WO2011045774A3 - Compositions pharmaceutiques à libération prolongée de palipéridone et leurs procédés de préparation - Google Patents

Compositions pharmaceutiques à libération prolongée de palipéridone et leurs procédés de préparation Download PDF

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Publication number
WO2011045774A3
WO2011045774A3 PCT/IB2010/054714 IB2010054714W WO2011045774A3 WO 2011045774 A3 WO2011045774 A3 WO 2011045774A3 IB 2010054714 W IB2010054714 W IB 2010054714W WO 2011045774 A3 WO2011045774 A3 WO 2011045774A3
Authority
WO
WIPO (PCT)
Prior art keywords
paliperidone
preparation
pharmaceutical compositions
extended release
processes
Prior art date
Application number
PCT/IB2010/054714
Other languages
English (en)
Other versions
WO2011045774A4 (fr
WO2011045774A2 (fr
Inventor
Kumaravel Vivek
Rajan Kumar Verma
Romi Barat Singh
Original Assignee
Ranbaxy Laboratories Limited
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 Ranbaxy Laboratories Limited filed Critical Ranbaxy Laboratories Limited
Priority to CA2777856A priority Critical patent/CA2777856A1/fr
Priority to EP10773995.5A priority patent/EP2488162A2/fr
Priority to AU2010308021A priority patent/AU2010308021A1/en
Priority to US13/502,016 priority patent/US20130129827A1/en
Publication of WO2011045774A2 publication Critical patent/WO2011045774A2/fr
Publication of WO2011045774A3 publication Critical patent/WO2011045774A3/fr
Publication of WO2011045774A4 publication Critical patent/WO2011045774A4/fr
Priority to ZA2012/03176A priority patent/ZA201203176B/en

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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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K9/2072—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
    • A61K9/2072—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
    • A61K9/20—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
    • A61K9/2072—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
    • A61K9/5005—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
    • A61K9/5005—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
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Landscapes

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

Abstract

La présente invention concerne des compositions pharmaceutiques à libération prolongée de palipéridone et leur procédé de préparation.
PCT/IB2010/054714 2009-10-16 2010-10-18 Compositions pharmaceutiques à libération prolongée de palipéridone et leurs procédés de préparation WO2011045774A2 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2777856A CA2777856A1 (fr) 2009-10-16 2010-10-18 Compositions pharmaceutiques a liberation prolongee de paliperidone et leurs procedes de preparation
EP10773995.5A EP2488162A2 (fr) 2009-10-16 2010-10-18 Compositions pharmaceutiques à libération prolongée de palipéridone et leurs procédés de préparation
AU2010308021A AU2010308021A1 (en) 2009-10-16 2010-10-18 Extended release pharmaceutical compositions of paliperidone and processes of preparation thereof
US13/502,016 US20130129827A1 (en) 2009-10-16 2010-10-18 Extended release pharmaceutical compositions of paliperidone and processes of preparation thereof
ZA2012/03176A ZA201203176B (en) 2009-10-16 2012-05-02 Extended release pharmaceutical compositions of paliperidone and processes of preparation thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2150DE2009 2009-10-16
IN2150/DEL/2009 2009-10-16

Publications (3)

Publication Number Publication Date
WO2011045774A2 WO2011045774A2 (fr) 2011-04-21
WO2011045774A3 true WO2011045774A3 (fr) 2011-06-16
WO2011045774A4 WO2011045774A4 (fr) 2011-08-11

Family

ID=43413726

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2010/054714 WO2011045774A2 (fr) 2009-10-16 2010-10-18 Compositions pharmaceutiques à libération prolongée de palipéridone et leurs procédés de préparation

Country Status (6)

Country Link
US (1) US20130129827A1 (fr)
EP (1) EP2488162A2 (fr)
AU (1) AU2010308021A1 (fr)
CA (1) CA2777856A1 (fr)
WO (1) WO2011045774A2 (fr)
ZA (1) ZA201203176B (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9271939B2 (en) 2010-03-15 2016-03-01 Inventia Healthcare Private Limited Stabilized prolonged release pharmaceutical composition comprising atypical antipsychotic
US20130034605A1 (en) * 2011-08-01 2013-02-07 Micro Labs Limited Extended release pharmaceutical compositions containing paliperidone
EP3041463A1 (fr) * 2013-09-02 2016-07-13 Sun Pharmaceutical Industries Ltd Forme galénique à libération pulsatile
GR1008842B (el) * 2015-08-06 2016-09-05 Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων Φαρμακευτικο σκευασμα περιεχον εναν ατυπο αντιψυχωσιμο παραγοντα και μεθοδος για την παρασκευη αυτου
EP3439638A1 (fr) * 2016-04-05 2019-02-13 Pharmathen S.A. Composition pharmaceutique comprenant un agent antipsychotique atypique et son procédé de préparation

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004010981A1 (fr) * 2002-07-29 2004-02-05 Alza Corporation Techniques et formes de dose d'apport commande de paliperidone
WO2009025859A1 (fr) * 2007-08-21 2009-02-26 Teva Pharmaceutical Industries Ltd. Formulation à libération prolongée de palipéridone
WO2009109993A1 (fr) * 2008-02-04 2009-09-11 Torrent Pharmaceuticals Ltd. Forme pharmaceutique à libération prolongée de palipéridone

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5158952A (en) 1988-11-07 1992-10-27 Janssen Pharmaceutica N.V. 3-[2-[4-(6-fluoro-1,2-benzisoxozol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9 tetrahydro-9-hydroxy-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one, compositions and method of use
ES2213404T3 (es) 1998-12-17 2004-08-16 Alza Corporation Transformacion de capsulas de gelatina rellenas de liquido en sistemas de liberacion controlada mediante multiples revestimientos.
US20050232995A1 (en) 2002-07-29 2005-10-20 Yam Nyomi V Methods and dosage forms for controlled delivery of paliperidone and risperidone

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004010981A1 (fr) * 2002-07-29 2004-02-05 Alza Corporation Techniques et formes de dose d'apport commande de paliperidone
WO2009025859A1 (fr) * 2007-08-21 2009-02-26 Teva Pharmaceutical Industries Ltd. Formulation à libération prolongée de palipéridone
WO2009109993A1 (fr) * 2008-02-04 2009-09-11 Torrent Pharmaceuticals Ltd. Forme pharmaceutique à libération prolongée de palipéridone

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
KRAMER M ET AL: "Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: A randomized, double-blind, placebo-controlled study", JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY, WILLIAMS AND WILKINS, US, vol. 27, no. 1, 1 February 2007 (2007-02-01), pages 6 - 14, XP009087471, ISSN: 0271-0749, DOI: DOI:10.1097/JCP.0B013E31802DDA4A *

Also Published As

Publication number Publication date
WO2011045774A4 (fr) 2011-08-11
ZA201203176B (en) 2013-01-30
EP2488162A2 (fr) 2012-08-22
US20130129827A1 (en) 2013-05-23
AU2010308021A1 (en) 2012-05-17
WO2011045774A2 (fr) 2011-04-21
CA2777856A1 (fr) 2011-04-21

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