WO2011060945A2 - Capsules de principes actifs pharmaceutiques et d'esters d'acides gras polyinsaturés pour le traitement de maladies cardiovasculaires - Google Patents

Capsules de principes actifs pharmaceutiques et d'esters d'acides gras polyinsaturés pour le traitement de maladies cardiovasculaires Download PDF

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Publication number
WO2011060945A2
WO2011060945A2 PCT/EP2010/007025 EP2010007025W WO2011060945A2 WO 2011060945 A2 WO2011060945 A2 WO 2011060945A2 EP 2010007025 W EP2010007025 W EP 2010007025W WO 2011060945 A2 WO2011060945 A2 WO 2011060945A2
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WO
WIPO (PCT)
Prior art keywords
capsule according
pharmaceutical
pharmaceutical capsule
microcapsules
group formed
Prior art date
Application number
PCT/EP2010/007025
Other languages
English (en)
Other versions
WO2011060945A3 (fr
Inventor
Antonio PARENTE DUEÑA
Paolo Carminati
Original Assignee
Gp Pharm, S.A.
Defiante Farmaceutica, S.A.
Singrossi, Maria, Gabriella
Carminati, Silvia
Carminati, Giuseppe, Paolo
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 Gp Pharm, S.A., Defiante Farmaceutica, S.A., Singrossi, Maria, Gabriella, Carminati, Silvia, Carminati, Giuseppe, Paolo filed Critical Gp Pharm, S.A.
Priority to RU2012122886/15A priority Critical patent/RU2012122886A/ru
Priority to CN201080052613XA priority patent/CN102711735A/zh
Priority to AU2010321248A priority patent/AU2010321248A1/en
Priority to CA2781434A priority patent/CA2781434A1/fr
Priority to EP10781842A priority patent/EP2501365A2/fr
Priority to JP2012539231A priority patent/JP2013511480A/ja
Priority to MX2012005744A priority patent/MX2012005744A/es
Priority to BR112012011902A priority patent/BR112012011902A2/pt
Publication of WO2011060945A2 publication Critical patent/WO2011060945A2/fr
Publication of WO2011060945A3 publication Critical patent/WO2011060945A3/fr
Priority to IL219874A priority patent/IL219874A0/en

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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
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • 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
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • 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
    • 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • 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
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • 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
    • A61K9/5052—Proteins, e.g. albumin
    • A61K9/5057—Gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Definitions

  • the outer coating of the capsule contains, as well as water, a notable quantity of conventional additives such as plasticizers, colorants, opacifiers and preservatives, it is also very difficult to satisfactorily prevent or control the possible incompatibilities between these and the active ingredient.
  • additives can facilitate the oxidation, degradation or hydrolysis processes, causing a loss of activity of the active ingredient formulated [EP 0769938 B1].
  • Another factor to take into account is the possible chemical interaction between the content and gelatin in the capsule, which may favor cross-linking and thus reduce the capsule's solubility in the aqueous medium (delaying its speed of disintegration).
  • WO 2007/103557 A2 it proposed as a solution to the problems of chemical incompatibilities in compositions with two or more active pharmaceutical ingredients, the physical separation of the components in a gelatin capsule, hard or soft, which contains a first active ingredient such as the omega-3 fatty acids, with one or more capsule coatings wherein at least one of them consists of a polymer combined with another active ingredient such as enalapril, and the coating which contains this active ingredient is isolated from the capsule and optionally from the outside by additional coatings.
  • the manufacturing process is complex due to the fragility and solubility in water of the gelatin coatings and requires a rigorous control of the temperature and speed of deposition during coating.
  • the polymer of the microcapsules of the pharmaceutical capsule of this invention is selected, without restriction, from the group formed by proteins, polysaccharides, polyesters, polyacrylates, polycyanoacrylates, polyethylene glycol and/or mixtures thereof.
  • the polymer of the microcapsules is selected from the group formed by gelatin, albumin, alginates, carrageenans, pectins, gum arabic, chitosan, carboxymethylcellulose, ethylcellulose, hydroxypropyl methylcellulose (HPMC), nitrocellulose, cellulose' acetate butyrate, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate-succinate, polyvinyl acetate phthalate, poly(E-caprolactone), poly(p-dioxanone), poly(5-valerolactone), poly(p-hydroxybutyrate), poly(p-hydroxybutyrate) copolymers and ⁇ -hydroxyvaler
  • the polymer is formed by copolymers of methacrylic acid (Eudragit ® L and S), polymers and copolymers of lactic and glycolic acids, polymers and copolymers of lactic and glycolic acids and polyethylene glycol, and/or mixtures thereof.
  • methacrylic acid Eudragit ® L and S
  • polymers and copolymers of lactic and glycolic acids polymers and copolymers of lactic and glycolic acids and polyethylene glycol, and/or mixtures thereof.
  • the pharmaceutical capsule of this invention can be a hard or soft capsule, of gelatin or any usual polymer in the preparation of capsules in the pharmaceutical industry, such as and not restricted to, hydroxypropyl methylcellulose (HPMC), pullulan, modified starches, carrageenans and/or mixtures thereof.
  • HPMC hydroxypropyl methylcellulose
  • the capsule is a gelatin capsule. More preferably, this capsule is made of soft gelatin.
  • the capsule has an enteric coating.
  • the capsule coating can contain other additives such as plasticizers, colorants, pigments, opacifiers, preservatives, moisturizers, surfactants, sweeteners and/or flavorings.
  • the preparation of the capsule is carried out through the usual procedures in the pharmaceutical industry, and can be any form and size known by the person skilled in the art.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne une composition pharmaceutique se présentant sous la forme d'une capsule qui contient des esters d'alkyle d'acides gras polyinsaturés (PUFA) et des principes actifs pour le traitement et/ou la prévention de maladies cardiovasculaires.
PCT/EP2010/007025 2009-11-20 2010-11-19 Capsules de principes actifs pharmaceutiques et d'esters d'acides gras polyinsaturés pour le traitement de maladies cardiovasculaires WO2011060945A2 (fr)

