BR0308761A - Formulação farmacêutica para o ingrediente ativo budesonida - Google Patents

Formulação farmacêutica para o ingrediente ativo budesonida

Info

Publication number
BR0308761A
BR0308761A BR0308761-1A BR0308761A BR0308761A BR 0308761 A BR0308761 A BR 0308761A BR 0308761 A BR0308761 A BR 0308761A BR 0308761 A BR0308761 A BR 0308761A
Authority
BR
Brazil
Prior art keywords
active ingredient
pharmaceutical formulation
layer
binding agent
bound
Prior art date
Application number
BR0308761-1A
Other languages
English (en)
Inventor
Thomas Beckert
Markus Rudolph
Jennifer Dressman
Original Assignee
R Hm Gmbh & Co Kg
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
Application filed by R Hm Gmbh & Co Kg filed Critical R Hm Gmbh & Co Kg
Publication of BR0308761A publication Critical patent/BR0308761A/pt

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
    • A61K9/48—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
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • 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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

"FORMULAçãO FARMACêUTICA PARA O INGREDIENTE ATIVO BUDESONIDA". A presente invenção refere-se a uma formulação farmacêutica contendo essencialmente, a) uma camada interna, que pode, opcionalmente, ser aplicada a um núcleo, com o ingrediente ativo budesonida, ligado a um agente aglutinante; b) uma camada intermediária com um agente de revestimento polimérico que é solúvel no suco intestinal ou retardador, e c) uma cobertura externa ou camada externa, resistente ao suco gástrico, tais camadas sendo capazes de conter de um modo conhecido habitual, outros adjuvantes farmaceuticamente aceitáveis. A formulação da invenção é caracterizada em que o agente de aglutinação é um polímero ou um copolímero com grupos ácidos e a formulação da camada interna sem as camadas intermediária e a camada externa libera o ingrediente ativo ligado no teste de liberação de acordo com a monografia USP XXIII <711> 'dissolução' com aparelho 2 (pás) em uma velocidade rotacional de 100 rotações /minuto em um tampão de fosfato a pH 7,5 até um valor de mais de 80% após 30 minutos.
BR0308761-1A 2002-03-27 2003-03-06 Formulação farmacêutica para o ingrediente ativo budesonida BR0308761A (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10214002A DE10214002A1 (de) 2002-03-27 2002-03-27 Pharmazeutische Formulierung für den Wirkstoff Budesonid
PCT/EP2003/002269 WO2003080032A2 (de) 2002-03-27 2003-03-06 Pharmazeutische formulierung für den wirkstoff budesonid

Publications (1)

Publication Number Publication Date
BR0308761A true BR0308761A (pt) 2005-01-11

Family

ID=27816040

Family Applications (1)

Application Number Title Priority Date Filing Date
BR0308761-1A BR0308761A (pt) 2002-03-27 2003-03-06 Formulação farmacêutica para o ingrediente ativo budesonida

Country Status (14)

Country Link
US (1) US20050089571A1 (pt)
EP (1) EP1487421B1 (pt)
JP (1) JP4488171B2 (pt)
KR (1) KR101200286B1 (pt)
AT (1) ATE316784T1 (pt)
AU (1) AU2003212306A1 (pt)
BR (1) BR0308761A (pt)
CA (1) CA2478506C (pt)
DE (2) DE10214002A1 (pt)
ES (1) ES2256722T3 (pt)
IL (2) IL162267A0 (pt)
MX (1) MXPA04009378A (pt)
PL (1) PL206241B1 (pt)
WO (1) WO2003080032A2 (pt)

