EP2709646A4 - Dry powder vancomycin compositions and associated methods - Google Patents

Dry powder vancomycin compositions and associated methods

Info

Publication number
EP2709646A4
EP2709646A4 EP12785744.9A EP12785744A EP2709646A4 EP 2709646 A4 EP2709646 A4 EP 2709646A4 EP 12785744 A EP12785744 A EP 12785744A EP 2709646 A4 EP2709646 A4 EP 2709646A4
Authority
EP
European Patent Office
Prior art keywords
dry powder
associated methods
vancomycin compositions
powder vancomycin
compositions
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.)
Withdrawn
Application number
EP12785744.9A
Other languages
German (de)
French (fr)
Other versions
EP2709646A1 (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
Publication of EP2709646A1 publication Critical patent/EP2709646A1/en
Publication of EP2709646A4 publication Critical patent/EP2709646A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K9/14Particulate 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)
EP12785744.9A 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods Withdrawn EP2709646A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161487971P 2011-05-19 2011-05-19
PCT/US2012/038775 WO2012159103A1 (en) 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods

Publications (2)

Publication Number Publication Date
EP2709646A1 EP2709646A1 (en) 2014-03-26
EP2709646A4 true EP2709646A4 (en) 2015-05-13

Family

ID=47177374

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12785744.9A Withdrawn EP2709646A4 (en) 2011-05-19 2012-05-21 Dry powder vancomycin compositions and associated methods

Country Status (11)

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

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2006322076C1 (en) 2005-12-08 2013-11-14 Insmed Incorporated 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
MX2015006681A (en) 2012-11-29 2016-04-06 Insmed Inc Stabilized vancomycin formulations.
CA2897651C (en) 2013-01-10 2021-09-21 Pulmokine, Inc. Non-selective kinase inhibitors
CN104043104B (en) * 2013-03-15 2018-07-10 浙江创新生物有限公司 The spray dried powder and its industrialized process for preparing of hydrochloric vancomycin
CA2926793C (en) 2013-10-11 2022-11-22 Lawrence S. ZISMAN Spray-dry formulations for treating pulmonary arterial hypertension
WO2015128495A1 (en) * 2014-02-28 2015-09-03 Algipharma As Use of alginate oligomers in the treatment of cystic fibrosis and other conditions associated with defective cftr ion channel function
ES2903419T3 (en) 2014-03-14 2022-04-01 Azurity Pharmaceuticals Inc Composition and method for vancomycin oral liquid
ES2981634T3 (en) 2014-05-15 2024-10-09 Insmed Incorporated Methods for treating nontuberculous pulmonary mycobacterial infections
RS59851B1 (en) * 2014-11-06 2020-02-28 Xellia Pharmaceuticals Aps Glycopeptide compositions
WO2016127087A1 (en) 2015-02-06 2016-08-11 Latitude Pharmaceuticals, Inc. Aqueous solution formulations of vancomycin
GB201609940D0 (en) * 2016-06-07 2016-07-20 Novabiotics Ltd Microparticles
CA3041679A1 (en) 2016-10-27 2018-05-03 Lawrence S. ZISMAN Combination therapy for treating pulmonary hypertension
CN106963939A (en) * 2017-03-22 2017-07-21 永信药品工业(昆山)股份有限公司 Vancomycin hydrochloride pharmaceutical composition and preparation method thereof
CA3062570A1 (en) * 2017-05-22 2018-11-29 Insmed Incorporated Lipo-glycopeptide cleavable derivatives and uses thereof
EP3773505A4 (en) 2018-03-30 2021-12-22 Insmed Incorporated Methods for continuous manufacture of liposomal drug products
WO2020081599A1 (en) * 2018-10-15 2020-04-23 Savara Inc. Separation of vancomycin and its degradation products

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997041833A1 (en) * 1996-05-08 1997-11-13 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
WO2001013893A2 (en) * 1999-08-25 2001-03-01 Advanced Inhalation Research, Inc. Use of simple amino acids to form porous particles
WO2001032144A1 (en) * 1999-10-29 2001-05-10 Inhale Therapeutic Systems, Inc. Dry powder compositions having improved dispersivity
WO2003037303A1 (en) * 2001-11-01 2003-05-08 Nektar Therapeutics Spray drying methods and compositions thereof

