EP4061378A4 - Feste pharmazeutische zusammensetzung mit aus einem polaren lösungsmittel isolierten amorphen dapagliflozin - Google Patents

Feste pharmazeutische zusammensetzung mit aus einem polaren lösungsmittel isolierten amorphen dapagliflozin Download PDF

Info

Publication number: EP4061378A4
Authority: EP; European Patent Office
Prior art keywords: isolated; pharmaceutical composition; polar solvent; solid pharmaceutical; amorphous dapagliflozin
Prior art date: 2019-11-20
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 Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Withdrawn

Application number

EP20890661.0A

Other languages

English (en)

French (fr)

Other versions

EP4061378A1 (de

Inventor

Fatih Sunel

Nur PEHLIVAN AKALIN

Tolga GULER

Aydan OZDEN

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.)

Sanovel Ilac Sanayi ve Ticaret AS

Original Assignee

Sanovel Ilac Sanayi ve Ticaret AS

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.)

2019-11-20

Filing date

2020-10-27

Publication date

2023-12-06

2020-10-27 Application filed by Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS

2022-09-28 Publication of EP4061378A1 publication Critical patent/EP4061378A1/de

2023-12-06 Publication of EP4061378A4 publication Critical patent/EP4061378A4/de

Status Withdrawn legal-status Critical Current

Classifications

- 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
- 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
- A61K9/20—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D309/00—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings
- C07D309/02—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings having no double bonds between ring members or between ring members and non-ring members
- C07D309/08—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings having no double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D309/10—Oxygen atoms

Landscapes

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

EP20890661.0A 2019-11-20 2020-10-27 Feste pharmazeutische zusammensetzung mit aus einem polaren lösungsmittel isolierten amorphen dapagliflozin Withdrawn EP4061378A4 (de)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
TR2019/18102A TR201918102A1 (tr)	2019-11-20	2019-11-20	Bi̇r polar çözücüden i̇zole edi̇lmi̇ş amorf dapagli̇flozi̇n i̇çeren kati farmasöti̇k kompozi̇syon
PCT/TR2020/050999 WO2021101482A1 (en)	2019-11-20	2020-10-27	A solid pharmaceutical composition comprising amorphous dapagliflozin isolated from a polar solvent

Publications (2)

Publication Number	Publication Date
EP4061378A1 EP4061378A1 (de)	2022-09-28
EP4061378A4 true EP4061378A4 (de)	2023-12-06

Family

ID=75980709

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP20890661.0A Withdrawn EP4061378A4 (de)	2019-11-20	2020-10-27	Feste pharmazeutische zusammensetzung mit aus einem polaren lösungsmittel isolierten amorphen dapagliflozin

Country Status (3)

Country	Link
EP (1)	EP4061378A4 (de)
TR (1)	TR201918102A1 (de)
WO (1)	WO2021101482A1 (de)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
CN113648304A (zh) *	2021-09-06	2021-11-16	扬子江药业集团上海海尼药业有限公司	一种含达格列净的药物组合物及其制备方法和应用
WO2023175573A1 (en) *	2022-03-17	2023-09-21	Zydus Lifesciences Limited	Pharmaceutical compositions comprising a β-blocker and an sglt2 inhibitor
WO2025144122A1 (en) *	2023-12-27	2025-07-03	Santa Farma Ilac Sanayii A.S.	Pharmaceutical composition comprising dapagliflozin base in amorphous form

Citations (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2015104658A2 (en) *	2014-01-08	2015-07-16	Dr. Reddy’S Laboratories Limited	Amorphous solid dispersion of dapagliflozin and process for the preparation of amorphous dapagliflozin
WO2016161995A1 (en) *	2015-04-08	2016-10-13	Zentiva, K.S.	Solid forms of amorphous dapagliflozin

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
IN2014MU00626A (de) *	2014-02-21	2015-09-25	Cadila Healthcare Ltd

2019
- 2019-11-20 TR TR2019/18102A patent/TR201918102A1/tr unknown
2020
- 2020-10-27 EP EP20890661.0A patent/EP4061378A4/de not_active Withdrawn
- 2020-10-27 WO PCT/TR2020/050999 patent/WO2021101482A1/en not_active Ceased

