ES2634020T3 - Formulaciones de compuestos orgánicos - Google Patents

Formulaciones de compuestos orgánicos Download PDF

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Publication number
ES2634020T3
ES2634020T3 ES14711613.1T ES14711613T ES2634020T3 ES 2634020 T3 ES2634020 T3 ES 2634020T3 ES 14711613 T ES14711613 T ES 14711613T ES 2634020 T3 ES2634020 T3 ES 2634020T3
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wire
organic compound
edm
guide
compound
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Charu Kochhar
Jacques Quinton
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Novartis AG
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Novartis AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/23—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
    • A61K31/231—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms having one or two double bonds
    • 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
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12068—Details concerning the detachment of the occluding device from the introduction device detachable by heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12086—Details concerning the detachment of the occluding device from the introduction device magnetically detachable

Abstract

Dispositivo para la electroerosión por hilo rotativo de una pieza de trabajo con una guía de hilo (8) en forma de disco para el guiado de un electrodo de hilo (1) para la electroerosión por hilo rotativo de una pieza de trabajo, siendo el grosor de 5 la guía de hilo (8) en forma de disco más pequeño que 1.5 veces el total del diámetro del electrodo de hilo (1), presentando la guía de hilo (8) en sentido más amplio en la circunferencia una ranura de guía, caracterizado por que la guía de hilo (8) presenta una escotadura en la zona activa de la electroerosión por chispas.

Description

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de sodio, en una cantidad que varía de aproximadamente 3% a aproximadamente 8% en peso con respecto al peso total de la composición total y (c) opcionalmente al menos un vehículo aceptable para uso farmacéutico adicional.
• Una composición farmacéutica sólida comprimida por rodillo que comprende (a) el compuesto 4-(trifluorometil)-5
(2,6-dimorfolinopirimidin-4-il)piridin-2-amina o una sal aceptable para uso farmacéutico del mismo en una cantidad que 5 varía de aproximadamente 20% a aproximadamente 22% en peso con respecto al peso total de la composición total,
(b) estearil fumarato de sodio, en una cantidad que varía de aproximadamente 3% a aproximadamente 8% en peso con respecto al peso total de la composición total y (c) opcionalmente al menos un vehículo aceptable para uso farmacéutico adicional.
Se entiende que la composición farmacéutica sólida de la presente invención se refiere a cualquier realización 10 individual que se describe en la presente.
Los detalles de una o más realizaciones de la divulgación se exponen en la descripción adjunta más arriba. Aunque En la memoria descriptiva y las reivindicaciones adjuntas, las formas singulares incluyen referentes plurales a menos que el contexto indique claramente lo contrario. A menos que se defina lo contrario, todos los términos científicos técnicos utilizados aquí tienen el mismo significado que el comúnmente entendido por un experto ordinario en el arte
15 al que pertenece esta divulgación. Los siguientes Ejemplos se presentan con el fin de ilustrar más completamente las formas de realización preferidas de la divulgación. Estos ejemplos de ningún modo deberán interpretarse como limitantes del alcance de la materia de paciente divulgada, tal como se define por las reivindicaciones adjuntas
Ejemplos
Ejemplo 1: Formulación de comprimido y parámetros del proceso
20 Composiciones de los comprimidos recubiertos del Compuesto A 50 mg (base libre).
Forma de dosificación 1
Núcleo del comprimido: Porción intragranular
Mg/unidad Composición por unidad (%)
Sal de clorhidrato del Compuesto A1
54,45 20,94
Celulosa microcristalina (Avicel PH102)2
126,80 48,77
Crospovidona PVPP XL
10,00 3,85
Estearil fumarato de sodio
3,13 1,20
Dióxido de silicio coloidal/ Sílice, anhidro coloidal (Aerosil 200PH)
2,50 0,96
Porción extragranular
Celulosa microcristalina (Avicel PH102)
35,00 13,46
Estearil fumarato de sodio
9,38 3,61
Crospovidona PVPP XL
7,50 2,88
Dióxido de silicio coloidal/ Sílice, anhidro coloidal (Aerosil 200PH)
1,25 0,48
Peso del núcleo del comprimido
250,00
Recubrimiento
Premezcla de recubrimiento básico, blanca
8,12 3,12
Premezcla de recubrimiento básico, amarilla
1,57 0,60
Premezcla de recubrimiento básico, rojo
0,29 0,11
Premezcla de recubrimiento básico, negra
0,026 0,01
Agua, purificada3
-
13
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Forma de dosificación 3
Núcleo del comprimido: Porción intragranular
Mg/unidad Composición por unidad (%)
Sal de clorhidrato del Compuesto A1
54,45 20,94
Celulosa microcristalina (Avicel PH102)2
104,3 40,12
Manitol
25,50 9,81
Crospovidona PVPP XL
7,50 2,88
Estearil fumarato de sodio
2,50 0,96
Dióxido de silicio coloidal/ Sílice, anhidro coloidal (Aerosil 200PH)
2,50 0,96
Porción extragranular
Celulosa microcristalina (Avicel PH102)
37,00 14,23
Estearil fumarato de sodio
10,00 3,85
Crospovidona PVPP XL
5,00 1,92
Dióxido de silicio coloidal/ Sílice, anhidro coloidal (Aerosil 200PH)
1,25 0,48
Peso del núcleo del comprimido
250,00
Recubrimiento
Laca básica blanca
8,12 3,12
Laca básica amarilla
1,57 0,60
Laca básica roja
0,29 0,11
Laca básica negra
0,026 0,01
Agua, purificada3
--
Peso del comprimido recubierto
260,00
11.089 mg de la sal del Compuesto A es equivalente a 1.000 mg de la base del Compuesto A 2La cantidad de sustancia farmacológica se ajusta para el contenido de fármaco <99,5% con celulosa microcristalina de la fase interna. 3Eliminado durante el procesamiento
Preparación
La composición se prepara mediante el pesaje de sal de clorhidrato del Compuesto A y los excipientes.
5 La porción intragranular se prepara mediante el mezclado en seco de celulosa microcristalina (un tercio de la cantidad total para la porción intragranular), Sal de clorhidrato del Compuesto A, manitol, crospovidona PVPP XL, dióxido de silicio coloidal/ sílice anhidro coloidal (Aerosil 200PH), estearil fumarato de sodio y celulosa microcristalina (dos tercios de la cantidad total para la porción intragranular) durante aproximadamente 15 minutos utilizando una mezcladora de tolva cilíndrica (velocidad de rotación 15 rpm). La mezcla se tamiza utilizando un molino de tamización Quadro-Comil
10 equipado con un tamiz de 1,0 mm, redondo (velocidad de rotación 200 rpm). La mezcla se mezcla en seco nuevamente durante aproximadamente 15 minutos utilizando una mezcladora de tolva cilíndrica (velocidad de rotación 15 rpm). La mezcla se descarga y se comprime utilizando una compactadora de rodillo Vector TFC220 con los siguientes parámetros del proceso:
17
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Claims (1)

