BRPI0109640B8 - forma farmacêutica multiparticulada adequada para liberação uniforme de um ingrediente farmacêutico ativo no intestino delgado e no intestino grosso, seu processo de produção e seu uso - Google Patents

forma farmacêutica multiparticulada adequada para liberação uniforme de um ingrediente farmacêutico ativo no intestino delgado e no intestino grosso, seu processo de produção e seu uso

Info

Publication number
BRPI0109640B8
BRPI0109640B8 BRPI0109640A BRPI0109640B8 BR PI0109640 B8 BRPI0109640 B8 BR PI0109640B8 BR PI0109640 A BRPI0109640 A BR PI0109640A BR PI0109640 B8 BRPI0109640 B8 BR PI0109640B8
Authority
BR
Brazil
Prior art keywords
multiparticulate
large intestine
active pharmaceutical
pharmaceutical ingredient
small
Prior art date
Application number
Other languages
English (en)
Inventor
Petereit Hans-Ulrich
Dressman Jennifer
Rudolph Markus
Beckert Thomas
Original Assignee
Evonik Roehm Gmbh
Roehm Gmbh
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 Evonik Roehm Gmbh, Roehm Gmbh filed Critical Evonik Roehm Gmbh
Priority claimed from PCT/EP2001/002679 external-priority patent/WO2002060415A1/de
Publication of BR0109640A publication Critical patent/BR0109640A/pt
Publication of BRPI0109640B1 publication Critical patent/BRPI0109640B1/pt
Publication of BRPI0109640B8 publication Critical patent/BRPI0109640B8/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
    • A61K31/56—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
    • 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
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • 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

Landscapes

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

Abstract

"forma de droga multiparticulada compreendendo pelo menos duas formas de pélete diferentemente revestidas". a invenção refere-se a uma forma de droga multiparticulada para liberação uniforme de um ingrediente farmacêutico ativo no intestino delgado e no intestino grosso, compreendendo pelo menos duas formas de péletes a e b que compreendem um ingrediente farmacêutico ativo no núcleo e tem revestimentos de polímero diferentes que determinam a liberação do ingrediente ativo em valores de ph diferentes, caracterizado pelo fato de que a forma de pélete a é suprida de um revestimento de polímero interno, e tem um revestimento entérico externo que rapidamente dissolve acima do ph em torno de 5,5, e a forma de pélete b é suprida de um revestimento de polímero que, no teste de liberação usp, libera menos do que 20% do ingrediente ativo em ph de 6,8 em 6 horas e libera mais do que 50% do ingrediente ativo em ph de 7,2 em 6 horas. a invenção adicionalmente refere-se a um processo para produzir a forma de droga multiparticulada e ao uso de formas de pélete a e b para produzir a forma de droga.
BR0109640-0 2001-01-31 2001-03-09 forma farmacêutica multiparticulada adequada para liberação uniforme de um ingrediente farmacêutico ativo no intestino delgado e no intestino grosso, seu processo de produção e seu uso BRPI0109640B8 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE10104504 2001-01-31
DE10104504.2 2001-01-31
DE10104880.7 2001-02-01
DE10104880A DE10104880A1 (de) 2001-01-31 2001-02-01 Multipartikuläre Arzneiform, enthaltend mindestens zwei unterschiedlich überzogene Pelletformen
PCT/EP2001/002679 WO2002060415A1 (de) 2001-01-31 2001-03-09 Multipartikuläre arzneiform, enthaltend mindestens zwei unterschiedlich überzogene pelletformen

Publications (3)

Publication Number Publication Date
BR0109640A BR0109640A (pt) 2003-04-22
BRPI0109640B1 BRPI0109640B1 (pt) 2020-03-10
BRPI0109640B8 true BRPI0109640B8 (pt) 2021-05-25

Family

ID=7672474

Family Applications (1)

Application Number Title Priority Date Filing Date
BR0109640-0 BRPI0109640B8 (pt) 2001-01-31 2001-03-09 forma farmacêutica multiparticulada adequada para liberação uniforme de um ingrediente farmacêutico ativo no intestino delgado e no intestino grosso, seu processo de produção e seu uso

Country Status (5)

Country Link
BG (1) BG65878B1 (pt)
BR (1) BRPI0109640B8 (pt)
DE (1) DE10104880A1 (pt)
IL (1) IL151150A (pt)
MX (1) MX2007010610A (pt)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102008048729A1 (de) * 2008-09-24 2010-03-25 Add Technologies Ltd Advanced Drug Delivery Multipartikuläre Tabletten und Verfahren zur deren Herstellung
GB201118182D0 (en) * 2011-10-21 2011-12-07 Jagotec Ag Improvements in or relating to organic compounds
DE102012105528A1 (de) 2012-06-25 2014-01-02 Hennig Arzneimittel Gmbh & Co. Kg Arzneiform zur Freisetzung von Wirkstoffen

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3438291A1 (de) * 1984-10-19 1986-04-24 Röhm GmbH, 6100 Darmstadt Verfahren zur herstellung einer waessrigen ueberzugsmitteldispersion und ihre verwendung zum ueberziehen von arzneimitteln
JPH072650A (ja) * 1993-06-18 1995-01-06 Tanabe Seiyaku Co Ltd 放出部位制御型製剤
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
DE29502547U1 (de) * 1995-02-16 1995-03-30 Röhm GmbH, 64293 Darmstadt Thermoplastisches Überzugs- und Bindemittel für Arzneiformen

Also Published As

Publication number Publication date
BRPI0109640B1 (pt) 2020-03-10
IL151150A (en) 2010-04-15
BR0109640A (pt) 2003-04-22
BG65878B1 (bg) 2010-04-30
BG107147A (bg) 2003-05-30
MX2007010610A (es) 2009-02-19
DE10104880A1 (de) 2002-08-08

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Legal Events

Date Code Title Description
B07A Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]
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

B09B Patent application refused [chapter 9.2 patent gazette]
B12B Appeal: appeal against refusal
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notice of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B16A Patent or certificate of addition of invention granted

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 10/03/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/03/2001 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B21A Expiry acc. art. 78, item i of ipl- expiry of the term of protection

Free format text: PATENTE EXTINTA EM 09/03/2021