PE17302009A1 - Formulations comprising a DPP4 inhibitor - Google Patents

Formulations comprising a DPP4 inhibitor

Info

Publication number
PE17302009A1
PE17302009A1 PE0004782009A PE0004782009A PE17302009A1 PE 17302009 A1 PE17302009 A1 PE 17302009A1 PE 0004782009 A PE0004782009 A PE 0004782009A PE 0004782009 A PE0004782009 A PE 0004782009A PE 17302009 A1 PE17302009 A1 PE 17302009A1
Authority
PE
Peru
Prior art keywords
yl
methyl
dose
dpp4 inhibitor
ii
Prior art date
Application number
PE0004782009A
Other languages
Spanish (es)
Inventor
Thomas Friedl
Michael Braun
Kenji Egusa
Hikaru Fujita
Takaaki Nishioka
Megumi Maruyama
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
Priority to EP08154039 priority Critical
Priority to US8734308P priority
Application filed by Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int
Publication of PE17302009A1 publication Critical patent/PE17302009A1/en
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39714040&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE17302009(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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 TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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 TOILET 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
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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 TOILET 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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 TOILET 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
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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

Abstract

SE REFIERE A UNA COMPOSICION FARMACEUTICA QUE CONTIENE: A) UN INHIBIDOR DE DPP4 TAL COMO LA BASE LIBRE DE LA 1-[(4-METIL-QUINAZOLIN-2-IL)METIL]-3-METIL-7-(2-BUTIN-1-IL)-8-(3-(R)-AMINO-PIPERIDIN-1-IL)-XANTINA, VILDAGLIPTINA, SAXAGLIPTINA Y ALOGLIPTINA QUE SE ENCUENTRAN EN UNA DOSIS DE 0,5MG A 20MG; It refers to a pharmaceutical composition containing: a) DPP4 inhibitor AS THE FREE BASE 1 - [(4-METHYL-QUINAZOLIN-2-YL) METHYL] -3-METHYL-7- (2-BUTIN- 1-yl) -8- (3- (R) -amino-piperidin-1-yl) -xanthine, vildagliptin, saxagliptin and alogliptin FOUND IN A DOSE OF A 20MG 0.5mg; B) UN FARMACO ACOMPANANTE TAL COMO i) BIGUANIDAS TAL COMO CLORHIDRATO DE METFORMINA EN UNA DOSIS DE 100MG A 1500MG, ii) TIAZOLIDINONAS TAL COMO CLORHIDRATO DE PIOGLITAZONA, iii) ESTATINAS TAL COMO ATORVASTATINA, E iv) ANTAGONISTAS DEL RECEPTOR DE ANGIOTENSINA II TAL COMO TELMISARTAN; B) a drug ACCOMPANYING AS i) biguanides AS metformin hydrochloride at a dose of 100mg a 1500mg, ii) thiazolidinones AS pioglitazone hydrochloride, iii) Statins AS atorvastatin, E iv) receptor antagonists Angiotensin II AS TELMISARTAN; C) UNA SUSTANCIA TAMPONANTE QUE ES UN AMINOACIDO BASICO TAL COMO L-ARGININA EN UNA CANTIDAD DE 1MG A 50MG, L-LISINA Y L-HISTIDINA; C) a substance buffering an amino acid AS BASIC L-Arginine IN AN AMOUNT 1mg 50mg, L-lysine and L-histidine; YD) EXCIPIENTES SELECCIONADOS DE ALMIDON DE MAIZ COMO RELLENO, ESTEARATO DE MAGNESIO COMO LUBRICANTE Y SILICE ANHIDRO COLOIDAL COMO DESLIZANTE. YD) excipients selected from corn starch as filler, magnesium stearate as a lubricant and colloidal anhydrous silica as a glidant. DICHA COMPOSICION ES UTIL PARA EL TRATAMIENTO DE LA DIABETES TIPO 1 O 2, ARTRITIS REUMATOIDE, OBESIDAD, OSTEOPOROSIS Said composition is useful for the treatment of type 1 or 2 diabetes, rheumatoid arthritis, obesity, osteoporosis
PE0004782009A 2008-04-03 2009-04-01 Formulations comprising a DPP4 inhibitor PE17302009A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP08154039 2008-04-03
US8734308P true 2008-08-08 2008-08-08

Publications (1)

Publication Number Publication Date
PE17302009A1 true PE17302009A1 (en) 2009-12-10

Family

ID=39714040

Family Applications (2)

Application Number Title Priority Date Filing Date
PE0004782009A PE17302009A1 (en) 2008-04-03 2009-04-01 Formulations comprising a DPP4 inhibitor
PE0023972013A PE09602014A1 (en) 2008-04-03 2009-04-01 Formulations comprising a DPP4 inhibitor

Family Applications After (1)

Application Number Title Priority Date Filing Date
PE0023972013A PE09602014A1 (en) 2008-04-03 2009-04-01 Formulations comprising a DPP4 inhibitor

Country Status (26)

Country Link
US (5) US9155705B2 (en)
EP (2) EP3453403A1 (en)
JP (2) JP5588428B2 (en)
KR (3) KR20170056021A (en)
CN (3) CN101983073B (en)
AR (1) AR071175A1 (en)
AU (1) AU2009232043B2 (en)
BR (1) BRPI0911273B1 (en)
CA (1) CA2720450C (en)
CO (1) CO6251277A2 (en)
DK (1) DK2285410T3 (en)
EA (2) EA201300121A1 (en)
EC (1) ECSP10010489A (en)
ES (1) ES2696124T3 (en)
HK (1) HK1149485A1 (en)
IL (2) IL207497D0 (en)
MA (1) MA32200B1 (en)
MX (2) MX2010010819A (en)
NZ (1) NZ587747A (en)
PE (2) PE17302009A1 (en)
PL (1) PL2285410T3 (en)
TW (2) TWI527816B (en)
UA (1) UA104136C2 (en)
UY (1) UY31747A (en)
WO (1) WO2009121945A2 (en)
ZA (1) ZA201005664B (en)

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