BR112012014935A2 - grânulos para preparações farmacêuticas, métodos e mecanismos para a sua produção - Google Patents

grânulos para preparações farmacêuticas, métodos e mecanismos para a sua produção

Info

Publication number
BR112012014935A2
BR112012014935A2 BR112012014935A BR112012014935A BR112012014935A2 BR 112012014935 A2 BR112012014935 A2 BR 112012014935A2 BR 112012014935 A BR112012014935 A BR 112012014935A BR 112012014935 A BR112012014935 A BR 112012014935A BR 112012014935 A2 BR112012014935 A2 BR 112012014935A2
Authority
BR
Brazil
Prior art keywords
granules
production
pharmaceutical preparations
methods
mechanisms
Prior art date
Application number
BR112012014935A
Other languages
English (en)
Other versions
BR112012014935B1 (pt
Inventor
Brigitte Nissen
Carsten Hoeg-Moller
Crilles Casper Larsen
Helle Poulsen
Jorgen Wittendorff
Kenneth Manby Pedersen
Tue Hansen
Original Assignee
Ferring Bv
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=42110308&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112012014935(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ferring Bv filed Critical Ferring Bv
Publication of BR112012014935A2 publication Critical patent/BR112012014935A2/pt
Publication of BR112012014935B1 publication Critical patent/BR112012014935B1/pt

Links

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
    • A61K31/609—Amides, e.g. salicylamide
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (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)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

grânulos para preparações farmacêuticas, métodos e mecanismos para a sua produção. são divulgadas preparações farmacêuticas granulares melhoradas, juntamente com os métodos e mecanismos melhorados para preparação de grânulos para uso em tais preparações. tais métodos são especialmente úteis para a produção de grânulos para preparações farmacêuticas sólidas de dose oral, e são particularmente adequados para a produção de grânulos compreendendo ácido 5-aminossalicílico (5-asa) para o tratamento de doença inflamatória do intestito. os grânulos apresentem uma distribuição de comprimento mais repentinamente levada ao ponto máximo e, portanto, a distribuição de relação de aspecto, e possuem um perfil de dissolução conseqüentemente muito mais acentuado após outro processamento.
BR112012014935-0A 2009-12-18 2010-12-15 Composição farmacêutica compreendendo grânulos, método para sua produção e uso de um separador de comprimento BR112012014935B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09179877A EP2340812A1 (en) 2009-12-18 2009-12-18 Granules for pharmaceutical preparations, methods and apparatus for their production
EP09179877.7 2009-12-18
PCT/EP2010/069733 WO2011073245A2 (en) 2009-12-18 2010-12-15 Granules for pharmaceutical preparations, methods and apparatus for their production

Publications (2)

Publication Number Publication Date
BR112012014935A2 true BR112012014935A2 (pt) 2016-03-08
BR112012014935B1 BR112012014935B1 (pt) 2021-12-21

Family

ID=42110308

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012014935-0A BR112012014935B1 (pt) 2009-12-18 2010-12-15 Composição farmacêutica compreendendo grânulos, método para sua produção e uso de um separador de comprimento

Country Status (27)