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    imagen2
ES14711613.1T 2013-03-06 2014-03-04 Formulaciones de compuestos orgánicos Active ES2634020T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361773492P 2013-03-06 2013-03-06
US201361773492P 2013-03-06
PCT/IB2014/059424 WO2014136048A1 (en) 2013-03-06 2014-03-04 Formulations of organic compounds

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ES2634020T3 true ES2634020T3 (es) 2017-09-26

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US (2) US9474534B2 (es)
EP (1) EP2964200B1 (es)
JP (1) JP6313343B2 (es)
KR (1) KR102233757B1 (es)
CN (1) CN105073099B (es)
AR (1) AR095032A1 (es)
AU (1) AU2014224238B2 (es)
BR (1) BR112015021097B1 (es)
CA (1) CA2904032C (es)
CL (1) CL2015002466A1 (es)
EA (1) EA028301B1 (es)
ES (1) ES2634020T3 (es)
HK (1) HK1212244A1 (es)
IL (1) IL240579B (es)
JO (1) JO3256B1 (es)
MA (1) MA38358B1 (es)
MX (1) MX370175B (es)
MY (1) MY174648A (es)
NZ (1) NZ711015A (es)
PE (1) PE20151607A1 (es)
PH (1) PH12015501945B1 (es)
PL (1) PL2964200T3 (es)
PT (1) PT2964200T (es)
SG (1) SG11201506392VA (es)
TN (1) TN2015000386A1 (es)
TW (1) TW201442712A (es)
UA (1) UA114948C2 (es)
WO (1) WO2014136048A1 (es)
ZA (1) ZA201505830B (es)

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UA114948C2 (uk) 2017-08-28
NZ711015A (en) 2020-02-28
AR095032A1 (es) 2015-09-16
MX2015011705A (es) 2016-05-18
PH12015501945A1 (en) 2016-01-11
CA2904032A1 (en) 2014-09-12
PL2964200T3 (pl) 2017-09-29
JP6313343B2 (ja) 2018-04-18
IL240579A0 (en) 2015-09-24
MX370175B (es) 2019-12-04
AU2014224238B2 (en) 2016-07-14
KR102233757B1 (ko) 2021-03-30
ZA201505830B (en) 2017-07-26
JP2016510065A (ja) 2016-04-04
CA2904032C (en) 2021-02-16
AU2014224238A1 (en) 2015-09-03
KR20150123248A (ko) 2015-11-03
MA38358A1 (fr) 2016-11-30
BR112015021097B1 (pt) 2022-08-30
MY174648A (en) 2020-05-05
CL2015002466A1 (es) 2016-03-04
US9474534B2 (en) 2016-10-25
TN2015000386A1 (en) 2017-01-03
CN105073099B (zh) 2018-10-26
WO2014136048A1 (en) 2014-09-12
US10342547B2 (en) 2019-07-09
MA38358B1 (fr) 2017-07-31
US20160045202A1 (en) 2016-02-18
TW201442712A (zh) 2014-11-16
JO3256B1 (ar) 2018-09-16
US20160015643A1 (en) 2016-01-21
HK1212244A1 (en) 2016-06-10
SG11201506392VA (en) 2015-09-29
CN105073099A (zh) 2015-11-18
PH12015501945B1 (en) 2016-01-11
EP2964200B1 (en) 2017-04-19
PT2964200T (pt) 2017-07-25
PE20151607A1 (es) 2015-11-26
EA201591649A1 (ru) 2016-01-29
EP2964200A1 (en) 2016-01-13
BR112015021097A2 (pt) 2017-07-18
EA028301B1 (ru) 2017-10-31
IL240579B (en) 2019-08-29

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