AU2017281931B2 - Surfactant formulations for inhalation - Google Patents

Surfactant formulations for inhalation Download PDF

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Publication number
AU2017281931B2
AU2017281931B2 AU2017281931A AU2017281931A AU2017281931B2 AU 2017281931 B2 AU2017281931 B2 AU 2017281931B2 AU 2017281931 A AU2017281931 A AU 2017281931A AU 2017281931 A AU2017281931 A AU 2017281931A AU 2017281931 B2 AU2017281931 B2 AU 2017281931B2
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AU
Australia
Prior art keywords
dppc
formulation
nacl
popg
powder
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Active
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AU2017281931A
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English (en)
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AU2017281931A1 (en
Inventor
Holly CHAN
Fahad GILANI
Abhijit Kamerkar
Michael M. Lipp
Michael Tauber
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Merz Pharmaceuticals LLC
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Merz Pharmaceuticals LLC
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Publication date
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Publication of AU2017281931A1 publication Critical patent/AU2017281931A1/en
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Priority to AU2023201990A priority Critical patent/AU2023201990B9/en
Assigned to MERZ PHARMACEUTICALS, LLC reassignment MERZ PHARMACEUTICALS, LLC Request for Assignment Assignors: CIVITAS THERAPEUTICS, INC.
Active legal-status Critical Current
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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0082—Lung surfactant, artificial mucus
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/16—Central respiratory analeptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/785—Alveolar surfactant peptides; Pulmonary surfactant peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Otolaryngology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Zoology (AREA)
  • AIDS & HIV (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2017281931A 2016-06-24 2017-06-23 Surfactant formulations for inhalation Active AU2017281931B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2023201990A AU2023201990B9 (en) 2016-06-24 2023-03-31 Surfactant Formulations for Inhalation

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662354382P 2016-06-24 2016-06-24
US62/354,382 2016-06-24
US201662420932P 2016-11-11 2016-11-11
US62/420,932 2016-11-11
PCT/US2017/039094 WO2017223502A1 (en) 2016-06-24 2017-06-23 Surfactant formulations for inhalation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2023201990A Division AU2023201990B9 (en) 2016-06-24 2023-03-31 Surfactant Formulations for Inhalation

Publications (2)

Publication Number Publication Date
AU2017281931A1 AU2017281931A1 (en) 2019-01-17
AU2017281931B2 true AU2017281931B2 (en) 2023-02-02

Family

ID=59295343

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2017281931A Active AU2017281931B2 (en) 2016-06-24 2017-06-23 Surfactant formulations for inhalation
AU2023201990A Active AU2023201990B9 (en) 2016-06-24 2023-03-31 Surfactant Formulations for Inhalation

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2023201990A Active AU2023201990B9 (en) 2016-06-24 2023-03-31 Surfactant Formulations for Inhalation

Country Status (10)

Country Link
US (2) US20190388444A1 (cg-RX-API-DMAC10.html)
EP (1) EP3474832B1 (cg-RX-API-DMAC10.html)
JP (2) JP7240178B2 (cg-RX-API-DMAC10.html)
AU (2) AU2017281931B2 (cg-RX-API-DMAC10.html)
CA (1) CA3028724A1 (cg-RX-API-DMAC10.html)
ES (1) ES3069827T3 (cg-RX-API-DMAC10.html)
MA (1) MA45451A (cg-RX-API-DMAC10.html)
MX (2) MX2018015969A (cg-RX-API-DMAC10.html)
WO (1) WO2017223502A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA201900337B (cg-RX-API-DMAC10.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2017281931B2 (en) * 2016-06-24 2023-02-02 Merz Pharmaceuticals, Llc Surfactant formulations for inhalation
MX2020006634A (es) * 2017-12-21 2021-01-15 Civitas Therapeutics Inc Formulaciones de surfactantes para inhalacion.
CA3085943A1 (en) * 2017-12-21 2019-06-27 Civitas Therapeutics, Inc. Surfactant formulations for inhalation
WO2022082082A2 (en) * 2020-10-16 2022-04-21 Sherwood Russ Lehrman Lung treatment compositions
WO2023281523A1 (en) * 2021-07-09 2023-01-12 Indian Council Of Medical Research A pharmaceutical composition with a recombinant fragment of human surfactant protein-d for sars-cov-2 infection

