CO6311066A2 - Composiciones de alta densidad que contienen posaconazol y formulaciones que comprenden las mismas - Google Patents
Composiciones de alta densidad que contienen posaconazol y formulaciones que comprenden las mismasInfo
- Publication number
- CO6311066A2 CO6311066A2 CO10141841A CO10141841A CO6311066A2 CO 6311066 A2 CO6311066 A2 CO 6311066A2 CO 10141841 A CO10141841 A CO 10141841A CO 10141841 A CO10141841 A CO 10141841A CO 6311066 A2 CO6311066 A2 CO 6311066A2
- Authority
- CO
- Colombia
- Prior art keywords
- posaconazole
- formulation
- oral administration
- provides
- patients
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 10
- RAGOYPUPXAKGKH-XAKZXMRKSA-N posaconazole Chemical compound 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 title abstract 9
- 229960001589 posaconazole Drugs 0.000 title abstract 9
- 238000009472 formulation Methods 0.000 abstract 6
- 230000036470 plasma concentration Effects 0.000 abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 230000001225 therapeutic effect Effects 0.000 abstract 2
- 239000008280 blood Substances 0.000 abstract 1
- 210000004369 blood Anatomy 0.000 abstract 1
- 210000002784 stomach Anatomy 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Inorganic Chemistry (AREA)
- Obesity (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Emergency Medicine (AREA)
- Endocrinology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Es deseable tener una formulación para administración oral la cual proporcione posaconazol a una población de pacientes con una menor variabilidad paciente a paciente en cuestión de biodisponibilidad, proporcionando así parámetros PK consistentes en una población de pacientes a quienes se administre la formulación, por ejemplo un rango observado más estrecho para valores Cmax y AUC en una población de pacientes a quienes se administra una cantidad fija de una formulación. Además, es deseable tener una formulación para administración oral la cual proporcione una biodisponibilidad de posaconazol superior a la disponible a partir de formulaciones anteriores, proporcionando así niveles superiores en plasma determinados a partir de sangre obtenida de un paciente a quien se administra una cantidad dada de posaconazol (denominados también en la presente por conveniencia niveles en plasma ). Además, es deseable tener una formulación para administración oral la cual proporcione un nivel en plasma aceptable de posaconazol cuando se administra a un paciente en ayunas. Se requiere una composición de posaconazol y una formulación farmacéutica que comprenda una composición de posaconazol que sea apropiada para una administración oral en pacientes en ayunas. y la cual proporcione niveles en plasma terapéuticos y exposición de posaconazol suficiente (AUC) para proporcionar un beneficio terapéutico. Adicionalmente, se requiere una formulación farmacéutica para administración oral la cual proporcione posaconazol en una forma que sea esencialmente insoluble cuando pasa a través del ambiente estomacal, ...
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US4517708P | 2008-04-15 | 2008-04-15 | |
| US16648709P | 2009-04-03 | 2009-04-03 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO6311066A2 true CO6311066A2 (es) | 2011-08-22 |
