WO2003084518A3 - Suspension orale de microcapsules de principes actifs - Google Patents

Suspension orale de microcapsules de principes actifs

Info

Publication number
WO2003084518A3
WO2003084518A3 PCT/FR2003/001096 FR0301096W WO03084518A3 WO 2003084518 A3 WO2003084518 A3 WO 2003084518A3 FR 0301096 W FR0301096 W FR 0301096W WO 03084518 A3 WO03084518 A3 WO 03084518A3
Authority
WO
WIPO (PCT)
Prior art keywords
active principle
microcapsules
modified release
suspension
active
Prior art date
Application number
PCT/FR2003/001096
Other languages
English (en)
Other versions
WO2003084518A2 (fr
Inventor
Catherine Castan
Florence Guimberteau
Remi Meyrueix
Original Assignee
Flamel Tech Sa
Catherine Castan
Florence Guimberteau
Remi Meyrueix
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
Priority claimed from FR0210847A external-priority patent/FR2843881B1/fr
Priority to EP03745832A priority Critical patent/EP1492511B3/fr
Priority to US10/510,643 priority patent/US7906145B2/en
Priority to JP2003581758A priority patent/JP4732696B2/ja
Priority to KR1020047016079A priority patent/KR101061351B1/ko
Priority to BR122013000700A priority patent/BR122013000700B8/pt
Priority to IL16422203A priority patent/IL164222A0/xx
Priority to IL16422103A priority patent/IL164221A0/xx
Priority to DE60325709T priority patent/DE60325709D1/de
Priority to BRPI0309142A priority patent/BRPI0309142C1/pt
Application filed by Flamel Tech Sa, Catherine Castan, Florence Guimberteau, Remi Meyrueix filed Critical Flamel Tech Sa
Priority to ES03745832T priority patent/ES2320438T7/es
Priority to CA2480826A priority patent/CA2480826C/fr
Priority to MXPA04009968A priority patent/MXPA04009968A/es
Priority to AU2003246792A priority patent/AU2003246792B2/en
Publication of WO2003084518A2 publication Critical patent/WO2003084518A2/fr
Publication of WO2003084518A3 publication Critical patent/WO2003084518A3/fr
Priority to IL164222A priority patent/IL164222A/en
Priority to HK05111660.1A priority patent/HK1079448A1/xx
Priority to US13/014,137 priority patent/US10004693B2/en
Priority to US14/848,603 priority patent/US20150374635A1/en
Priority to US14/848,699 priority patent/US9814684B2/en
Priority to US15/625,727 priority patent/US20170281558A1/en

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
    • A61K9/5005—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
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • 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
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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

Abstract

L'invention concerne des formulations pharmaceutiques liquides, administrables oralement, à libération modifiée de principe(s) actif(s) à l'exclusion de l'amoxicilline et constituées par des suspensions de particules de principes actifs enrobées (microcapsules). Les microcapsules constituant la phase dispersée de la suspension sont conçues, conformément à l'invention, pour permettre la libération modifiée du (ou des) principe(s) actif(s), selon un profil n'évoluant pas au cours du stockage de la suspension liquide. Pour ce faire, les inventeurs proposent de sélectionner une composition d'enrobage spécifique pour les microcapsules constituée d'au moins quatre composants permettant de conserver ces microcapsules dans l'eau sans modifier leurs propriétés de libération modifiée du principe actif, cette phase liquide étant par ailleurs saturée en principe(s) actif(s).
PCT/FR2003/001096 2002-04-09 2003-04-07 Suspension orale de microcapsules de principes actifs WO2003084518A2 (fr)

Priority Applications (19)

