[go: up one dir, main page]

RU2019119405A - DALBAVANCIN LYOPHILIZED PHARMACEUTICAL COMPOSITIONS - Google Patents

DALBAVANCIN LYOPHILIZED PHARMACEUTICAL COMPOSITIONS Download PDF

Info

Publication number
RU2019119405A
RU2019119405A RU2019119405A RU2019119405A RU2019119405A RU 2019119405 A RU2019119405 A RU 2019119405A RU 2019119405 A RU2019119405 A RU 2019119405A RU 2019119405 A RU2019119405 A RU 2019119405A RU 2019119405 A RU2019119405 A RU 2019119405A
Authority
RU
Russia
Prior art keywords
pharmaceutical composition
lyophilized pharmaceutical
proline
dalbavancin
composition
Prior art date
Application number
RU2019119405A
Other languages
Russian (ru)
Other versions
RU2019119405A3 (en
Inventor
Митеш Натаварлал Пател
Мафатлал Трибховандас Даве
Бина Поурусасхап АНКЛЕСАРИЯ
Пранавкумар Джаиеш Чокси
Original Assignee
Гуфик Байосайенсиз Лимитед
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 Гуфик Байосайенсиз Лимитед filed Critical Гуфик Байосайенсиз Лимитед
Publication of RU2019119405A publication Critical patent/RU2019119405A/en
Publication of RU2019119405A3 publication Critical patent/RU2019119405A3/ru

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/14—Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (22)

