AU2012326370C9 - Lyophilized liposomes - Google Patents

Lyophilized liposomes Download PDF

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Publication number
AU2012326370C9
AU2012326370C9 AU2012326370A AU2012326370A AU2012326370C9 AU 2012326370 C9 AU2012326370 C9 AU 2012326370C9 AU 2012326370 A AU2012326370 A AU 2012326370A AU 2012326370 A AU2012326370 A AU 2012326370A AU 2012326370 C9 AU2012326370 C9 AU 2012326370C9
Authority
AU
Australia
Prior art keywords
liposomes
composition
phase
lyophilization
cryoprotectant
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.)
Active, expires
Application number
AU2012326370A
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English (en)
Other versions
AU2012326370B2 (en
AU2012326370A2 (en
AU2012326370C1 (en
AU2012326370A1 (en
Inventor
Donna Cabral-Lilly
Lawrence Mayer
Paul Tardi
David Watkins
Yi Zeng
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.)
Jazz Pharmaceuticals Therapeutics Inc
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Jazz Pharmaceuticals Therapeutics Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48141268&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2012326370(C9) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Jazz Pharmaceuticals Therapeutics Inc filed Critical Jazz Pharmaceuticals Therapeutics Inc
Publication of AU2012326370A1 publication Critical patent/AU2012326370A1/en
Publication of AU2012326370A2 publication Critical patent/AU2012326370A2/en
Publication of AU2012326370B2 publication Critical patent/AU2012326370B2/en
Application granted granted Critical
Publication of AU2012326370C1 publication Critical patent/AU2012326370C1/en
Publication of AU2012326370C9 publication Critical patent/AU2012326370C9/en
Assigned to Jazz Pharmaceuticals Therapeutics, Inc. reassignment Jazz Pharmaceuticals Therapeutics, Inc. Request to Amend Deed and Register Assignors: CELATOR PHARMACEUTICALS, INC.
Active legal-status Critical Current
Adjusted expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4738Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • 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
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • A61K31/7072Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A61K9/1277Preparation processes; Proliposomes
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
AU2012326370A 2011-10-21 2012-10-15 Lyophilized liposomes Active 2037-06-03 AU2012326370C9 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161550047P 2011-10-21 2011-10-21
US61/550,047 2011-10-21
PCT/US2012/060293 WO2013059133A1 (en) 2011-10-21 2012-10-15 Lyophilized liposomes

Publications (5)

Publication Number Publication Date
AU2012326370A1 AU2012326370A1 (en) 2014-06-05
AU2012326370A2 AU2012326370A2 (en) 2014-06-12
AU2012326370B2 AU2012326370B2 (en) 2017-06-01
AU2012326370C1 AU2012326370C1 (en) 2023-03-30
AU2012326370C9 true AU2012326370C9 (en) 2023-05-18

Family

ID=48141268

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2012326370A Active 2037-06-03 AU2012326370C9 (en) 2011-10-21 2012-10-15 Lyophilized liposomes

Country Status (22)

Country Link
US (5) US10028912B2 (https=)
EP (2) EP3572071A1 (https=)
JP (6) JP6133308B2 (https=)
KR (5) KR102452305B1 (https=)
CN (2) CN108853031A (https=)
AU (1) AU2012326370C9 (https=)
BR (1) BR112014009305B1 (https=)
CA (1) CA2852777C (https=)
DK (1) DK2768484T3 (https=)
ES (1) ES2750368T3 (https=)
FR (1) FR19C1063I2 (https=)
HR (1) HRP20191683T1 (https=)
HU (2) HUE045978T2 (https=)
IL (1) IL232161B (https=)
LU (1) LUC00135I2 (https=)
NL (1) NL301016I2 (https=)
NO (1) NO2019041I1 (https=)
PL (1) PL2768484T3 (https=)
PT (1) PT2768484T (https=)
RU (1) RU2648753C2 (https=)
SI (1) SI2768484T1 (https=)
WO (1) WO2013059133A1 (https=)