Family
ID=41199703
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO10141841A CO6311066A2 (es) | 2008-04-15 | 2010-11-11 | Composiciones de alta densidad que contienen posaconazol y formulaciones que comprenden las mismas |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US20110123627A1 (es) |
| EP (1) | EP2285351A2 (es) |
| JP (3) | JP2011516612A (es) |
| KR (1) | KR20110004852A (es) |
| CN (2) | CN104983701A (es) |
| AR (1) | AR072858A1 (es) |
| AU (1) | AU2009236289B2 (es) |
| BR (1) | BRPI0910627A2 (es) |
| CA (1) | CA2720849A1 (es) |
| CL (1) | CL2009000902A1 (es) |
| CO (1) | CO6311066A2 (es) |
| MX (1) | MX2010011295A (es) |
| NZ (1) | NZ588460A (es) |
| PE (1) | PE20091778A1 (es) |
| PH (1) | PH12015500492A1 (es) |
| SG (1) | SG10201403986UA (es) |
| TW (1) | TWI388324B (es) |
| WO (1) | WO2009129300A2 (es) |
| ZA (1) | ZA201007370B (es) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2009236290A1 (en) * | 2008-04-15 | 2009-10-22 | Merck Sharp & Dohme Corp. | Oral pharmaceutical compositions in a solid dispersion comprising preferably posaconazole and HPMCAS |
| EP2540318B1 (en) * | 2010-02-22 | 2018-10-24 | Daiichi Sankyo Company, Limited | Sustained-release solid preparation for oral use |
| US10016508B2 (en) * | 2013-06-03 | 2018-07-10 | Shin-Etsu Chemical Co., Ltd. | Composition for hot-melt extrusion and method for producing hot-melt extrusion product using same |
| EP2837391B1 (en) | 2013-08-12 | 2017-05-10 | Shin-Etsu Chemical Co., Ltd. | Hypromellose acetate succinate for use as hot-melt extrusion carrier, hot-melt extrusion composition, and method for producing hot-melt extrudate |
| CN104510707A (zh) * | 2013-09-26 | 2015-04-15 | 博瑞生物医药技术(苏州)有限公司 | 一种泊沙康唑固体分散体及其制备方法 |
| CN104546667A (zh) * | 2013-10-22 | 2015-04-29 | 博瑞生物医药技术(苏州)有限公司 | 含泊沙康唑的固体分散体及其制备方法 |
| CN104721827A (zh) * | 2013-12-18 | 2015-06-24 | 博瑞生物医药技术(苏州)有限公司 | 一种难溶性抗真菌药物固体分散体及其制备方法 |
| AU2015214502B2 (en) | 2014-02-05 | 2019-06-06 | Merck Sharp & Dohme Llc | Tablet formulation for CGRP-active compounds |
| CN104971045A (zh) * | 2014-04-11 | 2015-10-14 | 上海宣泰医药科技有限公司 | 泊沙康唑药物组合物及其制备方法和药物制剂 |
| ES2759801T3 (es) | 2015-08-08 | 2020-05-12 | Tiefenbacher Alfred E Gmbh & Co Kg | Formulación gastro-resistente que contiene posaconazol |
| EP3925601A1 (en) | 2016-02-26 | 2021-12-22 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Gastro-resistant formulation containing posaconazole and a polymeric precipitation inhibitor |
| WO2017032908A1 (en) | 2016-07-08 | 2017-03-02 | Synthon B.V. | Pharmaceutical composition comprising amorphous posaconazole |
| CN106265526A (zh) * | 2016-09-22 | 2017-01-04 | 山东大学 | 一种抗真菌药物泊沙康唑的固体分散体及制备方法与应用 |
| TR201620462A2 (tr) | 2016-12-31 | 2018-07-23 | Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi | POSAKONAZOL İÇEREN FARMASÖTİK BİLEŞİMLER ve ÜRETİM YÖNTEMİ |
| US20180282527A1 (en) * | 2017-03-30 | 2018-10-04 | Shin-Etsu Chemical Co., Ltd. | Injection molding composition containing hypromellose acetate succinate and method for producing same |
| US10702520B1 (en) | 2019-01-29 | 2020-07-07 | Slayback Pharma Llc | Pharmaceutical compositions of posaconazole |
| WO2022034232A1 (en) | 2020-08-13 | 2022-02-17 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Gastro-resistant high-strength formulation containing posaconazole |
