HRP20200567T1 - Stabilni injektabilni farmaceutski pripravci koji sadrže 2-hidroksipropil-beta-ciklodekstrin i alfaksalon - Google Patents

Stabilni injektabilni farmaceutski pripravci koji sadrže 2-hidroksipropil-beta-ciklodekstrin i alfaksalon Download PDF

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HRP20200567T1
HRP20200567T1 HRP20200567TT HRP20200567T HRP20200567T1 HR P20200567 T1 HRP20200567 T1 HR P20200567T1 HR P20200567T T HRP20200567T T HR P20200567TT HR P20200567 T HRP20200567 T HR P20200567T HR P20200567 T1 HRP20200567 T1 HR P20200567T1
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injectable pharmaceutical
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HRP20200567TT
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Kirby Shawn Pasloske
Kai Lau
Sarah Jane Richardson
Amanda Aileen WILLIS
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Jurox Pty Ltd
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Claims (13)

1. Injektabilni farmaceutski pripravak, naznačen time, da sadrži: vodu; jedan ili više kompleksa topivih u vodi, svaki koji sadrži 2-hidroksipropil-β-ciklodekstrin i alfaksalon; opcionalno pufer učinkovit u osiguravanju pH u pripravku u rasponu od 4.0 do 9.0; najmanje jedan prezervativ, gdje se najmanje jedan prezervativ bira iz skupine koja se sastoji od: metilparabena, etilparabena, propilparabena, butilparabena, ili njihovih soli, ili benzetonij klorida u količini u rasponu od 0,005 do 1 % težina/volumen; m-krezola, ili klorokrezola, u količini u rasponu od 0,1 do 1 % težina/volumen; feniletanola ili fenoksietanola u količini u rasponu od 0,1 do 1 % težina/volumen; klorobutanola ili fenola u količini u rasponu od 0,05 do 1 % težina/volumen; borne kiseline, u količini u rasponu od 0,25 do 5 % težina/volumen; benzilnog alkohola u količini u rasponu od 0,1 do 5 % težina/volumen; benzalkonijevog klorida u količini u rasponu od 0,001 do 1 % težina/volumen; i njihovih mješavina; i najmanje jednog dodatnog otapala u količini u rasponu od 1 do 30 % težina/volumen odabrane iz skupine koja se sastoji od etanola, glicerina, izopropilnog alkohola, polietilen glikola i njihovih mješavina.
2. Postupak za proizvodnju injektabilnog farmaceutskog pripravka, naznačen time, da postupak obuhvaća: pripravu prvog pripravka na način da se: a) 2-hidroksipropil-β-ciklodekstrin otopi u vodi kako bi se dobila otopina; b) u otopinu dodaje alfakson; c) opcionalno dodaje dodatna voda kako bi se 2-hidroksipropil-β-ciklodekstrin otopio u potpunosti; d) opcionalno dodaju puferske soli; e) opcionalno podešava pH; pripravu drugog pripravka na način da se: otopi najmanje jedan prezervativ u jednom ili više dodatnih otapala, gdje se najmanje jedan prezervativ bira iz skupine koja se sastoji od: metilparabena, etilparabena, propilparabena, butilparabena, ili njihovih soli, ili benzetonij klorida u količini u rasponu od 0,005 do 1 % težina/volumen; m-krezola, ili klorokrezola, u količini u rasponu od 0,1 do 1 % težina/volumen; feniletanola ili fenoksietanola u količini u rasponu od 0,1 do 1 % težina/volumen; klorobutanola ili fenola u količini u rasponu od 0,05 do 1 % težina/volumen; borne kiseline, u količini u rasponu od 0,25 do 5 % težina/volumen; benzilnog alkohola u količini u rasponu od 0,1 do 5 % težina/volumen; benzalkonijevog klorida u količini u rasponu od 0,001 do 1 % težina/volumen; i njihovih mješavina; i najmanje jednog dodatnog otapala u količini u rasponu od 1 do 30 % težina/volumen odabrane iz skupine koja se sastoji od etanola, glicerina, izopropilnog alkohola, polietilen glikola i njihovih mješavina; i dobivanje injektabilnog farmaceutskog pripravka na način da se: a) spoje prvi i drugi pripravci; b) opcionalno doda dodatna voda kako bi se spojeni pripravak doveo do željenog volumena; i c) sterilizira spojeni pripravak.
