AR105184A1 - Comprimidos de liberación inmediata que contienen un fármaco y procesos para formar los comprimidos - Google Patents

Comprimidos de liberación inmediata que contienen un fármaco y procesos para formar los comprimidos

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Publication number
AR105184A1
AR105184A1 ARP160101961A ARP160101961A AR105184A1 AR 105184 A1 AR105184 A1 AR 105184A1 AR P160101961 A ARP160101961 A AR P160101961A AR P160101961 A ARP160101961 A AR P160101961A AR 105184 A1 AR105184 A1 AR 105184A1
Authority
AR
Argentina
Prior art keywords
weight
tablet
pharmaceutical
ranging
tablet core
Prior art date
Application number
ARP160101961A
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English (en)
Original Assignee
Genentech Inc
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
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of AR105184A1 publication Critical patent/AR105184A1/es

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    • 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
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Reivindicación 1: Un proceso para preparar un núcleo de comprimido de unidad de dosis farmacéutica, el proceso comprende: (1) mezclar un fármaco activo farmacéutico en partículas, un relleno intragranular, un disgregante intragranular y un lubricante intragranular para formar una premezcla, en donde el fármaco activo farmacéutico en partículas tiene un D [v, 0,5] de tamaño de partícula que va de aproximadamente 25 mm a aproximadamente 65 mm, de aproximadamente 25 mm a aproximadamente 50 mm o de aproximadamente 30 mm a aproximadamente 40 mm; (2) compactar la premezcla mediante la aplicación de una fuerza de compactación que va de aproximadamente 1 kN/cm a aproximadamente 8 kN/cm, de aproximadamente 2 kN/cm a aproximadamente 5 kN/cm o de aproximadamente 2 kN/cm a aproximadamente 4 kN/cm; (3) triturar y tamizar la premezcla compactada para formar gránulos; y (4) formar los gránulos en comprimidos mediante la aplicación de una fuerza de compresión formadora de comprimidos que va de aproximadamente 5 kN a aproximadamente 20 kN, de aproximadamente 14 kN a aproximadamente 19 kN, de aproximadamente 14 kN a aproximadamente 18 kN o de aproximadamente 8 kN a aproximadamente 13 kN, para formar el núcleo de comprimido de unidad de dosis farmacéutica. Reivindicación 17: El proceso de acuerdo con cualquiera de las reivindicaciones precedentes, en donde el fármaco activo farmacéutico en partículas es hemifumarato de cobimetinib polimorfo Forma A. Reivindicación 25: Un núcleo de comprimido de unidad de dosis farmacéutica, el núcleo de comprimido comprende: (1) aproximadamente 5% en peso o más de un fármaco activo farmacéutico en partículas; (2) un contenido de lubricante, basado en el peso del núcleo de comprimido de unidad de dosis farmacéutica, que va de aproximadamente 0,5% en peso a aproximadamente 5% en peso, de aproximadamente 0,5% en peso a aproximadamente 3% en peso, de aproximadamente 1% en peso a aproximadamente 3% en peso, de aproximadamente 1% en peso a aproximadamente 2,5% en peso, o de aproximadamente 1,5% en peso a aproximadamente 2% en peso; (3) un contenido de disgregante, basado en el peso del núcleo de comprimido de unidad de dosis farmacéutica, que va de aproximadamente 2% en peso a aproximadamente 7% en peso, de aproximadamente 2% en peso a aproximadamente 6% en peso, de aproximadamente 2% en peso a aproximadamente 5% en peso, de aproximadamente 3% en peso a aproximadamente 6% en peso o de aproximadamente 3% en peso a aproximadamente 5% en peso; (4) un contenido de relleno, basado en el peso del núcleo de comprimido de unidad de dosis farmacéutica, que va de aproximadamente 60% en peso a aproximadamente 78% en peso, de aproximadamente 65% en peso a aproximadamente 78% en peso, de aproximadamente 65% en peso a aproximadamente 77% en peso, de aproximadamente 70% en peso a aproximadamente 77% en peso, o de aproximadamente 71% en peso a aproximadamente 75% en peso; y (5) opcionalmente, hasta 10% en peso de un aglutinante. Reivindicación 52: Un producto farmacéutico que comprende: (1) un primer comprimido de acuerdo con cualquiera de las reivindicaciones 41, 42 ó 46 a 48; y (2) un segundo comprimido que comprende {3-[5-(4-clorofenil)-1H-pirrolo[2,3-b]piridin-3-carbonil]-2,4-difluoro-fenil}-amida del ácido propan-1-sulfónico (vemurafenib), o una sal farmacéuticamente aceptable de esta, en donde el primer comprimido y el segundo comprimido comprenden una preparación combinada para usar de modo concurrente o secuencial en el tratamiento de melanoma irresecable o metastásico positivo para la mutación BRAFV⁶⁰⁰, en donde se administran uno o varios primeros comprimidos para proporcionar una dosis total de 60 mg de cobimetinib, los días 1 - 21 de un ciclo de 28 días, y en donde se administran uno o varios segundos comprimidos para proporcionar una dosis total de 960 mg de vemurafenib, dos veces por día, cada día del ciclo de 28 días. Reivindicación 60: Un kit que comprende: (1) un primer comprimido de acuerdo con cualquiera de las reivindicaciones 41, 42 ó 46 a 48; y (2) un segundo comprimido que comprende {3-[5-(4-clorofenil)-1H-pirrolo[2,3-b]piridin-3-carbonil]-2,4-difluoro-fenil}-amida del ácido propan-1-sulfónico (vemurafenib), o una sal farmacéuticamente aceptable de esta.
ARP160101961A 2015-06-30 2016-06-29 Comprimidos de liberación inmediata que contienen un fármaco y procesos para formar los comprimidos AR105184A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201562186556P 2015-06-30 2015-06-30

