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HRP20170400T1 - Farmaceutski sastav, farmaceutski dozni oblik, postupak za njihovu proizvodnju, postupci za liječenje i njihove uporabe - Google Patents

Farmaceutski sastav, farmaceutski dozni oblik, postupak za njihovu proizvodnju, postupci za liječenje i njihove uporabe Download PDF

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Publication number
HRP20170400T1
HRP20170400T1 HRP20170400TT HRP20170400T HRP20170400T1 HR P20170400 T1 HRP20170400 T1 HR P20170400T1 HR P20170400T T HRP20170400T T HR P20170400TT HR P20170400 T HRP20170400 T HR P20170400T HR P20170400 T1 HRP20170400 T1 HR P20170400T1
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pharmaceutical composition
filler
composition according
obesity
glucose
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HRP20170400TT
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Peter Schneider
Wolfram Eisenreich
Nantharat Pearnchob
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Boehringer Ingelheim International Gmbh
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Publication of HRP20170400T1 publication Critical patent/HRP20170400T1/hr

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    • A—HUMAN NECESSITIES
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    • 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
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
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    • 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
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered 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
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    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
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    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
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    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
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    • 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
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Claims (13)

1. Kruti farmaceutski sastav, naznačen time, da obuhvaća SGLT-2-inhibitor 1-kloro-4-(β-D-glukopiranoz-1-il)-2-[4-((S)-tetrahidrofuran-3-iloksi)-benzil]-benzen, metformin-hidroklorid i jedno ili više farmaceutskih pomoćnih sredstava, pri čemu je SGLT-2-inhibitor prisutan u jačini doze od 5 mg ili 12,5 mg, i gdje je metformin-hidroklorid prisutan u jačini doze od 500 mg, 850 mg ili 1000 mg, i pritom kruti farmaceutski sastav obuhvaća kopovidon kao vezivno sredstvo.
2. Farmaceutski sastav prema zahtjevu 1, naznačen time, da su pomoćna sredstva odabrana iz skupine koja se sastoji od jednog ili više punila uključujući mikrokristalnu celulozu, D-manitol, kukuruzni škrob i predželatinizirani škrob; vezivno sredstvo koje uključuje kopovidon; mazivo koje uključuje magnezijev stearat ili natrijev stearil-fumarat; te klizno sredstvo koje uključuje koloidni bezvodni silicijev dioksid.
3. Farmaceutski sastav prema zahtjevu 2, naznačen time, da nadalje obuhvaća jedno ili više od sljedećih sredstava: punilo kukuruzni škrob, mazivo magnezijev stearat ili natrijev stearil-fumarat i klizno sredstvo koloidni bezvodni silicijev dioksid.
4. Farmaceutski sastav prema zahtjevu 2, naznačen time, da nadalje obuhvaća jedno ili više od sljedećih sredstava: punilo mikrokristalna celuloza, mazivo magnezijev stearat ili natrijev stearil-fumarat i klizno sredstvo koloidni bezvodni silicijev dioksid.
5. Kruti farmaceutski sastav prema jednom ili više od prethodnih zahtjeva, naznačen time, da obuhvaća jednu ili više od sljedećih količina (maseni postotak prema ukupnoj masi obložene tablete): 0,1-2,11 % SGLT-2-inhibitor, 47-88 % metformin HCl, 3,9-8,3 % vezivno sredstvo (npr. kopovidon), 2,3-8,0 % punilo 1 (npr. kukuruzni škrob), 0-4,4 % punilo 2 (npr. predželatinizirani škrob), 0-33 % punilo 3 (npr. D-manitol), 0,7-1,5 % mazivo (npr. magnezijev stearat), 0,05-0,5 % klizno sredstvo (npr. koloidni bezvodni silicijev dioksid), 0,00-3,0 % dezintegrator (npr. krospovidon ili kroskarmeloza-natrij).
6. Kruti farmaceutski sastav prema jednom ili više od prethodnih zahtjeva, naznačen time, da obuhvaća jednu ili više od sljedećih količina (maseni postotak prema ukupnoj masi obložene tablete): 0,1-2,11 % SGLT-2-inhibitor, 47-88 % metformin HCl, 3,9-8,3 % kopovidon kao vezivno sredstvo, 2,3-8,0 % kukuruzni škrob kao punilo, 0-4,4 % predželatinizirani škrob kao punilo, 0-33 % D-manitol kao punilo, 0,7-1,5 % magnezijev stearat kao mazivo, 0,05-0,5 % koloidni bezvodni silicijev dioksid kao klizno sredstvo, 0,00-3,0 % krospovidon ili kroskarmeloza-natrij kao dezintegrator.
7. Farmaceutski sastav prema bilo kojem od zahtjeva 1 do 6, naznačen time, da se nalazi u tableti kao doznom obliku.