Country Link
US (2) US8765185B2 (pt)
EP (2) EP2340812A1 (pt)
JP (1) JP5593396B2 (pt)
KR (1) KR101882880B1 (pt)
CN (2) CN102791257B (pt)
AR (1) AR079536A1 (pt)
AU (1) AU2010332884B2 (pt)
BR (1) BR112012014935B1 (pt)
CA (1) CA2784235C (pt)
DK (1) DK2512453T3 (pt)
ES (1) ES2612870T3 (pt)
HR (1) HRP20161639T1 (pt)
HU (1) HUE031228T2 (pt)
IL (1) IL220319A (pt)
JO (1) JO3762B1 (pt)
LT (1) LT2512453T (pt)
MX (2) MX351365B (pt)
NL (1) NL1038373C2 (pt)
NZ (1) NZ600582A (pt)
PL (1) PL2512453T3 (pt)
PT (1) PT2512453T (pt)
RS (1) RS55438B1 (pt)
RU (1) RU2584349C2 (pt)
SI (1) SI2512453T1 (pt)
TW (1) TWI511723B (pt)
WO (1) WO2011073245A2 (pt)
ZA (1) ZA201204441B (pt)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1615619A2 (en) * 2003-04-23 2006-01-18 Ferring B.V. Sachet for a pharmaceutical composition
WO2010040020A1 (en) 2008-10-02 2010-04-08 Salix Pharmaceuticals, Ltd. Methods of treating hepatic encephalopathy
EP2340812A1 (en) 2009-12-18 2011-07-06 Ferring International Center S.A. Granules for pharmaceutical preparations, methods and apparatus for their production
US20140141075A1 (en) 2012-11-21 2014-05-22 Warner Chilcott Company, Llc 5-aminosalicylic acid capsule formulation
DE202017102645U1 (de) * 2017-05-03 2018-08-06 Romaco Kilian Gmbh Ablaufvorrichtung für Presslinge einer Rundläufer-Tablettenpresse sowie Rundläufer-Tablettenpresse mit Ablaufvorrichtung
RU2667637C1 (ru) * 2017-06-26 2018-09-21 Гермес Арцнаймиттель ГмбХ Фармацевтическая композиция для перорального применения, содержащая n-ацетилцистеин с маскированным вкусом
ES2938608T3 (es) 2017-09-20 2023-04-13 Tillotts Pharma Ag Método para preparar una forma farmacéutica sólida que comprende anticuerpos mediante granulación en húmedo, extrusión y esferonización
EP3459529A1 (en) 2017-09-20 2019-03-27 Tillotts Pharma Ag Preparation of sustained release solid dosage forms comprising antibodies by spray drying
EP3459528B1 (en) 2017-09-20 2022-11-23 Tillotts Pharma Ag Preparation of solid dosage forms comprising antibodies by solution/suspension layering
KR102161235B1 (ko) * 2020-07-22 2020-09-29 주식회사 피티케이 이송 일체형 과립 제조 장치 및 방법
CN114472139A (zh) * 2022-01-04 2022-05-13 安徽宏信药业发展有限公司 一种中药药丸干燥筛选装置
CN115445902B (zh) * 2022-09-21 2023-06-06 重庆科技学院 一种条形颗粒物三维尺寸分选方法及装置
CN116942532B (zh) * 2023-09-20 2023-12-12 北京爱力佳医药科技有限公司 一种粉状药物制备装置

Family Cites Families (23)

