HUE029853T2 - 1-(béta-D-Glükopiranozil)-2-tienilmetilbenzol-származékokat SGLT inhibitoraiként tartalmazó gyógyászati formulációk - Google Patents

1-(béta-D-Glükopiranozil)-2-tienilmetilbenzol-származékokat SGLT inhibitoraiként tartalmazó gyógyászati formulációk Download PDF

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HUE029853T2
HUE029853T2 HUE11721616A HUE11721616A HUE029853T2 HU E029853 T2 HUE029853 T2 HU E029853T2 HU E11721616 A HUE11721616 A HU E11721616A HU E11721616 A HUE11721616 A HU E11721616A HU E029853 T2 HUE029853 T2 HU E029853T2
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Wenhua Wang
Todd Outwin
Thomas C Joseph
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Janssen Pharmaceutica Nv
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    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/381—Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004—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
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    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic 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
    • 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
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
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    • A—HUMAN NECESSITIES
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D409/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms
    • C07D409/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing two hetero rings
    • C07D409/10—Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing two hetero rings linked by a carbon chain containing aromatic rings

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Claims (9)

  1. Szabadakirl tgóeygeslok !, Orálisa« he&dhstlé gyógyászati ibsTxaláeiO, assay íaruaxwxs s kovsske/bkel (=5 5 ; i ; kópleiÜ Vïïuy ak:ï akot
    R: jelcstivs« haiogéa vagy C;.*aiki:l-csoposx:; vs IO jelvstfev le«i, akad a Imii adod esetbe« szskszlhtsâk: 03 szsbsziíisesssei a következek átköti;* csapódból v«b:e.z;sa h&ksgés, claiisesoyorg V : yakllcseporr, kaOgéz-OeybkilvsopiMt, Cs..f:slkoíd~ csapod:. hídogós-Ü^oíkísOcsapon:. eiediOtuiloO-csoges'k etOéooxI-cxaporg moso-C^alki- vagy ds~ C ;. «0 k ; i a ;« = oo -c xepo ; t, k&rbarsodcso-xxi: és extso-C: .:;alkls- vagy dkCs^sikd -karbasiiail-csopöri; akid: a kdogés kiby bret«, jód vagy feo*;. vagy gyégyászobiag ehagadhíaó sida; (b) lagndszer vagy OlíOansxg, sssdy ssxtalsezcza okkraknsialyas vvtkbáz és lakiOz fcorohloselöjki; le) legalább agy szétesés): clésegbo szeg amsly íarislmsz kms^mméíás-mxíismm: lé) legalább egy koáöaayag, asítely tartalmai kfdmxípmpp-eAdözí; és (s) legalább egy kesőasyag, .amely ;;akal:a*aa. aaagséaisavíS'-saaegeáíXíg ahol a a (I) kvpkiö vegy tavi 1 -80 sexscgO isrtornáeyeo belüli raeenyiscgbes) var= jeles; a b lakás ver vstgy Sőhaa-ayag 1= 13-95 iö85eg%: iad'oeA-sY·«; belob bsetsoyiaégfeos van Idea. a széfóSásí elbsegbd see? $,,1.-2.0 tötoegO mtmœktiptm belbb œe&sÿlsèjgfeea va« jeksx s koiôasyag 0 J-20 dsseg'-z amonsásvas keleti sncsxsysxégkes vss jelen; és a kettbsnyng 0,1-5 tömeg% tartományon öebiii smxmsy Regben vsa jelen, mindegyik hmb Mb«eg% a mf!Tsalác=6 axsmgere vonstkozanob:.
  2. 2, Az !.. igéaypoví széria) : gyógyászati kaszámé·);.·, aboi a fogáószer vagy tölldaay&g 30-50 dis;eg% tariogsásyon belob srmsioyiségbeo van jelen.
  3. 3, Az I. nyétsyposl: saerinii gyógyászait kéczhrnény, ahol az = 1} képiek) vegyidet =10-00 tönrngA ;sr1:ovsáoyas ndatl mermvhcgkc« vanjelen.
  4. 4, Az le Igénypert- sxvrhX: gyógyászati készltosény, ahol: síz II) képlet a vegyibe· l-(p-i>-glOkopl-z;x?zl:s)- 4-íae:0b-3-|;5'|A”ií:5i5rfetbt}-2-;ie!sii:a5eljl]be8ZOI); vagy gyógy sbzablag elíógaétssuó sóba 5, A 4, Igéé) posa szánod ζκχο ászad készítmény, ekoln vagyaim 25-όθΟ argnsennylségba;) va·) jeles., 0. à 4. Igénypont szened gyógyászod készlterény:. nhoi & v egy aies 50-3()0 sag mennyiségbe;) t as) selva Τ. Λ 4. igemgeak rhu; gyógyászai:; készksnévg, ahoi a vegyi; ;e; = öí? mg; messyixégbeti: vats lekm. S. A 4. Igen y posy azaieais gyógyászai! kászamény, alia! a vegyibe! 30(1 sag tiseiitiylxegbeii vats jekus,
  5. 9. Az !. igóssypoisi xzsbtill gybgyszzab kászámessy, allai a vegysllet 1'(^kl>-g!liköj>íyaíiaas!}^'S'saty~3~iS·' (44l«orfcay}'2-yKaíyniyaybc:$yas}y;tóaahu!:'áí. Kb A 4. igesgyneu szériád gyógyásza« keszüascüv Mbiomöiggö glslkóAsmiszporse·· Kiadják ívnkelieüesseg ke/s ubbc szolgáié eljárásba«: kktédj alkalKsazásra,
  6. 11. A Ki. sgéayixe';: szabói; gyógyászai:; készüoséssy, aha! a vágyásai 50-300 mg dózsxbas asgixiia sgyxzei' beadok. 12. A 10, igáfsypíXíi szabói! liyógyászsli kásalboéoy, ahol a vagyaiét H)0 mg doaisb&o aapossia beadott.
  7. 13. A ió. igskiypeai szabói! gyógyászai! kes/ksoibsy. aboi a vegyOlsi 380 mg dózisban naposba beadod.
  8. 14. Az i. sgb®y|x>x; szeiiod arakyas keaOteè gyógyásza« Sbmsoiádó, amely a kovetke zsákéi tabidioazza: (a) igbd j-g!akxpx;xsázbjd ar!átri^V-pA4-3:k!öfleak}4>--;;m'!Í;a'sei:i;k:íazy·;;. vagy gy Agyas zablag eiibgsísisaió séia, ssmby 40-AÓ sösoegsó iaztomèsiysm belüli omxssyisiigheo vsa jele«; lb) «sgäoszer vagy sohóaoysg. ao'sefy osrioisnazza osikKïkbslàsy-x oeilolOz ós iák sóz kossbioáelbját, és aoseiy .30-50 IAi«gg% labeoigtiyon beislli ;«emsy;segbeo vasijaié«; (c) legalább egy xzóiesési döxegOA szer 3-11) sAioegbk ;anm««nyon bdilii meooy bégbe«; (dylegalább ágy IcAiAiigyag, amely kk.5-5 tömeg*» sanoixiitiyoa belüli ü>e«ny;ságben vess jele«; es (e) legalább agy kesdaoyag, asaely 0,5-2 sAioegsÓ latbetoágyois belbli «setmyisègbe« vaa sebe: abas a ;Ameg% a sóimeláem Kaxegère vissaikoKiatosí. 15. A :4 Igánypeai szedőd gvóeyaszab kósziismmy. allai a vegyikéi s-{lbl>-gibk<>pira?ioz· 1)-4-iíiaiil-5-{5--{4.-t!a;)il;íaü)--2-lieo;ais*;41;xasaisO-bes'!aisidcá!.
  9. 16. Az s-15. sgéiiypissiisik báíxielylke aaebsbl gyógyászati kószáméiig, ahol a form«iádó tabletta.
HUE11721616A 2010-05-11 2011-05-11 1-(béta-D-Glükopiranozil)-2-tienilmetilbenzol-származékokat SGLT inhibitoraiként tartalmazó gyógyászati formulációk HUE029853T2 (hu)

