ES2537164T3 - Forma farmacéutica unitaria que contiene tenofovir DF, emtricitabina, efavirenz y un tensioactivo - Google Patents
Forma farmacéutica unitaria que contiene tenofovir DF, emtricitabina, efavirenz y un tensioactivo Download PDFInfo
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- ES2537164T3 ES2537164T3 ES11167101.2T ES11167101T ES2537164T3 ES 2537164 T3 ES2537164 T3 ES 2537164T3 ES 11167101 T ES11167101 T ES 11167101T ES 2537164 T3 ES2537164 T3 ES 2537164T3
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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
- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
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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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
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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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
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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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/536—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with carbocyclic ring systems
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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
- A61K31/55—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
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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
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
-
- 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
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- 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
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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
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- 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
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- 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
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- 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
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- AIDS & HIV (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)
- Plural Heterocyclic Compounds (AREA)
Abstract
Una composición unitaria que comprende tenofovir DF, efavirenz y emtricitabina y un tensioactivo, donde el tenofovir DF se encuentra en un primer componente y el efavirenz y el tensioactivo están en un segundo componente, en la que el primer y el segundo componentes son físicamente discretos y en la que la cantidad total de efavirenz, emtricitabina y tenofovir DF es mayor de aproximadamente el 60 % en peso de la composición.
Description
E11167101
18-05-2015
Tabla 3. Composición cuantitativa de los comprimidos bicapa recubiertos con película EFV/FTC/TDF
- Ingrediente
- % p/p del total Fórmula unitaria (mg/comprimido)
- Mezcla en polvo de efavirenz
- 57,94 898,0
- Mezcla en polvo de FTC/TDF
- 42,06 652,0
- Total por núcleos de comprimido
- 100,00 1550,0
- Opadry II Pink
- 3,00 46,5
- Agua purificada, USP/EPa
- Total para comprimidos recubiertos con película
- 1596,5
- a Agua eliminada durante el proceso de recubrimiento pelicular.
Los excipientes eran todos materiales incluidos en la Farmacopea.
Se granuló el efavirenz en húmedo usando un tren de equipo Niro-Fielder PMA-400. Se añadió efavirenz, celulosa microcristalina y lauril sulfato de sodio (Tabla 1) al PMA-400 y se mezcló durante 3 minutos. Se añadió croscarmelosa sódica e hidroxi propil celulosa (Tabla 1) a la pre mezcla y se mezclaron durante otros 2 minutos. Se
10 añadió agua purificada para formar una granulación apropiada seguida por amasado adicional en húmedo después de la adición de agua. La Tabla 4 enumera el resumen de los parámetros de granulación utilizados para dos lotes y sub partes representativas. Todas las sub partes usaron una proporción de agua con respecto a efavirenz de 1,30, excepto en la mezcla C AB509, que utilizó una proporción de agua con respecto a efavirenz de 1,25.
15 Tabla 4. Resumen de los parámetros del proceso de granulación en húmedo de efavirenz
- Proceso
- Parámetro AB507 AB509
- Mezcla A
- Mezcla B Mezcla C Mezcla A Mezcla B Mezcla C
- Granulación
- Agua total añadida (kg) 33,57 33,56 33,56 33,56 33,56 32,18
- Relación de agua:EFV
- 1,30 1,30 1,30 1,30 1,30 1,25
- Tiempo de adición total (Min:Seg)
- 9:36 9:29 9:24 9:17 9:32 9:02
- Potencia final del impulsor (% de carga)
- 10,4 9,8 8,5 11,3 11,3 9,9
- Amasado en húmedo
- Tiempo total (Min:Seg) 4,00 03:00 03:00 02:00 1:15 2:00
- Potencia final del impulsor (% de carga
- 11,6 12,0 11,7 18,0 17,7 10,5
- Secadoa
- Temperatura de entrada (°C) 70 70
- Tiempo (h:min)
- 1:45 1:51
- Temperatura final de salida (°C)
- 50 50
- LOD final (%)
- 0,3 0,8
- a Mezclas A, B, y C para cada lote se combinaron antes de secar.
En general, los gránulos húmedos se molieron, luego se secaron hasta una LOD menor o igual que 1,5 %. Los gránulos secos se molieron y se mezclaron con estearato de magnesio (Tabla 1).
20 La densidad aparente, tamaño de partícula y contenido de humedad por LOD de las granulaciones de efavirenz se indican en las primeras tres líneas de la Tabla 5 (los números del lote B son productos de efavirenz, los números del lote C son emtricitabina y tenofovir DF). Se determinó el tamaño de partícula tamizando muestras de 10 gramos a través de mallas de 7,62 cm (3 pulgadas) usando un tamizador sónico (Modelo L3P, ATM Corporation, Milwaukee, WI, Estados Unidos). Se usaron los siguientes tamaños de malla (aberturas) patrones de Estados Unidos: n°20 (850
8
Claims (1)
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imagen1 imagen2
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US69001005P | 2005-06-13 | 2005-06-13 | |
US690010P | 2005-06-13 | ||
US77127906P | 2006-02-07 | 2006-02-07 | |
US771279P | 2006-02-07 |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2537164T3 true ES2537164T3 (es) | 2015-06-03 |
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ID=37532913
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Application Number | Title | Priority Date | Filing Date |
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ES11167101.2T Active ES2537164T3 (es) | 2005-06-13 | 2006-06-13 | Forma farmacéutica unitaria que contiene tenofovir DF, emtricitabina, efavirenz y un tensioactivo |
Country Status (22)
Country | Link |
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US (4) | US8598185B2 (es) |
EP (3) | EP1919457A2 (es) |
JP (6) | JP5557999B2 (es) |
KR (1) | KR101151011B1 (es) |
CN (1) | CN101252920B (es) |
AR (1) | AR054060A1 (es) |
AU (1) | AU2006257795B2 (es) |
BR (1) | BRPI0611634A2 (es) |
CA (1) | CA2611523C (es) |
DK (1) | DK2386294T3 (es) |
EA (2) | EA201201265A1 (es) |
ES (1) | ES2537164T3 (es) |
HK (2) | HK1164123A1 (es) |
HU (1) | HUE025089T2 (es) |
IL (2) | IL188016A0 (es) |
NZ (1) | NZ564102A (es) |
PL (1) | PL2386294T3 (es) |
PT (1) | PT2386294E (es) |
SI (1) | SI2386294T1 (es) |
TW (1) | TWI471145B (es) |
UA (1) | UA108594C2 (es) |
WO (1) | WO2006135933A2 (es) |
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