Priority Applications (9)

Application Number Priority Date Filing Date Title
RU2012122886/15A RU2012122886A (ru) 2009-11-20 2010-11-19 Капсулы активных фармацевтических ингредиентов и сложных эфиров полиненасыщенной жирной кислоты для лечения сердечно-сосудистых заболеваний
CN201080052613XA CN102711735A (zh) 2009-11-20 2010-11-19 治疗心血管疾病的、活性药物成分与多不饱和脂肪酸酯的胶囊
AU2010321248A AU2010321248A1 (en) 2009-11-20 2010-11-19 Capsules of active pharmaceutical ingredients and polyunsaturated fatty acid esters for the treatment of cardiovascular diseases
CA2781434A CA2781434A1 (fr) 2009-11-20 2010-11-19 Capsules de principes actifs pharmaceutiques et d'esters d'acides gras polyinsatures pour le traitement de maladies cardiovasculaires
EP10781842A EP2501365A2 (fr) 2009-11-20 2010-11-19 Capsules de principes actifs pharmaceutiques et d'esters d'acides gras polyinsaturés pour le traitement de maladies cardiovasculaires
JP2012539231A JP2013511480A (ja) 2009-11-20 2010-11-19 心血管疾患の治療のための原薬及び多価不飽和脂肪酸エステルのカプセル
MX2012005744A MX2012005744A (es) 2009-11-20 2010-11-19 Capsulas de principios activos farmaceuticos y esteres de acidos grasos poliinsaturados para el tratamiento de enfermedades cardiovasculares.
BR112012011902A BR112012011902A2 (pt) 2009-11-20 2010-11-19 cápsula farmacêutica
IL219874A IL219874A0 (en) 2009-11-20 2012-05-17 Capsules of active pharmaceutical ingredients and polyunsaturated fatty acid esters for the treatment of cardiovascular diseases

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES200931024A ES2364011B1 (es) 2009-11-20 2009-11-20 Cápsulas de principios activos farmacéuticos y ésteres de ácidos grasos poliinsaturados para el tratamiento de enfermedades cardiovasculares.
ES200931024 2009-11-20

Publications (2)

Publication Number Publication Date
WO2011060945A2 true WO2011060945A2 (fr) 2011-05-26
WO2011060945A3 WO2011060945A3 (fr) 2012-01-19

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/007025 WO2011060945A2 (fr) 2009-11-20 2010-11-19 Capsules de principes actifs pharmaceutiques et d'esters d'acides gras polyinsaturés pour le traitement de maladies cardiovasculaires

Country Status (14)

Country Link
EP (1) EP2501365A2 (fr)
JP (1) JP2013511480A (fr)
KR (1) KR20120117986A (fr)
CN (1) CN102711735A (fr)
AR (1) AR079428A1 (fr)
AU (1) AU2010321248A1 (fr)
BR (1) BR112012011902A2 (fr)
CA (1) CA2781434A1 (fr)
ES (1) ES2364011B1 (fr)
IL (1) IL219874A0 (fr)
MX (1) MX2012005744A (fr)
RU (1) RU2012122886A (fr)
TW (1) TW201141469A (fr)
WO (1) WO2011060945A2 (fr)

Cited By (57)

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WO2012013331A3 (fr) * 2010-07-26 2012-06-28 Gp-Pharm, S.A. Capsules d'ingrédients pharmaceutiques actifs et d'acides gras polyinsaturés pour le traitement de maladies de la prostate
CN102895205A (zh) * 2012-11-09 2013-01-30 重庆市力扬医药开发有限公司 一种快速溶出的阿齐沙坦药物制剂
WO2014003305A1 (fr) * 2012-06-28 2014-01-03 보령제약 주식회사 Composition pharmaceutique contenant du fimasartan et de l'hydrochlorothiazide
WO2014010896A1 (fr) * 2012-07-10 2014-01-16 보령제약 주식회사 Composition pharmaceutique pour la prévention, le soulagement ou le traitement de l'insuffisance cardiaque, et formulations complexes la contenant
WO2014041445A2 (fr) * 2012-09-13 2014-03-20 Mahesh Kandula Compositions et procédés pour le traitement de l'hypertension et la gestion de la néphropathie diabétique
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CA2781434A1 (fr) 2011-05-26
WO2011060945A3 (fr) 2012-01-19
TW201141469A (en) 2011-12-01
ES2364011A1 (es) 2011-08-23
BR112012011902A2 (pt) 2017-10-10
AU2010321248A1 (en) 2012-06-07
IL219874A0 (en) 2012-07-31
KR20120117986A (ko) 2012-10-25
RU2012122886A (ru) 2013-12-27
EP2501365A2 (fr) 2012-09-26
ES2364011B1 (es) 2013-01-24
AR079428A1 (es) 2012-01-25
CN102711735A (zh) 2012-10-03
MX2012005744A (es) 2012-12-05
JP2013511480A (ja) 2013-04-04

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