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DE10220470A1 (de) * 2002-04-30 2003-11-20 Roehm Gmbh ph-sensitives Polymer
PT1183014E (pt) 1999-06-14 2003-12-31 Cosmo Spa Composicoes farmaceuticas orais de libertacao controlada e de dissimulacao de sabor
US8895064B2 (en) * 1999-06-14 2014-11-25 Cosmo Technologies Limited Controlled release and taste masking oral pharmaceutical composition
DE10011447A1 (de) * 2000-03-10 2001-09-20 Roehm Gmbh Dispersion mit nichtionischem Emulgator
US7616996B2 (en) * 2005-09-01 2009-11-10 Intrapace, Inc. Randomized stimulation of a gastrointestinal organ
US7979127B2 (en) * 2001-05-01 2011-07-12 Intrapace, Inc. Digestive organ retention device
US6535764B2 (en) * 2001-05-01 2003-03-18 Intrapace, Inc. Gastric treatment and diagnosis device and method
DE10208335A1 (de) * 2002-02-27 2003-09-04 Roehm Gmbh Arzneiform und Verfahren zu ihrer Herstellung
MXPA04010956A (es) * 2003-01-30 2005-01-25 Roehm Gmbh Forma de dosis farmaceutica y metodo para la produccion de la misma.
CA2538202C (en) * 2003-09-15 2013-01-15 Altana Pharma Ag Use of ciclesonide for the treatment of inflammatory bowel diseases
GB0403247D0 (en) 2004-02-13 2004-03-17 Tillotts Pharma Ag A pharmaceutical composition
DE102004035936A1 (de) * 2004-07-23 2006-03-16 Röhm GmbH & Co. KG Mehrschichtige Arzneiform
EP1883396B1 (en) 2005-05-18 2013-07-03 DA Volterra Colonic delivery of adsorbents
US8048413B2 (en) 2006-05-17 2011-11-01 Helene Huguet Site-specific intestinal delivery of adsorbents, alone or in combination with degrading molecules
EP2057985B1 (en) 2006-06-13 2013-10-16 Nippon Shinyaku Co., Ltd. Tablet coated with a polyvinyl alcohol copolymer
ES2311373B1 (es) * 2006-09-27 2009-12-21 Dmc Research Center, S.L. "utilizacion de un compuesto antibacteriano derivado de alliaceas, como aditivos en alimentacion animal".
CA2684655A1 (en) * 2007-03-26 2008-10-02 Teikoku Seiyaku Co., Ltd. Oral pharmaceutical preparation for colon-specific delivery
CA2707309A1 (en) 2007-12-18 2009-06-25 Acumen Pharmaceuticals, Inc. Novel addl receptor polypeptides, polynucleotides and host cells for recombinant production
JP4864024B2 (ja) * 2008-02-15 2012-01-25 エスエス製薬株式会社 時限放出製剤
GB0808537D0 (en) * 2008-05-12 2008-06-18 Archimedes Dev Ltd Compositions
DE102008048729A1 (de) * 2008-09-24 2010-03-25 Add Technologies Ltd Advanced Drug Delivery Multipartikuläre Tabletten und Verfahren zur deren Herstellung
US8945615B2 (en) 2009-02-17 2015-02-03 Mylan Pharmaceuticals Inc. Controlled release budesonide minitablets
US8945616B2 (en) * 2009-02-17 2015-02-03 Mylan Pharmaceuticals Inc. Controlled release budesonide minitablets
US10154964B2 (en) 2011-09-07 2018-12-18 Cosmo Technologies Limited Controlled release and taste masking oral pharmaceutical composition
IN2014CH01890A (pt) * 2014-04-10 2015-10-16 Aurobindo Pharma Ltd
CA2936746C (en) 2014-10-31 2017-06-27 Purdue Pharma Methods and compositions particularly for treatment of attention deficit disorder
CN107708677B (zh) 2015-06-05 2021-07-13 赢创运营有限公司 耐乙醇影响的药物或保健品组合物
RU2018111690A (ru) 2015-09-11 2019-10-11 Сан Фармасьютикл Индастриз Лтд. Пероральная лекарственная форма будесонида
EP3613414A1 (de) * 2018-08-24 2020-02-26 Dr. Falk Pharma Gmbh Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon
US10722473B2 (en) 2018-11-19 2020-07-28 Purdue Pharma L.P. Methods and compositions particularly for treatment of attention deficit disorder
EP4327806A4 (en) * 2021-04-20 2024-10-23 Jiangsu Hengrui Pharmaceuticals Co Ltd CAPSULE FOR SPECIFIC MEDICATION DELIVERY AND MANUFACTURING PROCESS THEREFOR
US11896719B2 (en) 2022-01-24 2024-02-13 Calliditas Therapeutics Ab Pharmaceutical compositions