| CN112697937A (zh) * | 2020-12-18 | 2021-04-23 | 卓和药业集团有限公司 | 泊沙康唑肠溶片溶出度的分析方法 |
| EP4091604B1 (en) | 2021-11-25 | 2024-04-03 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granules containing posaconazole |
| WO2023012378A1 (en) | 2021-11-25 | 2023-02-09 | Alfred E. Tiefenbacher (Gmbh Und Co. Kg) | Granules containing posaconazole |
| CN114184721A (zh) * | 2021-12-14 | 2022-03-15 | 江苏恒盛药业有限公司 | 泊沙康唑残留溶剂的检测方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4144346A (en) * | 1977-01-31 | 1979-03-13 | Janssen Pharmaceutica N.V. | Novel 1-(1,3-dioxolan-2-ylmethyl)-1H-imidazoles |
| SE7804231L (sv) * | 1978-04-14 | 1979-10-15 | Haessle Ab | Magsyrasekretionsmedel |
| US4978672A (en) * | 1986-03-07 | 1990-12-18 | Ciba-Geigy Corporation | Alpha-heterocyclc substituted tolunitriles |
| US4916134A (en) * | 1987-03-25 | 1990-04-10 | Janssen Pharmacuetica N.V. | 4-[4-[4-[4-[[2-(2,4-difluorophenyl)-2-(1H-azolylmethyl)-1,3-dioxolan-4-yl]me]phenyl]-1-piperazinyl]phenyl]triazolones |
| GB8908250D0 (en) * | 1989-04-12 | 1989-05-24 | Fisons Plc | Formulations |
| US5278175A (en) * | 1990-02-02 | 1994-01-11 | Pfizer Inc. | Triazole antifungal agents |
| US5703079A (en) * | 1993-12-21 | 1997-12-30 | Schering Corporation | Tetrahydrofuran antifungals |
| US5661151A (en) * | 1993-12-21 | 1997-08-26 | Schering Corporation | Tetrahydrofuran antifungals |
| NZ270418A (en) * | 1994-02-07 | 1997-09-22 | Eisai Co Ltd | Polycyclic triazole & imidazole derivatives, antifungal compositions |
| GB9602080D0 (en) * | 1996-02-02 | 1996-04-03 | Pfizer Ltd | Pharmaceutical compounds |
| DK0904060T3 (da) * | 1996-05-20 | 2004-04-13 | Janssen Pharmaceutica Nv | Antifungale præparater med forbedret biotilgængelighed |
| US5834472A (en) * | 1996-05-24 | 1998-11-10 | Schering Corporation | Antifungal composition with enhanced bioavailability |
| US5972381A (en) * | 1996-06-28 | 1999-10-26 | Schering Corporation | Solid solution of an antifungal agent with enhanced bioavailability |
| US5846971A (en) * | 1996-06-28 | 1998-12-08 | Schering Corporation | Oral antifungal composition |
| US6713481B1 (en) * | 1997-10-17 | 2004-03-30 | David R. Andrews | Crystalline antifungal polymorph |
| AU2331801A (en) * | 1999-12-23 | 2001-07-09 | F.H. Faulding & Co. Limited | Improved pharmaceutical compositions for poorly soluble drugs |
| UY26615A1 (es) * | 2000-03-16 | 2001-10-25 | Pfizer Prod Inc | Inhibidor de la glucogeno fosforilasa. |
| EP1372394A1 (en) * | 2001-04-03 | 2004-01-02 | Schering Corporation | Antifungal composition with enhanced bioavailability |
| JPWO2003077827A1 (ja) * | 2002-03-19 | 2005-07-14 | 日本新薬株式会社 | 医薬固体分散体の製造方法 |
| US20050043251A1 (en) * | 2003-08-20 | 2005-02-24 | Fairfield Clinical Trials, Llc | Method of treatment of otitis externa |
| US20060160823A1 (en) * | 2004-05-28 | 2006-07-20 | Leonore Witchey-Lakshmanan | Particulate-stabilized injectable pharmaceutical compositions of Posaconazole |
| WO2006034080A2 (en) * | 2004-09-17 | 2006-03-30 | Nektar Therapeutics | Formulation comprising itraconazole |
| US20060275230A1 (en) * | 2004-12-10 | 2006-12-07 | Frank Kochinke | Compositions and methods for treating conditions of the nail unit |