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2015104658A2 (en) *	2014-01-08	2015-07-16	Dr. Reddy’S Laboratories Limited	Amorphous solid dispersion of dapagliflozin and process for the preparation of amorphous dapagliflozin
WO2016161995A1 (en) *	2015-04-08	2016-10-13	Zentiva, K.S.	Solid forms of amorphous dapagliflozin

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2021101482A1 *

Also Published As

Publication number	Publication date
WO2021101482A1 (en)	2021-05-27
TR201918102A1 (tr)	2021-07-26
EP4061378A1 (de)	2022-09-28

Publication	Publication Date	Title
EP3829554A4 (de)	2022-04-20	Feste selbstemulgierende pharmazeutische zusammensetzungen
EP4061378A4 (de)	2023-12-06	Feste pharmazeutische zusammensetzung mit aus einem polaren lösungsmittel isolierten amorphen dapagliflozin
EP3829578A4 (de)	2022-08-17	Sirolimushaltige zusammensetzungen
EP3949967A4 (de)	2023-01-18	Feste pharmazeutische zusammensetzung mit tlr7-agonisten
EP4275726A4 (de)	2024-11-20	Sprühgerät
EP4119233A4 (de)	2023-10-11	Zerstäuber
EP4175626A4 (de)	2024-07-17	Neue pharmazeutische zusammensetzungen
AU2020356348B2 (en)	2025-07-24	Pharmaceutical compounds
EP4032573A4 (de)	2023-11-29	Zerstäuber
EP3914234A4 (de)	2022-09-14	Pharmazeutische zusammensetzungen
EP3909583A4 (de)	2022-08-17	Dihydropyrazolopyrazinonderivate mit mgat2-inhibitorischer aktivität
EP3978139A4 (de)	2023-07-05	Elektrostatische sprühvorrichtung
EP4074313A4 (de)	2024-01-03	Feste pharmazeutische zubereitung
EP4119234A4 (de)	2023-10-11	Zerstäuber
EP4119235A4 (de)	2023-10-11	Zerstäuber
EP3989430A4 (de)	2023-07-19	Elektrostatischer aktuator
EP3903782A4 (de)	2022-10-05	Pharmazeutische zusammensetzung
HK40079778A (en)	2023-04-21	Pharmaceutical compositions
EP4066852A4 (de)	2024-05-22	Pharmazeutische zusammensetzung
EP4438036A4 (de)	2025-03-19	Feste pharmazeutische zusammensetzung
EP4292628A4 (de)	2025-01-01	Zerstäuber
HK40059385A (en)	2022-05-06	Pharmaceutical composition
HK40077614A (en)	2023-03-10	Pharmaceutical compounds
HK40076183A (en)	2023-02-10	Pharmaceutical compounds
HK40068990A (en)	2022-09-30	Pharmaceutical compounds

Legal Events

Date	Code	Title	Description
2021-05-29	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE
2022-08-26	PUAI	Public reference made under article 153(3) epc to a published international application that has entered the european phase	Free format text: ORIGINAL CODE: 0009012
2022-08-26	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE
2022-09-28	17P	Request for examination filed	Effective date: 20220517
2022-09-28	AK	Designated contracting states	Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
2023-03-01	DAV	Request for validation of the european patent (deleted)
2023-03-01	DAX	Request for extension of the european patent (deleted)
2023-08-16	P01	Opt-out of the competence of the unified patent court (upc) registered	Effective date: 20230708
2023-12-06	A4	Supplementary search report drawn up and despatched	Effective date: 20231108
2023-12-06	RIC1	Information provided on ipc code assigned before grant	Ipc: A61P 3/10 20060101ALI20231102BHEP Ipc: C07D 309/10 20060101ALI20231102BHEP Ipc: A61K 31/7034 20060101ALI20231102BHEP Ipc: A61K 31/70 20060101AFI20231102BHEP
2024-09-19	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN
2024-10-23	18D	Application deemed to be withdrawn	Effective date: 20240529