ATE530170T1 - Paliperidonformulierung mit verzögerter freisetzung - Google Patents

Paliperidonformulierung mit verzögerter freisetzung

Info

Publication number
ATE530170T1
ATE530170T1 AT08795541T AT08795541T ATE530170T1 AT E530170 T1 ATE530170 T1 AT E530170T1 AT 08795541 T AT08795541 T AT 08795541T AT 08795541 T AT08795541 T AT 08795541T AT E530170 T1 ATE530170 T1 AT E530170T1
Authority
AT
Austria
Prior art keywords
sustained release
release formulation
paliperidone
paliperidone sustained
preparing
Prior art date
Application number
AT08795541T
Other languages
English (en)
Inventor
Michael Fox
Capua Simona Di
Ronny Reinberg
Original Assignee
Teva Pharma
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 Teva Pharma filed Critical Teva Pharma
Application granted granted Critical
Publication of ATE530170T1 publication Critical patent/ATE530170T1/de

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
    • A61K9/2072—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
    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further 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
    • A61K9/2072—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
    • 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
    • A61P25/00—Drugs for disorders of the nervous 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
    • A61K9/14—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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • 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
    • A61K9/5036—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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AT08795541T 2007-08-21 2008-08-21 Paliperidonformulierung mit verzögerter freisetzung ATE530170T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US93559707P 2007-08-21 2007-08-21
PCT/US2008/010014 WO2009025859A1 (en) 2007-08-21 2008-08-21 Paliperidone sustained release formulation

Publications (1)

Publication Number Publication Date
ATE530170T1 true ATE530170T1 (de) 2011-11-15

Family

ID=39853528

Family Applications (1)

Application Number Title Priority Date Filing Date
AT08795541T ATE530170T1 (de) 2007-08-21 2008-08-21 Paliperidonformulierung mit verzögerter freisetzung

Country Status (8)

Country Link
US (1) US20090087487A1 (de)
EP (1) EP2079446B1 (de)
AT (1) ATE530170T1 (de)
ES (1) ES2374200T3 (de)
HR (1) HRP20110863T1 (de)
PL (1) PL2079446T3 (de)
PT (1) PT2079446E (de)
WO (1) WO2009025859A1 (de)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009080651A1 (en) 2007-12-19 2009-07-02 Janssen Pharmaceutica Nv Dosing regimen associated with long acting injectable paliperidone esters
WO2009109993A1 (en) * 2008-02-04 2009-09-11 Torrent Pharmaceuticals Ltd. Extended release dosage form of paliperidone
WO2010009900A1 (en) * 2008-07-25 2010-01-28 Krka, D.D. Novo Mesto Paliperidone composition comprising solid matrix particles
EP2161019A1 (de) * 2008-09-05 2010-03-10 KRKA, D.D., Novo Mesto Verlängerte Freisetzung von einer pharmazeutischen Mehrteilchenzusammensetzung mit Paliperidon
WO2010089775A2 (en) * 2009-02-05 2010-08-12 Getz Pharma Research Improved drug dosage form for controlled delivery of one or more pharmaceutically active agent
WO2011018246A2 (en) 2009-08-13 2011-02-17 Synthon B.V. Controlled release paliperidone composition
US20110052687A1 (en) * 2009-08-26 2011-03-03 Glenmark Generics Ltd Extended release pharmaceutical composition of paliperidone
AU2010308021A1 (en) * 2009-10-16 2012-05-17 Ranbaxy Laboratories Limited Extended release pharmaceutical compositions of paliperidone and processes of preparation thereof
US9271939B2 (en) * 2010-03-15 2016-03-01 Inventia Healthcare Private Limited Stabilized prolonged release pharmaceutical composition comprising atypical antipsychotic
WO2012014052A2 (en) * 2010-07-30 2012-02-02 Micro Labs Limited Novel coated extended release pharmaceutical compositions containing paliperidone
US20130034605A1 (en) * 2011-08-01 2013-02-07 Micro Labs Limited Extended release pharmaceutical compositions containing paliperidone
MX355478B (es) * 2011-09-16 2018-04-19 Purdue Pharma Lp Formulaciones farmacéuticas resistentes a la manipulación.
JP6138798B2 (ja) * 2011-09-16 2017-05-31 パーデュー ファーマ エルピー 不正改変抵抗性即時放出性製剤
WO2014027973A1 (en) 2012-08-14 2014-02-20 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Paliperidone oral solution
WO2014027974A1 (en) 2012-08-17 2014-02-20 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Orally disintegrating formulation of paliperidone
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
EP3187176A1 (de) * 2015-12-29 2017-07-05 Sanovel Ilac Sanayi ve Ticaret A.S. Paliperidon-minitabletten

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4352811A (en) * 1981-11-12 1982-10-05 Hoechst-Roussel Pharmaceuticals Inc. 3-(1-Substituted-4-piperidyl)-1,2-benzisoxazoles
US4458076A (en) * 1983-05-31 1984-07-03 Hoechst-Roussel Pharmaceuticals 3-(4-Piperidinyl)-1,2-benzisothiazoles
US4804663A (en) * 1985-03-27 1989-02-14 Janssen Pharmaceutica N.V. 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
US5254556A (en) * 1988-11-07 1993-10-19 Janssen Pharmaceutica N.V. 3-piperidinyl-1,2-benzisoxazoles
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
SI0730594T1 (en) * 1993-11-23 1999-12-31 Janssen Pharmaceutica N.V. 9-HYDROXY-PYRIDO (1,2-a)PYRIMIDIN-4-ONE ETHER DERIVATIVES
PL210119B1 (pl) * 2002-07-29 2011-12-30 Alza Corp Lek do leczenia stanu wrażliwego na paliperidon
US20060210633A1 (en) * 2003-04-03 2006-09-21 Sun Pharmaceutical Industries Limited Programmed drug delivery system
WO2005065645A2 (en) * 2003-12-31 2005-07-21 Actavis Group Hf Donepezil formulations
MX2007001563A (es) * 2004-08-04 2008-03-05 Johnson & Johnson Composicion para liberacion sostenida de farmaco que demuestra un patron de liberacion ascendente del orden cero, metodos para la elaboracion de dicha composicion.
US20060189635A1 (en) * 2005-02-04 2006-08-24 Michelle Kramer Enhanced efficacy benzisoxazole derivative dosage forms and methods
US20080034927A1 (en) * 2006-08-04 2008-02-14 Emerson Electric Co. Basin wrench

Also Published As

Publication number Publication date
PT2079446E (pt) 2011-12-23
HRP20110863T1 (hr) 2011-12-31
PL2079446T3 (pl) 2012-04-30
ES2374200T3 (es) 2012-02-14
US20090087487A1 (en) 2009-04-02
EP2079446A1 (de) 2009-07-22
WO2009025859A1 (en) 2009-02-26
EP2079446B1 (de) 2011-10-26

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