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ES2574836T3 - Formulación de liberación prolongada de nevirapina - Google Patents

Formulación de liberación prolongada de nevirapina Download PDF

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Publication number
ES2574836T3
ES2574836T3 ES08756672.5T ES08756672T ES2574836T3 ES 2574836 T3 ES2574836 T3 ES 2574836T3 ES 08756672 T ES08756672 T ES 08756672T ES 2574836 T3 ES2574836 T3 ES 2574836T3
Authority
ES
Spain
Prior art keywords
nevirapine
release formulation
prolonged release
hpmc
tablets
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES08756672.5T
Other languages
English (en)
Inventor
Michael L. Cappola
Svetlana Sienkiewicz
Glenn Charles Snow
Feng-Jing Chen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boehringer Ingelheim International GmbH
Original Assignee
Boehringer Ingelheim International GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39739795&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2574836(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Ingelheim International GmbH filed Critical Boehringer Ingelheim International GmbH
Application granted granted Critical
Publication of ES2574836T3 publication Critical patent/ES2574836T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/18Antivirals for RNA viruses for HIV

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Un comprimido farmacéutico, en donde cada uno de los comprimidos comprende: (a) 400 mg de nevirapina anhidra; (b) 270 mg de Hipromelosa 2208; (c) 400 mg de lactosa monohidrato; y (d) 10 mg de estearato de magnesio; en donde cada uno de los comprimido se comprime mediante una fuerza de 10-25 kN.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
(estearato de magnesio) y se mezcla para preparar la mezcla final para su compresión en comprimidos. Los comprimidos se comprimen mediante una fuerza de aproximadamente 10-25 kN para formar comprimidos de 9,3 x 19,0 mm.
Los parámetros farmacocinéticos de las formulaciones antes descritas se confirmaron en una población de personas sanas de N = 17 tras una administración de dosis única. Un resumen de los resultados aparece en la Tabla 1, que figura más abajo.
Tabla 1 -Resumen de parámetros farmacocinéticos de dosis única [media geométrica (% de CV geométrica)] para Formulaciones de Nevirapina en personas normales (N = 17)
Formulación
AUC0-∞ (ng·h/mL) Cmáx (ng/mL) tmáx (h)
400 mg de Nevirapina, HPMC al 20% E
182,000 (31%) 1,990 (28%) 30,4 (31%)
400 mg de Nevirapina, HPMC al 20% K
149,000 (32%) 1,990 (27%) 23,5 (18%)
400 mg de Nevirapina, HPMC al 25% K
155,000 (30%) 1,970 (32%) 22,7 (44%)
400 mg de Nevirapina, HPMC al 30% K
166,000 (28%) 2,110 (24,3%) 27,5 (44%)
400 mg de Nevirapina, HPMC al 40% K
145,000 (47%) 1,610 (43%) 25,7 (43%)
300 mg de Nevirapina, HPMC al 20% E
118,000 (31%) 1,660 (26%) 24,6 (18%)
300 mg de Nevirapina, HPMC al 20% K
137,000 (51%) 1,660 (42%) 23,9 (27%)
300 mg de Nevirapina, HPMC al 25% K
126,000 (34%) 1,770 (25%) 24,5 (29%)
300 mg de Nevirapina, HPMC al 30% K
109,000 (29%) 1,340 (27%) 24,2 (41%)
300 mg de Nevirapina, HPMC al 40% K
97,800 (64%) 1,350 (44%) 25,0 (44%)
400 mg de Nevirapina, IR
210,000 (22%) 3,130 (12%) 4,31 (117%)
200 mg de Nevirapina, IR
114,000 (30%) 1,740 (21%) 2,17 (147%)
10 Los parámetros farmacocinéticos de las formulaciones descritas antes también se confirmaron tras una administración de dosis múltiple (nevirapina XR una vez al día durante 17 días) en una población de pacientes infestados con VIH, previamente tratados con comprimidos Viramune® de liberación inmediata. Un resumen de los resultados aparece en la Tabla 2, que figura más abajo.
Tabla 2 – Resumen de parámetros farmacocinéticos de estado estacionario para comprimidos de liberación 15 inmediata (IR) y 400 mg de liberación prolongada (XR) en pacientes infestados con el VIH
Tratamiento
tmáx (h) Cmáx (ng/mL) Cmin (ng/mL) AUC0-24 (h·ng/mL)
IR (N = 19)
g media 1,8 5,576 2,976 96,137
g CV%
130 26 31 26
ER 25% K (N =18)
g media 4,3 3,911 2,622 75,544
g CV%
134 26 35 29
ER 20% K (N =9)
g media 5,8 3,904 2,609 79,308
g CV%
92 37 45 38
7
imagen6