1. Стабильная лиофилизированная фармацевтическая композиция, содержащая:1. Stable freeze-dried pharmaceutical composition containing: i) гидрохлорид далбаванцина или его фармацевтически приемлемую соль;i) dalbavancin hydrochloride or a pharmaceutically acceptable salt thereof; ii) фармацевтически приемлемое количество аминокислоты в качестве стабилизатора; иii) a pharmaceutically acceptable amount of an amino acid as a stabilizer; and iii) подщелачивающий агент для регулирования pH;iii) an alkalizing agent to adjust the pH; причем указанная композиция имеет рН в диапазоне 5,1-6,0, и, таким образом, указанная композиция содержит не более примерно 1% MAG по массе через 3 месяца хранения при 40°C и относительной влажности 75%.wherein said composition has a pH in the range of 5.1-6.0, and thus, said composition contains no more than about 1% MAG by weight after 3 months of storage at 40 ° C. and 75% relative humidity. 2. Лиофилизированная фармацевтическая композиция по п. 1, в которой гидрохлорид далбаванцина находится в количестве от 100 до 1000 мг.2. The lyophilized pharmaceutical composition of claim 1, wherein the dalbavancin hydrochloride is in an amount of 100 to 1000 mg. 3. Лиофилизированная фармацевтическая композиция по п. 1, в которой аминокислоту выбирают из группы, состоящей из L-пролина, L-аргинина и L-серина.3. The lyophilized pharmaceutical composition of claim 1, wherein the amino acid is selected from the group consisting of L-proline, L-arginine, and L-serine. 4. Лиофилизированная фармацевтическая композиция по п. 3, в которой аминокислота представляет собой L-пролин.4. The lyophilized pharmaceutical composition of claim 3, wherein the amino acid is L-proline. 5. Лиофилизированная фармацевтическая композиция по п. 4, в которой L-пролин находится в количестве от 100 до 1000 мг.5. A lyophilized pharmaceutical composition according to claim 4, wherein L-proline is present in an amount of from 100 to 1000 mg. 6. Лиофилизированная фармацевтическая композиция по п. 1, в которой отношение основания далвабанцина к L-пролину находится в диапазоне от 1:0,8 до 1:1.6. The lyophilized pharmaceutical composition of claim 1, wherein the ratio of dalwabancin base to L-proline is in the range of 1: 0.8 to 1: 1. 7. Лиофилизированная фармацевтическая композиция по п. 1, в которой подщелачивающий агент представляет собой раствор гидроксида натрия.7. The lyophilized pharmaceutical composition of claim 1, wherein the alkalizing agent is sodium hydroxide solution. 8. Лиофилизированная фармацевтическая композиция по п. 1, содержащая:8. A lyophilized pharmaceutical composition according to claim 1, comprising: i) гидрохлорид далбаванцина, эквивалентный безводному далбаванцинину, в количестве 500 мг/флакон;i) dalbavancin hydrochloride equivalent to anhydrous dalbavancin at 500 mg / vial; ii) 400 мг L-пролина в водном носителе в качестве стабилизирующего агента;ii) 400 mg of L-proline in an aqueous carrier as a stabilizing agent; iii) раствор гидроксида натрия в качестве подщелачивающего агента для доведения рН указанной композиции до 5,1-6,0.iii) a solution of sodium hydroxide as an alkalizing agent for adjusting the pH of said composition to 5.1-6.0. 9. Лиофилизированная фармацевтическая композиция по п. 1, содержащая:9. A lyophilized pharmaceutical composition according to claim 1, comprising: i) гидрохлорид далбаванцин, эквивалентный безводному далбаванцинину, в количестве 500 мг/флакон;i) dalbavancin hydrochloride equivalent to anhydrous dalbavancinin, in an amount of 500 mg / vial; ii) 500 мг L-пролина в водном носителе в качестве стабилизирующего агента;ii) 500 mg of L-proline in an aqueous carrier as a stabilizing agent; iii) раствор гидроксида натрия в качестве подщелачивающего агента для доведения рН указанной композиции до 5,1-6,0.iii) a solution of sodium hydroxide as an alkalizing agent for adjusting the pH of said composition to 5.1-6.0. 10. Способ приготовления лиофилизированной фармацевтической композиции по п. 1, включающий:10. A method of preparing a lyophilized pharmaceutical composition according to claim 1, comprising: а) обеспечение пре-лиофилизированной композиции, состоящей из гидрохлорида далбаванцина, растворенного в водном носителе, содержащем стабилизирующий агент и подщелачивающий агент, иa) providing a pre-lyophilized composition consisting of dalbavancin hydrochloride dissolved in an aqueous carrier containing a stabilizing agent and an alkalizing agent, and b) лиофилизацию композиции для получения лиофилизированной фармацевтической композиции с содержанием воды менее 1,5%.b) lyophilizing the composition to obtain a lyophilized pharmaceutical composition with a water content of less than 1.5%.
RU2019119405A 2016-11-23 2017-11-21 DALBAVANCIN LYOPHILIZED PHARMACEUTICAL COMPOSITIONS RU2019119405A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201621039995 2016-11-23
IN201621039995 2016-11-23
PCT/IN2017/050546 WO2018096556A1 (en) 2016-11-23 2017-11-21 Lyophilized pharmaceutical compositions of dalbavancin

Publications (2)

Publication Number Publication Date
RU2019119405A true RU2019119405A (en) 2020-12-25
RU2019119405A3 RU2019119405A3 (en) 2020-12-30

Family

ID=62194924

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2019119405A RU2019119405A (en) 2016-11-23 2017-11-21 DALBAVANCIN LYOPHILIZED PHARMACEUTICAL COMPOSITIONS

Country Status (3)

Country Link
EP (1) EP3544616A4 (en)
RU (1) RU2019119405A (en)
WO (1) WO2018096556A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20250295727A1 (en) * 2022-04-26 2025-09-25 Hikma Pharmaceuticals Usa Inc. Stable, ready-to-administer aqueous formulations of dalbavancin
WO2024079224A1 (en) * 2022-10-12 2024-04-18 Xellia Pharmaceuticals Aps Liquid dalbavancin composition
EP4601615A1 (en) * 2022-10-12 2025-08-20 Hikma Pharmaceuticals USA Inc. Liquid dalbavancin composition
EP4431084A1 (en) * 2023-03-16 2024-09-18 Adalvo Limited Formulation of dalbavancin
GB202405996D0 (en) 2024-04-29 2024-06-12 Arecor Ltd Novel compositions
GB202405997D0 (en) 2024-04-29 2024-06-12 Arecor Ltd Novel compositions

