HRP20200039T1 - Formulacija fosfomicina za parenteralnu primjenu - Google Patents

Formulacija fosfomicina za parenteralnu primjenu Download PDF

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Publication number
HRP20200039T1
HRP20200039T1 HRP20200039TT HRP20200039T HRP20200039T1 HR P20200039 T1 HRP20200039 T1 HR P20200039T1 HR P20200039T T HRP20200039T T HR P20200039TT HR P20200039 T HRP20200039 T HR P20200039T HR P20200039 T1 HRP20200039 T1 HR P20200039T1
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Croatia
Prior art keywords
fosfomycin
closed container
solution
primarily
container
Prior art date
Application number
HRP20200039TT
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English (en)
Inventor
Apostolos Georgopoulos
Albert Schifer
Wolfgang Rous
Original Assignee
Apostolos Georgopoulos
Albert Schifer
Wolfgang Rous
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.)
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Publication date
Application filed by Apostolos Georgopoulos, Albert Schifer, Wolfgang Rous filed Critical Apostolos Georgopoulos
Publication of HRP20200039T1 publication Critical patent/HRP20200039T1/hr

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    • 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
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1412Containers with closing means, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1468Containers characterised by specific material properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002Compounding apparatus specially for enteral or parenteral nutritive solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/665Phosphorus compounds having oxygen as a ring hetero atom, e.g. fosfomycin
    • 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
    • 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
    • A61K9/0029Parenteral nutrition; Parenteral nutrition compositions as drug carriers
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Saccharide Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)

Claims (13)

1. Zatvoreni spremnik koji sadrži vodenu otopinu pripremljenu za parenteralnu primjenu, naznačen time, da su najmanje jedna farmaceutski prihvatljiva sol fosfomicina i farmaceutski prihvatljiva kiselina rastopljene u otopini, pri čemu je kiselina sukcinska kiselina, dok pritom otopina sadrži ukupnu dozu fosfomicina koja odgovara za 1 do 15 grama fosfomicina, gdje omjer mase sukcinske kiseline prema fosfomicinu u otopini, iznosi između 30:1 i 50:1, pri čemu volumen otopine iznosi od 1 ml do 100 ml / g fosfomicina.
2. Zatvoreni spremnik prema patentnom zahtjevu 1, naznačen time, da je otopina spremna za intravenoznu primjenu.
3. Zatvoreni spremnik prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da je zatvoreni spremnik zabrtvljen, poželjno je pritom spremnik zatvoren na takav način, da je otvaranje spremnika uglavnom neponovljivo.
4. Zatvoreni spremnik prema bilo kojem patentnom zahtjevu od 1 do 3, naznačen time, da je spremnik odabran od sljedećih: - ampula, prvenstveno načinjena od plastičnog materijala ili stakla, poželjno je to ampula na otkidanje, prvenstveno načinjena od plastičnog materijala ili stakla; - fijala koja se može probušiti, poželjno je zabrtvljena uporabom zaštitne kapice; - infuzijska vrećica; i - šprica, prvenstveno prethodno napunjena štrcaljka.
5. Zatvoreni spremnik prema bilo kojem patentnom zahtjevu od 1 do 4, naznačen time, da spremnik koji je poželjno fijala na otkidanje ili infuzijska vrećica, ima nedodirljivu pregradu, primjerice načinjenu od gume.
6. Zatvoreni spremnik prema bilo kojem patentnom zahtjevu od 1 do 5 naznačen time, da spremnik omogućava otopini zaštitu od svjetlosti, i prvenstveno je neproziran.
7. Zatvoreni spremnik prema bilo kojem patentnom zahtjevu od 1 do 6, naznačen time, da je farmaceutski prihvatljiva sol fosfomicina odabrana od sljedećih: dinatrijeva sol fosfomicina, mononatrijeva sol fosfomicina, kalijeva sol fosfomicina, litijeva sol fosfomicina, magnezijeva sol fosfomicina i kalcijeva sol fosfomicina.
8. Zatvoreni spremnik prema bilo kojem patentnom zahtjevu od 1 do 7, naznačen time, da otopina ima pH-vrijednost od 6,4 do 8,4, poželjno veću od 6,5 i manju od 8,0, još poželjnije od 6,9 do 7,9, posebno poželjno od 7,0 do 7,8, čak najviše poželjno od 7,1 do 7,7, ili čak od 7,3 do 7,5; ili time, da otopina ima pH-vrijednost manju od 10,0, poželjno manju od 9,0, još poželjnije manju od 8,5, čak još poželjnije manju od 8,0, prvenstveno manju od 7,75 ili dapače najveću do 7,5.
9. Zatvoreni spremnik prema bilo kojem patentnom zahtjevu od 1 do 8, naznačen time, da je maseni omjer sukcinske kiseline prema fosfomicinu uglavnom 40:1.
10. Zatvoreni spremnik prema bilo kojem patentnom zahtjevu od 1 do 9, naznačen time, da je zatvoreni spremnik u skladu s Europskim pravilnikom za dobro postupanje u proizvodnji medicinskih proizvoda za ljudsku i životinjsku uporabu - "EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use", koji je na snazi od 15. veljače 2016. godine, posebno prema Aneksu 1 u verziji od "25. studenog 2008. (revidiran)"; i/ili time, da je spremnik napunjen s otopinom i zatvoren u skladu s Aneksom 1 od spomenutog pravilnika "EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use", u verziji od "25. studenog 2008. (revidiran)".
11. Pakiranje, naznačeno time, da obuhvaća najmanje jedan zatvoreni spremnik u skladu s bilo kojim od patentnih zahtjeva 1 do 10 i poželjno informacijski letak za pacijenta; pri čemu pakiranje omogućava otopini i zatvorenom spremniku zaštitu od svjetlosti, prvenstveno je ono pritom uglavnom neprozirno, i/ili time, da spremnik omogućava otopini zaštitu od svjetlosti, s time da je on prvenstveno uglavnom neproziran.
12. Postupak, naznačen time, da obuhvaća skladištenje zatvorenog spremnika prema bilo kojem od patentnih zahtjeva 1 do 10, ili pakiranja prema patentnom zahtjevu 11, na temperaturi između 0°C i 60°C, prvenstveno na temperaturi od 15°C do 35°C ili na sobnoj temperaturi, u trajanju od najmanje jednog tjedna, poželjno u trajanju od najmanje jednog mjeseca, prvenstveno poželjno u trajanju od najmanje tri mjeseca, gdje je pritom skladištenje ostvareno pod zaštitom od svjetlosti.
13. Postupak za proizvodnju zatvorenog spremnika u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time, da obuhvaća punjenje spremnika s otopinom u sterilnim uvjetima, i zatvaranje spremnika, prema potrebi dalje obuhvaća brtvljenje zatvorenog spremnika; dok poželjno pritom otopina nije proizvedena od praškaste smjese farmaceutski prihvatljive soli fosfomicina i farmaceutski prihvatljive kiseline, koji su pomiješani u na sterilni način u skladu sa spomenutim pravilnikom "EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use", koji je na snazi od 15. veljače 2016. godine, posebno prema Aneksu 1 u verziji od "25. studenog 2008. (revidiran)".
HRP20200039TT 2016-03-16 2017-03-16 Formulacija fosfomicina za parenteralnu primjenu HRP20200039T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16160698.3A EP3219305A1 (de) 2016-03-16 2016-03-16 Fosfomycin-formulierung zur parenteralen verabreichung
EP17710315.7A EP3419598B1 (de) 2016-03-16 2017-03-16 Fosfomycin-formulierung zur parenteralen verabreichung
PCT/EP2017/056252 WO2017158099A1 (de) 2016-03-16 2017-03-16 Fosfomycin-formulierung zur parenteralen verabreichung

