MX2016001023A - Formulaciones que contienen dapagliflozina amorfa. - Google Patents

Formulaciones que contienen dapagliflozina amorfa.

Info

Publication number
MX2016001023A
MX2016001023A MX2016001023A MX2016001023A MX2016001023A MX 2016001023 A MX2016001023 A MX 2016001023A MX 2016001023 A MX2016001023 A MX 2016001023A MX 2016001023 A MX2016001023 A MX 2016001023A MX 2016001023 A MX2016001023 A MX 2016001023A
Authority
MX
Mexico
Prior art keywords
pharmaceutical composition
solid dispersion
formulations containing
dapagliflozin
adsorbate
Prior art date
Application number
MX2016001023A
Other languages
English (en)
Other versions
MX370853B (es
Inventor
Rok Staric
Sandra Berglez
Jernej Grmas
Tinaja Stanic Ljubin
Rok Grahek
Luka Peternel
Original Assignee
Sandoz Ag
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 Sandoz Ag filed Critical Sandoz Ag
Publication of MX2016001023A publication Critical patent/MX2016001023A/es
Publication of MX370853B publication Critical patent/MX370853B/es

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
    • A61K31/335—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
    • 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
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2022—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
    • A61K9/2095—Tabletting processes
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Mechanical Engineering (AREA)
  • Composite Materials (AREA)

Abstract

La presente invención pertenece al campo de la industria farmacéutica y se refiere a una dispersión sólida amorfa que comprende cuando menos un polímero y dapagliflozina, a una composición farmacéutica que comprende la dispersión sólida, a un proceso para la preparación de la misma, y a la dispersión sólida y la composición farmacéutica, respectivamente, que se pueden obtener mediante dicho proceso. Además, la presente invención se refiere a un adsorbato que comprende dapagliflozina y a una composición farmacéutica que comprende dicho adsorbato, así como a un proceso para la preparación de la misma. Finalmente, la presente invención se refiere a la dispersión sólida, el adsorbato o la composición farmacéutica, para utilizarse en el tratamiento de enfermedades relacionadas con hipoglucemia.
MX2016001023A 2013-07-22 2014-07-22 Formulaciones que contienen dapagliflozina amorfa. MX370853B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13177508 2013-07-22
PCT/EP2014/065661 WO2015011113A1 (en) 2013-07-22 2014-07-22 Formulations containing amorphous dapagliflozin

Publications (2)

Publication Number Publication Date
MX2016001023A true MX2016001023A (es) 2016-04-19
MX370853B MX370853B (es) 2020-01-08

Family

ID=48874149

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016001023A MX370853B (es) 2013-07-22 2014-07-22 Formulaciones que contienen dapagliflozina amorfa.

Country Status (12)

Country Link
US (2) US20160256433A1 (es)
EP (1) EP3024442B1 (es)
JP (2) JP6574417B2 (es)
KR (1) KR20160034348A (es)
CN (2) CN105555258A (es)
AU (2) AU2014295137B2 (es)
CA (1) CA2918570A1 (es)
ES (1) ES2721059T3 (es)
MX (1) MX370853B (es)
PT (1) PT3024442T (es)
TR (1) TR201905586T4 (es)
WO (1) WO2015011113A1 (es)