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7119061B2 (en) * 2002-11-18 2006-10-10 Vicuron Pharmaceuticals, Inc. Dalbavancin compositions for treatment of bacterial infections
US20060074014A1 (en) * 2002-11-18 2006-04-06 Vicuron Pharmaceuticals Inc. Dalbavancin compositions for treatment of bacterial infections
ES2743039T3 (en) * 2012-11-29 2020-02-18 Insmed Inc Vancomycin stabilized formulations
SI3542812T1 (en) * 2014-11-06 2021-04-30 Xellia Pharmaceuticals Aps Glycopeptide compositions

Also Published As

Publication number Publication date
WO2018096556A1 (en) 2018-05-31
RU2019119405A3 (en) 2020-12-30
EP3544616A4 (en) 2020-12-09
EP3544616A1 (en) 2019-10-02

Similar Documents

Publication Publication Date Title
RU2019119405A (en) DALBAVANCIN LYOPHILIZED PHARMACEUTICAL COMPOSITIONS
US9655898B2 (en) Pharmaceutical compositions containing pemetrexed having extended storage stability
JP2015506989A5 (en)
JP2015527402A5 (en)
AR083034A1 (en) STABILIZATION OF IMMUNOGLOBULINS AND OTHER PROTEINS THROUGH A WATERY FORMULATION WITH SODIUM CHLORIDE AT A WEAK ACID pH NEUTRAL
EA201492021A1 (en) ANTI-COMPOSITION
RU2016147362A (en) DRUGS OF LIQUID CONCENTRATE OF CYCLOPHOSPHAMIDE
JP2016503058A5 (en)
JP2017514924A5 (en)
MX2020008173A (en) Combination of an antimuscarinic or an anticholinergic agent and lipoic acid and uses thereof.
RU2009137380A (en) LYOPHILIZED DRUG CONTAINING INFLUENZA VACCINE AND METHOD FOR PRODUCING IT
JP2017511816A5 (en)
RU2018129077A (en) STABLE PHARMACEUTICAL COMPOSITION
HRP20190783T1 (en) Pharmaceutical formulations
HRP20220544T1 (en) Novel salts and polymorphs of scy-078
AR085273A1 (en) PROPELLENT FREE LIQUID FORMULATION THAT INCLUDES AN ANTIMUSCARINIC DRUG
RU2014124143A (en) STABLE COMPOSITION OF ANTIBODY SPECIFICALLY BINDING WITH HER2 RECEPTORS AND METHOD FOR PRODUCING IT
RU2010145064A (en) DRY TRANSGLUTAMINASE COMPOSITION
JP5922609B2 (en) Aqueous composition containing 2-amino-3- (4-bromobenzoyl) phenylacetic acid
EA202190126A1 (en) COMPOSITION OF CONDENSED TRICYCLIC GAMMA-AMINO ACID DERIVATIVES AND ITS PREPARATION
RU2014116256A (en) IMPROVED COMPOSITIONS OF RECOMBINANT HUMAN LIPASE STIMULATED BY BALIC ACID SALTS
RU2015100116A (en) TIGECYCLINE INJECTION COMPOSITION
RU2016101248A (en) LYOPHILIZED PRODUCTS BENDAMUSTINE HYDROCHLORIDE
RU2019136641A (en) STABLE LIQUID PHARMACEUTICAL COMPOSITION
WO2015046281A1 (en) Aqueous composition containing stabilized 2-amino-3-(4-bromobenzoyl)phenylacetic acid

Legal Events

Date Code Title Description
FA92 Acknowledgement of application withdrawn (lack of supplementary materials submitted)

Effective date: 20220207