DK2253329T3 - Oral ibuprofenlysinat-suspension. - Google Patents

Oral ibuprofenlysinat-suspension. Download PDF

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Publication number
DK2253329T3
DK2253329T3 DK09380086.0T DK09380086T DK2253329T3 DK 2253329 T3 DK2253329 T3 DK 2253329T3 DK 09380086 T DK09380086 T DK 09380086T DK 2253329 T3 DK2253329 T3 DK 2253329T3
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DK
Denmark
Prior art keywords
pharmaceutical composition
cyclodextrins
composition according
ibuprofen lysinate
ibuprofen
Prior art date
Application number
DK09380086.0T
Other languages
English (en)
Inventor
Pérez Maite Tarré
Original Assignee
Laboratorio De Aplicaciones Farm S A
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 Laboratorio De Aplicaciones Farm S A filed Critical Laboratorio De Aplicaciones Farm S A
Application granted granted Critical
Publication of DK2253329T3 publication Critical patent/DK2253329T3/da

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using 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
    • A61K9/0087—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nanotechnology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Biochemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (11)

1. Farmaceutisk sammensætning, indeholdende ibuprofenlysinat i kombination med cyclodextrin, mikrokrystallinsk cellulose i kombination med natri-umcarboxymethylcellulose som kolloidalt middel for at danne suspensionen, samt farmaceutisk acceptable hjælpestoffer, i form af en oral suspension.
2. Farmaceutisk sammensætning ifølge krav 1, kendetegnet ved, at cyclodextrinerne er beta-cyclodextriner eller hydroxypropyl beta-cyclodextriner.
3. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 eller 2, kendetegnet ved, at vægtforholdet mellem ibuprofenlysinat og cyclodextrin er mellem 1:1 og 1:5.
4. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, kendetegnet ved, at de farmaceutisk acceptable hjælpestoffer er udvalgt fra gruppen, som udgøres af konserveringsmidler, maltitol og sorbitol som fortyndingsmidler, sødemidler, duftmidler og kunstige farver.
5. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 4, kendetegnet ved, at det kolloidale middels vægt er mellem 0,4 og 3 %.
6. Farmaceutisk sammensætning ifølge krav 4, kendetegnet ved, at det konserverende middel udgør mellem 0,02 og 2 vægt-%.
7. Farmaceutisk sammensætning ifølge krav 4, kendetegnet ved, at det konserverende middel er udvalgt blandt konserveringsmidler såsom paraben og natriumsorbat.
8. Farmaceutisk sammensætning ifølge krav 4, kendetegnet ved, at de konserverende midler er kombinationer af natriumsorbat, methylparaben, ethylparaben og propylparaben.
9. Farmaceutisk sammensætning ifølge krav 4, kendetegnet ved, at fortyndingsmidlerne udgør mellem 2 vægt-% og 20 vægt-%.
10. Fremgangsmåde til fremstilling af en farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 9, omfattende de følgende trin: a) Indkapsling af ibuprofenlysinat i cyclodextrinerne; b) opløsning af et konserveringsmiddel i renset vand eller i propylengly-col; c) tilføjelse i trin b) af den mikrokrystallinske cellulose i kombination med natriumcarboxymethylcellulose og blanding ved høj hastighed med henblik på dannelse af suspensionen; d) tilføjelse i trin c) af fortyndingsmiddel, sødemiddel, ibuprofenlysinat-cyclodextriner, duftmiddel, kunstige farver og renset vand qsp. e) filtrering.
11. Procedure ifølge krav 1 0, kendetegnet ved, at trinnet a) med indkapsling af ibuprofenlysinat i cyclodextrinerne udføres ved sigtning og ultrahurtig blanding af ibuprofenlysinat og beta-cyclodextrinerne i et forhold 1:1 - 1:5.
DK09380086.0T 2009-04-27 2009-04-27 Oral ibuprofenlysinat-suspension. DK2253329T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP09380086.0A EP2253329B1 (en) 2009-04-27 2009-04-27 Ibuprofen lysinate oral suspension

Publications (1)

Publication Number Publication Date
DK2253329T3 true DK2253329T3 (da) 2017-01-16

Family

ID=40934066

Family Applications (1)

Application Number Title Priority Date Filing Date
DK09380086.0T DK2253329T3 (da) 2009-04-27 2009-04-27 Oral ibuprofenlysinat-suspension.

Country Status (6)

Country Link
EP (1) EP2253329B1 (da)
DK (1) DK2253329T3 (da)
ES (1) ES2608060T3 (da)
HU (1) HUE029953T2 (da)
LT (1) LT2253329T (da)
PL (1) PL2253329T3 (da)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114588107B (zh) * 2022-04-06 2023-04-18 河北一品生物医药有限公司 一种布洛芬赖氨酸盐注射液及其制备方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8813682D0 (en) * 1988-06-09 1988-07-13 Reckitt & Colmann Prod Ltd Pharmaceutical compositions
DE4038314A1 (de) * 1990-11-30 1992-06-04 Puetter Medice Chem Pharm Komplexe des aktiven enantiomers des ibuprofens mit cyclodextrin
GB9207990D0 (en) * 1992-04-10 1992-05-27 Smithkline Beecham Plc Pharmaceutical composition
GB9316580D0 (en) * 1993-08-10 1993-09-29 Smithkline Beecham Plc Pharmaceutical composition
ES2171110B1 (es) 2000-03-03 2003-06-16 Aplicaciones Farmacodinamicas Composicion farmaceutica a base de ibuprofeno y procedimiento para su preparacion.
WO2008064192A2 (en) * 2006-11-21 2008-05-29 Mcneil-Ppc, Inc. Modified release analgesic suspensions
FR2914187B1 (fr) * 2007-03-28 2011-01-21 Pf Medicament Complexes d'ibuprofene, de cyclodextrines et d'agents ternaires, et leurs utilisations en pharmaceutique.

Also Published As

Publication number Publication date
ES2608060T3 (es) 2017-04-05
LT2253329T (lt) 2017-02-27
EP2253329B1 (en) 2016-09-21
PL2253329T3 (pl) 2017-08-31
EP2253329A1 (en) 2010-11-24
HUE029953T2 (en) 2017-04-28

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