3. Postupak za čuvanje injektabilnog farmaceutskog pripravka koji sadrži vodu; jedan ili više kompleksa topivih u vodi, svaki koji sadrži 2-hidroksipropil-β-ciklodekstrin i alfaksalon; i opcionalno pufer učinkovit za osiguravanje pH u pripravku u rasponu od 4.0 do 9.0; naznačen time, da se dodaje učinkovita količina najmanje jednog prezervativa i najmanje jednog dodatnog otapala, gdje se najmanje jedan prezervativ bira iz skupine koja se sastoji od: metilparabena, etilparabena, propilparabena, butilparabena, ili njihovih soli, ili benzetonij klorida u količini u rasponu od 0,005 do 1 % težina/volumen; m-krezola, ili klorokrezola, u količini u rasponu od 0,1 do 1 % težina/volumen; feniletanola ili fenoksietanola u količini u rasponu od 0,1 do 1 % težina/volumen; klorobutanola ili fenola u količini u rasponu od 0,05 do 1 % težina/volumen; borne kiseline, u količini u rasponu od 0,25 do 5 % težina/volumen; benzilnog alkohola u količini u rasponu od 0,1 do 5 % težina/volumen; benzalkonijevog klorida u količini u rasponu od 0,001 do 1 % težina/volumen; i njihovih mješavina; i najmanje jednog dodatnog otapala u količini u rasponu od 1 do 30 % težina/volumen odabrane iz skupine koja se sastoji od etanola, glicerina, izopropilnog alkohola, polietilen glikola i njihovih mješavina.
4. Uporaba najmanje jednog dodatnog otapala i najmanje jednog prezervativa naznačena time, da se čuva injektabilni farmaceutski pripravak koji sadrži vodu; jedan ili više kompleksa topivih u vodi, svaki koji sadrži 2-hidroksipropil-β-ciklodekstrin i alfaksalon; i opcionalno pufer učinkovit za dobivanje pH u pripravku u rasponu od 4.0 do 9.0; gdje se dodaje učinkovita količina najmanje jednog prezervativa i najmanje jednog dodatnog otapala, gdje se najmanje jedan prezervativ bira iz skupine koja se sastoji od: metilparabena, etilparabena, propilparabena, butilparabena, ili njihovih soli, ili benzetonij klorida u količini u rasponu od 0,005 do 1 % težina/volumen; m-krezola, ili klorokrezola, u količini u rasponu od 0,1 do 1 % težina/volumen; feniletanola ili fenoksietanola u količini u rasponu od 0,1 do 1 % težina/volumen; klorobutanola ili fenola u količini u rasponu od 0,05 do 1 % težina/volumen; borne kiseline, u količini u rasponu od 0,25 do 5 % težina/volumen; benzilnog alkohola u količini u rasponu od 0,1 do 5 % težina/volumen; benzalkonijevog klorida u količini u rasponu od 0,001 do 1 % težina/volumen; ili njihovih mješavina; i najmanje jednog dodatnog otapala u količini u rasponu od 1 do 30 % težina/volumen odabrane iz skupine koja se sastoji od: etanola, glicerina, izopropilnog alkohola, polietilen glikola i njihovih mješavina.
5. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da je za uporabu u liječenju boli ili upale.
6. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da je za uporabu u postupku anestezije.
7. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, postupak za čuvanje injektabilnog farmaceutskog pripravka prema patentnom zahtjevu 2, uporaba najmanje jednog prezervativa prema patentnom zahtjevu 4, injektabilni farmaceutski pripravak za uporabu prema patentnom zahtjevu 5 ili patentnom zahtjevu 6, naznačeni time, da se najmanje jedno dodatno otapalo odabire iz skupine koja se sastoji od: etanola, glicerina, i njihovih mješavina.
8. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, postupak za čuvanje injektabilnog farmaceutskog pripravka prema patentnom zahtjevu 2, uporaba najmanje jednog prezervativa prema patentnom zahtjevu 4, injektabilni farmaceutski pripravak za uporabu prema patentnom zahtjevu 5 ili patentnom zahtjevu 6, naznačeni time, da je: najmanje jedno dodatno otapalo etanol.
9. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, postupak za čuvanje injektabilnog farmaceutskog pripravka prema patentnom zahtjevu 2, uporaba najmanje jednog prezervativa prema patentnom zahtjevu 4, injektabilni farmaceutski pripravak za uporabu prema patentnom zahtjevu 5 ili patentnom zahtjevu 6, naznačeni time, da se: najmanje jedan prezervativ odabire iz skupine od: klorokrezol, benzetonij klorid, ili njihovih mješavina.
10. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, postupak za čuvanje injektabilnog farmaceutskog pripravka prema patentnom zahtjevu 2, uporaba najmanje jednog prezervativa prema patentnom zahtjevu 4, injektabilni farmaceutski pripravak za uporabu prema patentnom zahtjevu 5 ili patentnom zahtjevu 6, naznačeni time, da je: najmanje jedno dodatno otapalo etanol, ili mješavina etanola i glicerina; i da se najmanje jedan prezervativ bira iz skupine koja se sastoji od: klorokrezola, benzetonijevog klorida, ili njihovih mješavina.
11. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, postupak za čuvanje injektabilnog farmaceutskog pripravka prema patentnom zahtjevu 2, uporaba najmanje jednog prezervativa prema patentnom zahtjevu 4, injektabilni farmaceutski pripravak za uporabu prema patentnom zahtjevu 5 ili patentnom zahtjevu 6, naznačeni time, da je: najmanje jedno dodatno otapalo etanol; i najmanje jedan prezervativ klorokrezol.
12. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, postupak za čuvanje injektabilnog farmaceutskog pripravka prema patentnom zahtjevu 2, uporaba najmanje jednog prezervativa prema patentnom zahtjevu 4, injektabilni farmaceutski pripravak za uporabu prema patentnom zahtjevu 5 ili patentnom zahtjevu 6, naznačeni time, da je prisutan pufer učinkovit u stabilizaciji hidrofobnog lijeka i osiguravanju pH pripravka u rasponu od 4.0 do 9.0 i bira se iz skupine koja se sastoji od pufera na osnovu fosfata, na osnovu kiselog fosfata ili na osnovu citrata.
13. Injektabilni farmaceutski pripravak prema patentnom zahtjevu 1, postupak za čuvanje injektabilnog farmaceutskog pripravka prema patentnom zahtjevu 2, uporaba najmanje jednog prezervativa prema patentnom zahtjevu 4, injektabilni farmaceutski pripravak za uporabu prema patentnom zahtjevu 5 ili patentnom zahtjevu 6, naznačeni time, da pripravak nadalje sadrži najmanje jedan hidrofilni lijek.
HRP20200567TT 2011-11-29 2020-04-07 Stabilni injektabilni farmaceutski pripravci koji sadrže 2-hidroksipropil-beta-ciklodekstrin i alfaksalon HRP20200567T1 (hr)

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PCT/AU2012/001452 WO2013078500A1 (en) 2011-11-29 2012-11-27 Methods of preserving injectable pharmaceutical compositions comprising a cyclodextrin and a hydrophobic drug
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Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2013273764B2 (en) * 2011-11-29 2016-05-05 Zoetis Services Llc Pharmaceutical compositions
CN112472814A (zh) 2012-01-23 2021-03-12 萨奇治疗股份有限公司 神经活性类固醇制剂和治疗中枢神经***障碍的方法
UA116217C2 (uk) 2012-10-09 2018-02-26 Санофі Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
RU2652783C2 (ru) 2012-12-21 2018-05-03 Санофи Двойные агонисты glp1/gip или тройные агонисты glp1/gip/глюкагона
JP6180241B2 (ja) * 2013-08-29 2017-08-16 学校法人同志社 シクロデキストリン誘導体及び医薬組成物
WO2015086729A1 (en) 2013-12-13 2015-06-18 Sanofi Dual glp-1/gip receptor agonists
TW201609796A (zh) 2013-12-13 2016-03-16 賽諾菲公司 非醯化之艾塞那肽－４（ｅｘｅｎｄｉｎ－４）胜肽類似物
TW201609797A (zh) 2013-12-13 2016-03-16 賽諾菲公司 雙重ｇｌｐ－１／升糖素受體促效劑
WO2015086728A1 (en) 2013-12-13 2015-06-18 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
TW201625670A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自ｅｘｅｎｄｉｎ－４之雙重ｇｌｐ－１／升糖素受體促效劑
TW201625669A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自艾塞那肽－４（Ｅｘｅｎｄｉｎ－４）之肽類雙重ＧＬＰ－１／升糖素受體促效劑
TW201625668A (zh) 2014-04-07 2016-07-16 賽諾菲公司 作為胜肽性雙重ｇｌｐ－１／昇糖素受體激動劑之艾塞那肽－４衍生物
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
MX2017011103A (es) * 2015-04-01 2018-05-07 Int Dioxcide Inc Composición estabilizada para el control de olor y la deshidratación potenciada combinados.
AR105319A1 (es) 2015-06-05 2017-09-27 Sanofi Sa Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico
TW201706291A (zh) 2015-07-10 2017-02-16 賽諾菲公司 作為選擇性肽雙重ｇｌｐ－１／升糖素受體促效劑之新毒蜥外泌肽（ｅｘｅｎｄｉｎ－４）衍生物
KR101718733B1 (ko) * 2015-08-21 2017-03-22 국제약품 주식회사 레바미피드의 가용화 방법 및 이에 의해 제조된 안구건조증 치료용 액제
NL2015865B1 (en) * 2015-11-27 2017-06-13 Le Vet B V Maropitant Formulation.
