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WO2010028794A1 - Comprimés à libération prolongée contenant de la quetiapine - Google Patents

Comprimés à libération prolongée contenant de la quetiapine Download PDF

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Publication number
WO2010028794A1
WO2010028794A1 PCT/EP2009/006496 EP2009006496W WO2010028794A1 WO 2010028794 A1 WO2010028794 A1 WO 2010028794A1 EP 2009006496 W EP2009006496 W EP 2009006496W WO 2010028794 A1 WO2010028794 A1 WO 2010028794A1
Authority
WO
WIPO (PCT)
Prior art keywords
water
tablet
formulation according
meth
organic
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2009/006496
Other languages
German (de)
English (en)
Inventor
Yogananda Gujjar Chaitanya
Bala Ramesha Chary Rallabandi
Lal Pasahn Manohar
Dieter Ruchatz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alfred E Tiefenbacher GmbH and Co KG
Original Assignee
Alfred E Tiefenbacher GmbH and 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 Alfred E Tiefenbacher GmbH and Co KG filed Critical Alfred E Tiefenbacher GmbH and Co KG
Priority to EP09778385A priority Critical patent/EP2323632A1/fr
Publication of WO2010028794A1 publication Critical patent/WO2010028794A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K9/20—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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; 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
    • A61K9/2072—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
    • 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
    • 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
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer

Definitions

  • WO 03/039516 describes a capsule or tablet comprising granules containing quetiapine.
  • the granules are characterized in that, in addition to quetiapine, they contain an adjuvant for improving the dispersibility of the active ingredient in an aqueous medium ("floating agent"), such as water-insoluble celluloses, for example crystalline cellulose, powder cellulose and low-substituted hydroxypropyl cellulose, Sodium alginate, propylene glycol alginate, tragacanth and xanthan gum.
  • floating agent aqueous medium
  • water-insoluble celluloses for example crystalline cellulose, powder cellulose and low-substituted hydroxypropyl cellulose, Sodium alginate, propylene glycol alginate, tragacanth and xanthan gum.
  • WO 2004/012699 discloses a quetiapine-containing sustained-release dosage form.
  • the retarding effect is achieved in that the water-soluble active ingredient quetiapine together with a hydrophobic excipient in microparticles, which in turn are coated with a hydrophobic film. These film-coated microparticles can then be pressed into tablets.
  • the microparticles are prepared by granulating the active ingredient with the hydrophobic adjuvant and using an organic solvent.
  • the mass ratio of the at least one matrix-forming, water-insoluble and non-swellable adjuvant to the at least one water-soluble binder in the matrix formulation according to the invention is in particular 1: 1 to 20: 1, preferably 2: 1 to 15: 1, preferably 3: 1 to 10: 1, more preferably 3.5: 1 to 8: 1, and most preferably 4: 1 to 6: 1.
  • the at least one, the matrix-forming, water-insoluble and non-swellable excipient may also be extragranular.
  • the active ingredient is granulated with a filler.
  • fillers z.
  • cellulose powder mannitol, various starches such. Corn starch, microcrystalline cellulose, silicified microcrystalline cellulose, sorbitol, dextrose, lactitol, lactose (anhydrous or as monohydrate) and the like.
  • the tablet was prepared as described in Example 8, wherein in the coating cellulose acetate butyrate replaced by cellulose acetate and Kollicoat IR ® by copovidone and acetone was used as the sole coating solvent. Release profile of the extended release tablet of Example 17 in comparison to the Seroquel ® 200 mg prolonged-release tablet (0.1 N hydrochloric acid solution)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une formulation matricielle d'un comprimé à libération prolongée ou d'un comprimé à libération prolongée enrobé d'une pellicule, comprenant comme principe actif de la quetiapine ou un sel pharmaceutiquement compatible de cette dernière, au moins un adjuvant non gonflable et non hydrosoluble constituant la matrice et au moins un liant hydrosoluble. L'invention concerne également un procédé de production de la formulation selon l'invention, et l'utilisation d'un adjuvant non hydrosoluble et non gonflable constituant la matrice et d'un liant hydrosoluble pour la production d'une formulation matrice ayant un profil de libération progressive et continue de la quetiapine ou d'un sel pharmaceutiquement compatible de cette dernière.
PCT/EP2009/006496 2008-09-10 2009-09-08 Comprimés à libération prolongée contenant de la quetiapine Ceased WO2010028794A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP09778385A EP2323632A1 (fr) 2008-09-10 2009-09-08 Comprimés à libération prolongée contenant de la quetiapine