Publications (1)

Publication Number Publication Date
HRP20200039T1 true HRP20200039T1 (hr) 2020-05-29

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ID=55637175

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20200039TT HRP20200039T1 (hr) 2016-03-16 2017-03-16 Formulacija fosfomicina za parenteralnu primjenu

Country Status (22)

Country Link
US (2) US10675291B2 (hr)
EP (3) EP3219305A1 (hr)
JP (1) JP2019511573A (hr)
KR (1) KR20180122346A (hr)
CN (1) CN108883062A (hr)
AU (1) AU2017235463A1 (hr)
BR (1) BR112018068510A2 (hr)
CA (1) CA3014503A1 (hr)
CY (1) CY1123109T1 (hr)
DK (1) DK3419598T3 (hr)
ES (1) ES2771486T3 (hr)
HR (1) HRP20200039T1 (hr)
HU (1) HUE047900T2 (hr)
LT (1) LT3419598T (hr)
MX (1) MX2018011217A (hr)
PL (1) PL3419598T3 (hr)
PT (1) PT3419598T (hr)
RS (1) RS59873B1 (hr)
RU (1) RU2018134749A (hr)
SI (1) SI3419598T1 (hr)
SM (1) SMT202000062T1 (hr)
WO (1) WO2017158099A1 (hr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3219305A1 (de) * 2016-03-16 2017-09-20 Apostolos Georgopoulos Fosfomycin-formulierung zur parenteralen verabreichung
KR20210148496A (ko) * 2020-05-28 2021-12-08 제주대학교 산학협력단 포스포마이신을 이용한 멜라닌 저색소증 개선제 조성물
TWI796597B (zh) * 2020-09-21 2023-03-21 長庚大學 使用紫蘇之經水萃取的產物來對抗冠狀病毒感染的方法
EP4268805A1 (de) * 2022-04-29 2023-11-01 Apostolos Georgopoulos Fosfomycin-formulierung zur parenteralen verabreichung und herstellungsverfahren

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Also Published As

Publication number Publication date
BR112018068510A2 (pt) 2021-04-13
ES2771486T3 (es) 2020-07-06
CY1123109T1 (el) 2021-10-29
EP3219305A1 (de) 2017-09-20
HUE047900T2 (hu) 2020-05-28
SMT202000062T1 (it) 2020-03-13
US10675291B2 (en) 2020-06-09
EP3603618A1 (de) 2020-02-05
US10993951B2 (en) 2021-05-04
US20200261478A1 (en) 2020-08-20
CN108883062A (zh) 2018-11-23
KR20180122346A (ko) 2018-11-12
RU2018134749A3 (hr) 2020-05-21
AU2017235463A1 (en) 2018-09-27
WO2017158099A1 (de) 2017-09-21
PL3419598T3 (pl) 2020-05-18
RS59873B1 (sr) 2020-03-31
EP3419598A1 (de) 2019-01-02
RU2018134749A (ru) 2020-04-16
JP2019511573A (ja) 2019-04-25
SI3419598T1 (sl) 2020-03-31
US20190070202A1 (en) 2019-03-07
MX2018011217A (es) 2019-03-28
PT3419598T (pt) 2020-02-18
DK3419598T3 (da) 2020-02-10
LT3419598T (lt) 2020-02-10
EP3419598B1 (de) 2019-11-06
CA3014503A1 (en) 2017-09-21

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