EP4061378A4 - A solid pharmaceutical composition comprising amorphous dapagliflozin isolated from a polar solvent - Google Patents

A solid pharmaceutical composition comprising amorphous dapagliflozin isolated from a polar solvent Download PDF

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Publication number
EP4061378A4
EP4061378A4 EP20890661.0A EP20890661A EP4061378A4 EP 4061378 A4 EP4061378 A4 EP 4061378A4 EP 20890661 A EP20890661 A EP 20890661A EP 4061378 A4 EP4061378 A4 EP 4061378A4
Authority
EP
European Patent Office
Prior art keywords
isolated
pharmaceutical composition
polar solvent
solid pharmaceutical
amorphous dapagliflozin
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.)
Pending
Application number
EP20890661.0A
Other languages
German (de)
French (fr)
Other versions
EP4061378A1 (en
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.)
Filing date
Publication date
Application filed by Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS
Publication of EP4061378A1 publication Critical patent/EP4061378A1/en
Publication of EP4061378A4 publication Critical patent/EP4061378A4/en
Pending legal-status Critical Current

Links

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
EP20890661.0A 2019-11-20 2020-10-27 A solid pharmaceutical composition comprising amorphous dapagliflozin isolated from a polar solvent Pending EP4061378A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2019/18102A TR201918102A1 (en) 2019-11-20 2019-11-20 A solid pharmaceutical composition comprising amorphous dapagliflozin isolated from a polar solvent
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 (en) 2022-09-28
EP4061378A4 true EP4061378A4 (en) 2023-12-06

Family

ID=75980709

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20890661.0A Pending EP4061378A4 (en) 2019-11-20 2020-10-27 A solid pharmaceutical composition comprising amorphous dapagliflozin isolated from a polar solvent

Country Status (3)

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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113648304A (en) * 2021-09-06 2021-11-16 扬子江药业集团上海海尼药业有限公司 Pharmaceutical composition containing dapagliflozin and preparation method and application thereof
WO2023175573A1 (en) * 2022-03-17 2023-09-21 Zydus Lifesciences Limited Pharmaceutical compositions comprising a β-blocker and an sglt2 inhibitor

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 (en) * 2014-02-21 2015-09-25 Cadila Healthcare Ltd

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
EP4061378A1 (en) 2022-09-28
WO2021101482A1 (en) 2021-05-27
TR201918102A1 (en) 2021-07-26

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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