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
Links
- JVHXJTBJCFBINQ-ADAARDCZSA-N Dapagliflozin Chemical compound C1=CC(OCC)=CC=C1CC1=CC([C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)=CC=C1Cl JVHXJTBJCFBINQ-ADAARDCZSA-N 0.000 title abstract 3
- 229960003834 dapagliflozin Drugs 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 4
- 239000007962 solid dispersion Substances 0.000 abstract 4
- 239000002156 adsorbate Substances 0.000 abstract 3
- 238000000034 method Methods 0.000 abstract 3
- 208000013016 Hypoglycemia Diseases 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 230000002218 hypoglycaemic effect Effects 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Dispersion Chemistry (AREA)
- Biophysics (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.
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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015128853A1 (en) * | 2014-02-28 | 2015-09-03 | Sun Pharmaceutical Industries Limited | Dapagliflozin compositions |
| WO2016161995A1 (en) * | 2015-04-08 | 2016-10-13 | Zentiva, K.S. | Solid forms of amorphous dapagliflozin |
| WO2016178148A1 (en) * | 2015-05-05 | 2016-11-10 | Glenmark Pharmaceuticals 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 |
| WO2017091373A1 (en) * | 2015-11-25 | 2017-06-01 | 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 |
| JP7082067B2 (ja) | 2016-05-13 | 2022-06-07 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング | 溶融押出用途のためのポリマーの粒子サイズおよび分布 |
| 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 |
| US20220304936A1 (en) * | 2019-08-28 | 2022-09-29 | Lubrizol Advanced Materials, Inc. | Drug-polymer amorphous solid dispersions using linear poly(acrylic acid) polymers |
| WO2021165316A1 (en) | 2020-02-21 | 2021-08-26 | Zakłady 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 |
| WO2021245253A1 (en) | 2020-06-05 | 2021-12-09 | Krka, D.D., Novo Mesto | Preparation of highly pure amorphous dapagliflozin |
| WO2022081532A1 (en) * | 2020-10-12 | 2022-04-21 | 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 |
| CN117982443A (zh) * | 2022-10-31 | 2024-05-07 | 北京伟林恒昌医药科技有限公司 | 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 |
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|---|---|---|---|---|
| US5225204A (en) * | 1991-11-05 | 1993-07-06 | Chen Jivn Ren | Stable dosage of levothyroxine sodium and process of production |
| CA2359945C (en) * | 1999-11-12 | 2011-04-26 | Abbott Laboratories | Inhibitors of crystallization in a solid dispersion |
| DK1334720T3 (da) * | 2000-10-24 | 2009-01-19 | Ajinomoto Kk | Nateglinid-indeholdende fremstillinger |
| CN101260130A (zh) * | 2003-01-03 | 2008-09-10 | 布里斯托尔-迈尔斯斯奎布公司 | 制备c-芳基葡糖苷sglt2抑制剂的方法 |
| US20080132560A1 (en) * | 2006-11-21 | 2008-06-05 | San-Laung Chow | Solid dispersion composition |
| TW200904405A (en) * | 2007-03-22 | 2009-02-01 | Bristol Myers Squibb Co | Pharmaceutical formulations containing an SGLT2 inhibitor |
| 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 |
| EP2493457B1 (en) * | 2009-10-30 | 2017-08-09 | IX Biopharma Ltd | Fast dissolving solid dosage form |
| ES2693686T3 (es) * | 2009-11-13 | 2018-12-13 | Astrazeneca Ab | Formulaciones de comprimidos de liberación inmediata |
| 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 |
| WO2011152297A1 (ja) * | 2010-05-31 | 2011-12-08 | アステラス製薬株式会社 | トリアゾール化合物の固体分散体 |
| EP2611442B1 (en) * | 2010-09-03 | 2018-07-04 | Bristol-Myers Squibb Company | Drug formulations using water soluble antioxidants |
| EP2714049A1 (en) * | 2011-06-03 | 2014-04-09 | Ratiopharm GmbH | Pharmaceutical composition comprising dapagliflozin and cyclodextrin |
| AU2012330818B2 (en) * | 2011-10-31 | 2015-09-17 | Julian Paul Henschke | Crystalline and non-crystalline forms of SGLT2 inhibitors |
-
2014
- 2014-07-22 EP EP14741876.8A patent/EP3024442B1/en active Active
- 2014-07-22 KR KR1020167004032A patent/KR20160034348A/ko not_active Ceased
- 2014-07-22 US US14/905,990 patent/US20160256433A1/en not_active Abandoned
- 2014-07-22 ES ES14741876T patent/ES2721059T3/es active Active
- 2014-07-22 TR TR2019/05586T patent/TR201905586T4/tr unknown
- 2014-07-22 MX MX2016001023A patent/MX370853B/es active IP Right Grant
- 2014-07-22 WO PCT/EP2014/065661 patent/WO2015011113A1/en not_active Ceased
- 2014-07-22 AU AU2014295137A patent/AU2014295137B2/en active Active
- 2014-07-22 CN CN201480051021.4A patent/CN105555258A/zh active Pending
- 2014-07-22 PT PT14741876T patent/PT3024442T/pt unknown
- 2014-07-22 CN CN201810833742.0A patent/CN108938583B/zh active Active
- 2014-07-22 JP JP2016528493A patent/JP6574417B2/ja active Active
- 2014-07-22 CA CA2918570A patent/CA2918570A1/en not_active Abandoned
-
2018
- 2018-06-20 JP JP2018116961A patent/JP2018184410A/ja active Pending
-
2019
- 2019-01-03 AU AU2019200016A patent/AU2019200016A1/en not_active Abandoned
- 2019-01-24 US US16/256,490 patent/US20190175543A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| WO2015011113A1 (en) | 2015-01-29 |
| AU2014295137A1 (en) | 2016-03-10 |
| EP3024442B1 (en) | 2019-01-16 |
| US20190175543A1 (en) | 2019-06-13 |
| EP3024442A1 (en) | 2016-06-01 |
| MX370853B (es) | 2020-01-08 |
| CN108938583B (zh) | 2021-05-04 |
| CN108938583A (zh) | 2018-12-07 |
| CA2918570A1 (en) | 2015-01-29 |
| TR201905586T4 (tr) | 2019-05-21 |
| AU2014295137B2 (en) | 2019-01-17 |
| ES2721059T3 (es) | 2019-07-26 |
| CN105555258A (zh) | 2016-05-04 |
| AU2019200016A1 (en) | 2019-01-24 |
| JP2018184410A (ja) | 2018-11-22 |
| PT3024442T (pt) | 2019-05-16 |
| KR20160034348A (ko) | 2016-03-29 |
| JP2016525527A (ja) | 2016-08-25 |
| JP6574417B2 (ja) | 2019-09-11 |
| US20160256433A1 (en) | 2016-09-08 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |