FR3087125B1 - Procede de fabrication d'une formulation solide pour administration orale, installation et formulation solide associees - Google Patents

Procede de fabrication d'une formulation solide pour administration orale, installation et formulation solide associees Download PDF

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Publication number
FR3087125B1
FR3087125B1 FR1859441A FR1859441A FR3087125B1 FR 3087125 B1 FR3087125 B1 FR 3087125B1 FR 1859441 A FR1859441 A FR 1859441A FR 1859441 A FR1859441 A FR 1859441A FR 3087125 B1 FR3087125 B1 FR 3087125B1
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FR
France
Prior art keywords
solid formulation
manufacturing
oral administration
substrate
solid
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
FR1859441A
Other languages
English (en)
Other versions
FR3087125A1 (fr
Inventor
Ludovic Leclerc
Robert Ronnback
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.)
Ferring BV
Original Assignee
Ferring BV
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 to FR1859441A priority Critical patent/FR3087125B1/fr
Application filed by Ferring BV filed Critical Ferring BV
Priority to CN201980067289.XA priority patent/CN113015522A/zh
Priority to JP2021520177A priority patent/JP2022504797A/ja
Priority to BR112021006688-8A priority patent/BR112021006688A2/pt
Priority to CA3115727A priority patent/CA3115727A1/fr
Priority to PCT/EP2019/077663 priority patent/WO2020074734A1/fr
Priority to AU2019358520A priority patent/AU2019358520A1/en
Priority to MX2021004025A priority patent/MX2021004025A/es
Priority to EP19783547.3A priority patent/EP3863611A1/fr
Priority to KR1020217013633A priority patent/KR20210075124A/ko
Priority to US17/283,178 priority patent/US20220054582A1/en
Priority to EA202190958A priority patent/EA202190958A1/ru
Priority to TW108136905A priority patent/TW202031246A/zh
Publication of FR3087125A1 publication Critical patent/FR3087125A1/fr
Priority to IL282068A priority patent/IL282068A/en
Application granted granted Critical
Publication of FR3087125B1 publication Critical patent/FR3087125B1/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
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • A61K38/095Oxytocins; Vasopressins; Related peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/005Coating of tablets or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/06Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B41PRINTING; LINING MACHINES; TYPEWRITERS; STAMPS
    • B41FPRINTING MACHINES OR PRESSES
    • B41F17/00Printing apparatus or machines of special types or for particular purposes, not otherwise provided for
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003Filling medical containers such as ampoules, vials, syringes or the like
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/04Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied
    • B65B31/046Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied the nozzles co-operating, or being combined, with a device for opening or closing the container or wrapper
    • B65B31/048Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied the nozzles co-operating, or being combined, with a device for opening or closing the container or wrapper specially adapted for wrappers or bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B35/00Supplying, feeding, arranging or orientating articles to be packaged
    • B65B35/30Arranging and feeding articles in groups
    • B65B35/44Arranging and feeding articles in groups by endless belts or chains
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B51/00Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
    • B65B51/10Applying or generating heat or pressure or combinations thereof
    • B65B51/26Devices specially adapted for producing transverse or longitudinal seams in webs or tubes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B57/00Automatic control, checking, warning, or safety devices
    • B65B57/10Automatic control, checking, warning, or safety devices responsive to absence, presence, abnormal feed, or misplacement of articles or materials to be packaged
    • B65B57/14Automatic control, checking, warning, or safety devices responsive to absence, presence, abnormal feed, or misplacement of articles or materials to be packaged and operating to control, or stop, the feed of articles or material to be packaged
    • B65B57/145Automatic control, checking, warning, or safety devices responsive to absence, presence, abnormal feed, or misplacement of articles or materials to be packaged and operating to control, or stop, the feed of articles or material to be packaged for fluent material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B57/00Automatic control, checking, warning, or safety devices
    • B65B57/18Automatic control, checking, warning, or safety devices causing operation of audible or visible alarm signals
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B59/00Arrangements to enable machines to handle articles of different sizes, to produce packages of different sizes, to vary the contents of packages, to handle different types of packaging material, or to give access for cleaning or maintenance purposes
    • B65B59/001Arrangements to enable adjustments related to the product to be packaged
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B61/00Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
    • B65B61/02Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for perforating, scoring, slitting, or applying code or date marks on material prior to packaging
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B61/00Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
    • B65B61/02Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for perforating, scoring, slitting, or applying code or date marks on material prior to packaging
    • B65B61/025Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for perforating, scoring, slitting, or applying code or date marks on material prior to packaging for applying, e.g. printing, code or date marks on material prior to packaging
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B61/00Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
    • B65B61/04Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages
    • B65B61/06Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages by cutting
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B9/00Enclosing successive articles, or quantities of material, e.g. liquids or semiliquids, in flat, folded, or tubular webs of flexible sheet material; Subdividing filled flexible tubes to form packages
    • B65B9/02Enclosing successive articles, or quantities of material between opposed webs
    • B65B9/026Enclosing successive articles, or quantities of material between opposed webs the webs forming a curtain
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D65/00Wrappers or flexible covers; Packaging materials of special type or form
    • B65D65/38Packaging materials of special type or form
    • B65D65/46Applications of disintegrable, dissolvable or edible materials
    • B65D65/463Edible packaging materials

