AR078499A1 - Composiciones de corticosteroides de administracion oral - Google Patents

Composiciones de corticosteroides de administracion oral

Info

Publication number
AR078499A1
AR078499A1 ARP100103589A ARP100103589A AR078499A1 AR 078499 A1 AR078499 A1 AR 078499A1 AR P100103589 A ARP100103589 A AR P100103589A AR P100103589 A ARP100103589 A AR P100103589A AR 078499 A1 AR078499 A1 AR 078499A1
Authority
AR
Argentina
Prior art keywords
pharmaceutical composition
solid pharmaceutical
corticosteroid
copolymers
acid
Prior art date
Application number
ARP100103589A
Other languages
English (en)
Inventor
Gopi M Venkatesh
Stephen Perrett
Fred Cohen
Original Assignee
Eurand 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43823361&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR078499(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Eurand Inc filed Critical Eurand Inc
Publication of AR078499A1 publication Critical patent/AR078499A1/es

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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P31/04—Antibacterial agents
    • 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
    • A61P31/10—Antimycotics
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

Abstract

Composiciones de corticosteroides de administracion oral. Método para tratar una afeccion asociada con la inflamacion del tracto gastrointestinal en un individuo. El método comprende administrarle al individuo que lo necesita una composicion farmacéutica de la presente. Reivindicacion 1: Una composicion farmacéutica solida caracterizada porque comprende 20 mg o menos de un corticosteroide, donde la composicion no presenta una actividad sistémica significativa como glucocorticoide o como mineralocorticoide después de una administracion oral, donde la composicion farmacéutica solida se desintegra en 60 segundos en un fluido de saliva simulada cuando se la evalua usando la prueba de desintegracion de la USP . Reivindicacion 3: La composicion farmacéutica solida de la reivindicacion 1, caracterizada porque dicho corticosteroide se selecciona del grupo que consiste en la budesonida, la fluticasona, la flunisolida, la ciclesonida, la mometasona, la beclometasona y sales, solvatos y ésteres de éstas. Reivindicacion 4: La composicion farmacéutica solida de la reivindicacion 1, caracterizada porque también comprende un agente adhesivo. Reivindicacion 5: La composicion farmacéutica solida de la reivindicacion 4, caracterizada porque el agente adhesivo se selecciona del grupo que consiste en el complejo de sulfato de aluminio y sacarosa, el quitosán y sus derivados, la polivinilpirrolidona, la metilcelulosa, la carboximetilcelulosa de sodio, la hidroxipropil celulosa, los poliacrilatos entrecruzados o no entrecruzados, los poliacrilatos entrecruzados, los poliacrilatos ácidos entrecruzados o no entrecruzados, los homopolímeros o los copolímeros de ácido poliacrílico, los copolímeros de metacrilato de aminoalquilo, los copolímeros de ácido metacrílico y metacrilato de metilo, los copolímeros de acrilato de alquilo y metacrilato de alquilo, los copolímeros de metacrilato de amonio, los homopolímeros o los copolímeros de carbomero, las gomas basadas en polisacáridos hidrofílicos, las maltodextrinas, los geles de goma de alginato entrecruzada, los polímeros de vinilo policarboxilado, las pectinas, las gomas xantana, el ácido algínico, los ácidos algínicos modificados y combinaciones de éstos. Reivindicacion 6: La composicion farmacéutica solida de la reivindicacion 1, caracterizada porque también comprende un desintegrante seleccionado del grupo que consiste en la crospovidona, el glicolato de almidon de sodio, la carboximetil celulosa entrecruzada, la hidroxilpropilcelulosa con un grado de sustitucion bajo, el manitol, el xilitol, el sorbitol, el maltol, el maltitol, la lactosa, la sacarosa, la maltosa y combinaciones de éstos. Reivindicacion 9: La composicion farmacéutica solida de la reivindicacion 1, caracterizada porque también comprende al menos un agente antifungico. Reivindicacion 12: La composicion farmacéutica solida de la reivindicacion 1, caracterizada porque también comprende al menos un agente antiviral. Reivindicacion 15: La composicion farmacéutica de la reivindicacion 1, caracterizada porque la composicion farmacéutica toma la forma de una tableta de desintegracion oral (ODT). Reivindicacion 16: La composicion farmacéutica de la reivindicacion 15, caracterizada porque la ODT comprende las partículas de la droga y gránulos de dispersion rápida, donde las partículas de la droga comprenden el corticosteroide y los gránulos de dispersion rápida comprenden un desintegrante y un alcohol de azucar y/o un sacárido. Reivindicacion 35: Una composicion farmacéutica líquida sustancialmente no acuosa caracterizada porque comprende un corticosteroide y un líquido farmacéuticamente aceptable. Reivindicacion 42: La composicion farmacéutica líquida de la reivindicacion 35, caracterizada porque, después de la administracion al paciente, dicha composicion sufre un incremento en la viscosidad al tomar contacto con la mucosa del tracto gastrointestinal del paciente, donde el tiempo de residencia del corticosteroide en la mucosa del tracto intestinal es prolongado. Reivindicacion 46: La composicion farmacéutica líquida de la reivindicacion 39, caracterizada porque el agente de cambio de fase es un polímero seleccionado del grupo que consiste en la poli(N-isopropilacrilamida), el poli(etilenglicol-(DL-ácido láctico-co-ácido glicolico)-etilenglicol) y mezclas de éstos.
ARP100103589A 2009-10-01 2010-10-01 Composiciones de corticosteroides de administracion oral AR078499A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US24764209P 2009-10-01 2009-10-01

Publications (1)

Publication Number Publication Date
AR078499A1 true AR078499A1 (es) 2011-11-09

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ID=43823361

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP100103589A AR078499A1 (es) 2009-10-01 2010-10-01 Composiciones de corticosteroides de administracion oral

Country Status (35)

Country Link
US (8) US8771729B2 (es)
EP (4) EP3403654B1 (es)
JP (7) JP2013506683A (es)
KR (3) KR20150043548A (es)
CN (3) CN107252488A (es)
AR (1) AR078499A1 (es)
AU (1) AU2010300550B2 (es)
BR (2) BR122022005637B1 (es)
CA (3) CA3037273C (es)
CL (1) CL2012000794A1 (es)
CO (1) CO6531427A2 (es)
CY (1) CY1122713T1 (es)
DE (1) DE202010018594U1 (es)
DK (2) DK2482822T3 (es)
EA (2) EA031157B9 (es)
ES (2) ES2683864T3 (es)
GE (1) GEP20156281B (es)
HR (2) HRP20181266T1 (es)
HU (2) HUE040119T2 (es)
IL (2) IL218928A (es)
LT (2) LT2482822T (es)
ME (1) ME03471B (es)
MX (4) MX364947B (es)
MY (1) MY171317A (es)
NZ (2) NZ624922A (es)
PL (2) PL2482822T3 (es)
PT (2) PT2482822T (es)
RS (2) RS59241B1 (es)
SG (3) SG10201405886WA (es)
SI (2) SI3403654T1 (es)
TW (2) TWI594754B (es)
UA (2) UA108360C2 (es)
UY (1) UY32925A (es)
WO (1) WO2011041509A1 (es)
ZA (2) ZA201202208B (es)

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