Application Number Priority Date Filing Date Title
ES03745832T ES2320438T7 (es) 2002-04-09 2003-04-07 Formulación farmaceútica oral de suspensión acuosa de microcápsulas que permiten la liberación modificada de principio(s) activo(s)
CA2480826A CA2480826C (fr) 2002-04-09 2003-04-07 Formulation pharmaceutique orale sous forme de suspension aqueuse de microcapsules permettant la liberation modifiee de principe(s) actif(s)
US10/510,643 US7906145B2 (en) 2002-04-09 2003-04-07 Oral pharmaceutical formulation in the form of aqueous suspension for modified release of active principle(s)
KR1020047016079A KR101061351B1 (ko) 2002-04-09 2003-04-07 활성 성분 마이크로캡슐의 경구 현탁액
BR122013000700A BR122013000700B8 (pt) 2002-04-09 2003-04-07 "suspensão microcápsulas em uma fase líquida aquasa"
IL16422203A IL164222A0 (en) 2002-04-09 2003-04-07 Oral pharmaceutical formulation in the form of aqueous suspension for modified release of active principle(s)
IL16422103A IL164221A0 (en) 2002-04-09 2003-04-07 Oral pharmaceutical formulation in the form of aqueous suspension of microcapsules for modified release of amoxicillim
DE60325709T DE60325709D1 (de) 2002-04-09 2003-04-07 Orale wässrige suspension, mikrokapseln enthaltend, zur kontrollierten freisetzung von wirkstoffen
MXPA04009968A MXPA04009968A (es) 2002-04-09 2003-04-07 Formulacion farmaceutica oral bajo forma de suspension acuosa de microcapsulas que permiten la liberacion modificada de principio (s) activo (s).
EP03745832A EP1492511B3 (fr) 2002-04-09 2003-04-07 Formulation pharmaceutique orale sous forme de suspension aqueuse de microcapsules permettant la liberation modifiee de principe(s) actif(s)
AU2003246792A AU2003246792B2 (en) 2002-04-09 2003-04-07 Oral suspension of active principle microcapsules
JP2003581758A JP4732696B2 (ja) 2002-04-09 2003-04-07 活性成分の改変された放出のための、マイクロカプセルの水性懸濁液形態での経口医薬品製剤
BRPI0309142A BRPI0309142C1 (pt) 2002-04-09 2003-04-07 suspensão de microcápsulas em uma fase líquida aquosa, que permite a liberação modificada de pelo menos um princípio ativo com exclusão da amoxicilina e que é destinada a ser administrada por via oral
IL164222A IL164222A (en) 2002-04-09 2004-09-22 Oral pharmacological formulation in the form of an aqueous suspension for the adjusted release of active ingredients
HK05111660.1A HK1079448A1 (en) 2002-04-09 2005-12-17 Oral pharmaceutical formulation in the form of aqueous suspension for modified release of active principle(s)
US13/014,137 US10004693B2 (en) 2002-04-09 2011-01-26 Oral pharmaceutical formulation in the form of aqueous suspension for modified release of active principle(s)
US14/848,603 US20150374635A1 (en) 2002-04-09 2015-09-09 Oral pharmaceutical formulation in the form of an aqueous suspension of microcapsules for the modified release of active principle(s)
US14/848,699 US9814684B2 (en) 2002-04-09 2015-09-09 Oral pharmaceutical formulation in the form of aqueous suspension for modified release of active principle(s)
US15/625,727 US20170281558A1 (en) 2002-04-09 2017-06-16 Oral pharmaceutical formulation in the form of an aqueous suspension of microcapsules for the modified release of active principle(s).

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
FR0204409 2002-04-09
FR02/04409 2002-04-09
FR0210847A FR2843881B1 (fr) 2002-09-02 2002-09-02 Formulation pharmaceutique orale sous forme de suspension aqueuse de microcapsules permettant la liberation modifiee de principe(s) actif(s)
FR02/10847 2002-09-02

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US10/510,643 A-371-Of-International US7906145B2 (en) 2002-04-09 2003-04-07 Oral pharmaceutical formulation in the form of aqueous suspension for modified release of active principle(s)
US10510643 A-371-Of-International 2003-04-07
US13/014,137 Continuation US10004693B2 (en) 2002-04-09 2011-01-26 Oral pharmaceutical formulation in the form of aqueous suspension for modified release of active principle(s)

Publications (2)

Publication Number Publication Date
WO2003084518A2 WO2003084518A2 (fr) 2003-10-16
WO2003084518A3 true WO2003084518A3 (fr) 2004-04-01

Family

ID=28793279

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2003/001096 WO2003084518A2 (fr) 2002-04-09 2003-04-07 Suspension orale de microcapsules de principes actifs

Country Status (16)

Country Link
US (5) US7906145B2 (fr)
EP (1) EP1492511B3 (fr)
JP (1) JP4732696B2 (fr)
KR (1) KR101061351B1 (fr)
CN (1) CN100553625C (fr)
AT (1) ATE419840T1 (fr)
AU (1) AU2003246792B2 (fr)
BR (1) BRPI0309142C1 (fr)
CA (1) CA2480826C (fr)
DE (1) DE60325709D1 (fr)
ES (1) ES2320438T7 (fr)
HK (1) HK1079448A1 (fr)
IL (2) IL164222A0 (fr)
MX (1) MXPA04009968A (fr)
PT (1) PT1492511E (fr)
WO (1) WO2003084518A2 (fr)

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HK1079448A1 (en) 2006-04-07
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US9814684B2 (en) 2017-11-14
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BRPI0309142B8 (pt) 2016-09-13
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US20150374636A1 (en) 2015-12-31
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IL164222A0 (en) 2005-12-18
CN1652755A (zh) 2005-08-10
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