8. Farmaceutski dozni oblik koji obuhvaća farmaceutski sastav prema jednom ili više od zahtjeva 1 do 7, naznačen time, da predstavlja kruti farmaceutski dozni oblik te da je to kapsula ili tableta.
9. Farmaceutski sastav prema bilo kojem od zahtjeva 1 do 7, naznačen time, da se upotrebljava za sljedeće: - prevencija, usporavanje njegove progresije, odgađanje ili liječenje metaboličkog poremećaja odabranog iz skupine koju čine: dijabetes melitus tipa 1, dijabetes melitus tipa 2, oslabljena tolerancija na glukozu, pogoršana glukoza u krvi natašte, hiperglikemija, reaktivna hiperglikemija, prekomjerna težina, pretilost i metabolički sindrom; ili - poboljšanje glikemijske kontrole i/ili za smanjenje glukoze u plazmi natašte, od reaktivne glukoze u plazmi i/ili od glikoziliranog hemoglobina HbA1c; ili - prevencija, usporavanje, odgađanje ili ukidanje progresije smanjene tolerancije na glukozu, otpornosti na inzulin i/ili od metaboličkog sindroma do dijabetesa melitus tipa 2; ili - prevencija, usporavanje njegove progresije, odgađanje ili liječenje stanja ili poremećaja odabranog iz skupine koju čine: komplikacije kod dijabetesa melitus, kao što su katarakti i mikrovaskularne i makrovaskularne bolesti, kao što je nefropatija, retinopatija, neuropatija, ishemija tkiva, arterioskleroza, infarkt miokarda, moždani udar i okluzivna bolest perifernih arterija; ili - prevencija, usporavanje, odgađanje ili liječenje degeneracije beta stanica pankreasa i/ili odstranjivanja funkcionalnosti beta stanica pankreasa i/ili za poboljšanje i/ili ponovno uspostavljanje funkcionalnosti beta stanica pankreasa i/ili ponovno uspostavljanje funkcionalnosti sekrecije inzulina pankreasa; ili - prevencija, usporavanje, odgađanje ili liječenje bolesti ili stanja, koja se pripisuju abnormalnoj akumulaciji masti u jetri; ili - održavanje i/ili poboljšanje osjetljivosti na inzulin i/ili liječenje ili prevencija hiperinzulinemije i/ili otpornosti na inzulin; za pacijenta kojemu je to potrebno.
10. Farmaceutski sastav za uporabu prema zahtjevu 9, naznačen time, da je pacijent pojedinac kojemu je dijagnosticirano jedno ili više stanja odabranih iz skupine koju čine: prekomjerna težina, pretilost, organska pretilost i abdominalna pretilost.
11. Farmaceutski sastav za uporabu prema zahtjevu 9, naznačen time, da je pacijent pojedinac kod kojega se pokazuje jedno, dva ili više sljedećih stanja: (a) koncentracija glukoze u krvi natašte ili glukoze u serumu, koja je veća od 110 mg/dL, posebno je veća od 125 mg/dL; (b) reaktivna glukoza u plazmi je jednaka ili veća od 140 mg/dL; (c) vrijednost HbA1c je jednaka ili veća od 6,5%, posebno jednaka ili veća od 7,0%.
12. Farmaceutski sastav za uporabu prema zahtjevu 9, naznačen time, da je pacijent pojedinac kod kojega su prisutna jedno, dva ili više sljedećih stanja: (a) pretilost, organska pretilost i/ili abdominalna pretilost; (b) razina triglicerida u krvi ≥ 150 mg/dL; (c) razina HDL-kolesterola u krvi < 40 mg/dL kod ženskih pacijenata i < 50 mg/dL kod muških pacijenata; (d) sistolički krvni tlak ≥ 130 mm Hg i dijastolički krvni tlak ≥ 85 mm Hg; (e) razina glukoze u krvi natašte ≥ 110 mg/dL.
13. Farmaceutski sastav za uporabu prema zahtjevu 9, naznačen time, da pacijent ima nedovoljnu glikemijsku kontrolu usprkos posebnoj prehrani i tjelovježbi ili usprkos monoterapiji s antidijabetičkim sredstvom, posebno s metforminom.
HRP20170400TT 2009-10-02 2010-10-01 Farmaceutski sastav, farmaceutski dozni oblik, postupak za njihovu proizvodnju, postupci za liječenje i njihove uporabe HRP20170400T1 (hr)

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Application Number Priority Date Filing Date Title
EP09172081 2009-10-02
EP10759923.5A EP2482806B1 (en) 2009-10-02 2010-10-01 Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
PCT/EP2010/064619 WO2011039337A1 (en) 2009-10-02 2010-10-01 Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof

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HRP20170400T1 true HRP20170400T1 (hr) 2017-05-19

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HRP20240752TT HRP20240752T1 (hr) 2009-10-02 2010-10-01 Postupak za proizvodnju tablete koja sadrži sglt-2 inhibitor i metformin
HRP20170400TT HRP20170400T1 (hr) 2009-10-02 2010-10-01 Farmaceutski sastav, farmaceutski dozni oblik, postupak za njihovu proizvodnju, postupci za liječenje i njihove uporabe

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HRP20240752TT HRP20240752T1 (hr) 2009-10-02 2010-10-01 Postupak za proizvodnju tablete koja sadrži sglt-2 inhibitor i metformin

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US (3) US10610489B2 (hr)
EP (3) EP3150200B1 (hr)
JP (1) JP5738300B2 (hr)
KR (1) KR101747152B1 (hr)
CN (2) CN104873974A (hr)
AP (1) AP3438A (hr)
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AU (1) AU2010302641B2 (hr)
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