CO6150128A2 - Formulacion de nevirapina de liberacion prolongada - Google Patents
Formulacion de nevirapina de liberacion prolongadaInfo
- Publication number
- CO6150128A2 CO6150128A2 CO09075419A CO09075419A CO6150128A2 CO 6150128 A2 CO6150128 A2 CO 6150128A2 CO 09075419 A CO09075419 A CO 09075419A CO 09075419 A CO09075419 A CO 09075419A CO 6150128 A2 CO6150128 A2 CO 6150128A2
- Authority
- CO
- Colombia
- Prior art keywords
- geometric mean
- nevirapine
- exhibits
- cmax
- administered
- Prior art date
Links
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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61P31/12—Antivirals
-
- 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
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Virology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- AIDS & HIV (AREA)
- Tropical Medicine & Parasitology (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
1.- Una composición farmacéutica que: (a) comprende 300 mg de nevirapina en una matriz de liberación prolongada y que, cuando se administra en forma de una dosis única a un ser humano en ayunas, exhibe (1) una Cmáx media geométrica de 1.000 a 2.300 ng/mL; y (2) una AUC0-∞ media geométrica de 73.400 a 178.100 h(ng/mL); o (b) comprende 400 mg de nevirapina en una matriz de liberación prolongada y que, cuando se administra en forma de una dosis única a un ser humano en ayunas, exhibe (1) una Cmáx media geométrica de 1.210 a 2.740 ng/mL; y (2) una AUC0-∞ media geométrica de 109.000 a 237.000 h(ng/mL). 2.- Una composición farmacéutica de acuerdo con la reivindicación 1, que exhibe un Tmax de dosis única en ayunas de 10 a 48 h. 3.- Una composición farmacéutica de acuerdo con la reivindicación 1, que: (a) comprende 300 mg de nevirapina en una matriz de liberación prolongada y que, cuando se administra en dosis múltiples a un ser humano, exhibe (1) una Cmáx.ss media geométrica de 2.300 a 3.700 ng/mL; y (2) una AUC0-24,ss-media geométrica de 45.000 a 75.000 h(ng/mL); o (b) comprende 400 mg de nevirapina en una matriz de liberación prolongada y que, cuando se administra en dosis múltiples a un ser humano, exhibe (1) una Cmáx,ss media geométrica de 3.100 a 4.900 ng/mL; y (2) una AUC0-24,ss-media geométrica de 60.000 a 99.000 h(ng/mL).4.- Una composición farmacéutica de acuerdo con la reivindicación 1, que exhibe una Cmáx,ss/Cmin,ss que está en el intervalo de 1,1 a 2, medida durante una dosificación múltiple.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US94276507P | 2007-06-08 | 2007-06-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO6150128A2 true CO6150128A2 (es) | 2010-04-20 |
Family
ID=39739795
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO09075419A CO6150128A2 (es) | 2007-06-08 | 2009-07-21 | Formulacion de nevirapina de liberacion prolongada |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US8460704B2 (es) |
| EP (1) | EP2155169B1 (es) |
| JP (1) | JP5417662B2 (es) |
| KR (1) | KR101017862B1 (es) |
| CN (1) | CN101784263B (es) |
| AR (1) | AR066924A1 (es) |
| AU (1) | AU2008262031B2 (es) |
| BR (1) | BRPI0811732A2 (es) |
| CA (1) | CA2687491C (es) |
| CL (1) | CL2008001678A1 (es) |
| CO (1) | CO6150128A2 (es) |
| DK (1) | DK2155169T3 (es) |
| EA (1) | EA018377B1 (es) |
| EC (1) | ECSP099561A (es) |
| ES (1) | ES2574836T3 (es) |
| HK (1) | HK1145806A1 (es) |
| HU (1) | HUE028598T2 (es) |
| IL (1) | IL199924A0 (es) |
| MA (1) | MA31430B1 (es) |
| MX (1) | MX2009007764A (es) |
| NZ (1) | NZ578664A (es) |
