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WO2013179307A3 - Compositions pharmaceutiques stabilisées de saxagliptine - Google Patents

Compositions pharmaceutiques stabilisées de saxagliptine Download PDF

Info

Publication number
WO2013179307A3
WO2013179307A3 PCT/IN2013/000339 IN2013000339W WO2013179307A3 WO 2013179307 A3 WO2013179307 A3 WO 2013179307A3 IN 2013000339 W IN2013000339 W IN 2013000339W WO 2013179307 A3 WO2013179307 A3 WO 2013179307A3
Authority
WO
WIPO (PCT)
Prior art keywords
saxagliptin
pharmaceutical compositions
stabilized pharmaceutical
stable
stabilized
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IN2013/000339
Other languages
English (en)
Other versions
WO2013179307A2 (fr
Inventor
Satya Sankar Sahoo
Harshal Kumar JADAV
Haraprasad CHATTERJEE
Ashis Kumar Mehta
Akhitesh DIXIT
Abhijit DESHMUKH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mylan Laboratories Ltd
Original Assignee
Mylan Laboratories Ltd
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 Mylan Laboratories Ltd filed Critical Mylan Laboratories Ltd
Publication of WO2013179307A2 publication Critical patent/WO2013179307A2/fr
Anticipated expiration legal-status Critical
Publication of WO2013179307A3 publication Critical patent/WO2013179307A3/fr
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/28—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/2072—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne des compositions pharmaceutiques stables solides comprenant de la saxagliptine seule ou en association avec du chlorhydrate de métformine. Ladite saxagliptine est stabilisée par l'incorporation de stabilisant(s) acide(s) et de vecteur(s) améliorant la stabilité. L'invention porte en outre sur un procédé de préparation desdites compositions pharmaceutiques orales stables et solides.
PCT/IN2013/000339 2012-05-29 2013-05-28 Compositions pharmaceutiques stabilisées de saxagliptine Ceased WO2013179307A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN2153CH2012 2012-05-29
IN2153/CHE/2012 2012-05-29
IN5181CH2012 2012-12-12
IN5181/CHE/2012 2012-12-12

Publications (2)

Publication Number Publication Date
WO2013179307A2 WO2013179307A2 (fr) 2013-12-05
WO2013179307A3 true WO2013179307A3 (fr) 2015-07-09

Family

ID=49673995

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2013/000339 Ceased WO2013179307A2 (fr) 2012-05-29 2013-05-28 Compositions pharmaceutiques stabilisées de saxagliptine

Country Status (1)

Country Link
WO (1) WO2013179307A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109157522A (zh) * 2018-09-18 2019-01-08 石药集团中奇制药技术（石家庄）有限公司 包含西格列汀或其可药用盐的药物组合物及其制备方法和用途

