BR112018070521A2 - processo para preparação de formulações sólidas de mesalazina - Google Patents
processo para preparação de formulações sólidas de mesalazinaInfo
- Publication number
- BR112018070521A2 BR112018070521A2 BR112018070521A BR112018070521A BR112018070521A2 BR 112018070521 A2 BR112018070521 A2 BR 112018070521A2 BR 112018070521 A BR112018070521 A BR 112018070521A BR 112018070521 A BR112018070521 A BR 112018070521A BR 112018070521 A2 BR112018070521 A2 BR 112018070521A2
- Authority
- BR
- Brazil
- Prior art keywords
- mesalazine
- preparing solid
- relates
- present
- formulations
- Prior art date
Links
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 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
- 230000004968 inflammatory condition Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 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]
Abstract
a presente invenção refere-se a um processo para preparar formulações farmacêuticas sólidas, compreendendo uma quantidade de mesalazina compreendida entre 75 e 95%, isto é, entre 1000 e 1600 mg de fármaco por unidade de dosagem. além disso, a presente invenção refere-se a um granulado e/ou comprimidos, obtidos ou que podem ser obtidos mediante o processo de acordo com a invenção, de preferência, revestidos, para permitir a liberação controlada do fármaco. finalmente, a presente invenção refere-se ao uso do granulado e/ou dos comprimidos como um medicamento, de preferência, para o tratamento de patologias inflamatórias crônicas, que, preferivelmente, afetam o trato 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 |
|---|---|
| BR112018070521A2 true BR112018070521A2 (pt) | 2019-01-29 |
Family
ID=56551461
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112018070521A BR112018070521A2 (pt) | 2016-04-05 | 2017-04-04 | processo para preparação de formulações sólidas de mesalazina |
Country Status (21)
| Country | Link |
|---|---|
| US (2) | US11504331B2 (pt) |
| EP (1) | EP3439637B1 (pt) |
| CN (2) | CN109069428A (pt) |
| AU (1) | AU2017247783B2 (pt) |
| BR (1) | BR112018070521A2 (pt) |
| CL (1) | CL2018002765A1 (pt) |
| CO (1) | CO2018010142A2 (pt) |
| DK (1) | DK3439637T3 (pt) |
| ES (1) | ES2924881T3 (pt) |
| HR (1) | HRP20221073T1 (pt) |
| HU (1) | HUE059531T2 (pt) |
| IT (1) | ITUA20162293A1 (pt) |
| LT (1) | LT3439637T (pt) |
| MA (1) | MA43793B1 (pt) |
| MD (1) | MD3439637T2 (pt) |
| MX (1) | MX2018011685A (pt) |
| PL (1) | PL3439637T3 (pt) |
| PT (1) | PT3439637T (pt) |
| RS (1) | RS63492B1 (pt) |
| SI (1) | SI3439637T1 (pt) |
| WO (1) | WO2017175123A1 (pt) |
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 |
| EP0955376A4 (en) | 1996-11-25 | 2001-03-28 | Takara Shuzo Co | ANTIBIOTIC TKR 459, PRODUCTION METHOD THEREOF 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. |
| ES2197600T3 (es) * | 1999-01-29 | 2004-01-01 | Disphar International B.V. | Composiciones farmaceuticas. |
| ITMI991316A1 (it) | 1999-06-14 | 2000-12-14 | Cip Ninety Two 92 S A | Composizioni farmaceutiche orali a rilascio modificato di mesalazina |
| MXPA04003506A (es) * | 2001-10-15 | 2004-07-23 | Ferring Bv | Metodo para la preparacion de una composicion farmaceutica que comprende acido 5-aminosalicilico para el uso en el tratamiento de la colitis ulcerativa y de la enfermedad de crohn. |
| 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 |
| 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 |
| EP2488163A1 (en) | 2009-10-16 | 2012-08-22 | 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 |
| AU2011300642B2 (en) | 2010-09-10 | 2015-02-26 | 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 |
| 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 |
| EP3445340A1 (en) * | 2016-04-19 | 2019-02-27 | 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/DK3439637T3/da active
- 2017-04-04 ES ES17726142T patent/ES2924881T3/es active Active
- 2017-04-04 RS RS20220761A patent/RS63492B1/sr unknown
- 2017-04-04 EP EP17726142.7A patent/EP3439637B1/en active Active
- 2017-04-04 LT LTEPPCT/IB2017/051907T patent/LT3439637T/lt unknown
- 2017-04-04 CN CN201780021690.0A patent/CN109069428A/zh active Pending
- 2017-04-04 MA MA43793A patent/MA43793B1/fr unknown
- 2017-04-04 BR BR112018070521A patent/BR112018070521A2/pt not_active Application Discontinuation
- 2017-04-04 HU HUE17726142A patent/HUE059531T2/hu unknown
- 2017-04-04 MD MDE20190198T patent/MD3439637T2/ro unknown
- 2017-04-04 CN CN202311389896.2A patent/CN117442562A/zh active Pending
- 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 PT PT177261427T patent/PT3439637T/pt unknown
- 2017-04-04 SI SI201731212T patent/SI3439637T1/sl unknown
- 2017-04-04 PL PL17726142.7T patent/PL3439637T3/pl unknown
- 2017-04-04 MX MX2018011685A patent/MX2018011685A/es unknown
- 2017-04-04 AU AU2017247783A patent/AU2017247783B2/en active Active
- 2017-04-04 HR HRP20221073TT patent/HRP20221073T1/hr 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/US20230104254A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| CN109069428A (zh) | 2018-12-21 |
| EP3439637B1 (en) | 2022-06-01 |
| LT3439637T (lt) | 2022-09-12 |
| AU2017247783B2 (en) | 2022-12-22 |
| MD3439637T2 (ro) | 2022-10-31 |
| SI3439637T1 (sl) | 2022-10-28 |
| MX2018011685A (es) | 2018-12-19 |
| EP3439637A1 (en) | 2019-02-13 |
| RS63492B1 (sr) | 2022-09-30 |
| MA43793A (fr) | 2018-11-28 |
| PT3439637T (pt) | 2022-08-30 |
| ITUA20162293A1 (it) | 2017-10-05 |
| CN117442562A (zh) | 2024-01-26 |
| HRP20221073T1 (hr) | 2022-11-25 |
| WO2017175123A1 (en) | 2017-10-12 |
| ES2924881T3 (es) | 2022-10-11 |
| CO2018010142A2 (es) | 2018-10-22 |
| MA43793B1 (fr) | 2022-09-30 |
| PL3439637T3 (pl) | 2022-09-26 |
| CL2018002765A1 (es) | 2019-01-18 |
| US20230104254A1 (en) | 2023-04-06 |
| US20190151245A1 (en) | 2019-05-23 |
| AU2017247783A1 (en) | 2018-10-25 |
| US11504331B2 (en) | 2022-11-22 |
| DK3439637T3 (da) | 2022-08-29 |
| HUE059531T2 (hu) | 2022-11-28 |
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Legal Events
| Date | Code | Title | Description |
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| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06W | Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette] | ||
| B350 | Update of information on the portal [chapter 15.35 patent gazette] | ||
| B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
| B09B | Patent application refused [chapter 9.2 patent gazette] |