Claims (1)

  1. imagen1
ES08756672.5T 2007-06-08 2008-06-04 Formulación de liberación prolongada de nevirapina Active ES2574836T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US94276507P 2007-06-08 2007-06-08
US942765P 2007-06-08
PCT/US2008/065705 WO2008154234A2 (en) 2007-06-08 2008-06-04 Extended release formulation of nevirapine

Publications (1)

Publication Number Publication Date
ES2574836T3 true ES2574836T3 (es) 2016-06-22

Family

ID=39739795

Family Applications (1)

Application Number Title Priority Date Filing Date
ES08756672.5T Active ES2574836T3 (es) 2007-06-08 2008-06-04 Formulación de liberación prolongada de nevirapina

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)

* Cited by examiner, † Cited by third party
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
WO2008154234A2 (en) 2007-06-08 2008-12-18 Boehringer Ingelheim International Gmbh Extended release formulation of nevirapine
CA2953975C (en) 2008-06-27 2019-11-26 Duke University Therapeutic agents comprising elastin-like peptides
CA2835272A1 (en) 2011-05-30 2012-12-06 Cipla Limited Pharmaceutical antiretroviral composition
CA2846209C (en) * 2011-08-24 2022-04-05 Phasebio Pharmaceuticals, Inc. Systemic sustained release formulation comprising elastin­like peptide repeating sequence and protein active agent
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)

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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
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US6541014B2 (en) * 2000-10-13 2003-04-01 Advancis Pharmaceutical Corp. Antiviral product, use and formulation thereof
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US20030050620A1 (en) 2001-09-07 2003-03-13 Isa Odidi Combinatorial type controlled release drug delivery device
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ES2340389T3 (es) 2003-11-13 2010-06-02 Psivida Us Inc. Implante inyectable de liberacion prolongada que comprende un nucleo de matriz bioerosionable y una piel bioerosionable.
AU2005279158C1 (en) * 2004-09-02 2010-12-16 Janssen Pharmaceutica N.V. Hydrochloride of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl] amino]benzonitrile
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MX2008000084A (es) 2005-06-29 2008-03-18 Panacea Biotec Ltd Composiciones farmaceuticas de liberacion sostenida y procedimientos de las mismas.
EP1906937B1 (en) * 2005-07-22 2016-10-19 Rubicon Research Pvt Ltd. Novel 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
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WO2008154234A2 (en) 2007-06-08 2008-12-18 Boehringer Ingelheim International Gmbh Extended release formulation of nevirapine

Also Published As

Publication number Publication date
CN101784263B (zh) 2012-11-07
PE20131035A1 (es) 2013-10-01
WO2008154234A2 (en) 2008-12-18
CL2008001678A1 (es) 2009-09-11
CA2687491A1 (en) 2008-12-18
TWI419716B (zh) 2013-12-21
CN101784263A (zh) 2010-07-21
AU2008262031B2 (en) 2011-08-25
US20100278918A1 (en) 2010-11-04
EP2155169A2 (en) 2010-02-24
EP2155169B1 (en) 2016-03-23
HUE028598T2 (en) 2016-12-28
NZ578664A (en) 2011-11-25
ZA200904939B (en) 2010-04-28
TN2009000510A1 (en) 2011-03-31
EA200900958A1 (ru) 2010-04-30
PE20090371A1 (es) 2009-04-24
TW200916127A (en) 2009-04-16
IL199924A0 (en) 2010-04-15
DK2155169T3 (en) 2016-06-13
WO2008154234A3 (en) 2010-01-21
AR066924A1 (es) 2009-09-23
ECSP099561A (es) 2009-09-29
MA31430B1 (fr) 2010-06-01
UA97971C2 (ru) 2012-04-10
PL2155169T3 (pl) 2016-09-30
MX2009007764A (es) 2009-09-10
JP5417662B2 (ja) 2014-02-19
BRPI0811732A2 (pt) 2014-11-18
UY31128A1 (es) 2009-01-30
CO6150128A2 (es) 2010-04-20
KR101017862B1 (ko) 2011-03-04
HK1145806A1 (en) 2011-05-06
KR20100020447A (ko) 2010-02-22
US8460704B2 (en) 2013-06-11
CA2687491C (en) 2011-09-20
WO2008154234A9 (en) 2009-11-26
JP2010520891A (ja) 2010-06-17
EA018377B1 (ru) 2013-07-30
AU2008262031A1 (en) 2008-12-18

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