CA2836643C - Compositions de poudre seche de vancomycine et methodes associees - Google Patents

Compositions de poudre seche de vancomycine et methodes associees Download PDF

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Publication number
CA2836643C
CA2836643C CA2836643A CA2836643A CA2836643C CA 2836643 C CA2836643 C CA 2836643C CA 2836643 A CA2836643 A CA 2836643A CA 2836643 A CA2836643 A CA 2836643A CA 2836643 C CA2836643 C CA 2836643C
Authority
CA
Canada
Prior art keywords
composition
dry powder
vancomycin
mean
value
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.)
Expired - Fee Related
Application number
CA2836643A
Other languages
English (en)
Other versions
CA2836643A1 (fr
Inventor
John Lord
Jaakko Taneli Jouhikainen
Herman E. Snyder
Pravin Soni
Mei-Chang Kuo
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.)
Savara Inc
Original Assignee
Savara Inc
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 Savara Inc filed Critical Savara Inc
Priority to CA2981038A priority Critical patent/CA2981038C/fr
Publication of CA2836643A1 publication Critical patent/CA2836643A1/fr
Application granted granted Critical
Publication of CA2836643C publication Critical patent/CA2836643C/fr
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K38/14Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Cette invention concerne des compositions de poudre sèche de vancomycine et des méthodes permettant de les administrer et de les préparer. Une composition de la présente invention peut être administrée à un sujet par administration pulmonaire en quantité efficace pour traiter et/ou prévenir une infection bactérienne chez le sujet. L'administration d'une quantité efficace d'une composition de la présente invention peut être particulièrement utile dans le traitement d'une infection bactérienne à Gram positif chez un sujet souffrant de pneumonie, de fibrose kystique, de bronchectasie ou d'une autre maladie pulmonaire chronique avec infection bactérienne des voies respiratoires et/ou du poumon du sujet.
CA2836643A 2011-05-19 2012-05-21 Compositions de poudre seche de vancomycine et methodes associees Expired - Fee Related CA2836643C (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2981038A CA2981038C (fr) 2011-05-19 2012-05-21 Compositions de poudre seche de vancomycine et methodes associees

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161487971P 2011-05-19 2011-05-19
US61/487,971 2011-05-19
PCT/US2012/038775 WO2012159103A1 (fr) 2011-05-19 2012-05-21 Compositions de poudre sèche de vancomycine et méthodes associées

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2981038A Division CA2981038C (fr) 2011-05-19 2012-05-21 Compositions de poudre seche de vancomycine et methodes associees

Publications (2)

Publication Number Publication Date
CA2836643A1 CA2836643A1 (fr) 2012-11-22
CA2836643C true CA2836643C (fr) 2017-11-14

Family

ID=47177374

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2836643A Expired - Fee Related CA2836643C (fr) 2011-05-19 2012-05-21 Compositions de poudre seche de vancomycine et methodes associees
CA2981038A Expired - Fee Related CA2981038C (fr) 2011-05-19 2012-05-21 Compositions de poudre seche de vancomycine et methodes associees

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2981038A Expired - Fee Related CA2981038C (fr) 2011-05-19 2012-05-21 Compositions de poudre seche de vancomycine et methodes associees

Country Status (11)

Country Link
EP (1) EP2709646A4 (fr)
JP (1) JP6012716B2 (fr)
KR (1) KR101763195B1 (fr)
CN (1) CN103717231B (fr)
AU (1) AU2012254999B2 (fr)
BR (1) BR112013029803B1 (fr)
CA (2) CA2836643C (fr)
IL (1) IL229506B (fr)
MX (1) MX346244B (fr)
SG (1) SG195038A1 (fr)
WO (1) WO2012159103A1 (fr)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2838111C (fr) 2005-12-08 2016-01-19 Insmed Incorporated Compositions a base de lipide d'anti-infectieux pour traiter des infections pulmonaires et procedes d'utilisation de celles-ci
US9119783B2 (en) 2007-05-07 2015-09-01 Insmed Incorporated Method of treating pulmonary disorders with liposomal amikacin formulations
EP3581186A1 (fr) 2012-11-29 2019-12-18 Insmed Incorporated Formulations de vancomycine stabilisées
CA2897651C (fr) 2013-01-10 2021-09-21 Pulmokine, Inc. Inhibiteurs de kinase non selectifs
CN104043104B (zh) * 2013-03-15 2018-07-10 浙江创新生物有限公司 含盐酸万古霉素的喷雾干粉及其工业化制备方法
CA2926793C (fr) 2013-10-11 2022-11-22 Lawrence S. ZISMAN Formulations a sechage par pulverisation pour le traitement de l'hypertension arterielle pulmonaire
KR20160119259A (ko) * 2014-02-28 2016-10-12 알지파마 에이에스 낭포성 섬유증 및 cftr 이온 채널의 기능 결함과 관련된 기타 병태의 치료제로서 알기네이트 올리고머의 용도
AU2015229069A1 (en) 2014-03-14 2016-11-03 CutisPharma,Inc. Composition and method for vancomycin oral liquid
PL3142643T3 (pl) 2014-05-15 2019-12-31 Insmed Incorporated Sposoby leczenia zakażeń płuc prątkami niegruźliczymi
NZ731955A (en) * 2014-11-06 2023-07-28 Xellia Pharmaceuticals Aps Glycopeptide compositions
JP6832281B2 (ja) * 2015-02-06 2021-02-24 ラティチュード ファーマシューティカルズ インコーポレイテッド バンコマイシンの水溶液製剤
GB201609940D0 (en) * 2016-06-07 2016-07-20 Novabiotics Ltd Microparticles
RU2763525C2 (ru) 2016-10-27 2021-12-30 Пульмокин, Инк. Комбинированная терапия для лечения легочной гипертензии
CN106963939A (zh) * 2017-03-22 2017-07-21 永信药品工业(昆山)股份有限公司 盐酸万古霉素药物组合物及其制备方法
JP7210476B2 (ja) * 2017-05-22 2023-01-23 インスメッド インコーポレイテッド リポ‐グリコペプチド可切断性誘導体及びその使用
EP3773505A4 (fr) 2018-03-30 2021-12-22 Insmed Incorporated Procédés pour la fabrication continue de produits médicamenteux liposomaux
WO2020081599A1 (fr) * 2018-10-15 2020-04-23 Savara Inc. Séparation de la vancomycine et de ses produits de dégradation

