MA43793B1 - Procédé de préparation de formulations solides de mésalazine - Google Patents

Procédé de préparation de formulations solides de mésalazine

Info

Publication number
MA43793B1
MA43793B1 MA43793A MA43793A MA43793B1 MA 43793 B1 MA43793 B1 MA 43793B1 MA 43793 A MA43793 A MA 43793A MA 43793 A MA43793 A MA 43793A MA 43793 B1 MA43793 B1 MA 43793B1
Authority
MA
Morocco
Prior art keywords
mesalazine
preparation
relates
present
solid formulations
Prior art date
Application number
MA43793A
Other languages
English (en)
Other versions
MA43793A (fr
Inventor
Carla Labruzzo
Original Assignee
Sofar Spa
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=56551461&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MA43793(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sofar Spa filed Critical Sofar Spa
Publication of MA43793A publication Critical patent/MA43793A/fr
Publication of MA43793B1 publication Critical patent/MA43793B1/fr

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
    • A61K9/14—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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • 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
    • 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]

Landscapes

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

Abstract

La présente invention concerne un procédé de préparation de formes pharmaceutiques solides comprenant une quantité de mésalazine comprise entre 75 et 95 %, c'est-à-dire entre 1000 et 1600 mg de médicament par unité de dose. En outre, la présente invention concerne un granulé et/ou des comprimés obtenus/pouvant être obtenus par le procédé selon l'invention, de préférence enrobés pour permettre la libération contrôlée du médicament. Enfin, la présente invention concerne l'utilisation du granulé et/ou des comprimés en tant que médicament, de préférence pour le traitement de pathologies inflammatoires chroniques qui affectent de préférence le tractus intestinal.
MA43793A 2016-04-05 2017-04-04 Procédé de préparation de formulations solides de mésalazine MA43793B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITUA2016A002293A ITUA20162293A1 (it) 2016-04-05 2016-04-05 Processo per formulazioni solide di mesalazina
PCT/IB2017/051907 WO2017175123A1 (fr) 2016-04-05 2017-04-04 Procédé de préparation de formulations solides de mésalazine

Publications (2)

Publication Number Publication Date
MA43793A MA43793A (fr) 2018-11-28
MA43793B1 true MA43793B1 (fr) 2022-09-30

Family

ID=56551461

Family Applications (1)

Application Number Title Priority Date Filing Date
MA43793A MA43793B1 (fr) 2016-04-05 2017-04-04 Procédé de préparation de formulations solides de mésalazine

Country Status (24)

Country Link
US (2) US11504331B2 (fr)
EP (1) EP3439637B2 (fr)
CN (2) CN117442562A (fr)
AU (1) AU2017247783B2 (fr)
BR (1) BR112018070521A2 (fr)
CL (1) CL2018002765A1 (fr)
CO (1) CO2018010142A2 (fr)
CY (1) CY1125503T1 (fr)
DK (1) DK3439637T4 (fr)
ES (1) ES2924881T5 (fr)
FI (1) FI3439637T4 (fr)
HR (1) HRP20221073T4 (fr)
HU (1) HUE059531T2 (fr)
IT (1) ITUA20162293A1 (fr)
LT (1) LT3439637T (fr)
MA (1) MA43793B1 (fr)
MD (1) MD3439637T4 (fr)
MX (1) MX386932B (fr)
PL (1) PL3439637T5 (fr)
PT (1) PT3439637T (fr)
RS (1) RS63492B2 (fr)
SI (1) SI3439637T2 (fr)
SM (1) SMT202200346T1 (fr)
WO (1) WO2017175123A1 (fr)

Families Citing this family (1)

* 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

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4539198A (en) † 1983-07-07 1985-09-03 Rowell Laboratories, Inc. Solid pharmaceutical formulations for slow, zero order release via controlled surface erosion: expanded range
AU4968597A (en) † 1996-11-25 1998-06-22 Takara Shuzo Co., Ltd. Antibiotic tkr 459, production method, and microorganism
WO1998026767A2 (fr) 1996-12-17 1998-06-25 Poli Industria Chimica S.P.A. Formulations a liberation lente et specifique d'un site, pour l'administration de mesalazine
IT1303753B1 (it) * 1998-11-13 2001-02-23 Ct Lab Farm Srl Composizioni farmaceutiche somministrabili per via orale contenentiun rivestimento gastroresistente a base di polimeri acrilici.
JP2002535353A (ja) * 1999-01-29 2002-10-22 ロザン ファルマ ゲゼルシャフトミットベシュレンクテルハフツンク 医薬品組成物
ITMI991316A1 (it) † 1999-06-14 2000-12-14 Cip Ninety Two 92 S A Composizioni farmaceutiche orali a rilascio modificato di mesalazina
CN100506234C (zh) * 2001-10-15 2009-07-01 凡林有限公司 用于治疗溃疡性结肠炎和克罗恩病的含有5-氨基水杨酸的药物组合物的制备方法
US8282955B2 (en) * 2001-10-15 2012-10-09 Ferring B.V. Method for the preparation of a pharmaceutical composition comprising 5-aminosalicylic acid for use in treatment of ulcerative colitis and Crohn's disease
US20090017110A1 (en) † 2005-05-31 2009-01-15 Capricorn Pharma Inc. Modified release formulations of anti-irritability drugs
US20090162434A1 (en) † 2007-12-21 2009-06-25 Disphar International Bv Mesalazine tablet
WO2011045775A1 (fr) * 2009-10-16 2011-04-21 Ranbaxy Laboratories Limited Composition pharmaceutique à libération retardée de mésalamine
EP2425826A1 (fr) † 2010-09-01 2012-03-07 Disphar International B.V. Comprimé de mésalazine doté d'une dissolution améliorée
WO2012032185A1 (fr) † 2010-09-10 2012-03-15 Pharmazell Gmbh Procédé de production d'acide 5-aminosalicylique cristallin
EP2468264A1 (fr) * 2010-12-27 2012-06-27 Laboratorios Liconsa, S.A. Comprimé pharmaceutique oral pour la libération prolongée de mésalazine et son procédé de fabrication
EP3154523B1 (fr) * 2014-06-16 2018-11-21 Valpharma International S.P.A. Formulation pour administration par voie orale contenant de la mésalazine
EP3162362A1 (fr) * 2015-10-30 2017-05-03 Dr. Falk Pharma Gmbh Comprimé optimisé a une haute dose contenant de la mesalazine
ITUA20162293A1 (it) 2016-04-05 2017-10-05 Sofar Spa Processo per formulazioni solide di mesalazina
CA3021071A1 (fr) * 2016-04-19 2017-10-26 Ferring B.V. Compositions pharmaceutiques orales de mesalazine

