BR112021021904A2 - Preparações de fator da coagulação para liberação em tecido do trato intestinal usando um dispositivo de liberação de fármacos ingerível - Google Patents

Preparações de fator da coagulação para liberação em tecido do trato intestinal usando um dispositivo de liberação de fármacos ingerível

Info

Publication number
BR112021021904A2
BR112021021904A2 BR112021021904A BR112021021904A BR112021021904A2 BR 112021021904 A2 BR112021021904 A2 BR 112021021904A2 BR 112021021904 A BR112021021904 A BR 112021021904A BR 112021021904 A BR112021021904 A BR 112021021904A BR 112021021904 A2 BR112021021904 A2 BR 112021021904A2
Authority
BR
Brazil
Prior art keywords
clotting
cfs
capsule
delivery
preparation
Prior art date
Application number
BR112021021904A
Other languages
English (en)
Portuguese (pt)
Inventor
Anusha Garapaty
Anvesh Dasari
Joel Harris
A Imran Mir
Mir Hashim
Radhika Korupolu
Sara Ansaloni
Original Assignee
Rani Therapeutics Llc
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 Rani Therapeutics Llc filed Critical Rani Therapeutics Llc
Publication of BR112021021904A2 publication Critical patent/BR112021021904A2/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • 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
    • A61K47/51—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 non-active ingredient being a modifying agent
    • A61K47/56—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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K47/51—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 non-active ingredient being a modifying agent
    • A61K47/68—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 non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A61M2005/14284—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation with needle insertion means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6072—Bar codes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Immunology (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medical Informatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
BR112021021904A 2019-05-03 2020-05-01 Preparações de fator da coagulação para liberação em tecido do trato intestinal usando um dispositivo de liberação de fármacos ingerível BR112021021904A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962843221P 2019-05-03 2019-05-03
US201962845209P 2019-05-08 2019-05-08
PCT/US2020/031197 WO2020227162A1 (en) 2019-05-03 2020-05-01 Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device

Publications (1)

Publication Number Publication Date
BR112021021904A2 true BR112021021904A2 (pt) 2022-02-22

Family

ID=73050863

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021021904A BR112021021904A2 (pt) 2019-05-03 2020-05-01 Preparações de fator da coagulação para liberação em tecido do trato intestinal usando um dispositivo de liberação de fármacos ingerível

Country Status (12)

Country Link
US (1) US20220118056A1 (enExample)
EP (1) EP3962516B1 (enExample)
JP (1) JP7692363B2 (enExample)
KR (1) KR20220004148A (enExample)
CN (1) CN114007638A (enExample)
AU (1) AU2020270420B2 (enExample)
BR (1) BR112021021904A2 (enExample)
CA (1) CA3137539A1 (enExample)
DK (1) DK3962516T3 (enExample)
ES (1) ES3074274T3 (enExample)
MX (1) MX2021013310A (enExample)
WO (1) WO2020227162A1 (enExample)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8721620B2 (en) 2009-12-24 2014-05-13 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
US8734429B2 (en) 2010-12-23 2014-05-27 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
US9402806B2 (en) 2010-12-23 2016-08-02 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US8809269B2 (en) 2010-12-23 2014-08-19 Rani Therapeutics, Llc Therapeutic agent preparations comprising insulin for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9259386B2 (en) 2010-12-23 2016-02-16 Rani Therapeutics, Llc Therapeutic preparation comprising somatostatin or somatostatin analogoue for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9415004B2 (en) 2010-12-23 2016-08-16 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US10689460B2 (en) 2014-05-15 2020-06-23 Incube Labs, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
EP3706720B1 (en) 2017-11-07 2026-07-01 Rani Therapeutics, LLC COAGULATION FACTOR PREPARATIONS FOR ADMINISTERING INTO INTESTINAL TRACT TISSUE BY MEANS OF AN ORGIVE-IN-SWALLOW MEDICATION DELIVERY DEVICE
MX2021011047A (es) * 2019-03-13 2021-12-15 Rani Therapeutics Llc Preparaciones de agentes terapéuticos y métodos para la administración de fármacos en un lumen del tracto intestinal usando un dispositivo de administración de fármacos ingerible.
BR112023016926A2 (pt) * 2021-02-24 2023-10-10 Rani Therapeutics Llc Tratamentos para hemofilia a
US20240189398A1 (en) * 2021-04-13 2024-06-13 Grifols Worldwide Operations Limited Liquid composition comprising factor viii or factor viii/von willebrand factor complex
CN115300774B (zh) * 2022-08-27 2024-01-30 深圳市资福医疗技术有限公司 一种药剂递送装置、释药方法及应用其的释药胶囊
CN118221797B (zh) * 2024-04-28 2025-02-18 内蒙古工业大学 一种具有脱敏效果的乳球蛋白肽及其应用

