ES2721059T3 - Formulaciones que contienen dapagliflozina amorfa - Google Patents

Formulaciones que contienen dapagliflozina amorfa Download PDF

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Publication number
ES2721059T3
ES2721059T3 ES14741876T ES14741876T ES2721059T3 ES 2721059 T3 ES2721059 T3 ES 2721059T3 ES 14741876 T ES14741876 T ES 14741876T ES 14741876 T ES14741876 T ES 14741876T ES 2721059 T3 ES2721059 T3 ES 2721059T3
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ES
Spain
Prior art keywords
dapagliflozin
poly
formula
formulations containing
containing amorphous
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.)
Active
Application number
ES14741876T
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English (en)
Inventor
Rok Staric
Sandra Berglez
Jernej Grmas
Ljubin Tijana Stanic
Rok Grahek
Luka Peternel
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.)
Sandoz AG
Original Assignee
Sandoz AG
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Publication date
Application filed by Sandoz AG filed Critical Sandoz AG
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Publication of ES2721059T3 publication Critical patent/ES2721059T3/es
Active legal-status Critical Current
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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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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

Abstract

Dispersión sólida amorfa de al menos un polímero apropiado y dapagliflozina ((2S,3R,4R,5S,6R)-2-[4-cloro- 3-(4- etoxibencil)fenil]-6-(hidroximetil)-tetrahidro-2H-piran-3,4,5-triol) de fórmula 1**Fórmula** en la que el al menos un polímero se selecciona del grupo que consiste en polivinilpirrolidona (PVP), alcohol polivinílico (PVA), ácido poliacrílico (PAA), poli(etilenglicol) (PEG), poli(óxido de etileno) (PEO), hidroxipropil celulosa (HPC), hidroxipropilmetil celulosa (HPMC), copovidona, succinato acetato de hipromelosa (AQOAT), poliacrilatos y mezclas de los mismos, y en la que la dapagliflozina está presente en su forma libre.
ES14741876T 2013-07-22 2014-07-22 Formulaciones que contienen dapagliflozina amorfa Active ES2721059T3 (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 (1)

Publication Number Publication Date
ES2721059T3 true ES2721059T3 (es) 2019-07-26

Family

ID=48874149

Family Applications (1)

Application Number Title Priority Date Filing Date
ES14741876T Active ES2721059T3 (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) CN108938583B (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 (26)

* Cited by examiner, † Cited by third party
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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
US11246935B2 (en) 2016-05-13 2022-02-15 Merck Patent Gmbh Particle size and distribution of polymer for melt extrusion application
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
AU2020336471A1 (en) 2019-08-28 2022-03-24 Lubrizol Advanced Materials, Inc. Drug-polymer amorphous solid dispersions using linear poly (acrylic acid) polymers
CA3169665A1 (en) 2020-02-21 2021-08-26 Zaklady Farmaceutyczne Polpharma S.A. Pharmaceutical composition comprising dapagliflozin
EP4114365A1 (en) 2020-03-05 2023-01-11 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
TR202019592A2 (tr) * 2020-12-03 2022-06-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Amorf dapagliflozinin katı farmasötik formülasyonları
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

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JP4501054B2 (ja) * 2000-10-24 2010-07-14 味の素株式会社 ナテグリニド含有製剤
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Also Published As

Publication number Publication date
US20160256433A1 (en) 2016-09-08
EP3024442A1 (en) 2016-06-01
JP2016525527A (ja) 2016-08-25
CA2918570A1 (en) 2015-01-29
WO2015011113A1 (en) 2015-01-29
AU2014295137B2 (en) 2019-01-17
MX2016001023A (es) 2016-04-19
CN105555258A (zh) 2016-05-04
CN108938583A (zh) 2018-12-07
US20190175543A1 (en) 2019-06-13
PT3024442T (pt) 2019-05-16
MX370853B (es) 2020-01-08
CN108938583B (zh) 2021-05-04
TR201905586T4 (tr) 2019-05-21
JP2018184410A (ja) 2018-11-22
EP3024442B1 (en) 2019-01-16
JP6574417B2 (ja) 2019-09-11
AU2014295137A1 (en) 2016-03-10
KR20160034348A (ko) 2016-03-29
AU2019200016A1 (en) 2019-01-24

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