AR075423A1 - Composicion farmaceutica que comprende un inhibidor de sglt-2, forma farmaceutica, procedimiento para su preparacion, metodos de tratamiento y sus usos - Google Patents

Composicion farmaceutica que comprende un inhibidor de sglt-2, forma farmaceutica, procedimiento para su preparacion, metodos de tratamiento y sus usos

Info

Publication number
AR075423A1
AR075423A1 ARP100100420A ARP100100420A AR075423A1 AR 075423 A1 AR075423 A1 AR 075423A1 AR P100100420 A ARP100100420 A AR P100100420A AR P100100420 A ARP100100420 A AR P100100420A AR 075423 A1 AR075423 A1 AR 075423A1
Authority
AR
Argentina
Prior art keywords
nmoles
auc0
cmax
inf
dose
Prior art date
Application number
ARP100100420A
Other languages
English (en)
Inventor
Nadia S Ladyzhynsky
Danping Li
Zeren Wang
Leon Schultz
Sreeraj Macha
Albert Barta
Wolfram Eisenreich
Original Assignee
Boehringer Ingelheim Int
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=42078871&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR075423(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int
Publication of AR075423A1 publication Critical patent/AR075423A1/es

Links

Classifications

    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • A61K31/431—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/351—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom not condensed with another ring
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • A61K9/2095—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Abstract

Reivindicacion 1: Una composicion farmacéutica caracterizada porque comprende un compuesto de la formula (1) que cuando se administra a un ser humano en ayunas: a) en una dosis de 2,5 mg presenta i) una Cmáx de 40,3 a 96,3 nmoles/l y ii) una AUC0-inf de 283 a 677 nmoIes*h/l o b) en una dosis de 5,0 mg presenta: i) una Cmáx de 123 a 230 nmoles/l y ii) una AUC0-inf de 1.000 a 1.310 nmoles*h/l o c) en una dosis de 10,0 mg presenta: i) una Cmáx de 143 a 796 nmoles/l y ii) una AUC0-inf de 1.170 a 3.190 nmoles*h/l o d) en una dosis de 25,0 mg presenta: i) una Cmáx de 334 a 1.030 nmoles/l y ii) una AUC0-inf de 2.660 a 7.640 nmoles*h/I o e) en una dosis de 50,0 mg presenta: i) una Cmáx de 722 a 2.020 nmoles/l y ii) una AUC0-inf de 6.450 a 14.100 nmoles*h/l. Reivindicacion 15: Un método de tratamiento de un trastorno metabolico, en particular para mejorar el control glucémico de un paciente, caracterizado porque comprende administrar a un paciente una composicion segun una cualquiera de las reivindicaciones 1 a 12 o una forma farmacéutica segun la reivindicacion 13 o 14.
ARP100100420A 2009-02-13 2010-02-12 Composicion farmaceutica que comprende un inhibidor de sglt-2, forma farmaceutica, procedimiento para su preparacion, metodos de tratamiento y sus usos AR075423A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15231709P 2009-02-13 2009-02-13
US25403309P 2009-10-22 2009-10-22

Publications (1)

Publication Number Publication Date
AR075423A1 true AR075423A1 (es) 2011-03-30

Family

ID=42078871

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP100100420A AR075423A1 (es) 2009-02-13 2010-02-12 Composicion farmaceutica que comprende un inhibidor de sglt-2, forma farmaceutica, procedimiento para su preparacion, metodos de tratamiento y sus usos

Country Status (31)

Country Link
US (3) US20110014284A1 (es)
EP (2) EP2395968B1 (es)
JP (1) JP5600328B2 (es)
KR (3) KR101921934B1 (es)
CN (2) CN102387783A (es)
AP (1) AP2011005780A0 (es)
AR (1) AR075423A1 (es)
AU (1) AU2010212868B2 (es)
BR (1) BRPI1013638A2 (es)
CA (1) CA2752435C (es)
CL (1) CL2011001966A1 (es)
CO (1) CO6410279A2 (es)
DK (1) DK2395968T3 (es)
EA (1) EA024072B1 (es)
EC (1) ECSP11011278A (es)
FI (1) FI2395968T3 (es)
GE (1) GEP20146145B (es)
IL (1) IL213722A0 (es)
LT (1) LT2395968T (es)
MA (1) MA33044B1 (es)
MX (1) MX345494B (es)
NZ (1) NZ594024A (es)
PE (1) PE20120250A1 (es)
PT (1) PT2395968T (es)
RS (1) RS65252B1 (es)
SG (1) SG173032A1 (es)
TN (1) TN2011000416A1 (es)
TW (1) TWI471320B (es)
UA (1) UA105033C2 (es)
UY (1) UY32456A (es)
WO (1) WO2010092126A1 (es)

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