HUE031227T2 - Száraz granulálási eljárás metformin tabletta kompozícióinak elõállítására és ennek kompozíciói - Google Patents

Száraz granulálási eljárás metformin tabletta kompozícióinak elõállítására és ennek kompozíciói Download PDF

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Publication number
HUE031227T2
HUE031227T2 HUE13834323A HUE13834323A HUE031227T2 HU E031227 T2 HUE031227 T2 HU E031227T2 HU E13834323 A HUE13834323 A HU E13834323A HU E13834323 A HUE13834323 A HU E13834323A HU E031227 T2 HUE031227 T2 HU E031227T2
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HU
Hungary
Prior art keywords
metformin
dpp
composition
inhibitor
vildagliptin
Prior art date
Application number
HUE13834323A
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English (en)
Inventor
Goezde Askar
Umut Oran
Naci Bitik
Mustafa Adiyaman
Original Assignee
Zentiva Saglik Ueruenleri San Ve Tic A S
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Application filed by Zentiva Saglik Ueruenleri San Ve Tic A S filed Critical Zentiva Saglik Ueruenleri San Ve Tic A S
Publication of HUE031227T2 publication Critical patent/HUE031227T2/hu

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    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/20—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
    • A61K9/2009—Inorganic compounds
    • 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
    • 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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/22—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by pressing in moulds or between rollers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (1)

