BR112018072948A2 - composição farmacêutica líquida, e, método para a estabilização de um antibiótico glicopeptídeo em uma solução farmacêutica líquida. - Google Patents

composição farmacêutica líquida, e, método para a estabilização de um antibiótico glicopeptídeo em uma solução farmacêutica líquida.

Info

Publication number
BR112018072948A2
BR112018072948A2 BR112018072948-5A BR112018072948A BR112018072948A2 BR 112018072948 A2 BR112018072948 A2 BR 112018072948A2 BR 112018072948 A BR112018072948 A BR 112018072948A BR 112018072948 A2 BR112018072948 A2 BR 112018072948A2
Authority
BR
Brazil
Prior art keywords
liquid pharmaceutical
stabilizing
glycopeptide antibiotic
pharmaceutical composition
solution
Prior art date
Application number
BR112018072948-5A
Other languages
English (en)
Inventor
KESER Sabina
Jasprica Ivona
Le-Cunff Jerome
Original Assignee
Xellia Pharmaceuticals Aps
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 Xellia Pharmaceuticals Aps filed Critical Xellia Pharmaceuticals Aps
Publication of BR112018072948A2 publication Critical patent/BR112018072948A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)

Abstract

são divulgadas aqui formulações líquidas de antibióticos glicopeptídeos ou seus sais farmaceuticamente aceitáveis, em que o antibiótico glicopeptídeo é selecionado a partir de vancomicina, telavancina, oritavancina, teicoplanina e dalbavancina. as ditas formulações são adequadas como soluções de infusão ou como um concentrado para a preparação de soluções de infusão.
BR112018072948-5A 2016-05-09 2017-05-04 composição farmacêutica líquida, e, método para a estabilização de um antibiótico glicopeptídeo em uma solução farmacêutica líquida. BR112018072948A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662333357P 2016-05-09 2016-05-09
US62/333,357 2016-05-09
PCT/EP2017/060653 WO2017194385A1 (en) 2016-05-09 2017-05-04 Stabilized glycopeptide antibiotic formulations

Publications (1)

Publication Number Publication Date
BR112018072948A2 true BR112018072948A2 (pt) 2019-02-19

Family

ID=58745200

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018072948-5A BR112018072948A2 (pt) 2016-05-09 2017-05-04 composição farmacêutica líquida, e, método para a estabilização de um antibiótico glicopeptídeo em uma solução farmacêutica líquida.

Country Status (20)

Country Link
US (1) US10729708B2 (pt)
EP (1) EP3454883A1 (pt)
JP (1) JP6946343B2 (pt)
KR (1) KR20190005940A (pt)
CN (1) CN109069580A (pt)
AR (1) AR109454A1 (pt)
AU (1) AU2017262943B2 (pt)
BR (1) BR112018072948A2 (pt)
CA (1) CA3021935A1 (pt)
CL (1) CL2018003147A1 (pt)
CO (1) CO2018011701A2 (pt)
EA (1) EA201892413A1 (pt)
IL (1) IL262796A (pt)
JO (2) JOP20170111B1 (pt)
MX (1) MX2018013584A (pt)
SA (1) SA518400392B1 (pt)
SG (1) SG11201809908TA (pt)
TW (2) TWI769694B (pt)
UY (1) UY37233A (pt)
WO (1) WO2017194385A1 (pt)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2015341763B2 (en) 2014-11-06 2019-01-17 Xellia Pharmaceuticals Aps Glycopeptide compositions
WO2021231361A1 (en) * 2020-05-11 2021-11-18 Anovent Pharmaceutical (U.S.), Llc Pharmaceutical formulation containing active metabolites of remdesivir for inhalation
EP4014969A1 (en) 2020-12-16 2022-06-22 EVER Valinject GmbH Aqueous solution
EP4014965A1 (en) 2020-12-16 2022-06-22 EVER Valinject GmbH Aqueous solution
CN115804832A (zh) * 2021-09-14 2023-03-17 海南普利制药股份有限公司 一种万古霉素水溶液组合物
WO2023171588A1 (ja) * 2022-03-08 2023-09-14 国立大学法人大阪大学 抗菌薬を含有するplga製剤
WO2023211501A1 (en) * 2022-04-26 2023-11-02 Hikma Pharmaceuticals Usa Inc. Stable, ready-to-administer aqueous formulations of dalbavancin
GB202207344D0 (en) 2022-05-19 2022-07-06 Arecor Ltd Novel composition
GB202207345D0 (en) 2022-05-19 2022-07-06 Arecor Ltd Novel composition
CN117618338A (zh) * 2022-08-16 2024-03-01 海南普利制药股份有限公司 一种稳定的奥利万星药物水溶液及其制备方法
WO2024079223A1 (en) * 2022-10-12 2024-04-18 Xellia Pharmaceuticals Aps Liquid dalbavancin composition
WO2024079224A1 (en) * 2022-10-12 2024-04-18 Xellia Pharmaceuticals Aps Liquid dalbavancin composition

