HRP20130109T4 - Formulacije kaspofungina - Google Patents

Formulacije kaspofungina Download PDF

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Publication number
HRP20130109T4
HRP20130109T4 HRP20130109TT HRP20130109T HRP20130109T4 HR P20130109 T4 HRP20130109 T4 HR P20130109T4 HR P20130109T T HRP20130109T T HR P20130109TT HR P20130109 T HRP20130109 T HR P20130109T HR P20130109 T4 HRP20130109 T4 HR P20130109T4
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HR
Croatia
Prior art keywords
pharmaceutical composition
caspofungin
composition according
solution
formulation
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Application number
HRP20130109TT
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English (en)
Inventor
Christian Welz
Gottfried Stubauer
Andreas Schmarda
Herwig Jennewein
Ingolf Macher
Johannes Ludescher
Original Assignee
Sandoz Ag
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38691922&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20130109(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sandoz Ag filed Critical Sandoz Ag
Publication of HRP20130109T1 publication Critical patent/HRP20130109T1/hr
Publication of HRP20130109T4 publication Critical patent/HRP20130109T4/hr

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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
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K9/0012Galenical 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
    • A61K9/14Particulate 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
    • 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
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • 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
    • A61K47/10Alcohols; 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

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

Claims (13)

1. Farmaceutski sastav, naznačen time, da obuhvaća a) kaspofungin diacetat ili kaspofungin dipropionat, i b) farmaceutski prihvatljivu količinu punila za povećanje mase, učinkovitog za tvorbu liofiliziranog kolača; pri čemu se ne dodaje nikakva dodatna količina sredstva za promjenu pH vrijednosti prilikom tvorbe sastava.
2. Farmaceutski sastav prema zahtjevu 1, naznačen time, da obuhvaća diacetat kaspofungina.
3. Farmaceutski sastav prema zahtjevu 1 ili 2, naznačen time, da se punilo za povećanje mase sastoji od jednog ili više sredstava za povećanje mase, te da je spomenuto punilo za povećanje mase poželjno manitol, saharoza ili njihova kombinacija.
4. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da obuhvaća a) 0,1 mg/ml do 500 mg/ml, poželjno 20 mg/ml do 60 mg/ml kaspofungina, računajući to kao kaspofungin bazu, b) 10 mg/ml do 200 mg/ml, poželjno 40 mg/ml do 60 mg/ml pomoćnog sredstva koje je punilo za povećanje mase, poželjno mješavina šećernih punila za povećanje mase, što je učinkovito za tvorbu liofiliziranog kolača, i vodu.
5. Farmaceutski sastav prema zahtjevu 4, naznačen time, da obuhvaća a) 42 mg/ml kaspofungina, računajući to kao kaspofungin bazu, što odgovara za 46,6 mg/ml kaspofungin diacetata, b) 50 mg/ml punila za povećanje mase, koje je mješavina 20 mg/ml manitola i 30 mg/ml saharoze, i vodu.
6. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da ima pH vrijednost od 5 do 7, poželjno od 5,5 do 6,5, najbolje 6,0.
7. Liofilizirani prašak, naznačen time, da se dobiva liofilizacijom farmaceutskog sastava prema bilo kojem od prethodnih zahtjeva, te time, da je pogodan za preoblikovanje u svrhu tvorbe tekućeg sastava za parenteralnu, poželjno intravenoznu primjenu.
8. Farmaceutski sastav, naznačen time, da se dobiva preoblikovanjem liofiliziranog praška prema zahtjevu 7 s vodenom otopinom odabranom između destilirane i/ili sterilne vode za injekcije; bakteriostatičke vode za injekcije, koja opcijski sadrži metilparaben i/ili propilparaben i/ili 0,9%-tni benzilni alkohol; normalne slane otopine ili fiziološke slane otopine, npr. 0,9%-tne otopine natrijevog klorida; 0,45%-tne ili 0,225%-tne otopine natrijevog klorida; te Ringerove otopine i/ili Ringerove laktatne otopine; pri čemu spomenuti sastav ima pH vrijednost poželjno od 5 do 8, još bolje od 6,0 do 7,5.
9. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da je to stabilna formulacija.
10. Farmaceutski sastav prema zahtjevu 8 ili formulacija prema zahtjevu 9, naznačen(a) time, da pokazuje smanjeni broj sub-vidljivih čestica, dok spomenuta formulacija ima poželjno manje od 500, još bolje manje od 300 sub-vidljivih čestica po ampuli, pri čemu čestice imaju veličinu veću od 10 μm, a količinski broj čestica se određuje prema USP 27, <788> Ispitivanje broja čestica putem laganog zatamnjenja za kruti materijal od čestica u injekcijama.
11. Uporaba sastava prema bilo kojem od prethodnih zahtjeva, naznačena time, da je za proizvodnju lijeka, poželjno intravenoznog lijeka, za prevenciju i/ili liječenje gljivičnih infekcija ili stanja uzrokovanih s Candida sp. i/ili Aspergillus sp. i/ili s Pneumocystic jiroveci kod sisavca, posebno kod čovjeka.
12. Postupak za proizvodnju farmaceutskog sastava koji sadrži farmaceutski prihvatljivu sol kaspofungina, naznačen time, da taj postupak obuhvaća sljedeće korake: 1) otapanje punila za povećanje mase ili kombinacije takvih punila u vodi, 2) dodavanje kaspofungin diacetata ili kaspofungin dipropionata u otopinu dobivenu u koraku 1) te njezino otapanje, 3) filtriranje otopine dobivene u koraku 2), 4) zamrzavanje otopine dobivene u koraku 3), i 5) liofiliziranje zamrznute otopine; pri čemu se ne dodaje nikakva dodatna količina sredstva za promjenu pH vrijednosti prilikom tvorbe sastava.
13. Sastav, naznačen time, da se dobiva postupkom prema zahtjevu 12.
HRP20130109TT 2006-07-26 2013-02-07 Formulacije kaspofungina HRP20130109T4 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP06117886 2006-07-26
EP07109723 2007-06-06
EP07819912.2A EP2049142B2 (en) 2006-07-26 2007-07-24 Caspofungin formulations
PCT/EP2007/057623 WO2008012310A1 (en) 2006-07-26 2007-07-24 Caspofungin formulations