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170056365A1 (en) * 2014-02-28 2017-03-02 Sun Pharmaceutical Industries Limited Dapagliflozin compositions
WO2016161995A1 (en) * 2015-04-08 2016-10-13 Zentiva, K.S. Solid forms of amorphous dapagliflozin
US10556877B2 (en) * 2015-05-05 2020-02-11 Glenmark Life Sciences Limited Process for preparation of dapagliflozin
CZ2015435A3 (cs) * 2015-06-25 2017-01-04 Zentiva, K.S. Pevné formy amorfního canagliflozinu
WO2017042683A1 (en) * 2015-09-07 2017-03-16 Dr. Reddy's Laboratories Limited Isolated intermediate of dapagliflozin, process for the preparation of isolated intermediate of dapagliflozin, process for the preparation of dapagliflozin
US9845303B2 (en) 2015-10-19 2017-12-19 Cadila Healthcare Limited Process for the preparation of dapagliflozin
CN106727368A (zh) * 2015-11-24 2017-05-31 上海星泰医药科技有限公司 一种达格列净药物组合物及其制备方法
US20180344646A1 (en) * 2015-11-25 2018-12-06 Patheon Development Services Inc. Amorphous dispersion granules and oral dosage forms
ITUB20156299A1 (it) * 2015-12-03 2017-06-03 S B M S R L Prodotto comprendente collagene e almeno un farmaco amorfo micronizzato, procedimento per la sua preparazione e relativi usi in campo medico.
WO2017118945A1 (en) 2016-01-08 2017-07-13 Lupin Limited Premix of dapagliflozin and process for the preparation thereof
KR20190008334A (ko) 2016-05-13 2019-01-23 메르크 파텐트 게엠베하 용융 압출 적용을 위한 중합체의 입자 크기 및 분포
WO2017203229A1 (en) 2016-05-27 2017-11-30 Cipla Limited Dapagliflozin premixes
KR20180058510A (ko) * 2016-11-24 2018-06-01 한미약품 주식회사 다파글리플로진 l-프롤린을 포함하는 약제학적 제제
WO2018167589A1 (en) * 2017-03-16 2018-09-20 Inventia Healthcare Private Limited Pharmaceutical composition comprising dapagliflozin
KR102025480B1 (ko) 2017-12-12 2019-09-25 영남대학교 산학협력단 다파글리플로진 유리염기를 함유하는 약제학적 조성물 및 이의 제조방법
KR102204439B1 (ko) 2018-05-14 2021-01-18 에이치케이이노엔 주식회사 Sglt-2 억제제 및 dpp-iv 억제제를 포함하는 약제학적 조성물
JP7370126B2 (ja) * 2018-11-27 2023-10-27 日本化薬株式会社 エルロチニブを有効成分とする医薬錠剤
CN110279666B (zh) * 2019-05-20 2022-05-13 湖北万润医药有限公司 一种盐酸曲美他嗪片及其制备方法
KR102234154B1 (ko) * 2019-06-18 2021-03-31 삼천당제약주식회사 다파글리플로진비용매화물 함유 정제 제조방법 및 그에 의해 제조된 다파글리플로진비용매화물 함유 정제
WO2021041824A1 (en) 2019-08-28 2021-03-04 Lubrizol Advanced Materials, Inc. Drug-polymer amorphous solid dispersions using linear poly (acrylic acid) polymers
EP4106732A1 (en) 2020-02-21 2022-12-28 Zaklady Farmaceutyczne Polpharma S.A. Pharmaceutical composition comprising dapagliflozin
WO2021176096A1 (en) 2020-03-05 2021-09-10 Krka, D.D., Novo Mesto Pharmaceutical composition comprising sglt2 inhibitor
CN115867538A (zh) 2020-06-05 2023-03-28 新梅斯托克公司 高纯的无定形达格列净的制备
US20230390192A1 (en) * 2020-10-12 2023-12-07 Auspex Pharmaceuticals, Inc. Gastro retentive dosage forms comprising deutetrabenazine
TR202019592A2 (tr) * 2020-12-03 2022-06-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Amorf dapagliflozinin katı farmasötik formülasyonları
CN117982443B (zh) * 2022-10-31 2026-03-06 优辉药业(北京)有限公司 一种达格列净二甲双胍缓释片剂
WO2024116195A1 (en) * 2022-11-28 2024-06-06 Syri Research Private Limited Oral liquid formulation comprising dapagliflozin or its pharmaceutically acceptable salt thereof
CN115869265A (zh) * 2023-01-04 2023-03-31 聊城高新生物技术有限公司 一种达格列净固体分散体和一种药物制剂及其制备方法
CN116421595B (zh) * 2023-02-21 2024-03-29 深圳市新阳唯康科技有限公司 一种达格列净药物组合物及制备方法和应用
CN116785251B (zh) * 2023-05-11 2025-09-16 泊诺(天津)创新医药研究有限公司 一种达格列净片剂及其制备方法
CN119112863A (zh) * 2024-09-29 2024-12-13 湖南九典制药股份有限公司 一种达格列净药物组合物及其制备方法和应用

