AR108231A1 - Composiciones farmacéuticas orales de mesalazina - Google Patents

Composiciones farmacéuticas orales de mesalazina

Info

Publication number
AR108231A1
AR108231A1 ARP170100993A ARP170100993A AR108231A1 AR 108231 A1 AR108231 A1 AR 108231A1 AR P170100993 A ARP170100993 A AR P170100993A AR P170100993 A ARP170100993 A AR P170100993A AR 108231 A1 AR108231 A1 AR 108231A1
Authority
AR
Argentina
Prior art keywords
delayed
mesalazine
release
tablets
mini
Prior art date
Application number
ARP170100993A
Other languages
English (en)
Inventor
Venkataramana Dingari
Alfred Chi Yeh Liang
Original Assignee
Ferring Bv
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 Ferring Bv filed Critical Ferring Bv
Publication of AR108231A1 publication Critical patent/AR108231A1/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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/606—Salicylic acid; Derivatives thereof having amino groups
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; 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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting 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
    • 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

Landscapes

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

Abstract

Composiciones farmacéuticas para la administración oral de mesalazina, métodos para preparar las composiciones farmacéuticas y métodos terapéuticos para usarlas. Las composiciones comprenden formulaciones de mesalazina de liberación demorada-inmediata y de liberación demorada-prolongada. Reivindicación 1: Un producto farmacéutico de dosis unitaria para la administración oral de nicotinamida a un sujeto, caracterizado porque comprende: (a) una pluralidad de minicomprimidos de liberación retardada-inmediata que comprenden una matriz comprimida que comprende mesalazina, provista de un recubrimiento entérico dependiente del pH, donde los minicomprimidos de liberación retardada-inmediata liberan mesalazina de manera selectiva en el íleon distal; y (b) una pluralidad de minicomprimidos de liberación retardada-extendida que comprenden una matriz comprimida que comprende mesalazina provista de un recubrimiento interior de liberación extendida independiente del pH y un recubrimiento entérico exterior dependiente del pH, donde los minicomprimidos de liberación retardada-extendida liberan mesalazina de manera selectiva en el colon; donde: las cantidades relativas de (a) y (b) en el producto farmacéutico de dosis unitaria son tales que entre 10 y 90% peso en peso de la mesalazina que se provee en la dosis farmacéutica unitaria está presente en los minicomprimidos de liberación retardada-extendida de (b); y la cantidad total de nicotinamida en el producto farmacéutico de dosis unitaria es de entre aproximadamente 0,4 y 6 g.
ARP170100993A 2016-04-19 2017-04-18 Composiciones farmacéuticas orales de mesalazina AR108231A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201662324416P 2016-04-19 2016-04-19

Publications (1)

Publication Number Publication Date
AR108231A1 true AR108231A1 (es) 2018-08-01

Family

ID=59298513

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170100993A AR108231A1 (es) 2016-04-19 2017-04-18 Composiciones farmacéuticas orales de mesalazina

Country Status (13)

Country Link
US (2) US10874617B2 (es)
EP (1) EP3445340A1 (es)
JP (1) JP2019513800A (es)
KR (1) KR102381586B1 (es)
CN (1) CN109310642B (es)
AR (1) AR108231A1 (es)
AU (1) AU2017252410A1 (es)
BR (1) BR112018071370A2 (es)
CA (1) CA3021071A1 (es)
MX (1) MX2018012618A (es)
RU (1) RU2744576C2 (es)
TW (1) TW201740932A (es)
WO (1) WO2017184566A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUA20162293A1 (it) * 2016-04-05 2017-10-05 Sofar Spa Processo per formulazioni solide di mesalazina
WO2017184563A1 (en) 2016-04-19 2017-10-26 Ferring B.V. Oral pharmaceutical compositions of nicotinamide
TR201722039A2 (tr) * 2017-12-27 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Mesalazi̇ni̇n kati oral farmasöti̇k kompozi̇syonlari
IT201800011120A1 (it) 2018-12-14 2020-06-14 Dpl Pharma S P A Composizioni farmaceutiche orali solide per la somministrazione di mesalazina o suoi derivati
KR20220044435A (ko) * 2019-05-03 2022-04-08 아조라 테라퓨틱스 인코포레이티드 인디고 및/또는 인디고 유도체를 포함하는 조성물 및 이의 사용 방법
US20210236519A1 (en) * 2020-01-30 2021-08-05 Atoz Pharmaceuticals Pvt Ltd Controlled release dosage forms of 5-aminosalicylic acid and process thereof
US20220125733A1 (en) * 2020-10-23 2022-04-28 Atoz Pharmaceuticals Pvt Ltd Nongranulated compressed tablets of mesalamine, and process of preparation thereof

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CA2359812C (en) * 2000-11-20 2004-02-10 The Procter & Gamble Company Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
JP5502254B2 (ja) * 2001-01-31 2014-05-28 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング 少なくとも２種類の異なる被覆ペレット形から成る多粒子剤形
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Also Published As

Publication number Publication date
TW201740932A (zh) 2017-12-01
BR112018071370A2 (pt) 2019-02-05
KR20180133503A (ko) 2018-12-14
EP3445340A1 (en) 2019-02-27
WO2017184566A1 (en) 2017-10-26
CN109310642B (zh) 2021-07-20
KR102381586B1 (ko) 2022-04-04
AU2017252410A1 (en) 2018-11-01
JP2019513800A (ja) 2019-05-30
US20190105275A1 (en) 2019-04-11
MX2018012618A (es) 2019-06-24
US10874617B2 (en) 2020-12-29
RU2744576C2 (ru) 2021-03-11
RU2018137359A (ru) 2020-05-19
RU2018137359A3 (es) 2020-07-03
CN109310642A (zh) 2019-02-05
CA3021071A1 (en) 2017-10-26
US20210220281A1 (en) 2021-07-22

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