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Publication number Priority date Publication date Assignee Title
WO1981002671A1 (en) 1980-03-20 1981-10-01 Ferring Farma Lab Pharmaceutical composition and method for the treatment of colitis ulcerosa and crohn's disease by oral administration
DE3786544T2 (de) 1986-03-10 1994-02-03 Cri Int Inc Verfahren zur Sortierung und Isolierung von Katalysator-Formteilchen nach ihrer Länge.
US4720473A (en) * 1986-03-10 1988-01-19 Cri International, Inc. Production of improved catalyst-type particles using length and density grading
JPH0827133B2 (ja) 1993-07-13 1996-03-21 不二パウダル株式会社 湿潤粉粒体の処理装置
US6004581A (en) * 1995-12-21 1999-12-21 Farmaceutisk Laboratorium Ferring A/S Modified release oral pharmaceutical composition and method for the treatment of bowel diseases
TR199801158T2 (xx) 1995-12-21 1998-09-21 Farmaceutisk Laboratorium Ferring A/S Ba��rsak hastal�klar� i�in oral farmas�tik kompozisyon.
AUPO637197A0 (en) 1997-04-23 1997-05-15 F.H. Faulding & Co. Limited Taste-masked pharmaceutical compositions
DE19724181A1 (de) * 1997-06-09 1998-12-10 Bayer Ag Multiple-unit-retard-Zubereitungen und Verfahren zu ihrer Herstellung
JP2000128774A (ja) 1998-10-26 2000-05-09 Tanabe Seiyaku Co Ltd 薬物を含有する球形微粒子の製法
US6146685A (en) 1998-11-05 2000-11-14 Delsys Pharmaceutical Corporation Method of deposition a dry powder and dispensing device
WO2000044353A1 (de) * 1999-01-29 2000-08-03 Losan Pharma Gmbh Pharmazeutische zusammensetzungen
US6735487B1 (en) 1999-07-01 2004-05-11 Ods Properties, Inc. Interactive wagering system with promotions
GB0113841D0 (en) * 2001-06-07 2001-08-01 Boots Co Plc Therapeutic agents
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
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
US7445796B2 (en) 2002-08-19 2008-11-04 L. Perrigo Company Pharmaceutically active particles of a monomodal particle size distribution and method
EP1615619A2 (en) 2003-04-23 2006-01-18 Ferring B.V. Sachet for a pharmaceutical composition
EP1470819A1 (en) * 2003-04-23 2004-10-27 Ferring B.V. High drug load mesalazine sachet
EP1547601A1 (en) 2003-12-23 2005-06-29 Ferring B.V. Coating method
US7207505B2 (en) 2004-06-04 2007-04-24 Bender Martin P Method for producing small granules
DE102004028977A1 (de) * 2004-06-16 2006-01-05 Add Advanced Drug Delivery Technologies Ltd. Neutralpellets
WO2007061717A2 (en) 2005-11-17 2007-05-31 Teva Pharmaceutical Industries, Ltd. Methods for isolating propargylated aminoindans
EP2340812A1 (en) 2009-12-18 2011-07-06 Ferring International Center S.A. Granules for pharmaceutical preparations, methods and apparatus for their production

Also Published As

Publication number Publication date
MX2012006851A (es) 2012-08-31
US9114083B2 (en) 2015-08-25
MX351365B (es) 2017-10-12
US20130022681A1 (en) 2013-01-24
US8765185B2 (en) 2014-07-01
US20140328934A1 (en) 2014-11-06
AR079536A1 (es) 2012-02-01
PL2512453T3 (pl) 2017-03-31
TW201125556A (en) 2011-08-01
ZA201204441B (en) 2013-02-27
JO3762B1 (ar) 2021-01-31
TWI511723B (zh) 2015-12-11
WO2011073245A2 (en) 2011-06-23
RU2012124834A (ru) 2014-01-27
EP2340812A1 (en) 2011-07-06
JP2013514312A (ja) 2013-04-25
IL220319A (en) 2016-03-31
NL1038373C2 (en) 2011-06-21
EP2512453A2 (en) 2012-10-24
AU2010332884B2 (en) 2015-12-10
DK2512453T3 (en) 2017-01-09
CA2784235A1 (en) 2011-06-23
WO2011073245A3 (en) 2011-08-11
ES2612870T3 (es) 2017-05-19
BR112012014935B1 (pt) 2021-12-21
IL220319A0 (en) 2012-08-30
PT2512453T (pt) 2016-12-16
NZ600582A (en) 2014-09-26
KR20120102775A (ko) 2012-09-18
CN105769772A (zh) 2016-07-20
RS55438B1 (sr) 2017-04-28
KR101882880B1 (ko) 2018-07-27
JP5593396B2 (ja) 2014-09-24
RU2584349C2 (ru) 2016-05-20
CN102791257B (zh) 2017-03-01
LT2512453T (lt) 2016-12-27
CN102791257A (zh) 2012-11-21
HUE031228T2 (en) 2017-07-28
HRP20161639T1 (hr) 2017-02-10
CA2784235C (en) 2019-01-15
AU2010332884A1 (en) 2012-07-05
EP2512453B1 (en) 2016-11-09
SI2512453T1 (sl) 2017-02-28

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B15K Others concerning applications: alteration of classification

Free format text: A CLASSIFICACAO ANTERIOR ERA: A61K 9/16

Ipc: A61K 9/16 (2006.01), A61K 31/606 (2006.01), A61K 9

B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 15/12/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.