| PE (2) | PE20131035A1 (es) |
| PL (1) | PL2155169T3 (es) |
| TN (1) | TN2009000510A1 (es) |
| TW (1) | TWI419716B (es) |
| UA (1) | UA97971C2 (es) |
| UY (1) | UY31128A1 (es) |
| WO (1) | WO2008154234A2 (es) |
| ZA (1) | ZA200904939B (es) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MY149159A (en) | 2005-11-15 | 2013-07-31 | Hoffmann La Roche | Method for treating joint damage |
| US20130172274A1 (en) | 2005-12-20 | 2013-07-04 | Duke University | Methods and compositions for delivering active agents with enhanced pharmacological properties |
| BRPI0811732A2 (pt) | 2007-06-08 | 2014-11-18 | Boehring Ingelheim Internat Gmbh | Formulação de liberação prolongada de nevirapina |
| EP2307038A4 (en) | 2008-06-27 | 2013-03-27 | Univ Duke | THERAPEUTIC AGENTS COMPRISING ELASTINE-LIKE PEPTIDES |
| AU2012264475A1 (en) | 2011-05-30 | 2013-10-31 | Cipla Limited | Pharmaceutical antiretroviral composition |
| EP2747832A4 (en) * | 2011-08-24 | 2015-01-07 | Phasebio Pharmaceuticals Inc | FORMULATIONS OF ACTIVE AGENTS FOR PROLONGED RELEASE |
| AU2013229274A1 (en) * | 2012-03-05 | 2014-09-04 | Cipla Limited | Pharmaceutical antiretroviral combinations comprising lamivudine, festinavir and nevirapine |
| CN104523630B (zh) * | 2015-01-22 | 2017-08-25 | 山东新时代药业有限公司 | 一种奈韦拉平片剂 |
| EP3153157A1 (en) | 2015-10-09 | 2017-04-12 | Teva Pharmaceutical Works Private Limited Company | Pharmaceutical composition for prolonged release of nevirapine |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5366972A (en) | 1989-04-20 | 1994-11-22 | Boehringer Ingelheim Pharmaceuticals, Inc. | 5,11-dihydro-6H-dipyrido(3,2-B:2',3'-E)(1,4)diazepines and their use in the prevention or treatment of HIV infection |
| US5133974A (en) | 1989-05-05 | 1992-07-28 | Kv Pharmaceutical Company | Extended release pharmaceutical formulations |
| CA2030056C (en) | 1989-11-17 | 1995-10-17 | Karl D. Hargrave | 5,11-dihydro-6h-dipyrido[3,2-b:2',3'-e][1,4]diazepines and their use in the prevention or treatment of hiv infection |
| US5419917A (en) * | 1994-02-14 | 1995-05-30 | Andrx Pharmaceuticals, Inc. | Controlled release hydrogel formulation |
| US6514530B2 (en) * | 1997-09-09 | 2003-02-04 | Alza Corporation | Dosage form comprising means for changing drug delivery shape |
| AU1534699A (en) | 1997-12-05 | 1999-06-28 | Alza Corporation | Osmotic dosage form comprising first and second coats |
| AU765909C (en) | 1998-12-17 | 2004-09-23 | Alza Corporation | Conversion of liquid filled gelatin capsules into controlled release systems by multiple coatings |
| CA2371940C (en) * | 1999-03-31 | 2008-07-15 | Janssen Pharmaceutica N.V. | Pregelatinized starch in a controlled release formulation |
| ATE316781T1 (de) * | 1999-09-24 | 2006-02-15 | Janssen Pharmaceutica Nv | Antivirale feste dispersionen |
| KR100738276B1 (ko) | 1999-12-09 | 2007-07-12 | 알자 코포레이션 | 항바이러스성 약제 |
| US6541014B2 (en) | 2000-10-13 | 2003-04-01 | Advancis Pharmaceutical Corp. | Antiviral product, use and formulation thereof |
| WO2002092095A1 (en) | 2001-05-11 | 2002-11-21 | Boehringer Ingelheim International Gmbh | Use of nevirapine to treat or prevent lipid pathology in patients with hiv that is resistant to nevirapine |
| US20030050620A1 (en) | 2001-09-07 | 2003-03-13 | Isa Odidi | Combinatorial type controlled release drug delivery device |
| WO2004043435A2 (en) | 2002-11-13 | 2004-05-27 | Control Delivery Systems, Inc. | Systemic delivery of antiviral agents |