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5643602A (en) * 1989-11-22 1997-07-01 Astra Aktiebolag Oral composition for the treatment of inflammatory bowel disease
US5260068A (en) * 1992-05-04 1993-11-09 Anda Sr Pharmaceuticals Inc. Multiparticulate pulsatile drug delivery system
DE4332394A1 (de) * 1993-09-23 1995-03-30 Falk Pharma Gmbh Budesonid-Pellets mit kontrolliertem Freigabeprofil und Verfahren zu ihrer Herstellung
DE4402666A1 (de) * 1994-01-29 1995-08-03 Roehm Gmbh Verfahren zum kurzzeitigen Behandeln einer Kunststoffschmelze mit einem flüssigen Behandlungsmittel und dabei hergestellter thermoplastischer Kunststoff
DE9414065U1 (de) * 1994-08-31 1994-11-03 Röhm GmbH & Co. KG, 64293 Darmstadt Thermoplastischer Kunststoff für darmsaftlösliche Arznei-Umhüllungen
DE9414066U1 (de) * 1994-08-31 1994-11-03 Röhm GmbH & Co. KG, 64293 Darmstadt Überzugs- und Bindemittel für Arzneiformen sowie damit hergestellte Arzneiform
DE19544562B4 (de) * 1995-11-30 2004-05-27 Röhm GmbH & Co. KG Verfahren zur Herstellung von Poly(meth)acrylimiden mit bei thermischer Belastung verbesserter Farbstabilität und daraus erhältliche Formkörper
DE19718597C1 (de) * 1997-05-02 1999-01-07 Roehm Gmbh Zweistufiges Verfahren zur Entwässerung von Kunststoffdispersionen
NZ510250A (en) * 1998-09-18 2003-07-25 Rohm Gmbh & Co Shaping tool for information carrier disc blanks having a die orifice of less than 0.3mm and a die clearance of 0.2mm
DE10220470A1 (de) * 2002-04-30 2003-11-20 Roehm Gmbh ph-sensitives Polymer
DE10011447A1 (de) * 2000-03-10 2001-09-20 Roehm Gmbh Dispersion mit nichtionischem Emulgator
DE10013029A1 (de) * 2000-03-17 2001-09-20 Roehm Gmbh Mehrschichtige Arzneiform für die Colonfreigabe
DE10065492A1 (de) * 2000-12-28 2003-06-26 Roehm Gmbh Diffus ausgestattete Formmassen und hieraus erhältliche Formkörper
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DE10208335A1 (de) * 2002-02-27 2003-09-04 Roehm Gmbh Arzneiform und Verfahren zu ihrer Herstellung

Also Published As

Publication number Publication date
WO2003080032A2 (de) 2003-10-02
PL371121A1 (en) 2005-06-13
CA2478506A1 (en) 2003-10-02
MXPA04009378A (es) 2005-01-25
PL206241B1 (pl) 2010-07-30
ES2256722T3 (es) 2006-07-16
KR101200286B1 (ko) 2012-11-13
ATE316784T1 (de) 2006-02-15
EP1487421A2 (de) 2004-12-22
AU2003212306A1 (en) 2003-10-08
DE50302336D1 (de) 2006-04-13
KR20040102060A (ko) 2004-12-03
EP1487421B1 (de) 2006-02-01
CA2478506C (en) 2009-09-08
JP2005521696A (ja) 2005-07-21
IL162267A0 (en) 2005-11-20
IL162267A (en) 2010-02-17
JP4488171B2 (ja) 2010-06-23
WO2003080032A3 (de) 2004-01-08
DE10214002A1 (de) 2003-10-09
US20050089571A1 (en) 2005-04-28

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Legal Events

Date Code Title Description
B25D Requested change of name of applicant approved

Owner name: ROEHM GMBH (DE)

Free format text: NOME ALTERADO DE: ROEEHM GMBH AND CO. KG

B25D Requested change of name of applicant approved

Owner name: EVONIK ROEHM GMBH (DE)

Free format text: NOME ALTERADO DE: ROEHM GMBH

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 11A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2259 DE 22/04/2014.