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CL2018002765A1 - Proceso de producción de formulaciones sólidas de mesalazina. - Google Patents

Proceso de producción de formulaciones sólidas de mesalazina.

Info

Publication number
CL2018002765A1
CL2018002765A1 CL2018002765A CL2018002765A CL2018002765A1 CL 2018002765 A1 CL2018002765 A1 CL 2018002765A1 CL 2018002765 A CL2018002765 A CL 2018002765A CL 2018002765 A CL2018002765 A CL 2018002765A CL 2018002765 A1 CL2018002765 A1 CL 2018002765A1
Authority
CL
Chile
Prior art keywords
mesalazine
solid
formulations
production process
granulate
Prior art date
Application number
CL2018002765A
Other languages
English (en)
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=CL2018002765(A1) "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 CL2018002765A1 publication Critical patent/CL2018002765A1/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
    • A61K9/14—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; 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
    • 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 PRESENTE INVENCIÓN SE RELACIONA CON UN PROCESO DE PREPARACIÓN DE FORMAS FARMACÉUTICAS SÓLIDAS QUE COMPRENDEN UNA CANTIDAD DE MESALAZINA COMPRENDIDA ENTRE 75 Y 95 % (ES DECIR, ENTRE 1.000 Y 1.600 MG DE FÁRMACO POR UNIDAD DE DOSIFICACIÓN. ADEMÁS, LA PRESENTE INVENCIÓN SE RELACIONA CON UN GRANULADO Y/O TABLETAS OBTENIDAS U OBTENIBLES CON EL PROCESO SEGÚN LA INVENCIÓN, DE PREFERENCIA RECUBIERTAS PARA OBTENER UNA LIBERACIÓN CONTROLADA DEL FÁRMACO. FINALMENTE, LA PRESENTE INVENCIÓN SE RELACIONA CON EL USO DEL GRANULADO Y/O TABLETAS COMO MEDICAMENTO, DE PREFERENCIA PARA EL TRATAMIENTO DE PATOLOGÍAS INFLAMATORIAS CRÓNICAS, DE PREFERENCIA QUE AFECTEN AL TUBO INTESTINAL.
CL2018002765A 2016-04-05 2018-09-28 Proceso de producción de formulaciones sólidas de mesalazina. CL2018002765A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ITUA2016A002293A ITUA20162293A1 (it) 2016-04-05 2016-04-05 Processo per formulazioni solide di mesalazina

Publications (1)

Publication Number Publication Date
CL2018002765A1 true CL2018002765A1 (es) 2019-01-18

Family

ID=56551461

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2018002765A CL2018002765A1 (es) 2016-04-05 2018-09-28 Proceso de producción de formulaciones sólidas de mesalazina.

Country Status (23)

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

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
AU5775398A (en) 1996-12-17 1998-07-15 Poli Industria Chimica S.P.A. Site-specific controlled release dosage formulation for mesalamine
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.
DE59905248D1 (de) * 1999-01-29 2003-05-28 Disphar Int Bv Pharmazeutische zusammensetzungen
ITMI991316A1 (it) † 1999-06-14 2000-12-14 Cip Ninety Two 92 S A Composizioni farmaceutiche orali a rilascio modificato di mesalazina
KR100859358B1 (ko) * 2001-10-15 2008-09-22 훼링 비.브이. 궤양성 대장염 및 크론병의 치료에 유용한5-아미노살리실산을 포함하는 약학적 조성물의 제조 방법
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 (en) * 2009-10-16 2011-04-21 Ranbaxy Laboratories Limited A delayed release pharmaceutical composition of mesalamine
EP2425826A1 (en) † 2010-09-01 2012-03-07 Disphar International B.V. Mesalazine tablet having improved dissolution
CN103153944A (zh) † 2010-09-10 2013-06-12 法莫再尔公司 晶态5-氨基水杨酸的制备方法
EP2468264A1 (en) * 2010-12-27 2012-06-27 Laboratorios Liconsa, S.A. Oral pharmaceutical tablet for controled release of mesalazine and process for obtaining it
US20170143743A1 (en) * 2014-06-16 2017-05-25 Valpharma International S.P.A. Formulation for oral administration containing mesalazine
EP3162362A1 (de) * 2015-10-30 2017-05-03 Dr. Falk Pharma Gmbh Optimierte mesalazinhaltige hochdosistablette
ITUA20162293A1 (it) 2016-04-05 2017-10-05 Sofar Spa Processo per formulazioni solide di mesalazina
AU2017252410A1 (en) * 2016-04-19 2018-11-01 Ferring B.V. Oral pharmaceutical compositions of mesalazine

Also Published As

Publication number Publication date
MA43793B1 (fr) 2022-09-30
AU2017247783A1 (en) 2018-10-25
PL3439637T3 (pl) 2022-09-26
PL3439637T5 (pl) 2025-11-17
EP3439637A1 (en) 2019-02-13
US20230104254A1 (en) 2023-04-06
MX386932B (es) 2025-03-19
BR112018070521A2 (pt) 2019-01-29
ES2924881T3 (es) 2022-10-11
MA43793A (fr) 2018-11-28
PT3439637T (pt) 2022-08-30
RS63492B2 (sr) 2025-10-31
FI3439637T4 (fi) 2025-09-12
CN109069428A (zh) 2018-12-21
CO2018010142A2 (es) 2018-10-22
SI3439637T2 (sl) 2025-11-28
EP3439637B2 (en) 2025-07-30
ES2924881T5 (en) 2025-11-17
HRP20221073T1 (hr) 2022-11-25
DK3439637T3 (da) 2022-08-29
MX2018011685A (es) 2018-12-19
CN117442562A (zh) 2024-01-26
HRP20221073T4 (hr) 2025-09-26
US11504331B2 (en) 2022-11-22
LT3439637T (lt) 2022-09-12
SMT202200346T1 (it) 2022-09-14
EP3439637B1 (en) 2022-06-01
US12201729B2 (en) 2025-01-21
AU2017247783B2 (en) 2022-12-22
DK3439637T4 (da) 2025-10-20
HUE059531T2 (hu) 2022-11-28
RS63492B1 (sr) 2022-09-30
WO2017175123A1 (en) 2017-10-12
MD3439637T4 (ro) 2025-12-31
US20190151245A1 (en) 2019-05-23
MD3439637T2 (ro) 2022-10-31
SI3439637T1 (sl) 2022-10-28
ITUA20162293A1 (it) 2017-10-05

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