GB201609222D0 (en) 2016-05-25 2016-07-06 F2G Ltd Pharmaceutical formulation
CN110215430A (zh) * 2018-03-02 2019-09-10 刘力 新型可注射的***药物组合物
KR102141826B1 (ko) * 2018-10-05 2020-08-07 건국대학교 산학협력단 양이온성 베타 시클로덱스트린 올리고머를 이용한 외부 pH 자극 반응형 자가치유성 하이드로젤
WO2020093256A1 (zh) * 2018-11-07 2020-05-14 比卡生物科技（广州）有限公司 一种澄清丙泊酚注射液及其制备方法
MX2021009777A (es) 2019-02-15 2021-12-15 Saol Int Development Ltd Formulaciones inyectables de fenol y metodos de su uso.
EP3725298A1 (en) 2019-04-16 2020-10-21 Faes Farma, S.A. Stable and preserved pharmaceutical compositions of bilastine
US11819503B2 (en) 2019-04-23 2023-11-21 F2G Ltd Method of treating coccidioides infection
EP3766475A1 (en) 2019-07-15 2021-01-20 OP-Hygiene IP GmbH Wipes
FR3117337B1 (fr) * 2020-12-10 2023-04-28 Centre Hospitalier Univ De Lille Composition pharmaceutique contenant du propofol, une cyclodextrine ou un dérivé de cyclodextrine et un sel pharmaceuticalement acceptable
KR20230122271A (ko) 2022-02-14 2023-08-22 주식회사 에이아이인사이트 파라벤계 보존제의 안정성 증진용 조성물 및 이를 포함하는 보존제

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4728509A (en) 1985-08-19 1988-03-01 Takeda Chemical Industries, Ltd. Aqueous liquid preparation
TW401300B (en) * 1992-12-25 2000-08-11 Senju Pharma Co Antiallergic composition for ophthalmic or nasal use
JPH06293638A (ja) 1993-04-06 1994-10-21 Lion Corp 安定なビタミンａ類点眼剤
ZA962214B (en) * 1995-04-10 1996-10-07 Farmarc Nederland Bv Pharmaceutical composition
JP3934705B2 (ja) 1995-05-26 2007-06-20 ノバルティス ファーマ株式会社 サイクロデキストリン組成物
TW434023B (en) 1995-09-18 2001-05-16 Novartis Ag Preserved ophthalmic composition
CA2342797A1 (en) 1998-09-02 2000-03-09 Allergan Sales, Inc. Preserved cyclodextrin-containing compositions
AUPQ633900A0 (en) 2000-03-20 2000-04-15 Jurox Pty Ltd Anaesthetic composition
IN187686B (hr) * 2000-06-21 2002-06-08 Bharat Serums & Vaccines Ltd
US7034013B2 (en) 2001-03-20 2006-04-25 Cydex, Inc. Formulations containing propofol and a sulfoalkyl ether cyclodextrin
JP2003089632A (ja) 2001-09-17 2003-03-28 Otsuka Pharmaceut Factory Inc 注射用水性製剤
US20050239746A1 (en) * 2002-02-01 2005-10-27 Penkler Lawrence J Pharmaceutical composition
US6869939B2 (en) 2002-05-04 2005-03-22 Cydex, Inc. Formulations containing amiodarone and sulfoalkyl ether cyclodextrin
US20040053895A1 (en) * 2002-09-18 2004-03-18 Bone Care International, Inc. Multi-use vessels for vitamin D formulations
JP4275394B2 (ja) 2002-12-05 2009-06-10 株式会社大塚製薬工場 注射用シロスタゾール水性製剤
US8183230B2 (en) 2004-01-30 2012-05-22 Pfizer Inc. Antimicrobial preservatives to achieve multi-dose formulation using beta-cyclodextrins for liquid dosage forms
US6969706B1 (en) * 2004-05-12 2005-11-29 Allergan, Inc. Preserved pharmaceutical compositions comprising cyclodextrins
JP5577021B2 (ja) 2005-02-17 2014-08-20 アボット・ラボラトリーズ 動物における障害を治療および予防するための薬剤組成物の経粘膜投与
CN101360503A (zh) 2005-11-18 2009-02-04 阿斯利康公司 液体制剂
AU2009314072C1 (en) * 2008-11-15 2016-11-10 Melinta Subsidiary Corp. Antimicrobial compositions
SG181997A1 (en) * 2010-01-21 2012-08-30 Goodchild Invest Pty Ltd Anaesthetic formulation

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