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Dispersion Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne un procédé de fabrication d'une formulation solide (10, 40, 60) pour administration orale, comprenant une portion (12) de substrat comestible sur laquelle est déposée une composition (14) comprenant un principe actif pharmaceutique. Ledit procédé comprend les étapes suivantes : fourniture d'une formulation liquide comprenant le principe actif et un solvant ; puis pulvérisation de la formulation liquide sur le substrat (12) et évaporation du solvant, de sorte à former la composition solide (14) ; division du substrat en une pluralité de portions, de sorte que chaque portion supporte une quantité de principe actif correspondant à une valeur prédéterminée ; et après l'étape de pulvérisation, mesure de la quantité de principe actif supportée par chaque portion et comparaison avec la valeur prédéterminée ; ladite mesure étant non destructive de la formulation solide.
FR1859441A 2018-10-11 2018-10-11 Procede de fabrication d'une formulation solide pour administration orale, installation et formulation solide associees Active FR3087125B1 (fr)

Priority Applications (14)

Application Number Priority Date Filing Date Title
FR1859441A FR3087125B1 (fr) 2018-10-11 2018-10-11 Procede de fabrication d'une formulation solide pour administration orale, installation et formulation solide associees
US17/283,178 US20220054582A1 (en) 2018-10-11 2019-10-11 Method for manufacturing a solid formulation for oral administration, associated facility and solid forumulation
BR112021006688-8A BR112021006688A2 (pt) 2018-10-11 2019-10-11 método para fabricar uma formulação sólida para administração oral, instalação associada e formulação sólida
CA3115727A CA3115727A1 (fr) 2018-10-11 2019-10-11 Procede de fabrication d'une formulation solide pour administration orale, installation et formulation solide associees
PCT/EP2019/077663 WO2020074734A1 (fr) 2018-10-11 2019-10-11 Procédé de fabrication d'une formulation solide pour administration orale, installation et formulation solide associées
AU2019358520A AU2019358520A1 (en) 2018-10-11 2019-10-11 Method for manufacturing a solid formulation for oral administration, associated facility and solid formulation
MX2021004025A MX2021004025A (es) 2018-10-11 2019-10-11 Metodo para fabricar una formulacion solida para administracion oral, e instalacion y formulacion solida asociadas.
EP19783547.3A EP3863611A1 (fr) 2018-10-11 2019-10-11 Procédé de fabrication d'une formulation solide pour administration orale, installation et formulation solide associées
CN201980067289.XA CN113015522A (zh) 2018-10-11 2019-10-11 用于制造口服固体制剂的方法、相关设施和固体制剂
JP2021520177A JP2022504797A (ja) 2018-10-11 2019-10-11 経口投与用固形製剤の製造方法、関連装置及び製剤
EA202190958A EA202190958A1 (ru) 2018-10-11 2019-10-11 Способ изготовления твердого состава для перорального введения, связанные с ним оборудование и твердый состав
KR1020217013633A KR20210075124A (ko) 2018-10-11 2019-10-11 경구 투여용 고형 제제의 제조 방법, 관련 기구 및 제제
TW108136905A TW202031246A (zh) 2018-10-11 2019-10-14 用於口服的固體調配物的製造方法、相關裝置及調配物
IL282068A IL282068A (en) 2018-10-11 2021-04-05 A method for producing a solid formulation for oral administration, a related device and a solid formulation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1859441A FR3087125B1 (fr) 2018-10-11 2018-10-11 Procede de fabrication d'une formulation solide pour administration orale, installation et formulation solide associees

