CA2836643C - Dry powder vancomycin compositions and associated methods - Google Patents

Dry powder vancomycin compositions and associated methods 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)
French (fr)
Other versions
CA2836643A1 (en
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/en
Publication of CA2836643A1 publication Critical patent/CA2836643A1/en
Application granted granted Critical
Publication of CA2836643C publication Critical patent/CA2836643C/en
Expired - Fee Related 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
    • A61K38/14Peptides 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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Otolaryngology (AREA)
  • Oncology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Communicable Diseases (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CA2836643A 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods Expired - Fee Related CA2836643C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2981038A CA2981038C (en) 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods

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 (en) 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2981038A Division CA2981038C (en) 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods

Publications (2)

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

Family

ID=47177374

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2836643A Expired - Fee Related CA2836643C (en) 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods
CA2981038A Expired - Fee Related CA2981038C (en) 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2981038A Expired - Fee Related CA2981038C (en) 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods

Country Status (11)

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

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007067520A2 (en) 2005-12-08 2007-06-14 Transave, Inc. Lipid-based compositions of antiinfectives for treating pulmonary infections
US9119783B2 (en) 2007-05-07 2015-09-01 Insmed Incorporated Method of treating pulmonary disorders with liposomal amikacin formulations
EP3581186A1 (en) * 2012-11-29 2019-12-18 Insmed Incorporated Stabilized vancomycin formulations
CN105142624A (zh) 2013-01-10 2015-12-09 普尔莫凯恩股份有限公司 非选择性激酶抑制剂
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
JP6483714B2 (ja) 2013-10-11 2019-03-13 ローレンス エス. ジスマン, 噴霧乾燥製剤
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
EP4000628A1 (en) 2014-03-14 2022-05-25 Azurity Pharmaceuticals, Inc. Composition and method for vancomycin oral liquid
NZ726256A (en) 2014-05-15 2022-11-25 Insmed Inc Methods for treating pulmonary non-tuberculous mycobacterial infections
HUE053347T2 (hu) * 2014-11-06 2021-06-28 Xellia Pharmaceuticals Aps Glikopeptid-készítmények
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
CN110087653A (zh) 2016-10-27 2019-08-02 普尔莫凯恩股份有限公司 用于治疗肺高血压的组合疗法
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
EP3634464A4 (en) 2017-05-22 2021-04-07 Insmed Incorporated GLYCOPEPTIDE DERIVATIVE COMPOUNDS AND USES THEREOF
JP7460534B2 (ja) 2018-03-30 2024-04-02 インスメッド インコーポレイテッド リポソーム医薬品の連続製造方法
US20200115412A1 (en) * 2018-10-15 2020-04-16 Savara Inc. Separation of vancomycin and its degradation products

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES286422Y (es) 1982-10-08 1986-09-16 Glaxo Group Limited Dispositivo para administrar medicamentos a pacientes
US4778054A (en) 1982-10-08 1988-10-18 Glaxo Group Limited Pack for administering medicaments to patients
AU591152B2 (en) 1985-07-30 1989-11-30 Glaxo Group Limited Devices for administering medicaments to patients
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
JP4859320B2 (ja) * 1999-10-29 2012-01-25 ネクター セラピューティックス 改良された分散性を有する乾燥粉末組成物
DE60227691D1 (de) * 2001-11-01 2008-08-28 Nektar Therapeutics Sprühtrocknungsverfahren
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 (en) * 2007-10-15 2009-04-22 Laboratoires SMB Improved pharmaceutical dry powder compositions for inhalation.
KR20110091510A (ko) * 2008-10-07 2011-08-11 엠펙스 파마슈티컬즈, 인코포레이티드 약동학 개선을 위한 에어로졸 플루오로퀴놀론 제형
WO2010111641A2 (en) 2009-03-26 2010-09-30 Pulmatrix, Inc. Methods for treating and preventing pneumonia and ventilator-associated tracheobronchitis
CN108434126B (zh) * 2009-03-26 2021-11-19 普马特里克斯营业公司 治疗肺病的干粉配方与方法

Also Published As

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

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Effective date: 20150424

MKLA Lapsed

Effective date: 20220524