WO2022102457A1 - Comprimé à désintégration orale contenant de la linagliptine - Google Patents

Comprimé à désintégration orale contenant de la linagliptine Download PDF

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Publication number
WO2022102457A1
WO2022102457A1 PCT/JP2021/040258 JP2021040258W WO2022102457A1 WO 2022102457 A1 WO2022102457 A1 WO 2022102457A1 JP 2021040258 W JP2021040258 W JP 2021040258W WO 2022102457 A1 WO2022102457 A1 WO 2022102457A1
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WO
WIPO (PCT)
Prior art keywords
linagliptin
orally disintegrating
disintegrating tablet
carmellose
tablet
Prior art date
Application number
PCT/JP2021/040258
Other languages
English (en)
Japanese (ja)
Inventor
康史 福原
克彦 尾曲
Original Assignee
沢井製薬株式会社
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 沢井製薬株式会社 filed Critical 沢井製薬株式会社
Priority to JP2022561834A priority Critical patent/JPWO2022102457A1/ja
Publication of WO2022102457A1 publication Critical patent/WO2022102457A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D473/00Heterocyclic compounds containing purine ring systems
    • C07D473/02Heterocyclic compounds containing purine ring systems with oxygen, sulphur, or nitrogen atoms directly attached in positions 2 and 6
    • C07D473/04Heterocyclic compounds containing purine ring systems with oxygen, sulphur, or nitrogen atoms directly attached in positions 2 and 6 two oxygen atoms
    • C07D473/06Heterocyclic compounds containing purine ring systems with oxygen, sulphur, or nitrogen atoms directly attached in positions 2 and 6 two oxygen atoms with radicals containing only hydrogen and carbon atoms, attached in position 1 or 3

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne : un comprimé à désintégration orale contenant de la linagliptine qui est capable de masquer suffisamment l'amertume ; et un procédé de production de celui-ci. Selon un mode de réalisation, la présente invention concerne un comprimé à désintégration orale contenant de la linagliptine contenant : de la linagliptine; et un additif comprenant au moins un élément choisi dans le groupe constitué par la carmellose calcique, la croscarmellose sodique, la carmellose et l'acide glycolique d'amidon sodique. L'additif peut également comprendre au moins un élément choisi dans le groupe constitué par la carmellose calcique, le sodium réticulé et la carmellose.
PCT/JP2021/040258 2020-11-10 2021-11-01 Comprimé à désintégration orale contenant de la linagliptine WO2022102457A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022561834A JPWO2022102457A1 (fr) 2020-11-10 2021-11-01

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020-187106 2020-11-10
JP2020187106 2020-11-10

Publications (1)

Publication Number Publication Date
WO2022102457A1 true WO2022102457A1 (fr) 2022-05-19

Family

ID=81602200

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2021/040258 WO2022102457A1 (fr) 2020-11-10 2021-11-01 Comprimé à désintégration orale contenant de la linagliptine

Country Status (2)

Country Link
JP (1) JPWO2022102457A1 (fr)
WO (1) WO2022102457A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022192036A (ja) * 2021-06-16 2022-12-28 日本ジェネリック株式会社 リナグリプチン含有製剤及びリナグリプチン含有口腔内崩壊性錠剤

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013161823A1 (fr) * 2012-04-24 2013-10-31 第一三共株式会社 Comprimé à désintégration orale et son procédé de production
EP2848242A1 (fr) * 2013-09-12 2015-03-18 Sanovel Ilac Sanayi ve Ticaret A.S. Formulations orodispersibles de Linagliptin
CN105853382A (zh) * 2016-05-19 2016-08-17 广州迈达康医药科技有限公司 一种利格列汀口崩片及其制备方法
JP2018530566A (ja) * 2015-10-09 2018-10-18 ヘクサル・アクチェンゲゼルシャフトHexal AG 8−[(3r)−3−アミノ−1−ピペリジニル]−7−(2−ブチン−1−イル)−3,7−ジヒドロ−3−メチル−1−[4−メチル−2−キナゾリニル)メチル]−1h−プリン−2,6−ジオンまたは薬学上許容できるその塩を含有する医薬組成物
JP2020158435A (ja) * 2019-03-26 2020-10-01 エルメッド株式会社 リナグリプチン含有医薬組成物及びその製造方法、並びにリナグリプチン含有医薬組成物の品質の向上方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013161823A1 (fr) * 2012-04-24 2013-10-31 第一三共株式会社 Comprimé à désintégration orale et son procédé de production
EP2848242A1 (fr) * 2013-09-12 2015-03-18 Sanovel Ilac Sanayi ve Ticaret A.S. Formulations orodispersibles de Linagliptin
JP2018530566A (ja) * 2015-10-09 2018-10-18 ヘクサル・アクチェンゲゼルシャフトHexal AG 8−[(3r)−3−アミノ−1−ピペリジニル]−7−(2−ブチン−1−イル)−3,7−ジヒドロ−3−メチル−1−[4−メチル−2−キナゾリニル)メチル]−1h−プリン−2,6−ジオンまたは薬学上許容できるその塩を含有する医薬組成物
CN105853382A (zh) * 2016-05-19 2016-08-17 广州迈达康医药科技有限公司 一种利格列汀口崩片及其制备方法
JP2020158435A (ja) * 2019-03-26 2020-10-01 エルメッド株式会社 リナグリプチン含有医薬組成物及びその製造方法、並びにリナグリプチン含有医薬組成物の品質の向上方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
NAKAGAWA, TOMOYA ET AL.: "Drug Development Research with Taste Sensor, Part 2: Taste Masking and Formulation Development of Donepezil Hydrochloride OD Tablets", PHARM TECH JAPAN, vol. 28, no. 3, 1 January 2012 (2012-01-01), JP , pages 511 - 517, XP009536655, ISSN: 0910-4739 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022192036A (ja) * 2021-06-16 2022-12-28 日本ジェネリック株式会社 リナグリプチン含有製剤及びリナグリプチン含有口腔内崩壊性錠剤
JP7210794B2 (ja) 2021-06-16 2023-01-23 日本ジェネリック株式会社 リナグリプチン含有製剤及びリナグリプチン含有口腔内崩壊性錠剤

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JPWO2022102457A1 (fr) 2022-05-19

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