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KR (1) KR101931209B1 (hu)
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UA105480C2 (uk) * 2007-09-10 2014-05-26 Янссен Фармацевтика Н.В. Спосіб одержання сполук, які застосовують як інгібітори натрійзалежного переносника глюкози
US9056850B2 (en) * 2008-10-17 2015-06-16 Janssen Pharmaceutica N.V. Process for the preparation of compounds useful as inhibitors of SGLT
US20110009347A1 (en) * 2009-07-08 2011-01-13 Yin Liang Combination therapy for the treatment of diabetes
EA022186B1 (ru) 2009-07-10 2015-11-30 Янссен Фармацевтика Нв СПОСОБ КРИСТАЛЛИЗАЦИИ 1-(β-D-ГЛЮКОПИРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНИЛ)-2-ТИЕНИЛМЕТИЛ]БЕНЗОЛА
DK2488515T3 (en) * 2009-10-14 2017-02-27 Janssen Pharmaceutica Nv PROCEDURE FOR THE PREPARATION OF COMPOUNDS USED AS INHIBITORS OF SGLT2
HUE029853T2 (hu) 2010-05-11 2017-04-28 Janssen Pharmaceutica Nv 1-(béta-D-Glükopiranozil)-2-tienilmetilbenzol-származékokat SGLT inhibitoraiként tartalmazó gyógyászati formulációk
CA2832938C (en) 2011-04-13 2019-09-03 Janssen Pharmaceutica Nv Process for the preparation of compounds useful as inhibitors of sglt2
US9035044B2 (en) 2011-05-09 2015-05-19 Janssen Pharmaceutica Nv L-proline and citric acid co-crystals of (2S, 3R, 4R, 5S,6R)-2-(3-((5-(4-fluorophenyl)thiopen-2-yl)methyl)4-methylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
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