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008046650.6 2008-09-10
DE200810046650 DE102008046650A1 (de) 2008-09-10 2008-09-10 Quetiapin enthaltende Retardtablette

Publications (1)

Publication Number Publication Date
WO2010028794A1 true WO2010028794A1 (fr) 2010-03-18

Family

ID=41259833

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2009/006496 Ceased WO2010028794A1 (fr) 2008-09-10 2009-09-08 Comprimés à libération prolongée contenant de la quetiapine

Country Status (3)

Country Link
EP (1) EP2323632A1 (fr)
DE (1) DE102008046650A1 (fr)
WO (1) WO2010028794A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101912374A (zh) * 2010-08-08 2010-12-15 浙江华海药业股份有限公司 喹硫平缓释片及其制备方法
WO2010089259A3 (fr) * 2009-02-04 2011-07-07 Woerwag R&D Gmbh Composition à libération prolongée contenant de la quétiapine
CN102335155A (zh) * 2011-10-17 2012-02-01 苏州大学 一种富马酸喹硫平缓释片及其制备方法
DE102011115690A1 (de) 2011-10-11 2013-04-11 Acino Pharma Ag Quetiapin enthaltende Formulierungen
WO2013074048A2 (fr) 2011-08-08 2013-05-23 Mahmut Bilgic Formes pharmaceutiques de type comprimés comprenant un fumarate de quétiapine
RU2588840C1 (ru) * 2015-03-26 2016-07-10 Общество с ограниченной ответственностью ООО "ВАЛЕНТА-ИНТЕЛЛЕКТ" Таблетки кветиапина с пролонгированным высвобождением и способ их получения
EP3199168A1 (fr) 2016-01-28 2017-08-02 G.L. Pharma GmbH Médicament destine à traiter des carences en fer et en acide folique
EP3199145A1 (fr) 2016-01-28 2017-08-02 G.L. Pharma GmbH Formule stabilisee d'une preparation de fer/d'acides foliques
EP4464326A1 (fr) 2023-05-17 2024-11-20 KWIZDA Pharma GmbH Préparation d'une forme pharmaceutique de raifort et de capuinercré
EP4574137A1 (fr) 2023-12-19 2025-06-25 Stada Arzneimittel Ag Procédé de fabrication d'un lyophilisat de diamine oxydase stabilisé et forme pharmaceutique

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100303920A1 (en) * 2009-05-27 2010-12-02 Johan Hjartstam Aqueous Film Coating Composition / 841
WO2011154118A1 (fr) * 2010-06-07 2011-12-15 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Comprimés de quétiapine à libération prolongée
DE102010033527A1 (de) * 2010-08-05 2012-02-09 Acino Pharma Ag Quetiapin-Tabletten
WO2013100879A1 (fr) * 2011-12-27 2013-07-04 Mahmut Bilgic Compositions pharmaceutiques contenant de la quétiapine

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0240228A1 (fr) * 1986-03-27 1987-10-07 Ici Americas Inc. Dérivés de thiazépine
WO1997045124A1 (fr) * 1996-05-31 1997-12-04 Zeneca Limited Compositions pharmaceutiques
WO2005041935A1 (fr) * 2003-10-21 2005-05-12 Alpharma, Inc. Preparations pharmaceutiques contenant de la quetiapine
WO2008012346A1 (fr) * 2006-07-28 2008-01-31 Farmaprojects, S. A. Préparation pharmaceutique de métoprolol à libération prolongée et son procédé de préparation
WO2008090569A1 (fr) * 2007-01-25 2008-07-31 Panacea Biotec Ltd Composition pharmaceutique à libération modifiée et procédé de fabrication
WO2009113051A2 (fr) * 2008-03-12 2009-09-17 Dexcel Ltd. Formulations orales à libération modifiée contenant des thiazépines