  1. iisaag;?: gràÂalâlâïsi ei jásr-ks sgelŐíass&amp;áís kebléáia kofcpesicf ói sask élőéi k sasára ss® «anek keepessielől lk a t· sí its i :;;; i 1 g si sgasiSif i; if i i, til g si a s: a sgf 1 ! o asst a i: a® 1 sff : i a : k gasp &amp; s: i a ig:· 1 ms a a : i it! i Ilk: 3 ®a a 3 a , a sss at ;g a a a 1 a? la&amp;sass 3 as iakt i a :3.3 akai a® g à gâtags .ala fia I :¾ if! 3 ét a 1 fias;a 3 ég i a: Isa s: a; a; .·«,;, ., sasi s ai kaakifia:afii.!fss. sfaitgida kis viasaakkaa: ckifai·: IJags kailassist ásásaiét tifasméfté, I- M· 1,: a;aé:a!afaif.a saké 31 siti alikékiff saliaé ® áktfökélií.k^ f ai-ffi: ffaiff/a --.:. a " ,. a . a,. 1::. 1, .1¾ si saga a at massal aits élj ékéé* &amp;:1«1 -s s aatiarát téitéléééké· faiaaaáá aaa aéé-a iiikaifityja' ő.6kss&amp;őáéái a i;aaii>i kai aatî-ôï-asifi ójaat-ít a téti itiskaééráas i , 113--1 iiiiaitaiifaa a. .a: a a a ás a à a tő; iff a : i a 1 #aa t a at; .t ff a a ;; a ka éjit 1 a t i a, t a itt a a Hii a a c a égsa a t b é 1 ak isig ab jaak, t< a. a,; aáiaf. agiffift: ssaasa staffi éli érésa, gaa! a. 333--1 sbabilbitas; sí átlagsai tagg®, a.: aa ti > s/agaatafa;': ttia:aanaí >- : ; a · g g, ahai. a Sfaaa:faaa:iaa:ái. aasa aaiiaiáa őa 3é Sas® isis sgi- éttséaékfis bsflsssiass ta;sa is ?: >3ís:si3a:ista sis á g ásás g aa, a, sfaifi-aigts kíkísss-aalaiaa aáassly taia-sltiai .aa!aaaaa sisáéiaakéts;. aas ifaratia k i isiié téiaéiakikl: iss is a si assis a ksssi: élbiis á:bis3 káliai 3.3; isssaiaáss: kaseas: ka , à, ä 1. tfianfipiisa ífasrlsf s; 1 éfsapeiéleké·;. isisül s sassá: ;:arsas.ní Silasls kassáéi:. YUat y ίύΓ.ΥΓιΥο. Y a. ' YY' >. k, 1 lé :iiséfsisp:3iii: sasai ?á:bii;:i aassSsii'Sstais.és. gSíui isSSss SalsaSS tsflkibbá íSéé 333-1 fsaat^itifsa, iá, k k, I.gé;vjipöíáx: asssssIsffil klsísbgaséssá.a, sisal : ás s 3:3 sasi Sif 333-1 .33ifiifitSfal á: aiisfsati: t pfisList :j v! Icisisi'Lí,|f í: fifl: its ISsa igl. tif tftisi: t: a íSs;:f:lf:as::.::t; ifasfSfifs t tat·.;, :f is la.stfisisatf II·; í Is, Igkíiaffifif t ifass'tf;i:i assiasifaiísiks isisfl s sfäs-'t :ia:sii:ttfti:s?f a attfiasssttssf-iia,. SS yyy sayassy es SD; syy s; y bay.;: bibkyyy -.:¾ fos::;:: ybD: be yy:y::y:y;y aa: 7yyy<;el Df, ID, D 7, :; ::D::;VyK;®n;; eaerinti beaspyDyisyby·, shifi s Dsís®::-:D:;v::;;:::ÍD D« a tya Days y: k : : s á a Dá s®; y s: s® y t D DD s s syéei :s r; y-s y® t s s: s; es D b i -h k y 1s. 6.;: s y y s kse y, s y y. f y; y y « y; s .y y t y;;DDySÿ;st yayyity; ;y yeas:bee s yi iyaeytySsbab 7;,: eyb.yyyst: y LDsay i SeS yaDyas: y.yi: sysysyk boa ,· èskobbsk , y i:y:ebykiïbka .· kokasyy skkbyxsykbyyk \ yyk;ba:k:byy y yy: y. y yàx'yyx.y yyysyy y y, y yy y; : y , y.; .y y; : : y: ; y·; y yy y;®:-y y; y ..yyyyy y : : y> y. ·.:, :y ;yyy y yc y y; y. y y.;::.;, .y y: y y y y., T7 > y. .yb, kyéryyposxt y yyyylyy:: b byyyyoayky bb, si:®:;! a isabbesabsb yiyDDiysit y s; ses y: y y s y; y; 1 y y,b sas yy syy a y: syy L es. 1 s s y y ' ; yyk. ISO &amp; a yb a.syikiyvsyssab oyasSabsS: i bysisassabsykik, «bob s slk:os:bbbS: kso s byb.vbsb ;;1 i'bySDSbbb s; s oyyyyyby bsa:; s ab sa;: rkaasby, 7:¾y. yyoyy sassyyybSoSy < a a: ss;sy yyssyiye-yyy, yaks::;: y sa;; s;; S y-y;;: y i bxyyys :;yy S;pS., h .ba y yyysayyyasyyy: s iy-yLy; y ο>>1;κ s y y.> S: s.lkysssS. , ?yy 1 bois! bkybda^.lso·! SixlS; y; aty y; b .< kl. DD ssss; b y axOipyS baak k;bbbyy:yy:;xb sysea i yyyyy bxybÿbspksbyxb sbabb ;y ksksabyakobb
    Síi. Bas':®®!? “a-a-aJBiaá áaéáaaaenx ®:?κ a ;;n ti. kagayagli'i ft. alyl raga aaia: a xa:':paaxcí ;> χ 1áai x«as:.aaaa aát:s: a kB .'tv la^s :aíl.a:aBk BOB· "aia Beik :':\ ϊ -, iBOB yy :¾¾ íiyxaai á;y Oi :ygt áa áyk ág ká.C; "kg' yiákágBixp;: gá; akik’B'i áaágiyáík xia a i y agayy i y :éá ai a a..];. ásás Î .a :1 k .# gy k i: ál g 1: á á k B® á ,
HUE13834323A 2012-12-27 2013-12-17 Száraz granulálási eljárás metformin tabletta kompozícióinak elõállítására és ennek kompozíciói HUE031227T2 (hu)

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Application Number Priority Date Filing Date Title
TR201215479 2012-12-27

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HUE031227T2 true HUE031227T2 (hu) 2017-07-28

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HUE13834323A HUE031227T2 (hu) 2012-12-27 2013-12-17 Száraz granulálási eljárás metformin tabletta kompozícióinak elõállítására és ennek kompozíciói

Country Status (8)

Country Link
EP (1) EP2938362B1 (hu)
ES (1) ES2617522T3 (hu)
HU (1) HUE031227T2 (hu)
MX (1) MX2015008427A (hu)
PL (1) PL2938362T3 (hu)
PT (1) PT2938362T (hu)
RU (1) RU2647421C2 (hu)
WO (1) WO2014101986A1 (hu)

Families Citing this family (18)

