MD3439637T2 - Procedeu pentru formulări solide de mesalazină - Google Patents
Procedeu pentru formulări solide de mesalazinăInfo
- Publication number
- MD3439637T2 MD3439637T2 MDE20190198T MDE20190198T MD3439637T2 MD 3439637 T2 MD3439637 T2 MD 3439637T2 MD E20190198 T MDE20190198 T MD E20190198T MD E20190198 T MDE20190198 T MD E20190198T MD 3439637 T2 MD3439637 T2 MD 3439637T2
- Authority
- MD
- Moldova
- Prior art keywords
- mesalazine
- relates
- present
- solid formulations
- granules
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 3
- KBOPZPXVLCULAV-UHFFFAOYSA-N mesalamine Chemical compound NC1=CC=C(O)C(C(O)=O)=C1 KBOPZPXVLCULAV-UHFFFAOYSA-N 0.000 title abstract 2
- 229960004963 mesalazine Drugs 0.000 title abstract 2
- 239000007787 solid Substances 0.000 title abstract 2
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 239000003814 drug Substances 0.000 abstract 3
- 229940079593 drug Drugs 0.000 abstract 2
- 239000008187 granular material Substances 0.000 abstract 2
- 230000001684 chronic effect Effects 0.000 abstract 1
- 238000013270 controlled release Methods 0.000 abstract 1
- 210000001035 gastrointestinal tract Anatomy 0.000 abstract 1
- 230000002757 inflammatory effect Effects 0.000 abstract 1
- 230000007170 pathology Effects 0.000 abstract 1
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)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Luminescent Compositions (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
Invenţia de faţă se referă la un procedeu de preparare de forme farmaceutice solide cuprinzând o cantitate de mesalazină cuprinsă între 75 şi 95%, adică între 1000 şi 1600 mg de medicament per unitate de dozare.De asemenea, invenţia de faţă se referă la granulate şi/sau comprimate obţinute/care pot fi obţinute cu procedeul conform invenţiei, preferabil acoperite pentru a permite eliberarea controlată a medicamentului.În sfârşit, invenţia de faţă se referă la utilizarea granulatelor şi/sau comprimatelor ca medicament, preferabil pentru tratamentul patologiilor inflamatorii cronice, preferabil cele care afectează tractul intestinal.
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 (1)
Publication Number | Publication Date |
---|---|
MD3439637T2 true MD3439637T2 (ro) | 2022-10-31 |
Family
ID=56551461
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MDE20190198T MD3439637T2 (ro) | 2016-04-05 | 2017-04-04 | Procedeu pentru formulări solide de mesalazină |
Country Status (21)
Country | Link |
---|---|
US (2) | US11504331B2 (ro) |
EP (1) | EP3439637B1 (ro) |
CN (2) | CN117442562A (ro) |
AU (1) | AU2017247783B2 (ro) |
BR (1) | BR112018070521A2 (ro) |
CL (1) | CL2018002765A1 (ro) |
CO (1) | CO2018010142A2 (ro) |
DK (1) | DK3439637T3 (ro) |
ES (1) | ES2924881T3 (ro) |
HR (1) | HRP20221073T1 (ro) |
HU (1) | HUE059531T2 (ro) |
IT (1) | ITUA20162293A1 (ro) |
LT (1) | LT3439637T (ro) |
MA (1) | MA43793B1 (ro) |
MD (1) | MD3439637T2 (ro) |
MX (1) | MX2018011685A (ro) |
PL (1) | PL3439637T3 (ro) |
PT (1) | PT3439637T (ro) |
RS (1) | RS63492B1 (ro) |
SI (1) | SI3439637T1 (ro) |
WO (1) | WO2017175123A1 (ro) |
Families Citing this family (1)
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 (16)
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 |
