BR112013029803B1 - Composições de vancomicina em pó seco - Google Patents

Composições de vancomicina em pó seco Download PDF

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Publication number
BR112013029803B1
BR112013029803B1 BR112013029803-0A BR112013029803A BR112013029803B1 BR 112013029803 B1 BR112013029803 B1 BR 112013029803B1 BR 112013029803 A BR112013029803 A BR 112013029803A BR 112013029803 B1 BR112013029803 B1 BR 112013029803B1
Authority
BR
Brazil
Prior art keywords
composition
vancomycin
dry powder
compositions
amount
Prior art date
Application number
BR112013029803-0A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112013029803A2 (pt
Inventor
John Lord
Jaakko Taneli Jouhikainen
Herman E. Snyder
Pravin Soni
Mei-chang Kuo
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 BR112013029803A2 publication Critical patent/BR112013029803A2/pt
Publication of BR112013029803B1 publication Critical patent/BR112013029803B1/pt

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    • 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

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  • 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)
BR112013029803-0A 2011-05-19 2012-05-21 Composições de vancomicina em pó seco BR112013029803B1 (pt)

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

Publications (2)

Publication Number Publication Date
BR112013029803A2 BR112013029803A2 (pt) 2017-01-17
BR112013029803B1 true BR112013029803B1 (pt) 2021-07-13

Family

ID=47177374

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013029803-0A BR112013029803B1 (pt) 2011-05-19 2012-05-21 Composições de vancomicina em pó seco

Country Status (11)

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

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE029994T2 (en) 2005-12-08 2017-04-28 Insmed 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
RU2018135921A (ru) * 2012-11-29 2019-02-05 Инсмед Инкорпорейтед Стабилизированные составы ванкомицина
EP3007689B1 (en) 2013-01-10 2018-03-07 Pulmokine, Inc. Non-selective kinase inhibitors
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
US9925184B2 (en) 2013-10-11 2018-03-27 Pulmokine, Inc. Spray-dry formulations
RU2016136449A (ru) * 2014-02-28 2018-04-02 АльгиФарма АС Применение олигометов альгината в лечении муковисцидоза и других состояний, ассоциированных с нарушенной функцией ионных каналов cftr
AU2015229069A1 (en) * 2014-03-14 2016-11-03 CutisPharma,Inc. Composition and method for vancomycin oral liquid
SMT202000516T1 (it) 2014-05-15 2020-11-10 Insmed Inc Metodi per trattamento di infezioni micobatteriche polmonati non tubercolari
HUE053347T2 (hu) * 2014-11-06 2021-06-28 Xellia Pharmaceuticals Aps Glikopeptid-készítmények
CA2974220C (en) 2015-02-06 2023-05-16 Latitude Pharmaceuticals, Inc. Aqueous solution formulations of vancomycin
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
GB2577420B (en) * 2017-05-22 2022-07-06 Insmed Inc Glycopeptide derivative compounds and uses thereof
EP3773505B1 (en) 2018-03-30 2026-04-29 Insmed Incorporated Methods for continuous manufacture of liposomal drug products
WO2019213398A1 (en) 2018-05-02 2019-11-07 Insmed Incorporated Methods for the manufacture of liposomal drug formulations
WO2020081599A1 (en) * 2018-10-15 2020-04-23 Savara Inc. Separation of vancomycin and its degradation products
EP3866775B1 (en) 2018-10-17 2025-03-19 Novabiotics Limited Cysteamine for use in the treatment of lung diseases

Family Cites Families (17)

* 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
DK172541B1 (da) 1982-10-08 1998-12-07 Glaxo Group Ltd Apparat til administrering af medikamenter til patienter og en medikamentpakning til brug i apparatet
DE3682457D1 (de) 1985-07-30 1991-12-19 Glaxo Group Ltd Geraet zur verabreichung von medikamenten an patienten.
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
DE60025019T2 (de) * 1999-10-29 2006-08-24 Nektar Therapeutics, San Carlos Trockenpulverzusammensetzungen mit verbesserter dispersivität
WO2003037303A1 (en) * 2001-11-01 2003-05-08 Nektar Therapeutics Spray drying methods and compositions thereof
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.
JP2012505223A (ja) * 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 薬物動態の改善のためのエアゾールフルオロキノロン配合物
US20120058198A1 (en) * 2009-03-26 2012-03-08 Pulmatrix, Inc. Methods for treating and preventing pneumonia and ventilator-associated tracheobronchitis
CA2754691C (en) 2009-03-26 2019-07-30 Pulmatrix, Inc. Dry powder formulations and methods for treating pulmonary diseases

Also Published As

Publication number Publication date
EP2709646A1 (en) 2014-03-26
JP2014515356A (ja) 2014-06-30
EP2709646A4 (en) 2015-05-13
MX346244B (es) 2017-03-13
BR112013029803A2 (pt) 2017-01-17
MX2013013503A (es) 2014-05-12
IL229506B (en) 2019-07-31
CN103717231B (zh) 2016-08-17
CN103717231A (zh) 2014-04-09
CA2836643C (en) 2017-11-14
CA2981038A1 (en) 2012-11-22
CA2836643A1 (en) 2012-11-22
IL229506A0 (en) 2014-01-30
AU2012254999B2 (en) 2016-02-11
KR20140032450A (ko) 2014-03-14
WO2012159103A1 (en) 2012-11-22
NZ704819A (en) 2016-05-27
NZ618002A (en) 2015-03-27
JP6012716B2 (ja) 2016-10-25
KR101763195B1 (ko) 2017-07-31
SG195038A1 (en) 2013-12-30
CA2981038C (en) 2018-09-25

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Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/05/2012, OBSERVADAS AS CONDICOES LEGAIS.

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 11A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2724 DE 21-03-2023 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.