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9922271D0 (en) 1999-09-21 1999-11-17 Zeneca Ltd Formulation
DE10029201A1 (de) * 2000-06-19 2001-12-20 Basf Ag Verfahren zur Herstellung fester oraler Darreichungsformen mit retardierender Wirkstoffreisetzung
WO2003039516A1 (fr) 2001-11-07 2003-05-15 Fujisawa Pharmaceuticla Co., Ltd. Procede pour ameliorer la dissolution de medicaments a faible pouvoir de dissolution
US8216609B2 (en) 2002-08-05 2012-07-10 Torrent Pharmaceuticals Limited Modified release composition of highly soluble drugs
BRPI0506710A (pt) * 2004-01-06 2007-05-02 Panacea Biotec Ltd composições farmacêuticas de liberação controlada
US20100178333A1 (en) 2006-01-25 2010-07-15 Astron Research Limited Sustained release dosage form of phenothiazine derivatives containing channelizer
EP2457563B1 (fr) 2006-05-09 2017-03-22 Mallinckrodt LLC Formes posologiques solides à libération modifiée d'ordre zéro
PT103884A (pt) 2006-11-17 2008-05-19 Astrazeneca Ab Composições de libertação prolongada e métodos para a sua preparação

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0240228A1 (fr) * 1986-03-27 1987-10-07 Ici Americas Inc. Dérivés de thiazépine
WO1997045124A1 (fr) * 1996-05-31 1997-12-04 Zeneca Limited Compositions pharmaceutiques
WO2005041935A1 (fr) * 2003-10-21 2005-05-12 Alpharma, Inc. Preparations pharmaceutiques contenant de la quetiapine
WO2008012346A1 (fr) * 2006-07-28 2008-01-31 Farmaprojects, S. A. Préparation pharmaceutique de métoprolol à libération prolongée et son procédé de préparation
WO2008090569A1 (fr) * 2007-01-25 2008-07-31 Panacea Biotec Ltd Composition pharmaceutique à libération modifiée et procédé de fabrication
WO2009113051A2 (fr) * 2008-03-12 2009-09-17 Dexcel Ltd. Formulations orales à libération modifiée contenant des thiazépines

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010089259A3 (fr) * 2009-02-04 2011-07-07 Woerwag R&D Gmbh Composition à libération prolongée contenant de la quétiapine
CN101912374A (zh) * 2010-08-08 2010-12-15 浙江华海药业股份有限公司 喹硫平缓释片及其制备方法
WO2013074048A2 (fr) 2011-08-08 2013-05-23 Mahmut Bilgic Formes pharmaceutiques de type comprimés comprenant un fumarate de quétiapine
DE102011115690A1 (de) 2011-10-11 2013-04-11 Acino Pharma Ag Quetiapin enthaltende Formulierungen
WO2013053485A1 (fr) 2011-10-11 2013-04-18 Acino Pharma Ag Formulations contenant de la quétiapine
CN102335155A (zh) * 2011-10-17 2012-02-01 苏州大学 一种富马酸喹硫平缓释片及其制备方法
RU2588840C1 (ru) * 2015-03-26 2016-07-10 Общество с ограниченной ответственностью ООО "ВАЛЕНТА-ИНТЕЛЛЕКТ" Таблетки кветиапина с пролонгированным высвобождением и способ их получения
EP3199168A1 (fr) 2016-01-28 2017-08-02 G.L. Pharma GmbH Médicament destine à traiter des carences en fer et en acide folique
EP3199145A1 (fr) 2016-01-28 2017-08-02 G.L. Pharma GmbH Formule stabilisee d'une preparation de fer/d'acides foliques
EP3199167A1 (fr) 2016-01-28 2017-08-02 G.L. Pharma GmbH Medicament destine a traiter des carences en fer et en acide folique
EP4464326A1 (fr) 2023-05-17 2024-11-20 KWIZDA Pharma GmbH Préparation d'une forme pharmaceutique de raifort et de capuinercré
WO2024236178A1 (fr) 2023-05-17 2024-11-21 Kwizda Pharma Gmbh Production d'une forme posologique pharmaceutique à partir de raifort et de nasturtium
EP4574137A1 (fr) 2023-12-19 2025-06-25 Stada Arzneimittel Ag Procédé de fabrication d'un lyophilisat de diamine oxydase stabilisé et forme pharmaceutique
WO2025132504A1 (fr) 2023-12-19 2025-06-26 Stada Arzneimittel Ag Procédé de production d'un lyophilisat de diamine oxydase stabilisé et forme galénique pharmaceutique

Also Published As

Publication number Publication date
DE102008046650A1 (de) 2010-03-11
EP2323632A1 (fr) 2011-05-25

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