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 |
AR036797A1 (es) * | 2001-10-15 | 2004-10-06 | Ferring Bv | Un metodo para preparar una composicion farmaceutica que comprende acido 5-aminosalicilico para utilizar en el tratamiento de colitis ulcerosa y enfermedades de crohn |
DE60130270T2 (de) * | 2001-10-15 | 2008-05-29 | Ferring B.V. | Verfahren zur herstellung einer pharmazeutischen zubereitung mit 5-aminosalicylsäure zur verwendung bei der behandlung von colitis ulcerosa und morbus crohn |
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 |
BR112013005695A2 (pt) | 2010-09-10 | 2016-05-10 | Pharmazell Gmbh | processo para produzir ácido 5-aminossalicílico cristalino |
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 |
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 |
CN109310642B (zh) * | 2016-04-19 | 2021-07-20 | 费灵有限公司 | 美沙拉嗪的口服药物组合物 |
-
2016
- 2016-04-05 IT ITUA2016A002293A patent/ITUA20162293A1/it unknown
-
2017
- 2017-04-04 HU HUE17726142A patent/HUE059531T2/hu unknown
- 2017-04-04 MX MX2018011685A patent/MX2018011685A/es unknown
- 2017-04-04 PT PT177261427T patent/PT3439637T/pt unknown
- 2017-04-04 DK DK17726142.7T patent/DK3439637T3/da active
- 2017-04-04 US US16/091,397 patent/US11504331B2/en active Active
- 2017-04-04 WO PCT/IB2017/051907 patent/WO2017175123A1/en active Application Filing
- 2017-04-04 CN CN202311389896.2A patent/CN117442562A/zh active Pending
- 2017-04-04 HR HRP20221073TT patent/HRP20221073T1/hr unknown
- 2017-04-04 MA MA43793A patent/MA43793B1/fr unknown
- 2017-04-04 RS RS20220761A patent/RS63492B1/sr unknown
- 2017-04-04 CN CN201780021690.0A patent/CN109069428A/zh active Pending
- 2017-04-04 ES ES17726142T patent/ES2924881T3/es active Active
- 2017-04-04 SI SI201731212T patent/SI3439637T1/sl unknown
- 2017-04-04 AU AU2017247783A patent/AU2017247783B2/en active Active
- 2017-04-04 BR BR112018070521A patent/BR112018070521A2/pt not_active Application Discontinuation
- 2017-04-04 MD MDE20190198T patent/MD3439637T2/ro unknown
- 2017-04-04 PL PL17726142.7T patent/PL3439637T3/pl unknown
- 2017-04-04 LT LTEPPCT/IB2017/051907T patent/LT3439637T/lt unknown
- 2017-04-04 EP EP17726142.7A patent/EP3439637B1/en active Active
-
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/US20230104254A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
HUE059531T2 (hu) | 2022-11-28 |
CL2018002765A1 (es) | 2019-01-18 |
RS63492B1 (sr) | 2022-09-30 |
ITUA20162293A1 (it) | 2017-10-05 |
ES2924881T3 (es) | 2022-10-11 |
EP3439637A1 (en) | 2019-02-13 |
CN117442562A (zh) | 2024-01-26 |
US11504331B2 (en) | 2022-11-22 |
DK3439637T3 (da) | 2022-08-29 |
AU2017247783B2 (en) | 2022-12-22 |
CO2018010142A2 (es) | 2018-10-22 |
PL3439637T3 (pl) | 2022-09-26 |
MX2018011685A (es) | 2018-12-19 |
BR112018070521A2 (pt) | 2019-01-29 |
MA43793B1 (fr) | 2022-09-30 |
LT3439637T (lt) | 2022-09-12 |
US20230104254A1 (en) | 2023-04-06 |
MA43793A (fr) | 2018-11-28 |
PT3439637T (pt) | 2022-08-30 |
WO2017175123A1 (en) | 2017-10-12 |
HRP20221073T1 (hr) | 2022-11-25 |
SI3439637T1 (sl) | 2022-10-28 |
AU2017247783A1 (en) | 2018-10-25 |
EP3439637B1 (en) | 2022-06-01 |
CN109069428A (zh) | 2018-12-21 |
US20190151245A1 (en) | 2019-05-23 |
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