FR2901478B1 - Forme pharmaceutique orale multimicroparticulaire a liberation prolongee - Google Patents

Forme pharmaceutique orale multimicroparticulaire a liberation prolongee

Info

Publication number
FR2901478B1
FR2901478B1 FR0604685A FR0604685A FR2901478B1 FR 2901478 B1 FR2901478 B1 FR 2901478B1 FR 0604685 A FR0604685 A FR 0604685A FR 0604685 A FR0604685 A FR 0604685A FR 2901478 B1 FR2901478 B1 FR 2901478B1
Authority
FR
France
Prior art keywords
multimicroparticulated
oral pharmaceutical
pharmaceutical form
prolonged release
prolonged
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.)
Active
Application number
FR0604685A
Other languages
English (en)
Other versions
FR2901478A1 (fr
Inventor
Florence Guimberteau
Frederic Dargelas
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.)
Flamel Ireland Ltd
Original Assignee
Flamel Technologies SA
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 Flamel Technologies SA filed Critical Flamel Technologies SA
Priority to FR0604685A priority Critical patent/FR2901478B1/fr
Priority to PCT/EP2007/055069 priority patent/WO2007135193A2/fr
Priority to JP2009511528A priority patent/JP5654750B2/ja
Priority to EP07729498A priority patent/EP2040685A2/fr
Priority to CNA200780018905XA priority patent/CN101453994A/zh
Priority to CA2651451A priority patent/CA2651451C/fr
Publication of FR2901478A1 publication Critical patent/FR2901478A1/fr
Application granted granted Critical
Publication of FR2901478B1 publication Critical patent/FR2901478B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/745Polymers of hydrocarbons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00Anaesthetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; 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
    • A61K9/1676Agglomerates; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
FR0604685A 2006-05-24 2006-05-24 Forme pharmaceutique orale multimicroparticulaire a liberation prolongee Active FR2901478B1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
FR0604685A FR2901478B1 (fr) 2006-05-24 2006-05-24 Forme pharmaceutique orale multimicroparticulaire a liberation prolongee
PCT/EP2007/055069 WO2007135193A2 (fr) 2006-05-24 2007-05-24 Forme pharmaceutique orale multimicroparticulaire a liberation prolongee comprenant des moyens anti-mesusage et resistant a l'alcool
JP2009511528A JP5654750B2 (ja) 2006-05-24 2007-05-24 持続性放出マルチ微粒子状経口医薬形態
EP07729498A EP2040685A2 (fr) 2006-05-24 2007-05-24 Forme pharmaceutique orale multimicroparticulaire a liberation prolongee comprenant des moyens anti-mesusage et resistant a l'alcool
CNA200780018905XA CN101453994A (zh) 2006-05-24 2007-05-24 延长释药的多微粒口服药物剂型
CA2651451A CA2651451C (fr) 2006-05-24 2007-05-24 Forme pharmaceutique orale multimicroparticulaire a liberation prolongee

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR0604685A FR2901478B1 (fr) 2006-05-24 2006-05-24 Forme pharmaceutique orale multimicroparticulaire a liberation prolongee

Publications (2)

Publication Number Publication Date
FR2901478A1 FR2901478A1 (fr) 2007-11-30
FR2901478B1 true FR2901478B1 (fr) 2015-06-05

Family

ID=37435577

Family Applications (1)

Application Number Title Priority Date Filing Date
FR0604685A Active FR2901478B1 (fr) 2006-05-24 2006-05-24 Forme pharmaceutique orale multimicroparticulaire a liberation prolongee

Country Status (6)

