AR108729A1 - Forma farmacéutica de unidades múltiples que comprende un núcleo con unidades centrales individuales cubiertas por un material muco-adhesivo, y un recubrimiento de núcleo entérico - Google Patents

Forma farmacéutica de unidades múltiples que comprende un núcleo con unidades centrales individuales cubiertas por un material muco-adhesivo, y un recubrimiento de núcleo entérico

Info

Publication number
AR108729A1
AR108729A1 ARP170101621A ARP170101621A AR108729A1 AR 108729 A1 AR108729 A1 AR 108729A1 AR P170101621 A ARP170101621 A AR P170101621A AR P170101621 A ARP170101621 A AR P170101621A AR 108729 A1 AR108729 A1 AR 108729A1
Authority
AR
Argentina
Prior art keywords
core
unit
coating layer
multiple units
pharmaceutical
Prior art date
Application number
ARP170101621A
Other languages
English (en)
Inventor
Daniel Preisig
Gonzalez Roberto Carlos Bravo
Varum Felipe Jose Oliveira
Original Assignee
Tillotts Pharma 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 Tillotts Pharma Ag filed Critical Tillotts Pharma Ag
Publication of AR108729A1 publication Critical patent/AR108729A1/es

Links

Classifications

    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/167—Agglomerates; 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
    • A61K9/1676—Agglomerates; 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • 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
    • A61K9/14—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
    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Una forma farmacéutica de unidades múltiples que comprende un núcleo, donde el núcleo comprende una pluralidad de unidades individuales, donde cada unidad comprende un principio farmacéuticamente activo y cada unidad está cubierta con un material muco-adhesivo, y donde la forma farmacéutica de unidades múltiples comprende, además, una capa de recubrimiento del núcleo. Además, uso de dicha forma farmacéutica de unidades múltiples en el tratamiento de trastornos inflamatorios, en especial para el tracto gastrointestinal. Reivindicación 2: La forma farmacéutica de unidades múltiples de acuerdo con la reivindicación 1, caracterizada porque el recubrimiento del núcleo (b) comprende una capa de recubrimiento adicional (b2), donde dicha capa de recubrimiento adicional (b2) está comprendida entre el núcleo (a) y la capa de recubrimiento externa (b1), y donde dicha capa de recubrimiento adicional (b2) comprende un material polimérico que es soluble en el fluido intestinal o en el fluido gástrico y que se selecciona del grupo que consiste en un polímero del ácido policarboxílico que está al menos parcialmente neutralizado y un polímero no iónico, cada uno en combinación con al menos un aditivo seleccionado de un agente buffer y/o una base y mezclas de los anteriores. Reivindicación 4: La forma farmacéutica de unidades múltiples de acuerdo con cualquiera de las reivindicaciones que anteceden, caracterizada porque al menos un material muco-adhesivo (a2) comprende chitosán o alginato, preferentemente chitosán. Reivindicación 12: La forma farmacéutica unitaria múltiple de acuerdo con cualquiera de las reivindicaciones 1 a 11, caracterizada porque el principio activo para uso farmacéutico (a1) se selecciona de metronidazol, vancomicina, ácido 5-amino-salicílico, budesonida, y anti-TNF, y es preferentemente metronidazol.
ARP170101621A 2016-06-14 2017-06-14 Forma farmacéutica de unidades múltiples que comprende un núcleo con unidades centrales individuales cubiertas por un material muco-adhesivo, y un recubrimiento de núcleo entérico AR108729A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP16174466.9A EP3257501A1 (en) 2016-06-14 2016-06-14 Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material, and an enteric core coating

Publications (1)

Publication Number Publication Date
AR108729A1 true AR108729A1 (es) 2018-09-19

Family

ID=56131433

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170101621A AR108729A1 (es) 2016-06-14 2017-06-14 Forma farmacéutica de unidades múltiples que comprende un núcleo con unidades centrales individuales cubiertas por un material muco-adhesivo, y un recubrimiento de núcleo entérico

Country Status (9)

Country Link
US (1) US20190336449A1 (es)
EP (2) EP3257501A1 (es)
JP (1) JP2019518758A (es)
AR (1) AR108729A1 (es)
CA (1) CA3026840A1 (es)
MA (1) MA45240A (es)
TW (1) TW201742621A (es)
UY (1) UY37293A (es)
WO (1) WO2017216088A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108434109A (zh) * 2018-04-25 2018-08-24 首都医科大学附属北京儿童医院 微型巯嘌呤片、微型巯嘌呤肠溶缓释片、及其制备方法
EP3613414A1 (de) 2018-08-24 2020-02-26 Dr. Falk Pharma Gmbh Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon
CA3111353A1 (en) * 2018-09-06 2020-03-12 Fachhochschule Nordwestschweiz Controlled drug release formulation
CN112770730B (zh) * 2018-09-06 2024-02-13 瑞士西北应用科学与艺术大学 受控的药物释放制剂
EP3662901A1 (en) * 2018-12-07 2020-06-10 Tillotts Pharma AG Delayed release drug formulation comprising an outerlayer with an enzymaticyaaly degradable polymer, its composition and its method of manufacturing

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ZA825384B (en) 1981-07-31 1983-05-25 Tillott J B Ltd Orally administrable pharmaceutical compositions
US4627851A (en) 1984-10-26 1986-12-09 Alza Corporation Colonic-therapeutic delivery system
KR101486590B1 (ko) * 2006-01-05 2015-01-26 벨로시스 파마슈티컬스 에이/에스 붕해성의 충전형 정제
GB0607534D0 (en) 2006-04-13 2006-05-24 Univ London Pharmacy 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
GB0808537D0 (en) * 2008-05-12 2008-06-18 Archimedes Dev Ltd Compositions
EP2168572A1 (en) 2008-09-30 2010-03-31 Omya Development Ag New controlled release active agent carrier
DK2264108T3 (da) 2009-06-15 2012-05-29 Omya Development Ag Fremgangsmåde til fremstilling af et calciumcarbonat, der har reageret på overfladen, under anvendelse af en svag syre
NO2659881T3 (es) 2012-04-30 2018-04-28
AU2013404367B2 (en) 2013-10-29 2020-02-27 Tillotts Pharma Ag A delayed release drug formulation

Also Published As

Publication number Publication date
TW201742621A (zh) 2017-12-16
WO2017216088A1 (en) 2017-12-21
MA45240A (fr) 2019-04-17
JP2019518758A (ja) 2019-07-04
UY37293A (es) 2018-01-02
EP3257501A1 (en) 2017-12-20
US20190336449A1 (en) 2019-11-07
CA3026840A1 (en) 2017-12-21
EP3468538A1 (en) 2019-04-17

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