PL2938362T3 - Proces granulacji na sucho do wytwarzania tabletkowych kompozycji metforminy i ich kompozycje - Google Patents

Proces granulacji na sucho do wytwarzania tabletkowych kompozycji metforminy i ich kompozycje

Info

Publication number
PL2938362T3
PL2938362T3 PL13834323T PL13834323T PL2938362T3 PL 2938362 T3 PL2938362 T3 PL 2938362T3 PL 13834323 T PL13834323 T PL 13834323T PL 13834323 T PL13834323 T PL 13834323T PL 2938362 T3 PL2938362 T3 PL 2938362T3
Authority
PL
Poland
Prior art keywords
compositions
metformin
granulation process
dry granulation
producing tablet
Prior art date
Application number
PL13834323T
Other languages
English (en)
Inventor
Gözde Askar
Umut Oran
Naci Bitik
Mustafa Adiyaman
Original Assignee
Zentiva Saglik Ürünleri San. Ve Tic. A.S.
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
Application filed by Zentiva Saglik Ürünleri San. Ve Tic. A.S. filed Critical Zentiva Saglik Ürünleri San. Ve Tic. A.S.
Publication of PL2938362T3 publication Critical patent/PL2938362T3/pl

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
    • A61K31/40—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
    • 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

Landscapes

  • 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)
PL13834323T 2012-12-27 2013-12-17 Proces granulacji na sucho do wytwarzania tabletkowych kompozycji metforminy i ich kompozycje PL2938362T3 (pl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR201215479 2012-12-27
EP13834323.1A EP2938362B1 (en) 2012-12-27 2013-12-17 Dry granulation process for producing tablet compositions of metformin and compositions thereof

Publications (1)

Publication Number Publication Date
PL2938362T3 true PL2938362T3 (pl) 2017-07-31

Family

ID=50190391

Family Applications (1)

Application Number Title Priority Date Filing Date
PL13834323T PL2938362T3 (pl) 2012-12-27 2013-12-17 Proces granulacji na sucho do wytwarzania tabletkowych kompozycji metforminy i ich kompozycje

Country Status (8)

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

Families Citing this family (21)

* Cited by examiner, † Cited by third party
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
PL3512505T3 (pl) * 2016-09-16 2023-08-07 Galenicum Health S.L.U. Farmaceutyczne kompozycje wildagliptyny
AU2019225236B2 (en) 2018-02-26 2025-01-30 R.P. Scherer Technologies, Llc Pharmaceutical dosage form for an emulsion of simethicone and loperamide
JP7419333B2 (ja) 2018-03-22 2024-01-22 コミファーム インターナショナル オーストラリア ピーティーワイ リミテッド メタ亜ヒ酸塩を含む医薬組成物および製造方法
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
TW202444706A (zh) 2019-05-16 2024-11-16 瑞士商諾華公司 N-[4-(氯二氟甲氧基)苯基]-6-[(3r)-3-羥基吡咯啶-1-基]-5-(1h-吡唑-5-基)吡啶-3-甲醯胺之結晶形狀
WO2020254404A1 (en) * 2019-06-17 2020-12-24 Dsm Ip Assets B.V. Pharmaceutical dosage form comprising metformin and calcium citrate
BR112021025200A2 (pt) 2019-06-17 2022-02-01 Dsm Ip Assets Bv Composição compreendendo metformina hcl, vitamina b12 e pelo menos um aditivo de fluxo
BR112021025192A2 (pt) 2019-06-17 2022-02-01 Dsm Ip Assets Bv Forma de dosagem oral sólida de liberação prolongada compreendendo vitamina b12 e um medicamento que elimina a vitamina b12
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
JP7719796B2 (ja) * 2020-04-24 2025-08-06 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
EP4066820A1 (en) * 2021-03-29 2022-10-05 Sanovel Ilac Sanayi Ve Ticaret A.S. 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

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
BRPI0616694B8 (pt) 2005-09-29 2021-05-25 Novartis Ag processo para preparar comprimido farmacêutico com 80 e 96% em peso com base no peso seco de vildagliptina e metformina ou seus sais farmaceuticamente aceitáveis
US8414921B2 (en) * 2005-12-16 2013-04-09 Merck Sharp & Dohme Corp. Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin
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

Also Published As

Publication number Publication date
HUE031227T2 (en) 2017-07-28
WO2014101986A8 (en) 2015-09-03
EP2938362A1 (en) 2015-11-04
RU2015130312A (ru) 2017-01-30
EP2938362B1 (en) 2016-12-07
RU2647421C2 (ru) 2018-03-15
MX2015008427A (es) 2015-10-22
ES2617522T3 (es) 2017-06-19
WO2014101986A1 (en) 2014-07-03
PT2938362T (pt) 2017-03-06

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