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US11504322B2 (en) 2014-08-28 2022-11-22 The General Hospital Corporation Injectable slurries and methods of manufacturing the same
US11471401B2 (en) 2014-08-28 2022-10-18 The General Hospital Corporation Injectable slurries and methods of manufacturing the same
KR20180016347A (ko) * 2015-04-13 2018-02-14 파운테인 테크놀로지스 인터내셔널, 엘엘씨 초-소형 지질 구조체의 생산을 위한 단일-단계 방법
SMT202100196T1 (it) 2015-07-22 2021-05-07 Nitto Denko Corp Composizioni e metodi per forme liofile di nanoparticelle
CN108778260A (zh) * 2015-11-11 2018-11-09 塞拉特药物股份有限公司 选择白血病对象的治疗方案的分析和方法
SG10201913504XA (en) 2016-02-26 2020-03-30 Massachusetts Gen Hospital Medical ice slurry production and delivery systems and methods
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
UY37341A (es) 2016-07-22 2017-11-30 Flamel Ireland Ltd Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12186296B1 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12478604B1 (en) 2016-07-22 2025-11-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
CN111093623A (zh) * 2017-07-10 2020-05-01 免疫疫苗技术公司 药物组合物、使用限定大小的脂质囊泡颗粒的制备方法及其用途
EP3856198A4 (en) 2018-09-25 2022-06-22 Celator Pharmaceuticals, Inc. Low-intensity treatment of hematological disorders
CN113473980A (zh) 2019-03-01 2021-10-01 弗拉梅尔爱尔兰有限公司 在进食状态下具有改善的药代动力学的γ-羟基丁酸酯组合物
ES3049663T3 (en) * 2019-06-28 2025-12-17 Univ Texas Method of reconstituting liposomal annamycin
WO2021016457A1 (en) * 2019-07-24 2021-01-28 The General Hospital Corporation Methods of creating a substance with different freezing points by encapsulation
US11980636B2 (en) 2020-11-18 2024-05-14 Jazz Pharmaceuticals Ireland Limited Treatment of hematological disorders
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
CN115252563B (zh) * 2022-06-24 2024-07-12 石药集团中奇制药技术(石家庄)有限公司 一种柔红霉素阿糖胞苷脂质体冻干品的制备方法
CN116003493B (zh) * 2022-12-16 2025-02-28 常州金远药业制造有限公司 一种二价铜离子及阿糖胞苷的回收方法

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US20190070112A1 (en) 2019-03-07
US10166184B2 (en) 2019-01-01
EP2768484B1 (en) 2019-07-24
CA2852777A1 (en) 2013-04-25
KR20200057104A (ko) 2020-05-25
IL232161B (en) 2019-07-31
JP6592556B2 (ja) 2019-10-16
JP6133308B2 (ja) 2017-05-24
HK1201039A1 (en) 2015-08-21
LUC00135I2 (https=) 2021-02-12
RU2648753C2 (ru) 2018-03-28
EP2768484A1 (en) 2014-08-27
JP2014532623A (ja) 2014-12-08
JP2024045183A (ja) 2024-04-02
KR20140092323A (ko) 2014-07-23
KR102113753B1 (ko) 2020-05-21
KR102452305B1 (ko) 2022-10-07
US20140255475A1 (en) 2014-09-11
AU2012326370B2 (en) 2017-06-01
FR19C1063I1 (fr) 2019-11-22
FR19C1063I2 (fr) 2020-10-30
KR20220141906A (ko) 2022-10-20
US10835492B2 (en) 2020-11-17
RU2014120475A (ru) 2015-11-27
EP3572071A1 (en) 2019-11-27
JP2022033892A (ja) 2022-03-02
KR102284689B1 (ko) 2021-08-02
RU2018107407A (ru) 2019-02-25
AU2012326370A2 (en) 2014-06-12
NL301016I1 (nl) 2019-10-30
RU2018107407A3 (https=) 2021-05-04
KR20210095746A (ko) 2021-08-02
KR102024836B1 (ko) 2019-09-24
JP6359717B2 (ja) 2018-07-18
CN104114156A (zh) 2014-10-22
CN108853031A (zh) 2018-11-23
US20230172855A1 (en) 2023-06-08
JP2017160211A (ja) 2017-09-14
JP2020007367A (ja) 2020-01-16
PL2768484T3 (pl) 2019-12-31
PT2768484T (pt) 2019-10-28
IL232161A0 (en) 2014-05-28
NO2019041I1 (no) 2019-11-25
DK2768484T3 (da) 2019-10-07
CA2852777C (en) 2020-10-27
HUS1900047I1 (hu) 2019-11-28
JP2018150342A (ja) 2018-09-27
AU2012326370C1 (en) 2023-03-30
SI2768484T1 (sl) 2019-12-31
BR112014009305A2 (pt) 2017-04-11
JP7476161B2 (ja) 2024-04-30
NL301016I2 (nl) 2020-04-16
WO2013059133A1 (en) 2013-04-25
LUC00135I1 (https=) 2019-10-25
ES2750368T3 (es) 2020-03-25
AU2012326370A1 (en) 2014-06-05
BR112014009305B1 (pt) 2023-01-24
KR20190111139A (ko) 2019-10-01
US10028912B2 (en) 2018-07-24
HRP20191683T1 (hr) 2019-12-13
US20180161273A1 (en) 2018-06-14
US20210169803A1 (en) 2021-06-10
HUE045978T2 (hu) 2020-01-28
EP2768484A4 (en) 2015-04-22

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DA2 Applications for amendment section 104

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TH Corrigenda

Free format text: IN VOL 36 , NO 51 , PAGE(S) 7001 UNDER THE HEADING AMENDMENTS - APPLICATION FOR AMENDMENTS UNDER THE NAME CELATOR PHARMACEUTICALS, INC., PATENT NO. 2012326370 CORRECT THE DATE OF THE STATEMENTS FILED TO READ 18 NOV 2022 AND 6 DEC 2022

DA3 Amendments made section 104

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SREP Specification republished
NDA Extension of term for standard patent accepted (sect.70)

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Filing date: 20220603

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