KR102122429B1 - 세포독성 디펩티드의 동결건조 제제 - Google Patents

세포독성 디펩티드의 동결건조 제제 Download PDF

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KR102122429B1
KR102122429B1 KR1020207003073A KR20207003073A KR102122429B1 KR 102122429 B1 KR102122429 B1 KR 102122429B1 KR 1020207003073 A KR1020207003073 A KR 1020207003073A KR 20207003073 A KR20207003073 A KR 20207003073A KR 102122429 B1 KR102122429 B1 KR 102122429B1
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South Korea
Prior art keywords
melphalan flufenamide
delete delete
solution
lyophilized
cyclodextrin
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KR1020207003073A
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English (en)
Korean (ko)
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KR20200014947A (ko
Inventor
잭 스피라
프레드릭 레만
Original Assignee
온코펩타이드즈 아베
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Priority claimed from PCT/EP2012/057577 external-priority patent/WO2012146625A1/en
Publication of KR20200014947A publication Critical patent/KR20200014947A/ko
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Publication of KR102122429B1 publication Critical patent/KR102122429B1/ko

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    • 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
    • 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
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • A61K38/05Dipeptides
    • 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
    • A61K38/10Peptides having 12 to 20 amino acids
    • A61K38/105Bombesin; Related peptides
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)
KR1020207003073A 2011-04-28 2012-04-25 세포독성 디펩티드의 동결건조 제제 KR102122429B1 (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
SE1150371-1 2011-04-28
SE1150371 2011-04-28
US201161535126P 2011-09-15 2011-09-15
US61/535,126 2011-09-15
PCT/EP2012/057577 WO2012146625A1 (en) 2011-04-28 2012-04-25 Lyophilized preparation of cytotoxic dipeptides

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020177035122A Division KR102122416B1 (ko) 2011-04-28 2012-04-25 세포독성 디펩티드의 동결건조 제제

Publications (2)

Publication Number Publication Date
KR20200014947A KR20200014947A (ko) 2020-02-11
KR102122429B1 true KR102122429B1 (ko) 2020-06-12

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Family Applications (2)

Application Number Title Priority Date Filing Date
KR1020207003073A KR102122429B1 (ko) 2011-04-28 2012-04-25 세포독성 디펩티드의 동결건조 제제
KR1020207016300A KR102194376B1 (ko) 2011-04-28 2012-04-25 세포독성 디펩티드의 동결건조 제제

Family Applications After (1)

Application Number Title Priority Date Filing Date
KR1020207016300A KR102194376B1 (ko) 2011-04-28 2012-04-25 세포독성 디펩티드의 동결건조 제제

Country Status (8)

Country Link
KR (2) KR102122429B1 (es)
ES (1) ES2813979T3 (es)
HK (1) HK1250492A1 (es)
HR (1) HRP20201300T1 (es)
HU (1) HUE051690T4 (es)
IL (1) IL280812B2 (es)
LT (1) LT3228319T (es)
PT (1) PT3228319T (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230398069A1 (en) * 2020-08-19 2023-12-14 Cellact Pharma Gmbh Etoposide toniribate formulation
JP2024517762A (ja) * 2021-04-28 2024-04-23 インチョン ナショナル ユニバーシティ リサーチ アンド ビジネス ファウンデーション 細胞外小胞の凍結乾燥保護剤
EP4233837A1 (en) * 2022-02-24 2023-08-30 CellAct Pharma GmbH Solid and oral etoposide toniribate compositions

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040034099A1 (en) 2002-06-27 2004-02-19 Ramsey Beverly J. Pharmaceutical composition
US20040097421A1 (en) 2000-06-13 2004-05-20 Rolf Lewensohn Melphalan derivatives and their use as cancer chemotherapeutic drugs

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE0002202D0 (sv) * 2000-06-13 2000-06-13 Karolinska Innovations Ab New peptides
US6780324B2 (en) * 2002-03-18 2004-08-24 Labopharm, Inc. Preparation of sterile stabilized nanodispersions

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040097421A1 (en) 2000-06-13 2004-05-20 Rolf Lewensohn Melphalan derivatives and their use as cancer chemotherapeutic drugs
US20040034099A1 (en) 2002-06-27 2004-02-19 Ramsey Beverly J. Pharmaceutical composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
J. Excipients and Food Chem. 1(1), 2010, 41-54

Also Published As

Publication number Publication date
KR20200084890A (ko) 2020-07-13
KR20200014947A (ko) 2020-02-11
PT3228319T (pt) 2020-08-27
KR102194376B1 (ko) 2020-12-23
IL280812B2 (en) 2023-04-01
LT3228319T (lt) 2020-09-25
IL280812B (en) 2022-12-01
IL280812A (en) 2021-04-29
HUE051690T2 (hu) 2021-03-29
HUE051690T4 (hu) 2023-09-28
HK1250492A1 (zh) 2018-12-21
HRP20201300T1 (hr) 2020-11-27
ES2813979T3 (es) 2021-03-25

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