BR112012033077B8 - Composição farmacêutica para administração intravenosa, uso de uma composição farmacêutica, e, kit - Google Patents
Composição farmacêutica para administração intravenosa, uso de uma composição farmacêutica, e, kitInfo
- Publication number
- BR112012033077B8 BR112012033077B8 BR112012033077A BR112012033077A BR112012033077B8 BR 112012033077 B8 BR112012033077 B8 BR 112012033077B8 BR 112012033077 A BR112012033077 A BR 112012033077A BR 112012033077 A BR112012033077 A BR 112012033077A BR 112012033077 B8 BR112012033077 B8 BR 112012033077B8
- Authority
- BR
- Brazil
- Prior art keywords
- pharmaceutical composition
- intravenous administration
- kit
- posaconazole
- compositions
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 4
- 238000001990 intravenous administration Methods 0.000 title abstract 3
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- RAGOYPUPXAKGKH-XAKZXMRKSA-N posaconazole Chemical group O=C1N([C@H]([C@H](C)O)CC)N=CN1C1=CC=C(N2CCN(CC2)C=2C=CC(OC[C@H]3C[C@@](CN4N=CN=C4)(OC3)C=3C(=CC(F)=CC=3)F)=CC=2)C=C1 RAGOYPUPXAKGKH-XAKZXMRKSA-N 0.000 abstract 2
- 229960001589 posaconazole Drugs 0.000 abstract 2
- 239000007864 aqueous solution Substances 0.000 abstract 1
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical class OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 abstract 1
- 239000002738 chelating agent Substances 0.000 abstract 1
- 229940009662 edetate Drugs 0.000 abstract 1
- 208000015181 infectious disease Diseases 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4965—Non-condensed pyrazines
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4965—Non-condensed pyrazines
- A61K31/497—Non-condensed pyrazines containing further heterocyclic rings
-
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/724—Cyclodextrins
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K39/0002—Fungal antigens, e.g. Trichophyton, Aspergillus, Candida
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6957—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a device or a kit, e.g. stents or microdevices
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
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- Chemical & Material Sciences (AREA)
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- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Tropical Medicine & Parasitology (AREA)
- Mycology (AREA)
- Virology (AREA)
- Transplantation (AREA)
- AIDS & HIV (AREA)
- Heart & Thoracic Surgery (AREA)
- Obesity (AREA)
- Microbiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
COMPOSIÇÃO FARMACÊUTICA PARA ADMINISTRAÇÃO INTRAVENOSA, MÉTODO PARA TRATAR OU PREVENIR UMA INFECÇÃO, E, KIT. A presente invenção se refere à soluções aquosas úteis como composições farmacêuticas de posaconazol para administração intravenosa. Estas composições incluem um agente de solubilização, tal como uma B ciclodextrina modificada em uma solução acidificada, que também pode incluir um agente quelante tal como Edetato de dissódio (EDTA). Em ensaios clínicos, uma dose de 200 mg de posaconazol da composição selecionada foi observada atingir propriedades farmacocinéticas aceitáveis.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US35970110P | 2010-06-29 | 2010-06-29 | |
PCT/US2011/041715 WO2012005973A1 (en) | 2010-06-29 | 2011-06-24 | Posaconazole intravenous solution formulations stabilized by substituted beta-cyclodextrin |
Publications (3)
Publication Number | Publication Date |
---|---|
BR112012033077A2 BR112012033077A2 (pt) | 2016-11-22 |
