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HRP20100591T1 - Smjese za suzbijanje beta-laktamazom posredovane rezistencije na antibiotike upotrebom inhibitora beta-laktamaze, korisne za injekcije - Google Patents

Smjese za suzbijanje beta-laktamazom posredovane rezistencije na antibiotike upotrebom inhibitora beta-laktamaze, korisne za injekcije Download PDF

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HRP20100591T1
HRP20100591T1 HR20100591T HRP20100591T HRP20100591T1 HR P20100591 T1 HRP20100591 T1 HR P20100591T1 HR 20100591 T HR20100591 T HR 20100591T HR P20100591 T HRP20100591 T HR P20100591T HR P20100591 T1 HRP20100591 T1 HR P20100591T1
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sodium
mixture
sulbactam
ceftriaxone
amount
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Chaudhary Manu
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Venus Remedies Limited
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Abstract

Farmaceutska smjesa za suzbijanje beta-laktamazom posredovane rezistencije na antibiotike, koja upotrebljava inhibitor beta-laktamaze, naznačena time, što sadrži: a) beta-laktamski antibiotik ceftriakson ili njegovu farmaceutski prihvatljivu sol, b) inhibitor beta-laktamaze sulbaktam ili njegovu farmaceutski prihvatljivu sol gdje su spojevi dijela (a) i dijela (b) pomješani u težinskom omjeru od 1:4 do 4:1, poželjno od 1:3 do 3:1, poželjnije 2:1 do 1:2, (c) inhibitor formiranja čestica koji je aminokarbonsko-kiselinsko helirajuće sredstvo, koje je EDTA ili njegova farmaceutski prihvatljiva sol, u opsegu od 0.002 mg/ml do 10 mg/ml, poslije rekonstitucije, igdje je spomenuta smjesa fiksna dozna kombinacija koja se primjenjuje parenteralno poslije rekonstituiranja sa volumenom vodene otopine odabrane između sterilne vode za injekcije, bakteriostatske vode za injekcije i izotonične sterilne otopine natrijeva klorida, gdje spomenuta smjesa dalje sadrži farmaceutski prihvatljivo sredstvo za podešavanje toničnosti koje smjesi daje fiziološku izotoničnost, odabrano iz grupe koja sadrži natrijev klorid i dekstrozu, spomenuto sredstvo za toničnost je prethodno pomiješano sa smjesom, ili upotrebljeno tokom spomenute rekonstitucije, ili alternativno u vrijeme infuzije. Patent sadrži još 9 patentnih zahtjeva.

Claims (10)