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US1278549A (en) * 1916-12-16 1918-09-10 J E Simmons Nut and bolt lock.
US4670258A (en) 1984-02-10 1987-06-02 Vanderbilt University Storable prepackaged aqueous solutions of vancomycin
US4885275A (en) 1987-10-15 1989-12-05 Eli Lilly And Company Vancomycin-HCL solutions and the lyophilization thereof
WO1997019690A1 (en) 1995-12-01 1997-06-05 Eli Lilly And Company Stable vancomycin hydrochloride solutions
JPH1180021A (ja) 1997-09-02 1999-03-23 Kayaku:Kk バンコマイシン注射剤
CN1223378C (zh) 2000-05-02 2005-10-19 施万制药 含有糖肽抗生素和环糊精的药物组合物
WO2001083520A2 (en) * 2000-05-02 2001-11-08 Theravance,Inc Polyacid glycopeptide derivatives
ATE402951T1 (de) * 2000-05-02 2008-08-15 Theravance Inc Verfahren zur reduktiven alkylierung von glykopeptiden
UA82824C2 (uk) * 2000-06-21 2008-05-26 К'Юбіст Фармасьютікалз, Інк. Композиція і спосіб поліпшення перорального всмоктування протимікробних засобів
UA75083C2 (uk) * 2000-06-22 2006-03-15 Тераванс, Інк. Похідні глікопептидфосфонатів
US7034013B2 (en) * 2001-03-20 2006-04-25 Cydex, Inc. Formulations containing propofol and a sulfoalkyl ether cyclodextrin
US7119061B2 (en) * 2002-11-18 2006-10-10 Vicuron Pharmaceuticals, Inc. Dalbavancin compositions for treatment of bacterial infections
EP1678211A4 (en) * 2003-10-31 2008-04-02 Univ Kansas SULFOALKYL ETHER-ALKYL ETHER CYCLODEXTRINS DERIVATIVES
AU2006213441B2 (en) 2005-02-14 2011-12-01 Venus Remedies Limited Parenteral combination therpy for infective conditions with drug resistant bacterium
CN1857716A (zh) * 2006-03-14 2006-11-08 浙江大学 注射用盐酸万古霉素及其制备方法
JP2008201778A (ja) 2007-01-25 2008-09-04 Mochida Pharmaceut Co Ltd バンコマイシン液状製剤
BRPI0816662A2 (pt) 2007-09-12 2017-06-13 Targanta Therapeutics Corp método de inibição de clostridium difficile pela administração de oritavancina
US7635773B2 (en) 2008-04-28 2009-12-22 Cydex Pharmaceuticals, Inc. Sulfoalkyl ether cyclodextrin compositions
CN102755629A (zh) * 2012-08-02 2012-10-31 上海瑞创医药科技有限公司 与万古霉素形成抗菌增效包合物的组分和制备方法及其应用
RU2018135921A (ru) 2012-11-29 2019-02-05 Инсмед Инкорпорейтед Стабилизированные составы ванкомицина
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
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AU2015341763B2 (en) * 2014-11-06 2019-01-17 Xellia Pharmaceuticals Aps Glycopeptide compositions
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CA3014294A1 (en) * 2016-02-18 2017-08-24 Melinta Therapeutics, Inc. Oritavancin formulations

Also Published As

Publication number Publication date
JP6946343B2 (ja) 2021-10-06
JP2019518733A (ja) 2019-07-04
MX2018013584A (es) 2019-04-01
WO2017194385A1 (en) 2017-11-16
US20190175632A1 (en) 2019-06-13
IL262796A (en) 2018-12-31
EA201892413A1 (ru) 2019-05-31
EP3454883A1 (en) 2019-03-20
AR109454A1 (es) 2018-12-12
CN109069580A (zh) 2018-12-21
TW202133875A (zh) 2021-09-16
JOP20170111B1 (ar) 2022-03-14
KR20190005940A (ko) 2019-01-16
AU2017262943A1 (en) 2018-11-22
SG11201809908TA (en) 2018-12-28
CA3021935A1 (en) 2017-11-16
US10729708B2 (en) 2020-08-04
UY37233A (es) 2018-01-02
CO2018011701A2 (es) 2019-02-08
SA518400392B1 (ar) 2022-05-09
CL2018003147A1 (es) 2018-12-28
TWI769694B (zh) 2022-07-01
TWI772296B (zh) 2022-08-01
AU2017262943B2 (en) 2020-05-14
JOP20220039A1 (ar) 2023-01-30
TW201740955A (zh) 2017-12-01

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Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2669 DE 03-03-2022 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.