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997026863A1 (de) * 1996-01-24 1997-07-31 Byk Gulden Lomberg Chemische Fabrik Gmbh Verfahren zur herstellung von pulverförmigen lungensurfactant-zubereitungen
WO2001013891A2 (en) * 1999-08-25 2001-03-01 Advanced Inhalation Research, Inc. Modulation of release from dry powder formulations
WO2001013893A2 (en) * 1999-08-25 2001-03-01 Advanced Inhalation Research, Inc. Use of simple amino acids to form porous particles
WO2001058423A1 (en) * 2000-02-11 2001-08-16 Altana Pharma Ag Novel use of pulmonary surfactant for the prophylaxis and treatment of chronic pulmonary diseases
WO2009026434A1 (en) * 2007-08-21 2009-02-26 Alkermes, Inc. Pulmonary pharmaceutical formulations

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4069819A (en) 1973-04-13 1978-01-24 Societa Farmaceutici S.P.A. Inhalation device
IT1228459B (it) 1989-02-23 1991-06-19 Phidea S R L Inalatore con svuotamento regolare e completo della capsula.
WO2007084136A2 (en) * 2006-01-23 2007-07-26 Ony, Inc. Treatment of acute respiratory distress syndrome
CN101448405B (zh) * 2006-03-22 2013-03-06 Wm.雷格利Jr.公司 压缩的口香糖及其制备方法
WO2008011559A2 (en) 2006-07-20 2008-01-24 University Of Rochester Synthetic lung surfactant and use thereof
WO2008016497A2 (en) * 2006-07-31 2008-02-07 Corn Products International, Inc. Isomaltitol compositions and process for making isomaltitol compositions
US8496002B2 (en) 2007-06-12 2013-07-30 Civitas Therapeutics, Inc. Powder inhaler devices
AU2017281931B2 (en) * 2016-06-24 2023-02-02 Merz Pharmaceuticals, Llc Surfactant formulations for inhalation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997026863A1 (de) * 1996-01-24 1997-07-31 Byk Gulden Lomberg Chemische Fabrik Gmbh Verfahren zur herstellung von pulverförmigen lungensurfactant-zubereitungen
WO2001013891A2 (en) * 1999-08-25 2001-03-01 Advanced Inhalation Research, Inc. Modulation of release from dry powder formulations
WO2001013893A2 (en) * 1999-08-25 2001-03-01 Advanced Inhalation Research, Inc. Use of simple amino acids to form porous particles
WO2001058423A1 (en) * 2000-02-11 2001-08-16 Altana Pharma Ag Novel use of pulmonary surfactant for the prophylaxis and treatment of chronic pulmonary diseases
WO2009026434A1 (en) * 2007-08-21 2009-02-26 Alkermes, Inc. Pulmonary pharmaceutical formulations

Also Published As

Publication number Publication date
US20240016823A1 (en) 2024-01-18
JP7240178B2 (ja) 2023-03-15
AU2017281931A1 (en) 2019-01-17
CA3028724A1 (en) 2017-12-28
JP7629159B2 (ja) 2025-02-13
US20190388444A1 (en) 2019-12-26
EP3474832B1 (en) 2026-03-18
EP3474832C0 (en) 2026-03-18
MX2018015969A (es) 2019-06-10
NZ749513A (en) 2024-09-27
AU2023201990A1 (en) 2023-05-04
JP2019518782A (ja) 2019-07-04
AU2023201990B2 (en) 2025-05-01
JP2023071886A (ja) 2023-05-23
ZA201900337B (en) 2019-10-30
WO2017223502A1 (en) 2017-12-28
ES3069827T3 (en) 2026-06-10
MX2023012602A (es) 2023-11-03
AU2023201990B9 (en) 2025-05-08
MA45451A (fr) 2019-05-01
EP3474832A1 (en) 2019-05-01

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Owner name: MERZ PHARMACEUTICALS, LLC

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