Also Published As

Publication number Publication date
MD3439637T2 (ro) 2022-10-31
MX2018011685A (es) 2018-12-19
CO2018010142A2 (es) 2018-10-22
SI3439637T2 (sl) 2025-11-28
MD3439637T4 (ro) 2025-12-31
MA43793A (fr) 2018-11-28
PT3439637T (pt) 2022-08-30
MX386932B (es) 2025-03-19
CN109069428A (zh) 2018-12-21
RS63492B2 (sr) 2025-10-31
RS63492B1 (sr) 2022-09-30
SI3439637T1 (sl) 2022-10-28
ITUA20162293A1 (it) 2017-10-05
AU2017247783A1 (en) 2018-10-25
PL3439637T5 (pl) 2025-11-17
CL2018002765A1 (es) 2019-01-18
US20190151245A1 (en) 2019-05-23
DK3439637T3 (da) 2022-08-29
DK3439637T4 (da) 2025-10-20
US12201729B2 (en) 2025-01-21
EP3439637B2 (fr) 2025-07-30
EP3439637A1 (fr) 2019-02-13
US11504331B2 (en) 2022-11-22
WO2017175123A1 (fr) 2017-10-12
US20230104254A1 (en) 2023-04-06
PL3439637T3 (pl) 2022-09-26
HRP20221073T1 (hr) 2022-11-25
LT3439637T (lt) 2022-09-12
FI3439637T4 (fi) 2025-09-12
ES2924881T3 (es) 2022-10-11
EP3439637B1 (fr) 2022-06-01
CY1125503T1 (el) 2026-02-25
ES2924881T5 (en) 2025-11-17
BR112018070521A2 (pt) 2019-01-29
SMT202200346T1 (it) 2022-09-14
HUE059531T2 (hu) 2022-11-28
AU2017247783B2 (en) 2022-12-22
CN117442562A (zh) 2024-01-26
HRP20221073T4 (hr) 2025-09-26

Similar Documents

Publication Publication Date Title
CY1124052T1 (el) Δισκιο διασπειρομενο στο στομα περιεχον οιστετρολη
MA41496B1 (fr) Compositions pharmaceutiques comprenant n-(3,5-dimethoxyphenyl)-n'-(1-methylethyl)-n-[3-(1-methyl-1h-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine
MA40768B1 (fr) Dérivés d'indole mono ou di-substitué en tant qu'inhibiteurs de réplication du virus de la dengue
MA33467B1 (fr) Promédicaments comprenant un conjugué insuline-lieur
MA38688A1 (fr) Composition solide pour administration orale contenant de l'acide ibandronique ou un sel pharmaceutiquement acceptable de celui-ci et de la vitamine d
MA50201B1 (fr) Comprimés de défériprone à libération retardée et procédés d'utilisation correspondants
MA39443A1 (fr) Nouvelle formulation de méloxicam
BR112012030641A2 (pt) métodos e composições para terapia farmacêutica oral
MA38358A1 (fr) Formulations de composés organiques
MA43876B1 (fr) Compositions pharmaceutiques et leur utilisations contre les maladies de surcharge lysosomale
MA39447A1 (fr) (s)-pirlindole ou ses sels pharmaceutiquement acceptables pour une utilisation en médecine
BR112023025552A2 (pt) Composições estabilizadas de apilimod e usos das mesmas
PH12019500516A1 (en) Pharmaceutical composition comprising mineralocorticoid receptor antagonist and use thereof
HRP20190211T1 (hr) Inhibitor proteina za prijenos kolesterilestera (cetp) i farmaceutski pripravci koji sadrže spomenuti inhibitor za primjenu u liječenju ili prevenciji kardiovaskularnih bolesti
MA46778B1 (fr) Composition intranasale comprenant de la bétahistine
EP3818981A4 (fr) Combinaison pharmaceutique synergique de l'énantiomère actif s-kétorolac et de gabapentine pour le traitement de la douleur neuropathique
MA41102A (fr) Compositions contenant de la curcumine à biodisponibilité améliorée
FR3064180B1 (fr) Formulations comprenant des actifs issus de la plante murraya koenigii
MA58507A1 (fr) Composition pharmaceutique aqueuse de levilimab
WO2020018048A3 (fr) Composition pharmaceutique à libération immédiate de médicaments anti-inflammatoires, de famotidine et d'un carbonate
MX386932B (es) Proceso para formulaciones sólidas de mesalazina.
JOP20200005B1 (ar) تركيبات صيدلية
WO2020013776A3 (fr) Effet synergique du naproxène et un agent protecteur gatrique qui traite la douleur et l'inflammation
MA40179A (fr) Combinaison d'adapalène et de peroxyde de benzoyle pour le traitement de l'acné sévère
JOP20200282A1 (ar) مركب جديد ينطوي على نشاط مثبط للإنتيروببتيداز