Publications (2)

Publication Number Publication Date
HRP20130109T1 HRP20130109T1 (en) 2013-03-31
HRP20130109T4 true HRP20130109T4 (hr) 2016-05-20

Family

ID=38691922

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20130109TT HRP20130109T4 (hr) 2006-07-26 2013-02-07 Formulacije kaspofungina

Country Status (11)

Country Link
US (2) US8232245B2 (hr)
EP (2) EP2049142B2 (hr)
JP (1) JP5373606B2 (hr)
KR (1) KR101536781B1 (hr)
BR (1) BRPI0715113A2 (hr)
CA (1) CA2657817C (hr)
ES (1) ES2401299T5 (hr)
HR (1) HRP20130109T4 (hr)
PL (1) PL2049142T5 (hr)
SI (1) SI2049142T2 (hr)
WO (1) WO2008012310A1 (hr)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2692053A1 (en) * 2007-06-26 2008-12-31 Merck Sharp & Dohme Corp. Lyophilized anti-fungal composition
WO2010005721A2 (en) 2008-06-16 2010-01-14 Bind Biosciences, Inc. Drug loaded polymeric nanoparticles and methods of making and using same
US8613951B2 (en) 2008-06-16 2013-12-24 Bind Therapeutics, Inc. Therapeutic polymeric nanoparticles with mTor inhibitors and methods of making and using same
ES2721850T3 (es) 2008-06-16 2019-08-05 Pfizer Nanopartículas poliméricas terapéuticas que comprenden alcaloides vinca y procedimientos de fabricación y uso de las mismas
EP2183271A1 (en) * 2008-06-25 2010-05-12 TEVA Gyógyszergyár Zártkörüen Müködö Részvénytársaság Caspofungin free of caspofungin impurity a
EP2240507A2 (en) * 2008-06-25 2010-10-20 TEVA Gyógyszergyár Zártkörüen Müködö Részvénytársaság Processes for preparing high purity aza cyclohexapeptides
WO2010068866A2 (en) * 2008-12-12 2010-06-17 Bind Biosciences Therapeutic particles suitable for parenteral administration and methods of making and using same
ES2776126T3 (es) * 2008-12-15 2020-07-29 Pfizer Nanopartículas de circulación prolongada para la liberación sostenida de agentes terapéuticos
WO2010108637A1 (en) * 2009-03-27 2010-09-30 Axellia Pharmaceuticals Aps Crystalline compound
US8835382B2 (en) 2009-11-23 2014-09-16 Cubist Pharmaceuticals, Inc. Lipopeptide compositions and related methods
JP5891175B2 (ja) 2009-12-11 2016-03-22 バインド セラピューティックス インコーポレイテッド 治療用粒子の凍結乾燥に対する安定製剤
ES2780156T3 (es) 2009-12-15 2020-08-24 Pfizer Composiciones terapéuticas de nanopartículas poliméricas con alta temperatura de transición vítrea o copolímeros de alto peso molecular
CN102232932B (zh) * 2010-04-27 2013-06-05 重庆莱美药业股份有限公司 果胶-阿霉素轭合物的冻干制剂及制备方法
HUE030464T2 (en) * 2010-09-20 2017-05-29 Xellia Pharmaceuticals Aps Caspofungin preparation
CN103180336B (zh) * 2010-09-28 2016-06-15 中化帝斯曼制药有限公司荷兰公司 用于分离环六肽的方法
CN102746384B (zh) * 2011-04-22 2016-01-20 上海天伟生物制药有限公司 一种高纯度的卡泊芬净或其盐及其制备方法和用途
CN104812381B (zh) 2012-09-17 2018-01-26 辉瑞大药厂 用于制备治疗性纳米颗粒的方法
PT2922530T (pt) * 2012-11-20 2016-12-22 Fresenius Kabi Usa Llc Formulações de acetato de caspofungina
US20140256638A1 (en) * 2013-02-14 2014-09-11 The Regents Of The University Of California Peptoid neutralizing agents
KR20140123782A (ko) * 2013-04-15 2014-10-23 에스케이케미칼주식회사 카스포펀진 및 완충제를 포함하는 안정성이 개선된 약학적 조성물
EP3054924B1 (en) 2013-10-07 2020-11-25 Galenicum Health S.L.U. Stable pharmaceutical formulations of caspofungin
ME03435B (me) 2014-03-14 2020-01-20 Pfizer Terapijske nanočestice koje sadrže terapijsko sredstvo,te postupci njihove proizvodnje i upotrebe
WO2017034961A1 (en) 2015-08-21 2017-03-02 Trilogy Therapeutics, Inc. Methods of treating lung infection with caspofungin
KR101875512B1 (ko) 2017-05-25 2018-07-06 이병돈 손잡이 각도가 조절되는 웨이트 트레이닝기구
WO2019157453A1 (en) 2018-02-12 2019-08-15 Trilogy Therapeutics, Inc. Caspofungin compositions for inhalation
EP4051285A4 (en) * 2019-10-28 2023-12-06 Brillian Pharma Inc. PHARMACEUTICAL UNIT DOSE SYSTEMS FOR ORAL DRY SOLUTION AND SUSPENSION
CA3170514A1 (en) 2020-03-12 2021-09-16 Baxter International Inc. Daptomycin formulations containing a combination of sorbitol and mannitol
EP4364566A1 (en) * 2022-11-04 2024-05-08 B. Braun Melsungen AG Anti-fungal composition