Country Link
EP (1) EP2040685A2 (fr)
JP (1) JP5654750B2 (fr)
CN (1) CN101453994A (fr)
CA (1) CA2651451C (fr)
FR (1) FR2901478B1 (fr)
WO (1) WO2007135193A2 (fr)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003024429A1 (fr) 2001-09-21 2003-03-27 Egalet A/S Systeme de liberation a base de polymere
US20040253310A1 (en) 2001-09-21 2004-12-16 Gina Fischer Morphine polymer release system
ATE495732T1 (de) 2003-03-26 2011-02-15 Egalet As Morphin-system mit kontrollierter freisetzung
WO2008148798A2 (fr) 2007-06-04 2008-12-11 Egalet A/S Compositions pharmaceutiques à libération contrôlée pour un effet prolongé
JP2011506318A (ja) * 2007-12-06 2011-03-03 デュレクト コーポレーション 経口医薬製剤
BRPI0913724B8 (pt) * 2008-09-18 2021-05-25 Purdue Pharma Lp formas farmacêuticas de liberação prolongada compreendendo naltrexona e poli (e-caprolactona) e seu preparo
US20100260844A1 (en) 2008-11-03 2010-10-14 Scicinski Jan J Oral pharmaceutical dosage forms
CA2751667C (fr) 2009-02-06 2016-12-13 Egalet Ltd. Composition a liberation immediate resistant a une maltraitance par prise d'alcool
AU2010265213B2 (en) 2009-06-24 2012-08-23 Egalet Ltd. Controlled release formulations
MX347753B (es) * 2010-02-24 2017-05-10 Cima Labs Inc Formulaciones resistentes al abuso.
DK4011364T3 (da) * 2011-03-23 2024-03-18 Ironshore Pharmaceuticals & Dev Inc Fremgangsmåder og sammensætninger til behandling af ADD (Attention Deficit Disorder)
CN102516473B (zh) * 2011-12-14 2013-07-24 华南理工大学 细胞片智能分离用共聚纳米复合水凝胶及其制备方法与应用
MX2014015880A (es) 2012-07-06 2015-08-05 Egalet Ltd Composiciones farmaceuticas disuasivas de abuso para liberacion controlada.
WO2014144975A1 (fr) 2013-03-15 2014-09-18 Durect Corporation Compositions ayant un agent de modification rhéologique pour réduire une variabilité de dissolution
CA3042642A1 (fr) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Comprime extrude anti-abus a liberation immediate
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9707184B2 (en) 2014-07-17 2017-07-18 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
CA2936746C (fr) * 2014-10-31 2017-06-27 Purdue Pharma Methodes et compositions destinees au traitement du trouble de deficit d'attention
CA3010636A1 (fr) 2016-06-29 2018-01-04 CannScience Innovations Inc. Resines de cannabis decarboxylees, leurs utilisations et leurs procedes de fabrication
EP3473246A1 (fr) 2017-10-19 2019-04-24 Capsugel Belgium NV Formulations anti-abus à libération immédiate
CN111841508B (zh) * 2020-07-28 2021-08-17 南昌航空大学 一种磺基水杨酸修饰壳聚糖/二氧化硅微球及其制备方法和应用

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2007181C (fr) * 1989-01-06 1998-11-24 Angelo Mario Morella Compose pharmaceutique a liberation continue
JP3677156B2 (ja) * 1997-09-05 2005-07-27 武田薬品工業株式会社 医薬
JP2002003366A (ja) * 2000-06-23 2002-01-09 Freunt Ind Co Ltd 固形薬剤用水系コーティング剤組成物
MXPA04001206A (es) * 2001-08-06 2004-07-08 Euro Celtique Sa Composiciones y metodos para prevenir el abuso de opioides.
US20030059397A1 (en) * 2001-09-17 2003-03-27 Lyn Hughes Dosage forms
US20030068276A1 (en) * 2001-09-17 2003-04-10 Lyn Hughes Dosage forms
SI1578350T1 (sl) * 2002-03-26 2009-10-31 Euro Celtique Sa Z gelom obloženi sestavki z zadržanim sproščanjem
CA2499994C (fr) * 2002-09-23 2012-07-10 Verion, Inc. Compositions pharmaceutiques n'induisant pas l'abus
DE10250084A1 (de) * 2002-10-25 2004-05-06 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
US20040110781A1 (en) * 2002-12-05 2004-06-10 Harmon Troy M. Pharmaceutical compositions containing indistinguishable drug components
JP5296314B2 (ja) * 2003-07-17 2013-09-25 バナー ファーマキャップス,インコーポレイティド 制御放出製剤
DE10336400A1 (de) * 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
TWI350762B (en) * 2004-02-12 2011-10-21 Euro Celtique Sa Particulates
FR2872044B1 (fr) * 2004-06-28 2007-06-29 Flamel Technologies Sa Formulation pharmaceutique a base d'antibiotique sous forme microcapsulaire
CA2572352A1 (fr) * 2004-07-01 2006-01-12 Gruenenthal Gmbh Forme posologique anti-abus pour administration par voie orale contenant du (1r, 2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol
JP5046946B2 (ja) * 2004-10-15 2012-10-10 スパーナス ファーマシューティカルズ インコーポレイテッド 低乱用性薬学的製剤
FR2892937B1 (fr) * 2005-11-10 2013-04-05 Flamel Tech Sa Forme pharmaceutique orale microparticulaire anti-mesusage

Also Published As

Publication number Publication date
CA2651451C (fr) 2013-08-20
CA2651451A1 (fr) 2007-11-29
CN101453994A (zh) 2009-06-10
JP2009537610A (ja) 2009-10-29
EP2040685A2 (fr) 2009-04-01
JP5654750B2 (ja) 2015-01-14
WO2007135193A2 (fr) 2007-11-29
WO2007135193A3 (fr) 2008-06-26
FR2901478A1 (fr) 2007-11-30

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Legal Events

Date Code Title Description
PLFP Fee payment

Year of fee payment: 10

TP Transmission of property

Owner name: FLAMEL IRELAND LIMITED, IE

Effective date: 20151119

PLFP Fee payment

Year of fee payment: 11

PLFP Fee payment

Year of fee payment: 12