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)
French (fr)
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 EP07729498A priority patent/EP2040685A2/fr
Priority to PCT/EP2007/055069 priority patent/WO2007135193A2/fr
Priority to CNA200780018905XA priority patent/CN101453994A/zh
Priority to CA2651451A priority patent/CA2651451C/fr
Priority to JP2009511528A priority patent/JP5654750B2/ja
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

    • 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
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic 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
    • A61K31/343—Heterocyclic 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
    • 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
    • A61K31/74—Synthetic polymeric materials
    • A61K31/745—Polymers of hydrocarbons
    • 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
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
    • A61K9/14—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
    • A61K9/48—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
    • 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

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)
  • Anesthesiology (AREA)
  • Neurosurgery (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
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
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
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
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

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 (ja)
JP (1) JP5654750B2 (ja)
CN (1) CN101453994A (ja)
CA (1) CA2651451C (ja)
FR (1) FR2901478B1 (ja)
WO (1) WO2007135193A2 (ja)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003024429A1 (en) 2001-09-21 2003-03-27 Egalet A/S Polymer release system
EP1429744A1 (en) 2001-09-21 2004-06-23 Egalet A/S Morphine polymer release system
EP1610767B1 (en) 2003-03-26 2011-01-19 Egalet A/S Morphine controlled release system
EP2155167A2 (en) 2007-06-04 2010-02-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
AU2008335809A1 (en) * 2007-12-06 2009-06-18 Durect Corporation Methods useful for the treatment of pain, arthritic conditions, or inflammation associated with a chronic condition
CN102159193B (zh) * 2008-09-18 2015-09-16 普渡制药公司 包含聚(ε-己内酯)的药物剂型
US20100260844A1 (en) 2008-11-03 2010-10-14 Scicinski Jan J Oral pharmaceutical dosage forms
US9005660B2 (en) 2009-02-06 2015-04-14 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
NZ603579A (en) 2009-06-24 2014-02-28 Egalet Ltd Controlled release formulations
US20130209560A1 (en) * 2010-02-24 2013-08-15 Cima Labs Inc. Abuse-resistant formulations
EP4316488A3 (en) * 2011-03-23 2024-02-28 Ironshore Pharmaceuticals & Development, Inc. Methods and compositions for treatment of 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
BR112015000150A2 (pt) 2012-07-06 2017-06-27 Egalet Ltd composições farmacêuticas dissuasoras de abuso de liberação controlada
CN105120659A (zh) 2013-03-15 2015-12-02 度瑞公司 用于降低溶解可变性的具有流变改性剂的组合物
WO2015023675A2 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
DK3169315T3 (da) 2014-07-17 2020-08-10 Pharmaceutical Manufacturing Res Services In Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
CA2936748C (en) * 2014-10-31 2017-08-08 Purdue Pharma Methods and compositions particularly for treatment of attention deficit disorder
US10143706B2 (en) 2016-06-29 2018-12-04 Cannscience Innovations, Inc. Decarboxylated cannabis resins, uses thereof and methods of making same
EP3473246A1 (en) 2017-10-19 2019-04-24 Capsugel Belgium NV Immediate release abuse deterrent formulations
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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CA2007181C (en) * 1989-01-06 1998-11-24 Angelo Mario Morella Sustained release pharmaceutical composition
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
IL160217A0 (en) * 2001-08-06 2004-07-25 Euro Celtique Sa Compositions and methods to prevent abuse of opioids
US20030068276A1 (en) * 2001-09-17 2003-04-10 Lyn Hughes Dosage forms
US20030059397A1 (en) * 2001-09-17 2003-03-27 Lyn Hughes Dosage forms
US7790215B2 (en) * 2002-03-26 2010-09-07 Purdue Pharma Lp Sustained-release gel coated compositions
EP1551402A4 (en) * 2002-09-23 2009-05-27 Verion Inc PHARMACEUTICAL COMPOSITIONS NOT INDUCING ABUSE
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
EP1653931A2 (en) * 2003-07-17 2006-05-10 Banner Pharmacaps, Inc. Controlled release preparations
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
KR101204657B1 (ko) * 2004-07-01 2012-11-27 그뤼넨탈 게엠베하 (1r,2r)-3-(3-디메틸아미노-1-에틸-2-메틸-프로필)-페놀을 함유하는 남용 방지 경구 투여 제형
WO2006044805A2 (en) * 2004-10-15 2006-04-27 Supernus Pharmaceuticals, Inc. Less abusable pharmaceutical preparations
FR2892937B1 (fr) * 2005-11-10 2013-04-05 Flamel Tech Sa Forme pharmaceutique orale microparticulaire anti-mesusage

Also Published As

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

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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