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0665646B2 (ja) * 1982-07-19 1994-08-24 旭化成工業株式会社 医薬用ニトログリセリン組成物
US5225204A (en) * 1991-11-05 1993-07-06 Chen Jivn Ren Stable dosage of levothyroxine sodium and process of production
WO2001034119A2 (en) * 1999-11-12 2001-05-17 Abbott Laboratories Inhibitors of crystallization in a solid dispersion
BR0114896A (pt) * 2000-10-24 2003-08-12 Ajinomoto Kk Preparação contendo nateglinida, e, método para produzir a mesma
AU2003299966A1 (en) * 2003-01-03 2004-08-10 Bristol-Myers Squibb Company Methods of producing c-aryl glucoside sglt2 inhibitors
US20080132560A1 (en) * 2006-11-21 2008-06-05 San-Laung Chow Solid dispersion composition
AR065809A1 (es) * 2007-03-22 2009-07-01 Bristol Myers Squibb Co Formulaciones farmaceuticas que contienen un inhibidor sglt2
KR101499533B1 (ko) * 2008-02-15 2015-03-09 주식회사 씨티씨바이오 콜린 알포세레이트 함유 약학 제제
US20110005961A1 (en) * 2008-02-28 2011-01-13 Ludovic Leplatois Extrusion-Coated Lidding Foil For Push-Through Blister Packaging
WO2010045656A2 (en) * 2008-10-17 2010-04-22 Nectid, Inc. Novel sglt2 inhibitor dosage forms
TR201902233T4 (tr) * 2009-10-30 2019-03-21 Ix Biopharma Ltd Hızlı çözünen katı dozaj formu.
CN104825417A (zh) * 2009-11-13 2015-08-12 阿斯利康(瑞典)有限公司 立即释放片剂
EP2356984A1 (en) * 2010-02-04 2011-08-17 Nycomed Austria GmbH Improved distigmine bromide formulation
EP2389927A1 (en) * 2010-05-30 2011-11-30 Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi Pharmaceutical formulations of rasagiline
US20130137739A1 (en) * 2010-05-31 2013-05-30 Astellas Pharma, Inc. Solid dispersion comprising triazole compound
AU2011295837B2 (en) * 2010-09-03 2015-06-18 Astrazeneca Uk Limited Drug formulations using water soluble antioxidants
CA2837232A1 (en) * 2011-06-03 2012-12-06 Ratiopharm Gmbh Pharmaceutical composition comprising dapagliflozin and cyclodextrin
BR112014010574A2 (pt) * 2011-10-31 2017-05-02 Scinopharm Taiwan Ltd formas cristalinas e não cristalinas de inibidores sglt2

Also Published As

Publication number Publication date
ES2721059T3 (es) 2019-07-26
KR20160034348A (ko) 2016-03-29
JP2018184410A (ja) 2018-11-22
CA2918570A1 (en) 2015-01-29
CN108938583A (zh) 2018-12-07
MX370853B (es) 2020-01-08
EP3024442B1 (en) 2019-01-16
JP2016525527A (ja) 2016-08-25
AU2014295137B2 (en) 2019-01-17
PT3024442T (pt) 2019-05-16
TR201905586T4 (tr) 2019-05-21
WO2015011113A1 (en) 2015-01-29
CN108938583B (zh) 2021-05-04
EP3024442A1 (en) 2016-06-01
AU2019200016A1 (en) 2019-01-24
CN105555258A (zh) 2016-05-04
US20160256433A1 (en) 2016-09-08
JP6574417B2 (ja) 2019-09-11
US20190175543A1 (en) 2019-06-13
AU2014295137A1 (en) 2016-03-10

Similar Documents

Publication Publication Date Title
MX370853B (es) Formulaciones que contienen dapagliflozina amorfa.
AU2018256591A1 (en) Thieno[3,2-d]pyrimidines derivatives for the treatment of viral infections
PH12015500274B1 (en) Alkylpyrimidine derivatives for the treatment of viral infections and further diseases
MX2015008627A (es) Derivados de acido boronico y usos terapeuticos de los mismos.
MX2016016666A (es) Derivados de acido boronico y usos terapeuticos de los mismos.
MX2016015093A (es) Derivados de acido boronico y sus usos terapeuticos.
GB201209613D0 (en) New compounds
WO2015085318A3 (en) Targeted adaptive vaccines
MX2015008628A (es) Derivados de acido boronico y usos terapeuticos de los mismos.
MY169159A (en) Piperidino-pyrimidine derivatives for the treatment of viral infections
PH12016500094A1 (en) Autotaxin inhibitors
MY164356A (en) Substituted 5-fluoro-1h-pyrazolopyridines and their use
PH12015500713A1 (en) Acylaminopyrimidine derivatives for the treatment of viral infections and further diseases
PH12014502496B1 (en) Bicyclically substituted uracils and the use thereof
PH12015500724B1 (en) 1, 2, 4-triazine derivatives for the treatment of viral infections
EP3081222A4 (en) Pharmaceutical composition for treating cerebrovascular diseases, containing stem cell-derived exosome as active ingredient
EP4338803A3 (en) Process for the preparation of erythrocytes loaded with one or more substances of pharmaceutical interest and so obtained erythrocytes
WO2014203275A3 (en) An improved process for the preparation of apixaban and intermediates thereof
MX357284B (es) Compuestos de quinona para tratar enfermedades mediadas por ape1.
MX2016006544A (es) Witanolidos utiles para el tratamiento de enfermedades neurodegenerativas.
MX2015000179A (es) Composiciones y formas de dosificacion de itraconazol y metodos de uso de las mismas.
WO2013163562A3 (en) Compositions and methods for treating ptsd and related diseases
WO2015071299A3 (en) Stable pharmaceutical glycylcycline compositions
IN2013CH04314A (es)
LV15003A (lv) Farmaceitiska kompozīcija ķermeņa masas pieauguma kontrolei

Legal Events

Date Code Title Description
FG Grant or registration