1. Farmaceutska smjesa za suzbijanje beta-laktamazom posredovane rezistencije na antibiotike, koja upotrebljava inhibitor beta-laktamaze, naznačena time, što sadrži: a) beta-laktamski antibiotik ceftriakson ili njegovu farmaceutski prihvatljivu sol, b) inhibitor beta-laktamaze sulbaktam ili njegovu farmaceutski prihvatljivu sol gdje su spojevi dijela (a) i dijela (b) pomješani u težinskom omjeru od 1:4 do 4:1, poželjno od 1:3 do 3:1, poželjnije 2:1 do 1:2, (c) inhibitor formiranja čestica koji je aminokarbonsko-kiselinsko helirajuće sredstvo, koje je EDTA ili njegova farmaceutski prihvatljiva sol, u opsegu od 0.002 mg/ml do 10 mg/ml, poslije rekonstitucije, i gdje je spomenuta smjesa fiksna dozna kombinacija koja se primjenjuje parenteralno poslije rekonstituiranja sa volumenom vodene otopine odabrane između sterilne vode za injekcije, bakteriostatske vode za injekcije i izotonične sterilne otopine natrijeva klorida, gdje spomenuta smjesa dalje sadrži farmaceutski prihvatljivo sredstvo za podešavanje toničnosti koje smjesi daje fiziološku izotoničnost, odabrano iz grupe koja sadrži natrijev klorid i dekstrozu, spomenuto sredstvo za toničnost je prethodno pomiješano sa smjesom, ili upotrebljeno tokom spomenute rekonstitucije, ili alternativno u vrijeme infuzije.
2. Smjesa prema zahtjevu 1, naznačena time, što je: a) ceftriakson prisutan u vidu svoje natrijeve soli, i b) sulbaktam je prisutan u vidu svoje natrijeve soli.
3. Smjesa prema zahtjevu 1 ili 2, naznačena time, što je ukupan sadržaj natrija u spomenutoj fiksnoj doznoj kombinaciji u opsegu od 16.5 mg (0.719 mEq) do 264.6 mg (11.48 mEq) natrija i prisutan je u farmaceutski efikasnoj količini koja odgovara 1 do 10 jediničnih doza, u graduiranom kontejneru.
4. Smjesa zahtjevana u bilo kojem od zahtjeva 1 do 3, naznačena time, što sadrži: (a) ceftriakson natrij u količini od , preračunato kao ceftriaksonska slobodna kiselina, (b) sulbaktam natrij u količini od , preračunato kao sulbaktamska slobodna kiselina, i (c) EDTA u količini od 2 mg, spomenuta smjesa je rekonstituirana sa 20 ml vode za injekcije, i gdje ukupna količina natrija sadržanog u spomenutom ceftriakson natriju i spomenutom sulbaktam natriju iznosi 264,6 mg, uz 11.48 mEq natrija.
5. Smjesa zahtjevana u bilo kojem od zahtjeva 1 do 3, naznačena time, što sadrži: (a) ceftriakson natrij u količini od , preračunato kao ceftriaksonska slobodna kiselina, (b) sulbaktam natrij u količini od , preračunato kao sulbaktamska slobodna kiselina, i (c) EDTA u količini od 1 mg, spomenuta smjesa je rekonstituirana sa 10 ml vode za injekcije, i gdje ukupna količina natrija sadržanog u spomenutom ceftriakson natriju i spomenutom sulbaktam natriju iznosi 132.3 mg, uz 5.74 mEq natrija.
6. Smjesa zahtjevana u bilo kojem od zahtjeva 1 do 3, naznačena time, što sadrži: (a) ceftriakson natrij u količini od , preračunato kao ceftriaksonska slobodna kiselina, (b) sulbaktam natrij u količini od , preračunato kao sulbaktamska slobodna kiselina, i (c) EDTA u količini od 0.5 mg, spomenuta smjesa je rekonstituirana sa 5 ml vode za injekcije, i gdje ukupna količina natrija sadržanog u spomenutom ceftriakson natriju i spomenutom sulbaktam natriju iznosi 66.15 mg, uz 2.87 mEq natrija.
7. Smjesa zahtjevana u bilo kojem od zahtjeva 1 do 3, naznačena time, što sadrži: (a) ceftriakson natrij u količini od , preračunato kao ceftriaksonska slobodna kiselina, (b) sulbaktam natrij u količini od , preračunato kao sulbaktamska slobodna kiselina, i (c) EDTA u količini od 0.25 mg, spomenuta smjesa je rekonstituirana sa 4 ml vode za injekcije, i gdje ukupna količina natrija sadržanog u spomenutom ceftriakson natriju i spomenutom sulbaktam natriju iznosi 33.075 mg, uz 1.435 mEq natrija.
8. Smjesa zahtjevana u bilo kojem od zahtjeva 1 do 3, naznačena time, što sadrži: (a) spomenuti ceftriakson natrij u količini od , preračunato kao ceftriaksonska slobodna kiselina, (b) spomenuti sulbaktam natrij u količini od , preračunato kao sulbaktamska slobodna kiselina, i (c) spomenuti EDTA prisutan u količini od 0.125 mg, spomenuta smjesa je rekonstituirana sa 2 ml vode za injekcije, i gdje ukupna količina natrija sadržanog u spomenutom ceftriakson natriju i spomenutom sulbaktam natriju iznosi 16.535 mg, uz 0.717 mEq natrija.
9. Smjesa zahtjevana u bilo kojem od zahtjeva 1 do 8 pakovana i zapečaćena u sterilnom kontejneru pod pokrovom od inertnog plina, naznačena time, što spomenuti kontejner predstavljaju jedna ili više fiola, ampula, šprica, paketića, fišeka i auto-injektora, gdje unutrašnji prostor spomenutog kontejnera obuhvaća volumen za punjenje zauzetu spomenutom smjesom u rekonstituiranoj formi i volumen vršnog dijela aseptički zauzet mikroatmosferom limitiranom inertnim plinom, koja uključuje suštinski jedan ili više inertnih plinova odabranih iz grupe koja sadrži plemenite plinove i dušik, poželjno dušik, volumen spomenutog plinovitog dušika nije veći od 5% od spomenutog volumena vršnog dijela, i gdje odnos spomenutog volumena za punjenje prema spomenutom volumenu vršnog dijela nije manji od 1:1
10. Postupak za pripremanje smjese za suzbijanje beta-laktamazom posredovane rezistencije na antibiotike koja koristi inhibitor beta-laktamaze, korisne za injekcije, spremne za farmaceutsku primjenu, naznačen time, što uključuje korake: (a) sterilno punjenje/miješanje dva aktivna sastojka, prvi aktivni sastojak je ceftriakson natrij, a drugi sastojak je sulbaktam natrij, (b) dodavanje inhibitora formiranja čestica koji je etilendiamin-tetraoctena kiselina dinatrijeva sol, (c) kontinuirano spomenuto sterilno miješanje tokom perioda u opsegu od 1 sata do 4 sata, (d) odmjeravanje sterilne mješavine iz koraka (a), aseptično, da bi se dobila željena doza u nekom od težinskih odnosa iz zahtjeva 1, i (d) ) aseptično zatvaranje uz pre-post uvođenje inertnog plina.
HR20100591T 2004-12-02 2005-11-28 Smjese za suzbijanje beta-laktamazom posredovane rezistencije na antibiotike upotrebom inhibitora beta-laktamaze, korisne za injekcije HRP20100591T1 (hr)

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PCT/IN2005/000382 WO2006059344A1 (en) 2004-12-02 2005-11-28 Compositions for combating beta-lactamase-mediated antibiotic resistance using beta-lactamase inhibitors useful for injection

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CN101129382B (zh) * 2006-08-25 2013-12-25 天津和美生物技术有限公司 含β-内酰胺类抗生素和缓冲组分的抗生素复方
CN101129381B (zh) * 2006-08-25 2012-02-01 天津和美生物技术有限公司 含β-内酰胺类抗生素和离子螯合剂的抗生素复方
JP5639471B2 (ja) * 2008-07-28 2014-12-10 惠三 山口 感染症治療効果増強剤
CN101537009B (zh) * 2009-04-30 2010-09-15 海口奇力制药股份有限公司 注射用头孢曲松钠他唑巴坦钠复方制剂的生产工艺
JP2012176899A (ja) * 2009-05-19 2012-09-13 Mitsubishi Tanabe Pharma Corp ２−（１−ピペラジニル）−５−メチルベンゼンスルホン酸誘導体を含む注射用水溶液
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PT1841432E (pt) 2010-10-25
MX2007006540A (es) 2008-01-31
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ATE476981T1 (de) 2010-08-15
UA91204C2 (ru) 2010-07-12
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