HRP20161236T1 - Kompozicija kaspofugina - Google Patents

Kompozicija kaspofugina Download PDF

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Publication number
HRP20161236T1
HRP20161236T1 HRP20161236TT HRP20161236T HRP20161236T1 HR P20161236 T1 HRP20161236 T1 HR P20161236T1 HR P20161236T T HRP20161236T T HR P20161236TT HR P20161236 T HRP20161236 T HR P20161236T HR P20161236 T1 HRP20161236 T1 HR P20161236T1
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HR
Croatia
Prior art keywords
caspofungin
pharmaceutically acceptable
mixture according
formulation
excipients
Prior art date
Application number
HRP20161236TT
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English (en)
Inventor
Swapnil P. Shirode
Piysh Patel
Atul Patil
Suresh Gidwani
Neil Parikh
Anita Bevetek Mocnik
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Xellia Pharmaceuticals Aps
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Publication of HRP20161236T1 publication Critical patent/HRP20161236T1/hr

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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
    • A61K47/26Carbohydrates, 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
    • A61K47/06Organic 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
    • 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
    • A61K47/08Organic 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
    • 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
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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

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

Claims (20)

1. Smjesa obuhvaća: a) farmaceutski djelotvornu količinu acetatne soli kaspofungina; b) farmaceutski prihvatljivu količinu jedne ili više farmaceutski prihvatljive pomoćne tvari djelotvorne za tvorbu liofilizirane torte; i c) farmaceutski djelotvornu količinu puferskog sredstva, gdje je pufersko sredstvo sukcinat.
2. Smjesa prema zahtjevu 1, naznačena time sto je farmaceutski prihvatljiva sol kaspofungina diacetatna sol kaspofungina.
3. Smjesa prema bilo kojem od prethodnih zahtjeva, naznačeno time da se jedna ili više pomoćnih tvari odabire iz grupe koja se sastoji od razrjeđivača, antioksidansa i konzervansa.
4. Smjesa prema bilo kojem zahtjevu od 1 do 3, naznačeno time da se pomoćne tvari odabiru iz grupe koja se sastoji od sukroze i manitola; ili od njihove kombinacije.
5. Smjesa prema bilo kojem od prethodnih zahtjeva, naznačeno time da ista obuhvaća: a) farmaceutski djelotvornu količinu acetatne soli kaspofungina; b) oko 10-200 mg/ml jedne ili više farmaceutski prihvatljive pomoćne tvari djelotvorne za tvorbu liofilizirane kolača; c) farmaceutski djelotvorna količina sukcinata djelotvorna za osiguranje farmaceutski prihvatljive pH vrijednosti.
6. Smjesa prema zahtjevu 5, naznačeno time da ista obuhvaća količinu kaspofungina od oko 42 mg/ml.
7. Smjesa prema zahtjevu 6, naznačeno time da ista obuhvaća: a) oko 46 mg/ml diacetatne soli kaspofungina; b) oko 30 mg/ml sukroze i oko 20 mg/ml manitola; i c) oko 1,5 mg/ml sukcinata.
8. Postupak pripreme smjese kaspofungina prema bilo kojem zahtjevu od 1 do 7 obuhvaćajući slijedeće korake: a) miješanje vodene otopine koja obuhvaća farmaceutski prihvatljivu količinu jedne ili više pomoćnih tvari s farmaceutski djelotvornom količinom puferskog sredstva; gdje je pufersko sredstvo sukcinat; b) po želji, prilagođavanje pH vrijednosti povećavanjem bazičnosti u svrhu dobivanja farmaceutski prihvatljive pH vrijednosti; c) dodavanje farmaceutski prihvatljive količine acetatne soli kaspofungina smjesi pod a) d) po želji, prilagođavanje pH vrijednosti povećavanjem bazičnosti u svrhu dobivanja farmaceutski prihvatljive pH vrijednosti; e) filtriranje otopine dobivene pod d).
9. Postupak pripreme smjese kaspofungina prema zahtjevu 8, naznačeno time da se korak a) provodi prvo pripremom vodene otopine koja obuhvaća farmaceutski djelotvornu količinu puferskog sredstva, pri čemu je pufersko sredstvo sukcinat; a zatim dodavanjem farmaceutski prihvatljive količine jedne ili više pomoćnih tvari otopljenih u vodi navedenoj otopini puferskog sredstva.
10. Postupak pripreme smjese kaspofungina prema zahtjevu 8, pri čemu se korak a) provodi prvo otapanjem farmaceutski prihvatljive količine jedne ili više pomoćnih tvari u vodi; a zatim dodavanjem farmaceutski djelotvorne količine puferskog sredstva; pri čemu je navedeno pufersko sredstvo sukcinat.
11. Postupak prema bilo kojem zahtjevu od 8 do 10, pri čemu se pH vrijednost u koraku b) podešava na vrijednosti od 5,0 do 5,7.
12. Postupak prema bilo kojem zahtjevu od 8 do 10, pri čemu se pH vrijednost u koraku d) podešava na oko 6.
13. Postupak prema bilo kojem zahtjevu od 8 do 12, pri čemu se kaspofungin diacetat dodaje u koraku c).
14. Lipofilizirana formulacija koja se sastoji od smjese koja prije lipofilizacije odgovara smjesi prema bilo kojem zahtjevu od 1 do 7.
15. Formulacija za parenteralnu primjenu koja se sastoji od lipofilizirane formulacije prema zahtjevu 14, pri čemu se navedena lipofilizirana formulacija otapa u farmaceutski prihvatljivoj rekonstituiranoj otopini prikladnoj za parenteralnu primjenu u potrebitih pacijenata.
16. Formulacija za parenteralnu primjenu prema zahtjevu 15 pri čemu se farmaceutski prihvatljiva rekonstituirana otopina odabire iz grupe koja se sastoji od destilirane ili sterilne vode obično korištene za injekcije, fiziološke otopine ili bakteriostatsku vodu.
17. Pribor koji obuhvaća ravnu posudu s lipofiliziranom formulacijom prema zahtjevu 14 i drugu posudu s parenteralno prihvatljivim otapalom za rekonstituciju te, po želji, posudu sa sredstvom za primjenu rekonstituirane otopine u potrebitih pacijenata.
18. Upotreba smjese prema bilo kojem zahtjevu od 1 do 7 u pripremi formulacije za parenteralnu primjenu za liječenje ili sprječavanje gljivične infekcije.
19. Upotreba smjese prema zahtjevu 18, pri čemu je infekcija izazvana gljivicom iz roda Candida ili Aspergillus.
20. Upotreba smjese prema zahtjevu 18, pri čemu je infekcija izazvana gljivicom iz roda C. albicans, C. tropicalis, C. krusel, C. glabrata, A. fumigatus. A. flavus i A. niger.
HRP20161236TT 2010-09-20 2016-09-28 Kompozicija kaspofugina HRP20161236T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US38433310P 2010-09-20 2010-09-20
EP11761049.3A EP2618814B1 (en) 2010-09-20 2011-09-19 Caspofungin composition
PCT/EP2011/066202 WO2012038371A1 (en) 2010-09-20 2011-09-19 Caspofungin composition