BR112012033077B1 BR112012033077B1 (pt) | 2020-01-21 |
BR112012033077B8 true BR112012033077B8 (pt) | 2023-04-25 |
Family
ID=45441500
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112012033077A BR112012033077B8 (pt) | 2010-06-29 | 2011-06-24 | Composição farmacêutica para administração intravenosa, uso de uma composição farmacêutica, e, kit |
Country Status (20)
Country | Link |
---|---|
US (2) | US9023790B2 (pt) |
EP (3) | EP3391890B1 (pt) |
JP (1) | JP6008849B2 (pt) |
KR (1) | KR101834024B1 (pt) |
CN (2) | CN107049935A (pt) |
AU (1) | AU2011276680B2 (pt) |
BR (1) | BR112012033077B8 (pt) |
CA (1) | CA2802929C (pt) |
CY (1) | CY1124690T1 (pt) |
DK (1) | DK3391890T3 (pt) |
ES (1) | ES2893444T3 (pt) |
HR (1) | HRP20211686T1 (pt) |
HU (1) | HUE056581T2 (pt) |
LT (1) | LT3391890T (pt) |
MX (2) | MX338685B (pt) |
PL (1) | PL3391890T3 (pt) |
PT (1) | PT3391890T (pt) |
RS (1) | RS62583B1 (pt) |
SI (1) | SI3391890T1 (pt) |
WO (1) | WO2012005973A1 (pt) |
Families Citing this family (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090175810A1 (en) | 2008-01-03 | 2009-07-09 | Gareth Winckle | Compositions and methods for treating diseases of the nail |
US7635773B2 (en) | 2008-04-28 | 2009-12-22 | Cydex Pharmaceuticals, Inc. | Sulfoalkyl ether cyclodextrin compositions |
JP6008849B2 (ja) | 2010-06-29 | 2016-10-19 | メルク・シャープ・エンド・ドーム・コーポレイション | 置換β−シクロデキストリンにより安定化されたポサコナゾール静脈注射用溶液製剤 |
US8039494B1 (en) | 2010-07-08 | 2011-10-18 | Dow Pharmaceutical Sciences, Inc. | Compositions and methods for treating diseases of the nail |
PL3702374T3 (pl) | 2012-02-15 | 2022-11-21 | Cydex Pharmaceuticals, Inc. | Sposób wytwarzania pochodnych cyklodekstryny |
CA2924748C (en) | 2013-10-03 | 2019-09-03 | Dow Pharmaceutical Sciences, Inc. | Stabilized efinaconazole formulations |
CN104546724A (zh) * | 2013-10-12 | 2015-04-29 | 博瑞生物医药技术(苏州)有限公司 | 一种抗真菌药的固体分散体 |
CN112999223A (zh) | 2013-11-22 | 2021-06-22 | 博世健康爱尔兰有限公司 | 抗感染的方法、组合物和装置 |
CN105879041A (zh) * | 2014-11-14 | 2016-08-24 | 北京赛林泰医药技术有限公司 | 一种泊沙康唑口服液及其制备方法 |
EA201791100A1 (ru) * | 2014-11-19 | 2017-11-30 | Гуфик Байосайенсиз Лимитед | Способ получения парентерального состава на основе анидулафунгина |
CN104473871B (zh) * | 2014-11-28 | 2017-03-08 | 济南康和医药科技有限公司 | 一种泊沙康唑脂肪乳注射液及其制备方法 |
CN106265534A (zh) * | 2015-05-25 | 2017-01-04 | 江苏正大丰海制药有限公司 | 一种泊沙康唑冻干粉针剂的制备方法 |
CN106511262A (zh) * | 2015-09-11 | 2017-03-22 | 上海美悦生物科技发展有限公司 | 一种泊沙康唑口服溶液剂及其制备方法 |
CN107033186B (zh) | 2016-02-04 | 2020-06-09 | 武汉朗来科技发展有限公司 | 泊沙康唑衍生物、其药物组合物和用途 |
CN110022857A (zh) | 2016-11-18 | 2019-07-16 | 艾库里斯抗感染治疗有限公司 | 基于改性环糊精和酸化剂的脒取代β-内酰胺化合物的新制剂、其制备及作为抗微生物药物组合物的用途 |
CN110711174A (zh) * | 2018-07-11 | 2020-01-21 | 郑州泰丰制药有限公司 | 一种泊沙康唑注射液中间体溶液配制方法 |
WO2020139209A1 (en) * | 2018-12-28 | 2020-07-02 | Polifarma Ilac Sanayi Ve Ticaret Anonim Srketi | Stable injectable posaconazole formulations comprising cyclodextrin and sugar |
US20230285391A1 (en) * | 2020-06-06 | 2023-09-14 | Inventia Healthcare Limited | Stable liquid compositions of posaconazole |
WO2023148763A1 (en) * | 2022-02-01 | 2023-08-10 | Cipla Limited | Injectable pharmaceutical compositions of azole antifungal agents |
Family Cites Families (27)
Publication number | Priority date | Publication date | Assignee | Title |
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US5257985A (en) | 1989-12-04 | 1993-11-02 | Richard Puhl | Multi-chamber intravenous bag apparatus |
KR0166088B1 (ko) | 1990-01-23 | 1999-01-15 | . | 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도 |
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