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WO2020138791A3 - Sustained-release preparation comprising tofacitinib or pharmaceutically acceptable salt thereof and manufacturing method therefor - Google Patents

Sustained-release preparation comprising tofacitinib or pharmaceutically acceptable salt thereof and manufacturing method therefor Download PDF

Info

Publication number
WO2020138791A3
WO2020138791A3 PCT/KR2019/017717 KR2019017717W WO2020138791A3 WO 2020138791 A3 WO2020138791 A3 WO 2020138791A3 KR 2019017717 W KR2019017717 W KR 2019017717W WO 2020138791 A3 WO2020138791 A3 WO 2020138791A3
Authority
WO
WIPO (PCT)
Prior art keywords
sustained
release preparation
tofacitinib
pharmaceutically acceptable
acceptable salt
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.)
Ceased
Application number
PCT/KR2019/017717
Other languages
French (fr)
Korean (ko)
Other versions
WO2020138791A2 (en
Inventor
박경희
윤재희
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.)
Daewoong Pharmaceutical Co Ltd
Original Assignee
Daewoong Pharmaceutical Co Ltd
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 Daewoong Pharmaceutical Co Ltd filed Critical Daewoong Pharmaceutical Co Ltd
Publication of WO2020138791A2 publication Critical patent/WO2020138791A2/en
Publication of WO2020138791A3 publication Critical patent/WO2020138791A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to a sustained-release preparation comprising tofacitinib or a pharmaceutically acceptable salt thereof, a release sustaining agent, and a hydrophilic binder. Disclosed is a sustained-release preparation in a hydrophilic matrix formulation form that shows in vivo effects as good as those of an immediate release preparation at a lower dose than that of currently commercialized sustained-release products, that is, at a dose of 10 mg and which is relatively simple in the manufacturing procedure thereof and as such, exhibits excellent productivity and economical benefit.
PCT/KR2019/017717 2018-12-28 2019-12-13 Sustained-release preparation comprising tofacitinib or pharmaceutically acceptable salt thereof and manufacturing method therefor Ceased WO2020138791A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2018-0172103 2018-12-28
KR1020180172103A KR20200082006A (en) 2018-12-28 2018-12-28 Extended release formulation containing tofacitinib or pharmaceutically acceptable salts thereof as an active ingredient and the preparation method for the same

Publications (2)

Publication Number Publication Date
WO2020138791A2 WO2020138791A2 (en) 2020-07-02
WO2020138791A3 true WO2020138791A3 (en) 2020-08-20

Family

ID=71126346

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2019/017717 Ceased WO2020138791A2 (en) 2018-12-28 2019-12-13 Sustained-release preparation comprising tofacitinib or pharmaceutically acceptable salt thereof and manufacturing method therefor

Country Status (3)

Country Link
KR (1) KR20200082006A (en)
TW (1) TW202038917A (en)
WO (1) WO2020138791A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7324210B2 (en) * 2018-01-31 2023-08-09 ティダブリューアイ・バイオテクノロジー・インコーポレイテッド Topical preparations containing tofacitinib
CN114588158B (en) * 2022-03-14 2023-09-05 武汉工程大学 Application of indole piperidine pyrimidine derivatives in the preparation of novel coronavirus inhibitors
CN115006361B (en) * 2022-06-10 2024-10-01 北京诺康达医药科技股份有限公司 Tofacitinib slow-release packaging chip and preparation method thereof
AU2023329168A1 (en) * 2022-08-26 2025-03-20 Synthon B.V. Prolonged release tofacitinib compositions without functional coating
CN115887408B (en) * 2022-11-29 2024-05-24 江苏慧聚药业股份有限公司 Pharmaceutical compositions and pharmaceutical preparations containing tofacitinib

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008004001A2 (en) * 2006-07-05 2008-01-10 Merck Sharp & Dohme Limited The use of pvp to control the release profile of an active ingredient from a hydrophilic polymer matrix tablet
WO2014147526A1 (en) * 2013-03-16 2014-09-25 Pfizer Inc. Tofacitinib oral sustained release dosage forms
WO2014174073A1 (en) * 2013-04-26 2014-10-30 Sandoz Ag Sustained release formulations of tofacitinib
KR20160117596A (en) * 2014-02-07 2016-10-10 오스펙스 파마슈티칼스, 인코포레이티드 Novel pharmaceutical formulations
US20170049774A1 (en) * 2015-08-19 2017-02-23 Sun Pharmaceutical Industries Limited Sustained release oral pharmaceutical compositions of tofacitinib

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2481411A1 (en) 2011-01-27 2012-08-01 Ratiopharm GmbH Oral dosage forms for modified release comprising the JAK3 inhibitor tasocitinib

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008004001A2 (en) * 2006-07-05 2008-01-10 Merck Sharp & Dohme Limited The use of pvp to control the release profile of an active ingredient from a hydrophilic polymer matrix tablet
WO2014147526A1 (en) * 2013-03-16 2014-09-25 Pfizer Inc. Tofacitinib oral sustained release dosage forms
WO2014174073A1 (en) * 2013-04-26 2014-10-30 Sandoz Ag Sustained release formulations of tofacitinib
KR20160117596A (en) * 2014-02-07 2016-10-10 오스펙스 파마슈티칼스, 인코포레이티드 Novel pharmaceutical formulations
US20170049774A1 (en) * 2015-08-19 2017-02-23 Sun Pharmaceutical Industries Limited Sustained release oral pharmaceutical compositions of tofacitinib

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
NOKHODCHI, A.: "The role of oral controlled release matrix tablets in drug delivery systems", BIOLMPACTS, vol. 2, no. 4, 4 November 2012 (2012-11-04), pages 175 - 187, XP055216956, DOI: 10.5681/bi.2012.027 *

Also Published As

Publication number Publication date
KR20200082006A (en) 2020-07-08
WO2020138791A2 (en) 2020-07-02
TW202038917A (en) 2020-11-01

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