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2129691B (en) 1982-10-08 1987-08-05 Glaxo Group Ltd Devices for administering medicaments to patients
US4778054A (en) 1982-10-08 1988-10-18 Glaxo Group Limited Pack for administering medicaments to patients
NO166268C (no) 1985-07-30 1991-07-03 Glaxo Group Ltd Innretning for administrering av medikamenter til pasienter.
JPH03193735A (ja) * 1989-12-22 1991-08-23 Shionogi & Co Ltd グリコペプチド系抗生物質の安定化組成物
JPH05963A (ja) 1990-04-13 1993-01-08 Toray Ind Inc ポリペプチド類組成物
US6582728B1 (en) 1992-07-08 2003-06-24 Inhale Therapeutic Systems, Inc. Spray drying of macromolecules to produce inhaleable dry powders
US6051256A (en) * 1994-03-07 2000-04-18 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
JP4142149B2 (ja) * 1997-07-10 2008-08-27 明治製菓株式会社 バンコマイシンの凍結乾燥製剤
US6586008B1 (en) * 1999-08-25 2003-07-01 Advanced Inhalation Research, Inc. Use of simple amino acids to form porous particles during spray drying
HU229310B1 (en) * 1999-10-29 2013-10-28 Nektar Therapeutics Dry powder compositions having improved dispersivity
EP1992335A1 (fr) * 2001-11-01 2008-11-19 Nektar Therapeutics Procédés de séchage par pulvérisation et compositions correspondantes
DE10358387A1 (de) * 2003-12-13 2005-07-07 Boehringer Ingelheim Pharma Gmbh & Co. Kg Pulver enthaltend niedermolekulares Dextran und Verfahren zu deren Herstellung
FR2872044B1 (fr) * 2004-06-28 2007-06-29 Flamel Technologies Sa Formulation pharmaceutique a base d'antibiotique sous forme microcapsulaire
EP2050437A1 (fr) * 2007-10-15 2009-04-22 Laboratoires SMB Compositions de poudre sèche pharmaceutiquement améliorées pour l'inhalation
PL2344129T3 (pl) * 2008-10-07 2018-07-31 Horizon Orphan Llc Formulacje fluorochinolonu w aerozolu dla poprawy właściwości farmakokinetycznych
AU2010229721A1 (en) * 2009-03-26 2011-10-06 Pulmatrix, Inc. Methods for treating and preventing pneumonia and ventilator-associated tracheobronchitis
PT2410981T (pt) * 2009-03-26 2017-05-25 Pulmatrix Inc Formulações em pó seco e métodos para tratar doenças pulmonares

Also Published As

Publication number Publication date
EP2709646A4 (fr) 2015-05-13
AU2012254999B2 (en) 2016-02-11
MX346244B (es) 2017-03-13
BR112013029803A2 (pt) 2017-01-17
BR112013029803B1 (pt) 2021-07-13
IL229506A0 (en) 2014-01-30
KR20140032450A (ko) 2014-03-14
CA2981038A1 (fr) 2012-11-22
KR101763195B1 (ko) 2017-07-31
CN103717231A (zh) 2014-04-09
NZ618002A (en) 2015-03-27
IL229506B (en) 2019-07-31
CN103717231B (zh) 2016-08-17
JP2014515356A (ja) 2014-06-30
EP2709646A1 (fr) 2014-03-26
WO2012159103A1 (fr) 2012-11-22
CA2981038C (fr) 2018-09-25
MX2013013503A (es) 2014-05-12
NZ704819A (en) 2016-05-27
SG195038A1 (en) 2013-12-30
JP6012716B2 (ja) 2016-10-25
CA2836643A1 (fr) 2012-11-22

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EEER Examination request

Effective date: 20150424

MKLA Lapsed

Effective date: 20220524