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4778054A (en) 1982-10-08 1988-10-18 Glaxo Group Limited Pack for administering medicaments to patients
NO160330C (en) 1982-10-08 1989-04-12 Glaxo Group Ltd DEVICE FOR AA ADMINISTRATING MEDICINES TO PATIENTS AND MEDICINAL PACKAGING FOR THE DEVICE.
NO166268C (en) 1985-07-30 1991-07-03 Glaxo Group Ltd DEVICE FOR ADMINISTRATING PATIENTS TO PATIENTS.
JPH03193735A (en) * 1989-12-22 1991-08-23 Shionogi & Co Ltd Stabilized composition of glycopeptide-based antibiotic
JPH05963A (en) 1990-04-13 1993-01-08 Toray Ind Inc Polypeptide composition
US6582728B1 (en) 1992-07-08 2003-06-24 Inhale Therapeutic Systems, Inc. Spray drying of macromolecules to produce inhaleable dry powders
JP4142149B2 (en) * 1997-07-10 2008-08-27 明治製菓株式会社 Vancomycin lyophilized formulation
DE10358387A1 (en) * 2003-12-13 2005-07-07 Boehringer Ingelheim Pharma Gmbh & Co. Kg Powder containing low molecular weight dextran and process for their preparation
FR2872044B1 (en) * 2004-06-28 2007-06-29 Flamel Technologies Sa PHARMACEUTICAL FORMULATION BASED ON ANTIBIOTICS IN THE MICROCAPSULAR FORM
EP2050437A1 (en) * 2007-10-15 2009-04-22 Laboratoires SMB Improved pharmaceutical dry powder compositions for inhalation.
JP2012505223A (en) * 2008-10-07 2012-03-01 エムペックス・ファーマシューティカルズ・インコーポレーテッド Aerosol fluoroquinolone formulation for improved pharmacokinetics
EP2410981B2 (en) * 2009-03-26 2020-02-26 Pulmatrix Operating Company, Inc. Dry powder formulations and methods for treating pulmonary diseases
WO2010111641A2 (en) * 2009-03-26 2010-09-30 Pulmatrix, Inc. Methods for treating and preventing pneumonia and ventilator-associated tracheobronchitis

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997041833A1 (en) * 1996-05-08 1997-11-13 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
WO2001013893A2 (en) * 1999-08-25 2001-03-01 Advanced Inhalation Research, Inc. Use of simple amino acids to form porous particles
WO2001032144A1 (en) * 1999-10-29 2001-05-10 Inhale Therapeutic Systems, Inc. Dry powder compositions having improved dispersivity
WO2003037303A1 (en) * 2001-11-01 2003-05-08 Nektar Therapeutics Spray drying methods and compositions thereof

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Handbook of Pharmaceutical Excipients. Fifth Edition", 2006, PHARMACEUTICAL PRESS, article "Leucine", pages: 412, XP002729817 *
M. J. DE JESUS VALLE ET AL: "Pulmonary versus Systemic Delivery of Antibiotics: Comparison of Vancomycin Dispositions in the Isolated Rat Lung", ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, vol. 51, no. 10, 6 August 2007 (2007-08-06), pages 3771 - 3774, XP055140353, ISSN: 0066-4804, DOI: 10.1128/AAC.00099-07 *
PRAJAKTA S. GADGILP: "A comparative study between high potency dry powder inhalation and nebulized solution of vancomycin hydrochloride for lung delivery", 11 August 2011 (2011-08-11), pages FP - 109, XP055140679, Retrieved from the Internet <URL:http://search.proquest.com/pqdtscieng/docview/889930798as02134> [retrieved on 20141111] *
REINHARD VEHRING: "Pharmaceutical Particle Engineering via Spray Drying", PHARMACEUTICAL RESEARCH, vol. 25, no. 5, 28 November 2007 (2007-11-28), KLUWER ACADEMIC PUBLISHERS-PLENUM PUBLISHERS, NL, pages 999 - 1022, XP019613056, ISSN: 1573-904X *
See also references of WO2012159103A1 *

Also Published As

Publication number Publication date
CA2836643C (en) 2017-11-14
WO2012159103A1 (en) 2012-11-22
EP2709646A1 (en) 2014-03-26
CN103717231A (en) 2014-04-09
KR20140032450A (en) 2014-03-14
KR101763195B1 (en) 2017-07-31
CA2836643A1 (en) 2012-11-22
MX2013013503A (en) 2014-05-12
SG195038A1 (en) 2013-12-30
CN103717231B (en) 2016-08-17
BR112013029803B1 (en) 2021-07-13
JP2014515356A (en) 2014-06-30
CA2981038C (en) 2018-09-25
JP6012716B2 (en) 2016-10-25
IL229506B (en) 2019-07-31
MX346244B (en) 2017-03-13
NZ704819A (en) 2016-05-27
NZ618002A (en) 2015-03-27
CA2981038A1 (en) 2012-11-22
IL229506A0 (en) 2014-01-30
BR112013029803A2 (en) 2017-01-17
AU2012254999B2 (en) 2016-02-11

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