DK3439637T4 - Fremgangsmåde til mesalazin-faststofformuleringer - Google Patents

Fremgangsmåde til mesalazin-faststofformuleringer

Info

Publication number: DK3439637T4
Authority: DK; Denmark
Prior art keywords: mesalazine; solid formulations; formulations; solid; mesalazine solid
Prior art date: 2016-04-05

Application number

DK17726142.7T

Other languages

English (en)

Other versions

DK3439637T3 (da

Inventor

Carla Labruzzo

Original Assignee

Alfasigma 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.)

2016-04-05

Filing date

2017-04-04

Publication date

2025-10-20

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=DK3439637(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2017-04-04 Application filed by Alfasigma Spa filed Critical Alfasigma Spa

2022-08-29 Publication of DK3439637T3 publication Critical patent/DK3439637T3/da

2025-10-20 Application granted granted Critical

2025-10-20 Publication of DK3439637T4 publication Critical patent/DK3439637T4/da

Classifications

- 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
- A61K9/14—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
- 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)

DK17726142.7T 2016-04-05 2017-04-04 Fremgangsmåde til mesalazin-faststofformuleringer DK3439637T4 (da)

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 (en)	2016-04-05	2017-04-04	Process for mesalazine solid formulations

Publications (2)

Publication Number	Publication Date
DK3439637T3 DK3439637T3 (da)	2022-08-29
DK3439637T4 true DK3439637T4 (da)	2025-10-20

Family

ID=56551461

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
DK17726142.7T DK3439637T4 (da)	2016-04-05	2017-04-04	Fremgangsmåde til mesalazin-faststofformuleringer

Country Status (23)

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

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
EP0955376A4 (en) †	1996-11-25	2001-03-28	Takara Shuzo Co	ANTIBIOTIC TKR 459, PRODUCTION METHOD THEREOF AND MICROORGANISM
WO1998026767A2 (en)	1996-12-17	1998-06-25	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.
NZ513037A (en) *	1999-01-29	2003-05-30	Disphar Internat B	Coated sustained release pharmaceutical composition for the release of an agent in the gastrointestinal tract
ITMI991316A1 (it) †	1999-06-14	2000-12-14	Cip Ninety Two 92 S A	Composizioni farmaceutiche orali a rilascio modificato di mesalazina
ATE371441T1 (de)	2001-10-15	2007-09-15	Ferring Bv	Verfahren zur herstellung einer pharmazeutischen zubereitung mit 5-aminosalicylsäure zur verwendung bei der behandlung von colitis ulcerosa und morbus crohn
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
CA2810283A1 (en) †	2010-09-10	2012-03-15	Pharmazell Gmbh	Process for producing crystalline 5-aminosalicylic acid
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

2016
- 2016-04-05 IT ITUA2016A002293A patent/ITUA20162293A1/it unknown
2017
- 2017-04-04 DK DK17726142.7T patent/DK3439637T4/da active
- 2017-04-04 MX MX2018011685A patent/MX386932B/es unknown
- 2017-04-04 LT LTEPPCT/IB2017/051907T patent/LT3439637T/lt unknown
- 2017-04-04 US US16/091,397 patent/US11504331B2/en active Active
- 2017-04-04 SI SI201731212T patent/SI3439637T2/sl unknown
- 2017-04-04 PT PT177261427T patent/PT3439637T/pt unknown
- 2017-04-04 PL PL17726142.7T patent/PL3439637T5/pl unknown
- 2017-04-04 HR HRP20221073TT patent/HRP20221073T4/hr unknown
- 2017-04-04 AU AU2017247783A patent/AU2017247783B2/en active Active
- 2017-04-04 RS RS20220761A patent/RS63492B2/sr unknown
- 2017-04-04 CN CN202311389896.2A patent/CN117442562A/zh active Pending
- 2017-04-04 ES ES17726142T patent/ES2924881T5/es active Active
- 2017-04-04 HU HUE17726142A patent/HUE059531T2/hu unknown
- 2017-04-04 MA MA43793A patent/MA43793B1/fr unknown
- 2017-04-04 CN CN201780021690.0A patent/CN109069428A/zh active Pending
- 2017-04-04 WO PCT/IB2017/051907 patent/WO2017175123A1/en not_active Ceased
- 2017-04-04 BR BR112018070521A patent/BR112018070521A2/pt not_active Application Discontinuation
- 2017-04-04 SM SM20220346T patent/SMT202200346T1/it unknown
- 2017-04-04 FI FIEP17726142.7T patent/FI3439637T4/fi active
- 2017-04-04 EP EP17726142.7A patent/EP3439637B2/en active Active
- 2017-04-04 MD MDE20190198T patent/MD3439637T4/ro unknown
2018
- 2018-09-25 CO CONC2018/0010142A patent/CO2018010142A2/es unknown
- 2018-09-28 CL CL2018002765A patent/CL2018002765A1/es unknown
2022
- 2022-10-19 US US18/047,964 patent/US12201729B2/en active Active

Also Published As

Publication number	Publication date
HUE059531T2 (hu)	2022-11-28
DK3439637T3 (da)	2022-08-29
MX2018011685A (es)	2018-12-19
MD3439637T2 (ro)	2022-10-31
US20190151245A1 (en)	2019-05-23
MD3439637T4 (ro)	2025-12-31
EP3439637A1 (en)	2019-02-13
SI3439637T1 (sl)	2022-10-28
HRP20221073T1 (hr)	2022-11-25
SMT202200346T1 (it)	2022-09-14
CO2018010142A2 (es)	2018-10-22
SI3439637T2 (sl)	2025-11-28
CN109069428A (zh)	2018-12-21
MA43793A (fr)	2018-11-28
PT3439637T (pt)	2022-08-30
AU2017247783B2 (en)	2022-12-22
CN117442562A (zh)	2024-01-26
US11504331B2 (en)	2022-11-22
WO2017175123A1 (en)	2017-10-12
LT3439637T (lt)	2022-09-12
PL3439637T3 (pl)	2022-09-26
FI3439637T4 (fi)	2025-09-12
EP3439637B2 (en)	2025-07-30
US12201729B2 (en)	2025-01-21
EP3439637B1 (en)	2022-06-01
HRP20221073T4 (hr)	2025-09-26
ES2924881T5 (en)	2025-11-17
AU2017247783A1 (en)	2018-10-25
CL2018002765A1 (es)	2019-01-18
ES2924881T3 (es)	2022-10-11
MX386932B (es)	2025-03-19
BR112018070521A2 (pt)	2019-01-29
PL3439637T5 (pl)	2025-11-17
MA43793B1 (fr)	2022-09-30
ITUA20162293A1 (it)	2017-10-05
US20230104254A1 (en)	2023-04-06
RS63492B2 (sr)	2025-10-31
RS63492B1 (sr)	2022-09-30

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