SI3840734T1 - Pelete z večplastno strukturo za zakasnelo sproščanje učinkovine v distalnem kolonu - Google Patents

Pelete z večplastno strukturo za zakasnelo sproščanje učinkovine v distalnem kolonu

Info

Publication number
SI3840734T1
SI3840734T1 SI201930318T SI201930318T SI3840734T1 SI 3840734 T1 SI3840734 T1 SI 3840734T1 SI 201930318 T SI201930318 T SI 201930318T SI 201930318 T SI201930318 T SI 201930318T SI 3840734 T1 SI3840734 T1 SI 3840734T1
Authority
SI
Slovenia
Prior art keywords
pellets
drug
multilayer structure
delayed release
distal colon
Prior art date
Application number
SI201930318T
Other languages
English (en)
Inventor
Rudolph Wilhelm
Markus Prols
Roland Greinwald
Tanju Nacak
Ansgar Bogershausen
Original Assignee
Dr. Falk Pharma Gmbh
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 Dr. Falk Pharma Gmbh filed Critical Dr. Falk Pharma Gmbh
Publication of SI3840734T1 publication Critical patent/SI3840734T1/sl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009Sachets, pouches characterised by the material or function of the envelope
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
SI201930318T 2018-08-24 2019-08-22 Pelete z večplastno strukturo za zakasnelo sproščanje učinkovine v distalnem kolonu SI3840734T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18190638.9A EP3613414A1 (de) 2018-08-24 2018-08-24 Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon
PCT/EP2019/072429 WO2020039017A1 (de) 2018-08-24 2019-08-22 Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon
EP19765417.1A EP3840734B1 (de) 2018-08-24 2019-08-22 Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon

Publications (1)

Publication Number Publication Date
SI3840734T1 true SI3840734T1 (sl) 2022-10-28

Family

ID=63405023

Family Applications (1)

Application Number Title Priority Date Filing Date
SI201930318T SI3840734T1 (sl) 2018-08-24 2019-08-22 Pelete z večplastno strukturo za zakasnelo sproščanje učinkovine v distalnem kolonu

Country Status (20)

Country Link
US (1) US11173121B2 (sl)
EP (2) EP3613414A1 (sl)
JP (1) JP7374992B2 (sl)
CN (1) CN112512513A (sl)
AU (1) AU2019326752A1 (sl)
CA (1) CA3108257A1 (sl)
DK (1) DK3840734T3 (sl)
EA (1) EA202190565A1 (sl)
ES (1) ES2927000T3 (sl)
HR (1) HRP20221162T1 (sl)
HU (1) HUE060169T2 (sl)
IL (1) IL279825B2 (sl)
LT (1) LT3840734T (sl)
PL (1) PL3840734T3 (sl)
PT (1) PT3840734T (sl)
RS (1) RS63628B1 (sl)
SI (1) SI3840734T1 (sl)
UA (1) UA127521C2 (sl)
WO (1) WO2020039017A1 (sl)
ZA (1) ZA202100512B (sl)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4382099A1 (en) 2022-12-05 2024-06-12 ADD Advanced Drug Delivery Technologies, Ltd. Drug loaded modified release pellets

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5643602A (en) * 1989-11-22 1997-07-01 Astra Aktiebolag Oral composition for the treatment of inflammatory bowel disease
SE8903914D0 (sv) 1989-11-22 1989-11-22 Draco Ab Oral composition for the treatment of inflammatory bowel diseases
DE4332394A1 (de) 1993-09-23 1995-03-30 Falk Pharma Gmbh Budesonid-Pellets mit kontrolliertem Freigabeprofil und Verfahren zu ihrer Herstellung
DE4340057A1 (de) * 1993-11-24 1995-06-01 Falk Pharma Gmbh Budesonid-Arzneimittel zur Verbesserung der enteralen Flüssigkeitsresorption, insbesondere nach postoperativen Zuständen
RU2246293C2 (ru) 1999-06-14 2005-02-20 Космо С.П.А. Фармацевтические композиции для перорального введения с регулируемым высвобождением активного ингредиента и маскируемым вкусом
DE50013843D1 (de) 2000-08-29 2007-01-18 Mepha Ag Arzneimittel zur behandlung von darmerkrankungen
NZ532564A (en) 2001-11-23 2006-06-30 Procter & Gamble Solid unit dosage forms for oral administration which minimise the impact of coating fractures especially for larger or heavier dosage forms
DE10214002A1 (de) * 2002-03-27 2003-10-09 Roehm Gmbh Pharmazeutische Formulierung für den Wirkstoff Budesonid
DE10250543A1 (de) * 2002-10-29 2004-05-19 Röhm GmbH & Co. KG Mehrschichtige Arzneiform
EP1607087A1 (en) * 2003-03-27 2005-12-21 Hisamitsu Pharmaceutical Co., Inc. Medicinal oral preparations for colon delivery, medicinal oral preparations for treating colon cancer and medicinal oral preparations for treating colitis
CA2538202C (en) 2003-09-15 2013-01-15 Altana Pharma Ag Use of ciclesonide for the treatment of inflammatory bowel diseases
CN101108171A (zh) * 2006-07-17 2008-01-23 复旦大学 一种布地奈德肠溶缓释微丸及其制备方法
JPWO2008117814A1 (ja) 2007-03-26 2010-07-15 帝國製薬株式会社 大腸送達用経口製剤
GB0808537D0 (en) 2008-05-12 2008-06-18 Archimedes Dev Ltd Compositions
CN103705481B (zh) 2013-11-15 2017-10-20 中国药科大学 一种萘普生结肠定位释药微丸及其制备方法
EP3346996A4 (en) * 2015-09-11 2019-04-17 Sun Pharmaceutical Industries Limited ORAL PHARMACEUTICAL PHARMACEUTICAL FORM OF BUDESONID
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

Also Published As

Publication number Publication date
EP3840734B1 (de) 2022-07-20
EP3840734A1 (de) 2021-06-30
HUE060169T2 (hu) 2023-02-28
CN112512513A (zh) 2021-03-16
WO2020039017A1 (de) 2020-02-27
IL279825B1 (en) 2023-12-01
JP7374992B2 (ja) 2023-11-07
ZA202100512B (en) 2022-02-23
IL279825A (en) 2021-03-01
EA202190565A1 (ru) 2021-06-01
IL279825B2 (en) 2024-04-01
AU2019326752A1 (en) 2021-01-28
US20210228487A1 (en) 2021-07-29
EP3613414A1 (de) 2020-02-26
DK3840734T3 (da) 2022-09-26
US11173121B2 (en) 2021-11-16
UA127521C2 (uk) 2023-09-20
PL3840734T3 (pl) 2022-12-19
ES2927000T3 (es) 2022-10-31
LT3840734T (lt) 2022-10-25
RS63628B1 (sr) 2022-10-31
JP2022503581A (ja) 2022-01-12
CA3108257A1 (en) 2020-02-27
HRP20221162T1 (hr) 2022-11-25
PT3840734T (pt) 2022-09-19

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