Publications (1)

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AR105184A1 true AR105184A1 (es) 2017-09-13

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ID=56373188

Family Applications (2)

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ARP160101961A AR105184A1 (es) 2015-06-30 2016-06-29 Comprimidos de liberación inmediata que contienen un fármaco y procesos para formar los comprimidos
ARP210100699A AR121624A2 (es) 2015-06-30 2021-03-19 Comprimidos de liberación inmediata que contienen un fármaco y procesos para formar los comprimidos

Family Applications After (1)

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ARP210100699A AR121624A2 (es) 2015-06-30 2021-03-19 Comprimidos de liberación inmediata que contienen un fármaco y procesos para formar los comprimidos

Country Status (18)

Country Link
US (3) US10478400B2 (es)
EP (3) EP4272735A1 (es)
JP (3) JP6914202B2 (es)
KR (1) KR20180021814A (es)
CN (2) CN108135854B (es)
AR (2) AR105184A1 (es)
AU (2) AU2016287422B2 (es)
BR (1) BR112017028218A2 (es)
CA (1) CA2987912C (es)
ES (2) ES2969014T3 (es)
HK (1) HK1254389A1 (es)
HR (2) HRP20240045T1 (es)
IL (2) IL256299B2 (es)
MX (3) MX2017016163A (es)
PL (2) PL3316867T3 (es)
SI (2) SI3316867T1 (es)
TW (3) TWI804919B (es)
WO (1) WO2017004122A1 (es)

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JP7232284B2 (ja) 2023-03-02
TWI804919B (zh) 2023-06-11
TWI795344B (zh) 2023-03-11
EP3316867A1 (en) 2018-05-09
MX2022015606A (es) 2023-02-01
TW202206068A (zh) 2022-02-16
SI3881833T1 (sl) 2024-03-29
IL256299B2 (en) 2023-11-01
HRP20210828T1 (hr) 2021-07-09
EP3881833A1 (en) 2021-09-22
PL3881833T3 (pl) 2024-05-13
TW202337463A (zh) 2023-10-01
IL256299A (en) 2018-02-28
MX2020013162A (es) 2021-02-18
SI3316867T1 (sl) 2021-08-31
US20200085749A1 (en) 2020-03-19
EP3316867B1 (en) 2021-03-10
AU2016287422B2 (en) 2021-11-18
US10478400B2 (en) 2019-11-19
CA2987912A1 (en) 2017-01-05
EP3881833B1 (en) 2023-11-01
AU2022201067A1 (en) 2022-03-10
WO2017004122A1 (en) 2017-01-05
US20180116966A1 (en) 2018-05-03
BR112017028218A2 (pt) 2018-08-28
CN108135854A (zh) 2018-06-08
ES2871175T3 (es) 2021-10-28
HRP20240045T1 (hr) 2024-03-29
JP2023071769A (ja) 2023-05-23
CN114177157A (zh) 2022-03-15
ES2969014T3 (es) 2024-05-16
CA2987912C (en) 2023-01-24
KR20180021814A (ko) 2018-03-05
IL256299B1 (en) 2023-07-01
HK1254389A1 (zh) 2019-07-19
JP6914202B2 (ja) 2021-08-04
AU2016287422A1 (en) 2018-01-04
IL303352A (en) 2023-08-01
US20220339111A1 (en) 2022-10-27
CN108135854B (zh) 2022-03-11
PL3316867T3 (pl) 2021-10-11
TW201705944A (zh) 2017-02-16
JP2018519305A (ja) 2018-07-19
AR121624A2 (es) 2022-06-22
MX2017016163A (es) 2018-08-15
EP4272735A1 (en) 2023-11-08
JP2021138716A (ja) 2021-09-16

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