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US7407955B2 (en) 2002-08-21 2008-08-05 Boehringer Ingelheim Pharma Gmbh & Co., Kg 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
DE102004054054A1 (de) 2004-11-05 2006-05-11 Boehringer Ingelheim Pharma Gmbh & Co. Kg Verfahren zur Herstellung chiraler 8-(3-Amino-piperidin-1-yl)-xanthine
PE20110235A1 (es) 2006-05-04 2011-04-14 Boehringer Ingelheim Int Combinaciones farmaceuticas que comprenden linagliptina y metmorfina
CN109503584A (zh) 2006-05-04 2019-03-22 勃林格殷格翰国际有限公司 多晶型
EP1852108A1 (fr) 2006-05-04 2007-11-07 Boehringer Ingelheim Pharma GmbH & Co.KG Compositions d'inhibiteurs de la DPP IV
AR071175A1 (es) 2008-04-03 2010-06-02 Boehringer Ingelheim Int Composicion farmaceutica que comprende un inhibidor de la dipeptidil-peptidasa-4 (dpp4) y un farmaco acompanante
KR20200118243A (ko) 2008-08-06 2020-10-14 베링거 인겔하임 인터내셔날 게엠베하 메트포르민 요법이 부적합한 환자에서의 당뇨병 치료
US20200155558A1 (en) 2018-11-20 2020-05-21 Boehringer Ingelheim International Gmbh Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral antidiabetic drug
EP2504002B1 (fr) 2009-11-27 2019-10-09 Boehringer Ingelheim International GmbH Traitement de patients diabétiques génotypés par des inhibiteurs de dpp-iv tels que la linagliptine
AU2011249722B2 (en) 2010-05-05 2015-09-17 Boehringer Ingelheim International Gmbh Combination therapy
AR083878A1 (es) 2010-11-15 2013-03-27 Boehringer Ingelheim Int Terapia antidiabetica vasoprotectora y cardioprotectora, linagliptina, metodo de tratamiento
US9555001B2 (en) 2012-03-07 2017-01-31 Boehringer Ingelheim International Gmbh Pharmaceutical composition and uses thereof
EP4151218A1 (fr) 2012-05-14 2023-03-22 Boehringer Ingelheim International GmbH Linagliptine, dérivé de xanthine en tant qu'inhibiteur de dpp-4, destinée à être utilisée dans le traitement de sirs et/ou de sepsis
US20130303462A1 (en) 2012-05-14 2013-11-14 Boehringer Ingelheim International Gmbh Use of a dpp-4 inhibitor in podocytes related disorders and/or nephrotic syndrome
WO2013174767A1 (fr) 2012-05-24 2013-11-28 Boehringer Ingelheim International Gmbh Dérivé de xanthine en tant qu'inhibiteur de la dpp-4 à utiliser dans la modification de l'apport alimentaire et dans la régulation des préférences alimentaires
WO2015071887A1 (fr) * 2013-11-18 2015-05-21 Ranbaxy Laboratories Limited Compositions pharmaceutiques orales de saxagliptine
WO2015071889A1 (fr) * 2013-11-18 2015-05-21 Ranbaxy Laboratories Limited Compositions orales de saxagliptine
ES2950384T3 (es) 2014-02-28 2023-10-09 Boehringer Ingelheim Int Uso médico de un inhibidor de DPP-4
WO2016059378A1 (fr) * 2014-10-15 2016-04-21 Astrazeneca Ab Compositions pharmaceutiques particulaires et formes dosifiées de saxagliptine, et leurs procédés de fabrication
CN105497023B (zh) * 2014-10-15 2021-05-25 北京福元医药股份有限公司 一种沙格列汀药物制剂
WO2016059219A1 (fr) * 2014-10-17 2016-04-21 Boehringer Ingelheim International Gmbh Composition pharmaceutique et utilisations de celle-ci
CN105193772A (zh) * 2015-10-28 2015-12-30 陈跃坚 一种沙格列汀口腔膜剂及其制备方法
CN109310697A (zh) 2016-06-10 2019-02-05 勃林格殷格翰国际有限公司 利格列汀和二甲双胍的组合
WO2018185669A1 (fr) * 2017-04-07 2018-10-11 Zenvision Pharma Llp Compositions effervescentes comprenant de la saxagliptine ou un sel de celle-ci
TR201907905A1 (tr) 2019-05-24 2020-12-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Alogli̇pti̇n ve metformi̇n i̇çeren bi̇r kombi̇nasyon
JP7560272B2 (ja) * 2019-05-31 2024-10-02 沢井製薬株式会社 サキサグリプチンの安定化方法
CN112546013B (zh) * 2020-12-29 2022-06-10 平光制药股份有限公司 一种沙格列汀二甲双胍双层片及其制备工艺
TR202022612A2 (tr) * 2020-12-31 2022-07-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Alogli̇pti̇ni̇n farmasöti̇k kapsül kompozi̇syonlari
CN116440103A (zh) * 2023-05-11 2023-07-18 南京康川济医药科技有限公司 一种沙格列汀二甲双胍缓释制剂及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
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US20060018963A1 (en) * 2004-07-22 2006-01-26 Joan Cucala Escoi Extended release venlafaxine besylate tablets
US7994183B2 (en) * 2007-03-13 2011-08-09 Takeda Pharmaceutical Company Limited Solid preparation comprising 2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-4-fluorobenzonitrile
US20110200672A1 (en) * 2004-05-28 2011-08-18 Bristol-Myers Squibb Company Coated tablet formulation and method
US20110206766A1 (en) * 2008-04-03 2011-08-25 Boehringer Ingelheim International Gmbh Dpp-iv inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
US20120083517A1 (en) * 2010-10-04 2012-04-05 Marina Marinkovic Polymorphs of saxagliptin hydrochloride and processes for preparing them

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110200672A1 (en) * 2004-05-28 2011-08-18 Bristol-Myers Squibb Company Coated tablet formulation and method
US20060018963A1 (en) * 2004-07-22 2006-01-26 Joan Cucala Escoi Extended release venlafaxine besylate tablets
US7994183B2 (en) * 2007-03-13 2011-08-09 Takeda Pharmaceutical Company Limited Solid preparation comprising 2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-4-fluorobenzonitrile
US20110206766A1 (en) * 2008-04-03 2011-08-25 Boehringer Ingelheim International Gmbh Dpp-iv inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
US20120083517A1 (en) * 2010-10-04 2012-04-05 Marina Marinkovic Polymorphs of saxagliptin hydrochloride and processes for preparing them

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109157522A (zh) * 2018-09-18 2019-01-08 石药集团中奇制药技术（石家庄）有限公司 包含西格列汀或其可药用盐的药物组合物及其制备方法和用途

Also Published As

Publication number Publication date
WO2013179307A2 (fr) 2013-12-05

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