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
US5378804A (en) 1993-03-16 1995-01-03 Merck & Co., Inc. Aza cyclohexapeptide compounds
US5552521A (en) 1995-02-10 1996-09-03 Merck & Co., Inc. Process for preparing certain aza cyclohexapeptides
AR006598A1 (es) 1996-04-19 1999-09-08 Merck Sharp & Dohme "composiciones anti-fungosas, su uso en la manufactura de medicamentos y un procedimiento para su preparación"
US5952300A (en) * 1996-04-19 1999-09-14 Merck & Co., Inc. Antifungal compositions
HRP970318B1 (en) 1996-06-14 2002-06-30 Merck & Co Inc A process for preparing certain aza cyclohexapeptides
MY137726A (en) * 2000-11-22 2009-03-31 Nycomed Gmbh Freeze-dried pantoprazole preparation and pantoprazole injection
US6900184B2 (en) * 2003-04-14 2005-05-31 Wyeth Holdings Corporation Compositions containing pipercillin and tazobactam useful for injection
KR101200227B1 (ko) 2005-05-04 2012-11-13 질랜드 파마 에이/에스 글루카곤 유사 펩티드-2(glp-2) 유사체
EP1785432A1 (en) 2005-11-15 2007-05-16 Sandoz AG Process and intermediates for the synthesis of caspofungin.

Also Published As

Publication number Publication date
ES2401299T5 (es) 2016-04-06
WO2008012310A1 (en) 2008-01-31
CA2657817A1 (en) 2008-01-31
SI2049142T1 (sl) 2013-02-28
CA2657817C (en) 2016-05-31
US8232245B2 (en) 2012-07-31
EP2049142A1 (en) 2009-04-22
EP2340846A1 (en) 2011-07-06
ES2401299T3 (es) 2013-04-18
US20130028940A1 (en) 2013-01-31
HRP20130109T1 (en) 2013-03-31
KR101536781B1 (ko) 2015-07-14
JP5373606B2 (ja) 2013-12-18
KR20090046865A (ko) 2009-05-11
BRPI0715113A2 (pt) 2013-06-04
EP2049142B1 (en) 2012-12-12
PL2049142T3 (pl) 2013-06-28
SI2049142T2 (sl) 2016-04-29
EP2049142B2 (en) 2016-01-20
US20090170753A1 (en) 2009-07-02
JP2009544662A (ja) 2009-12-17
PL2049142T5 (pl) 2016-09-30

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