| EP1643946A2 (en) | 2003-06-20 | 2006-04-12 | Viral Genomix, Inc. | Compositions for and methods for treating hiv |
| EP1673072B1 (en) | 2003-10-01 | 2007-04-04 | Lupin Limited | A controlled release pharmaceutical composition and a process for preparing the same |
| EP1696822B1 (en) | 2003-11-13 | 2010-03-17 | PSivida US Inc. | Injectable sustained release implant having a bioerodible matrix core and a bioerodible skin |
| CA2577288C (en) * | 2004-09-02 | 2010-11-30 | Janssen Pharmaceutica N.V. | Hydrochloride of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile |
| US20110104267A1 (en) * | 2005-04-25 | 2011-05-05 | Aurobindo Pharma Limited | Pharmaceutical compositions of antiretrovirals |
| WO2007000779A2 (en) | 2005-06-29 | 2007-01-04 | Panacea Biotec Ltd. | Pharmaceutical sustained release compositions and processes thereof |
| US9198862B2 (en) * | 2005-07-22 | 2015-12-01 | Rubicon Research Private Limited | Dispersible tablet composition |
| FR2891459B1 (fr) | 2005-09-30 | 2007-12-28 | Flamel Technologies Sa | Microparticules a liberation modifiee d'au moins un principe actif et forme galenique orale en comprenant |
| CA2625776A1 (en) | 2005-10-14 | 2007-04-26 | Microdose Technologies, Inc. | Pharmaceutical packaging of an oral dosage combination |
| BRPI0811732A2 (pt) | 2007-06-08 | 2014-11-18 | Boehring Ingelheim Internat Gmbh | Formulação de liberação prolongada de nevirapina |
-
2008
- 2008-06-04 BR BRPI0811732-2A2A patent/BRPI0811732A2/pt not_active IP Right Cessation
- 2008-06-04 EA EA200900958A patent/EA018377B1/ru not_active IP Right Cessation
- 2008-06-04 HU HUE08756672A patent/HUE028598T2/en unknown
- 2008-06-04 UA UAA200908230A patent/UA97971C2/ru unknown
- 2008-06-04 CN CN2008800193577A patent/CN101784263B/zh active Active
- 2008-06-04 MX MX2009007764A patent/MX2009007764A/es active IP Right Grant
- 2008-06-04 DK DK08756672.5T patent/DK2155169T3/en active
- 2008-06-04 JP JP2009552940A patent/JP5417662B2/ja active Active
- 2008-06-04 CA CA2687491A patent/CA2687491C/en active Active
- 2008-06-04 AU AU2008262031A patent/AU2008262031B2/en not_active Ceased
- 2008-06-04 PL PL08756672.5T patent/PL2155169T3/pl unknown
- 2008-06-04 EP EP08756672.5A patent/EP2155169B1/en not_active Revoked
- 2008-06-04 NZ NZ578664A patent/NZ578664A/en not_active IP Right Cessation
- 2008-06-04 WO PCT/US2008/065705 patent/WO2008154234A2/en active Application Filing
- 2008-06-04 US US12/523,226 patent/US8460704B2/en active Active
- 2008-06-04 ES ES08756672.5T patent/ES2574836T3/es active Active
- 2008-06-04 KR KR1020097016610A patent/KR101017862B1/ko active IP Right Grant
- 2008-06-06 UY UY31128A patent/UY31128A1/es not_active Application Discontinuation
- 2008-06-06 AR ARP080102446A patent/AR066924A1/es unknown
- 2008-06-06 PE PE2013000070A patent/PE20131035A1/es not_active Application Discontinuation
- 2008-06-06 CL CL2008001678A patent/CL2008001678A1/es unknown
- 2008-06-06 PE PE2008000969A patent/PE20090371A1/es not_active Application Discontinuation
- 2008-06-06 TW TW097121294A patent/TWI419716B/zh active
-
2009
- 2009-07-15 ZA ZA200904939A patent/ZA200904939B/xx unknown
- 2009-07-16 IL IL199924A patent/IL199924A0/en unknown
- 2009-07-21 CO CO09075419A patent/CO6150128A2/es unknown
- 2009-08-05 EC EC2009009561A patent/ECSP099561A/es unknown
- 2009-12-04 TN TNP2009000510A patent/TN2009000510A1/fr unknown
- 2009-12-07 MA MA32400A patent/MA31430B1/fr unknown
-
2011
- 2011-01-05 HK HK11100032.7A patent/HK1145806A1/xx unknown
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