Publications (2)

Publication Number Publication Date
FR3087125A1 FR3087125A1 (fr) 2020-04-17
FR3087125B1 true FR3087125B1 (fr) 2021-07-02

Family

ID=65244248

Family Applications (1)

Application Number Title Priority Date Filing Date
FR1859441A Active FR3087125B1 (fr) 2018-10-11 2018-10-11 Procede de fabrication d'une formulation solide pour administration orale, installation et formulation solide associees

Country Status (14)

Country Link
US (1) US20220054582A1 (fr)
EP (1) EP3863611A1 (fr)
JP (1) JP2022504797A (fr)
KR (1) KR20210075124A (fr)
CN (1) CN113015522A (fr)
AU (1) AU2019358520A1 (fr)
BR (1) BR112021006688A2 (fr)
CA (1) CA3115727A1 (fr)
EA (1) EA202190958A1 (fr)
FR (1) FR3087125B1 (fr)
IL (1) IL282068A (fr)
MX (1) MX2021004025A (fr)
TW (1) TW202031246A (fr)
WO (1) WO2020074734A1 (fr)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1061557A (en) * 1964-04-01 1967-03-15 Ashe Chemical Ltd New impregnated or coated films
ZA767136B (en) * 1975-12-15 1977-10-26 Hoffmann La Roche Novel dosage form
US6623785B2 (en) * 2001-06-07 2003-09-23 Hewlett-Packard Development Company, L.P. Pharmaceutical dispensing apparatus and method
DE102011088909A1 (de) * 2011-08-12 2013-02-14 Labtec Gmbh Verfahren zur Herstellung und Kontrolle von oralen Wirkstoff-Filmen
KR101547219B1 (ko) * 2014-12-31 2015-08-25 (주)씨엘팜 다열 다제 구강용해 필름 제조장치 및 제조방법
WO2016163403A1 (fr) 2015-04-07 2016-10-13 ニプロ株式会社 Préparation de film oral
CL2016000112A1 (es) * 2016-01-15 2016-07-01 Univ Chile Forma farmacéutica para administración bucal de dosis altamente controlada. liberación controlada y estable de biomacromolécula que comprende película polimérica como sustrato de impresión y una tinta de inyección impresa sobre dicha película polimérica que comprende nanopartículas o suspensiones de nanopartículas con dicha biomacromolécula y métodos de preparación.
US20170216220A1 (en) 2016-02-03 2017-08-03 Intelgenx Corp. Loxapine film oral dosage form
CN107412177B (zh) * 2017-08-25 2020-12-15 广东药科大学 3d打印氢氯噻嗪片及其制备方法

Also Published As

Publication number Publication date
IL282068A (en) 2021-06-30
JP2022504797A (ja) 2022-01-13
BR112021006688A2 (pt) 2021-07-27
EP3863611A1 (fr) 2021-08-18
CN113015522A (zh) 2021-06-22
MX2021004025A (es) 2021-08-11
WO2020074734A1 (fr) 2020-04-16
EA202190958A1 (ru) 2021-07-16
FR3087125A1 (fr) 2020-04-17
KR20210075124A (ko) 2021-06-22
AU2019358520A1 (en) 2021-05-20
US20220054582A1 (en) 2022-02-24
TW202031246A (zh) 2020-09-01
CA3115727A1 (fr) 2020-04-16

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