Publications (1)

Publication Number Publication Date
HRP20161236T1 true HRP20161236T1 (hr) 2016-11-18

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HRP20161236TT HRP20161236T1 (hr) 2010-09-20 2016-09-28 Kompozicija kaspofugina

Country Status (20)

Country Link
US (2) US20120101030A1 (hr)
EP (1) EP2618814B1 (hr)
JP (1) JP5914486B2 (hr)
KR (1) KR20130136466A (hr)
CN (1) CN103118663A (hr)
AU (1) AU2011304408B2 (hr)
CA (1) CA2810112A1 (hr)
DK (1) DK2618814T3 (hr)
ES (1) ES2593727T3 (hr)
HR (1) HRP20161236T1 (hr)
HU (1) HUE030464T2 (hr)
IL (1) IL225339A0 (hr)
MX (1) MX2013003045A (hr)
PL (1) PL2618814T3 (hr)
PT (1) PT2618814T (hr)
RS (1) RS55216B1 (hr)
RU (1) RU2013114993A (hr)
UA (1) UA111599C2 (hr)
WO (1) WO2012038371A1 (hr)
ZA (1) ZA201302113B (hr)

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CN103212058A (zh) * 2012-01-18 2013-07-24 江苏恒瑞医药股份有限公司 含有抗真菌药物和乳酸盐缓冲剂的组合物
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CN103142997A (zh) * 2013-03-13 2013-06-12 浙江海正药业股份有限公司 含有抗真菌剂和琥珀酸盐缓冲液的药物组合物
KR20140123782A (ko) * 2013-04-15 2014-10-23 에스케이케미칼주식회사 카스포펀진 및 완충제를 포함하는 안정성이 개선된 약학적 조성물
CN104116716A (zh) * 2013-04-25 2014-10-29 四川海思科制药有限公司 一种含卡泊芬净的冻干粉针剂药物组合物
ES2853349T3 (es) * 2013-10-07 2021-09-15 Galenicum Health S L U Formulaciones farmacéuticas estables
GR1008818B (el) * 2015-05-22 2016-08-01 Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων Φαρμακευτικο σκευασμα περιεχον εναν αντιμυκητιασικο παραγοντα εχινοκανδινης και μεθοδος παρασκευης αυτου
CN108760937B (zh) * 2018-07-27 2020-12-29 杭州华东医药集团新药研究院有限公司 醋酸卡泊芬净中残留乙二胺的测定及其应用
CN109758426B (zh) * 2019-01-24 2021-04-27 四川制药制剂有限公司 一种注射用醋酸卡泊芬净药物组合物及其制备方法
CN110859950B (zh) * 2019-11-25 2021-08-10 武汉大学 一种用于白念珠菌棘白菌素类药物耐药菌的药物组合物及其应用
EP4364566A1 (en) * 2022-11-04 2024-05-08 B. Braun Melsungen AG Anti-fungal composition

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Publication number Publication date
RS55216B1 (sr) 2017-02-28
IL225339A0 (en) 2013-06-27
AU2011304408B2 (en) 2015-01-15
CA2810112A1 (en) 2012-03-29
JP2013537212A (ja) 2013-09-30
PT2618814T (pt) 2016-10-06
ZA201302113B (en) 2014-05-28
HUE030464T2 (en) 2017-05-29
CN103118663A (zh) 2013-05-22
AU2011304408A1 (en) 2013-03-28
RU2013114993A (ru) 2014-10-27
PL2618814T3 (pl) 2017-01-31
EP2618814B1 (en) 2016-07-27
EP2618814A1 (en) 2013-07-31
DK2618814T3 (en) 2016-10-10
ES2593727T3 (es) 2016-12-12
UA111599C2 (uk) 2016-05-25
MX2013003045A (es) 2013-06-24
WO2012038371A1 (en) 2012-03-29
US20120101030A1 (en) 2012-04-26
KR20130136466A (ko) 2013-12-12
US9393307B2 (en) 2016-07-19
JP5914486B2 (ja) 2016-05-11
US20150072923A1 (en) 2015-03-12

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