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Publication number Priority date Publication date Assignee Title
CN105769796B (zh) * 2016-05-04 2019-06-04 杭州百诚医药科技股份有限公司 一种含有维格列汀和盐酸二甲双胍的药物制剂及其制备方法
ES2946233T3 (es) 2016-09-16 2023-07-14 Galenicum Health S L U Composiciones farmacéuticas de vildagliptina
GR1009644B (el) * 2018-09-25 2019-11-12 Φαρματεν Α.Β.Ε.Ε. Φαρμακευτικο σκευασμα που περιλαμβανει βιλνταγλιπτινη και μετφορμινη και μεθοδος για την παρασκευη αυτου
JP7376582B2 (ja) * 2018-10-22 2023-11-08 イーオーイー オレオ ゲーエムベーハー 成形体への圧縮を目的とした粉末材料用添加剤
WO2020098904A1 (en) * 2018-11-12 2020-05-22 Pharmaceutical Oriented Services Ltd Dosage form containing metformin and a dipeptidyl peptidase iv inhibitor
CN110051685A (zh) * 2019-03-13 2019-07-26 安庆瑄宇医药科技有限公司 一种维达列汀降糖咀嚼片及其制备方法
EP3982934A1 (en) * 2019-06-17 2022-04-20 DSM IP Assets B.V. Pharmaceutical dosage form comprising metformin and calcium citrate
CN114025745A (zh) 2019-06-17 2022-02-08 帝斯曼知识产权资产管理有限公司 包含盐酸二甲双胍、维生素b12和至少一种流动助剂的组合物
WO2020254401A1 (en) 2019-06-17 2020-12-24 Dsm Ip Assets B.V. Extended-release solid oral dosage form comprising vitamin b12 and a vitamin b12 depleting drug
TR201913472A2 (tr) * 2019-09-06 2021-03-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Vi̇ldagli̇pti̇n ve metformi̇n i̇çeren bi̇r kombi̇nasyon
GB2595203A (en) * 2020-03-03 2021-11-24 Alkaloid Ad Skopje Formulation
JP2023522247A (ja) * 2020-04-24 2023-05-29 アストラゼネカ・アクチエボラーグ 医薬製剤
TR202009949A1 (tr) * 2020-06-25 2022-01-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Vi̇ldagli̇pti̇n ve metformi̇n hci i̇çeren bi̇r fi̇lm kapli tablet
CN114306267A (zh) * 2020-09-30 2022-04-12 深圳翰宇药业股份有限公司 一种西格列汀二甲双胍片制剂及其制备方法
CN112999167B (zh) * 2021-03-01 2023-05-02 安徽九华华源药业有限公司 人参子速释微丸及其制备方法
WO2022211762A1 (en) * 2021-03-29 2022-10-06 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi The film coated tablet of vildagliptin and metformin hydrochloride
KR102346790B1 (ko) * 2021-04-29 2022-01-04 주식회사 에이스바이오메드 콜히친과 메트포르민을 유효성분으로 하는 항비만 치료제
CN116139092A (zh) * 2023-04-17 2023-05-23 山东新时代药业有限公司 一种维格列汀片剂及其制备方法

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US3174901A (en) 1963-01-31 1965-03-23 Jan Marcel Didier Aron Samuel Process for the oral treatment of diabetes
US6667054B2 (en) 2001-12-05 2003-12-23 Bernard Charles Sherman Metformin hydrochloride tablets
JOP20180109A1 (ar) 2005-09-29 2019-01-30 Novartis Ag تركيبة جديدة
JP5165582B2 (ja) * 2005-12-16 2013-03-21 メルク・シャープ・エンド・ドーム・コーポレイション ジペプチジルペプチダーゼ−４インヒビターとメトホルミンとを組み合わせた医薬組成物
FI20061146A0 (fi) * 2006-11-10 2006-12-21 Iprbox Oy Rakeita, tabletteja ja rakeistusmenetelmä
ITFI20070042A1 (it) * 2007-02-21 2008-08-22 Laboratori Guidotti Spa Formulazione farmaceutica e compressa comprendente detta formulazione.
WO2009091663A1 (en) * 2008-01-14 2009-07-23 Phenomix Corporation Stable pharmaceutical formulation of a dpp-iv inhibitor with metformin
EP2295083A1 (de) 2009-09-15 2011-03-16 Ratiopharm GmbH Pharmazeutische Zusammensetzung mit den Wirkstoffen Metformin und Sitagliptin oder Vildagliptin
EP2402342B1 (en) 2010-03-08 2014-08-06 Jiangsu Hengrui Medicine Co., Ltd. Pharmaceutical composition for treatment of 2 type diabetes

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Publication number Publication date
MX2015008427A (es) 2015-10-22
PL2938362T3 (pl) 2017-07-31
RU2647421C2 (ru) 2018-03-15
WO2014101986A8 (en) 2015-09-03
RU2015130312A (ru) 2017-01-30
ES2617522T3 (es) 2017-06-19
PT2938362T (pt) 2017-03-06
WO2014101986A1 (en) 2014-07-03
EP2938362B1 (en) 2016-12-07
EP2938362A1 (en) 2015-11-04

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