de fármaco en polímero; y (e) opcionalmente una o más capas exteriores externas a la capa de fármaco en polímero o la capa selladora. La capa de fármaco en polímero consiste esencialmente en (i) un fármaco seleccionado del grupo que consiste en un fármaco de 15-ceto prostaglandina, un fármaco de 13,14-dihidro prostaglandina, y un fármaco de 13,14-dihidro-15-ceto prostaglandina; y (ii) un polímero seleccionado del grupo que consiste en polivinilpirrolidona, copolímero de vinilpirrolidona-vinilacetato o una de sus mezclas. La capa de fármaco en polímero puede ser una dispersión sólida del fármaco en el polímero. Se divulgan además composiciones farmacéuticas que comprenden una pluralidad de perlas multicapa y un excipiente farmacéuticamente aceptable y métodos de tratamiento de un trastorno gastrointestinal. Reivindicación 2: Una perla multicapa de la reivindicación 1, donde el fármaco es seleccionado del grupo que consiste en: ácido (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluorpentil)-2-hidroxi-6-oxooctahidrociclopenta[b]piran-5-il]heptanoico (lubiprostona); ácido (-)-7-{(2R,4aR,5R,7aR)-2-[(3S)-1,1-difluoro-3-metilpentil]-2-hidroxi-6-oxooctahidrociclopenta[b]piran-5-il}heptanoico (cobiprostona); (+)-isopropil (Z)-7-[(1R,2R,3R,5S)-3,5-dihidroxi-2-(3-oxodecil)ciclopentil]hept-5-enoato, (isopropil unoprostona); ácido (Z)-7-[(1R,2R,3R,5S)-3,5-dihidroxi-2-(3-oxodecil)ciclopentil]hept-5-enoico; ácido (-)-7-[(1R,2R)-2-(4,4-difluoro-3-oxooctil)-5-oxociclopentil]heptanoico; y ácido (E)-7-[(1R,2R)-2-(4,4-difluoro-3-oxooctil)-5-oxociclopentil]hept-2-enoico.
ARP170102802A 2016-10-06 2017-10-06 Perlas multicapa para uso farmacéutico AR109898A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201662405131P 2016-10-06 2016-10-06

Publications (1)

Publication Number Publication Date
AR109898A1 true AR109898A1 (es) 2019-02-06

Family

ID=60543581

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170102802A AR109898A1 (es) 2016-10-06 2017-10-06 Perlas multicapa para uso farmacéutico

Country Status (5)

Country Link
US (1) US11534404B2 (es)
JP (1) JP6957610B2 (es)
AR (1) AR109898A1 (es)
TW (1) TW201815383A (es)
WO (1) WO2018065826A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11534404B2 (en) 2016-10-06 2022-12-27 Sucampo Ag Multilayer beads for pharmaceutical use
MX392727B (es) * 2016-12-09 2025-03-24 Bayer Animal Health Gmbh Preparación framaceútica de estructura multicapa y método para su fabricación
JPWO2019221215A1 (ja) * 2018-05-18 2021-05-27 ニプロ株式会社 ルビプロストン含有粒子状医薬組成物
CN109701461B (zh) * 2018-10-25 2021-06-08 西南交通大学 一种基于PEG/Dex双水相的碳酸钙/海藻酸钙复合微囊的制备及其应用
JP2020075874A (ja) * 2018-11-06 2020-05-21 ニプロ株式会社 ルビプロストン含有フィルム状医薬組成物
WO2020180690A1 (en) * 2019-03-01 2020-09-10 Avadel Legacy Pharmaceuticals, Llc Liquid pharmaceutical compositions with stable drug release profiles
JP7518661B2 (ja) * 2020-05-14 2024-07-18 沢井製薬株式会社 ルビプロストン含有整粒物、ルビプロストン含有錠剤およびそれらの製造方法

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JPS5942313A (ja) * 1982-09-01 1984-03-08 Teijin Ltd ポリビニルポリピロリドンを用いた製剤
JPS6377821A (ja) * 1986-09-19 1988-04-08 Teikoku Seiyaku Kk 安定なプロスタグランジンe組成物
US5317032A (en) 1987-10-02 1994-05-31 Kabushiki Kaisha Ueno Seiyaku Oyo Kenkyujo Prostaglandin cathartic
DK0503887T3 (da) * 1991-03-14 1996-09-16 R Tech Ueno Ltd Fremme af sårheling med 15-ketoprostaglandinforbindelser
PT1426361E (pt) 1999-10-15 2008-10-08 Sucampo Ag Nova composição contendo um composto bicíclico e um glicérido
DE19962544A1 (de) 1999-12-23 2001-07-19 Degussa Verfahren zum Beschichten eines keramischen Wabenkörpers
AU4472701A (en) * 2000-04-06 2001-10-23 Sucampo Ag Bile secretion promoting composition
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TWI302100B (en) 2001-05-02 2008-10-21 Sucampo Ag Composition for treating drug-induced constipation
BR0209863A (pt) 2001-05-18 2004-06-08 Sucampo Ag Composição catártica
EP1420794B1 (en) 2001-08-31 2017-12-27 Sucampo AG Prostaglandin analogs as chloride channel openers
JP2005139085A (ja) * 2003-11-04 2005-06-02 Ono Pharmaceut Co Ltd 顆粒
EP1863453A2 (en) * 2005-03-29 2007-12-12 Evonik Röhm GmbH Multiparticulate pharmaceutical form comprising pellets with a substance having a modular effect in relation to active ingredient release
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US11534404B2 (en) 2016-10-06 2022-12-27 Sucampo Ag Multilayer beads for pharmaceutical use

Also Published As

Publication number Publication date
TW201815383A (zh) 2018-05-01
US20200390708A1 (en) 2020-12-17
JP2019529467A (ja) 2019-10-17
US11534404B2 (en) 2022-12-27
JP6957610B2 (ja) 2021-11-02
WO2018065826A1 (en) 2018-04-12

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