| US20070178152A1 (en) * | 2005-11-04 | 2007-08-02 | Shelton Michael C | Carboxyalkylcellulose esters for administration of poorly soluble pharmaceutically active agents |
| JP2009538927A (ja) * | 2006-05-30 | 2009-11-12 | エラン ファーマ インターナショナル，リミティド | ナノ粒子状のポサコナゾール製剤 |
| WO2008138755A2 (en) * | 2007-05-11 | 2008-11-20 | F. Hoffmann-La Roche Ag | Pharmaceutical compositions for poorly soluble drugs |
| AU2009236290A1 (en) * | 2008-04-15 | 2009-10-22 | Merck Sharp & Dohme Corp. | Oral pharmaceutical compositions in a solid dispersion comprising preferably posaconazole and HPMCAS |
-
2009
- 2009-04-15 AR ARP090101320A patent/AR072858A1/es unknown
- 2009-04-15 US US12/999,547 patent/US20110123627A1/en not_active Abandoned
- 2009-04-15 CL CL2009000902A patent/CL2009000902A1/es unknown
- 2009-04-15 CN CN201510421108.2A patent/CN104983701A/zh active Pending
- 2009-04-15 KR KR1020107023010A patent/KR20110004852A/ko not_active Application Discontinuation
- 2009-04-15 EP EP09732010A patent/EP2285351A2/en not_active Withdrawn
- 2009-04-15 TW TW098112539A patent/TWI388324B/zh active
- 2009-04-15 NZ NZ588460A patent/NZ588460A/en unknown
- 2009-04-15 BR BRPI0910627A patent/BRPI0910627A2/pt not_active IP Right Cessation
- 2009-04-15 WO PCT/US2009/040652 patent/WO2009129300A2/en active Application Filing
- 2009-04-15 MX MX2010011295A patent/MX2010011295A/es active IP Right Grant
- 2009-04-15 CN CN2009801224878A patent/CN102065842A/zh active Pending
- 2009-04-15 SG SG10201403986UA patent/SG10201403986UA/en unknown
- 2009-04-15 AU AU2009236289A patent/AU2009236289B2/en not_active Expired - Fee Related
- 2009-04-15 CA CA2720849A patent/CA2720849A1/en not_active Abandoned
- 2009-04-15 PE PE2009000520A patent/PE20091778A1/es active IP Right Grant
- 2009-04-15 JP JP2011505163A patent/JP2011516612A/ja not_active Ceased
-
2010
- 2010-10-14 ZA ZA2010/07370A patent/ZA201007370B/en unknown
- 2010-11-11 CO CO10141841A patent/CO6311066A2/es not_active Application Discontinuation
-
2014
- 2014-04-02 JP JP2014075980A patent/JP2014139230A/ja active Pending
- 2014-11-24 US US14/551,903 patent/US20150150990A1/en not_active Abandoned
-
2015
- 2015-03-06 PH PH12015500492A patent/PH12015500492A1/en unknown
- 2015-11-24 JP JP2015228422A patent/JP2016074698A/ja not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| AR072858A1 (es) | 2010-09-29 |
| AU2009236289A1 (en) | 2009-10-22 |
| SG10201403986UA (en) | 2014-10-30 |
| JP2011516612A (ja) | 2011-05-26 |
| WO2009129300A3 (en) | 2010-02-11 |
| CA2720849A1 (en) | 2009-10-22 |
| KR20110004852A (ko) | 2011-01-14 |
| NZ588460A (en) | 2012-07-27 |
| ZA201007370B (en) | 2011-06-29 |
| TW200946121A (en) | 2009-11-16 |
| CN102065842A (zh) | 2011-05-18 |
| JP2014139230A (ja) | 2014-07-31 |
| WO2009129300A2 (en) | 2009-10-22 |
| US20110123627A1 (en) | 2011-05-26 |
| EP2285351A2 (en) | 2011-02-23 |
| PH12015500492A1 (en) | 2017-04-10 |
| US20150150990A1 (en) | 2015-06-04 |
| TWI388324B (zh) | 2013-03-11 |
| MX2010011295A (es) | 2010-11-12 |
| PE20091778A1 (es) | 2009-11-13 |
| AU2009236289B2 (en) | 2014-08-21 |
| JP2016074698A (ja) | 2016-05-12 |
| CN104983701A (zh) | 2015-10-21 |
| BRPI0910627A2 (pt) | 2015-09-22 |
| CL2009000902A1 (es) | 2010-07-23 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Application refused |