Family Cites Families (20)

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Publication number Priority date Publication date Assignee Title
GR860984B (en) 1985-04-17 1986-08-18 Zymogenetics Inc Expression of factor vii and ix activities in mammalian cells
DE3751873T2 (de) 1986-04-09 1997-02-13 Genzyme Corp Genetisch transformierte Tiere, die ein gewünschtes Protein in Milch absondern
FR2619314B1 (fr) 1987-08-11 1990-06-15 Transgene Sa Analogue du facteur viii, procede de preparation et composition pharmaceutique le contenant
AT405517B (de) 1997-02-27 1999-09-27 Immuno Ag Faktor x-deletionsmutanten und analoge davon
US8721620B2 (en) * 2009-12-24 2014-05-13 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
CN105168174B (zh) * 2010-03-10 2019-01-08 拉尼医疗有限公司 用于利用可吞咽式药剂递送装置递送到肠道内腔中的治疗剂制剂
US8809269B2 (en) 2010-12-23 2014-08-19 Rani Therapeutics, Llc Therapeutic agent preparations comprising insulin for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9149617B2 (en) * 2010-12-23 2015-10-06 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
US8734429B2 (en) * 2010-12-23 2014-05-27 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
US9629799B2 (en) * 2010-12-23 2017-04-25 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
EP4169525A1 (en) * 2011-07-08 2023-04-26 Bioverativ Therapeutics Inc. Factor viii chimeric and hybrid polypeptides, and methods of use thereof
US20140019297A1 (en) * 2012-07-10 2014-01-16 Bootic, Inc. Electronic Commerce System Incorporating Shopping Baskets
US10689460B2 (en) * 2014-05-15 2020-06-23 Incube Labs, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US11548940B2 (en) 2014-05-15 2023-01-10 Rani Therapeutics, Llc Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
AU2016257813B2 (en) * 2015-05-01 2021-05-13 Rani Therapeutics, Llc Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
AU2016320867B2 (en) * 2015-09-08 2023-03-30 Rani Therapeutics, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
JP6877469B2 (ja) * 2016-06-24 2021-05-26 モガム・インスティテュート・フォー・バイオメディカル・リサーチＭｏｇａｍ Ｉｎｓｔｉｔｕｔｅ Ｆｏｒ Ｂｉｏｍｅｄｉｃａｌ Ｒｅｓｅａｒｃｈ Ｆｖｉｉｉおよびｖｗｆ因子を含むキメラタンパク質、ならびにそれらの使用
CN106279437B (zh) * 2016-08-19 2017-10-31 安源医药科技（上海）有限公司 高糖基化人凝血因子viii融合蛋白及其制备方法与用途
KR20190090827A (ko) * 2016-12-02 2019-08-02 바이오버라티브 테라퓨틱스 인크. 키메라 응고 인자를 사용해 혈우병성 관절증을 치료하는 방법
EP3706720B1 (en) * 2017-11-07 2026-07-01 Rani Therapeutics, LLC COAGULATION FACTOR PREPARATIONS FOR ADMINISTERING INTO INTESTINAL TRACT TISSUE BY MEANS OF AN ORGIVE-IN-SWALLOW MEDICATION DELIVERY DEVICE

Also Published As

Publication number Publication date
MX2021013310A (es) 2022-02-11
DK3962516T3 (da) 2026-06-01
ES3074274T3 (en) 2026-07-20
KR20220004148A (ko) 2022-01-11
AU2020270420A1 (en) 2021-11-18
EP3962516B1 (en) 2026-04-29
JP2022530615A (ja) 2022-06-30
JP7692363B2 (ja) 2025-06-13
AU2020270420B2 (en) 2026-03-26
US20220118056A1 (en) 2022-04-21
WO2020227162A1 (en) 2020-11-12
EP3962516A4 (en) 2023-01-04
CA3137539A1 (en) 2020-10-20
CN114007638A (zh) 2022-02-01
EP3962516A1 (en) 2022-03-09

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