WO2014207664A3 - Composition pharmaceutique stable d'asénapine - Google Patents

Composition pharmaceutique stable d'asénapine Download PDF

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Publication number
WO2014207664A3
WO2014207664A3 PCT/IB2014/062575 IB2014062575W WO2014207664A3 WO 2014207664 A3 WO2014207664 A3 WO 2014207664A3 IB 2014062575 W IB2014062575 W IB 2014062575W WO 2014207664 A3 WO2014207664 A3 WO 2014207664A3
Authority
WO
WIPO (PCT)
Prior art keywords
asenapine
pharmaceutical composition
stable pharmaceutical
pharmaceutically acceptable
water
Prior art date
Application number
PCT/IB2014/062575
Other languages
English (en)
Other versions
WO2014207664A2 (fr
Inventor
Veerababu Ramabrahmmam Taduri
Viral Ramesh VAIDYA
Jigar Rameshchandra LALANI
Original Assignee
Alembic Pharmaceuticals Limited
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 Alembic Pharmaceuticals Limited filed Critical Alembic Pharmaceuticals Limited
Publication of WO2014207664A2 publication Critical patent/WO2014207664A2/fr
Publication of WO2014207664A3 publication Critical patent/WO2014207664A3/fr

Links

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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/407Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

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)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne une composition pharmaceutique stable pour l'administration par voie buccale et/ou sublinguale comprenant de l'asénapine ou un de ses sel pharmaceutiquement acceptable, un antioxydant, un polymère soluble dans l'eau, un diluant soluble dans l'eau, un délitant et éventuellement un ou plusieurs excipients pharmaceutiquement acceptables présentant une biodisponibilité améliorée ou bioéquivalente au produit commercialisé Saphris ®, Sycrest ® et un procédé de préparation de ceux-ci.
PCT/IB2014/062575 2013-06-28 2014-06-25 Composition pharmaceutique stable d'asénapine WO2014207664A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2206/MUM/2013 2013-06-28
IN2206MU2013 IN2013MU02206A (fr) 2013-06-28 2014-06-25

Publications (2)

Publication Number Publication Date
WO2014207664A2 WO2014207664A2 (fr) 2014-12-31
WO2014207664A3 true WO2014207664A3 (fr) 2015-04-02

Family

ID=52142775

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/062575 WO2014207664A2 (fr) 2013-06-28 2014-06-25 Composition pharmaceutique stable d'asénapine

Country Status (2)

Country Link
IN (1) IN2013MU02206A (fr)
WO (1) WO2014207664A2 (fr)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170007537A1 (en) * 2014-02-18 2017-01-12 Hetero Research Foundation Pharmaceutical compositions of asenapine
US10085971B2 (en) 2016-08-22 2018-10-02 Navinta Iii Inc Pharmaceutical solution of asenapine for sublingual or buccal use
KR102614709B1 (ko) 2016-12-20 2023-12-18 에르테에스 로만 테라피-시스테메 아게 아세나핀 및 폴리실록산 또는 폴리이소부틸렌을 함유하는 경피흡수 치료 시스템
CN110087640A (zh) 2016-12-20 2019-08-02 罗曼治疗系统股份公司 包含阿塞那平的透皮治疗系统
US11033512B2 (en) 2017-06-26 2021-06-15 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine and silicone acrylic hybrid polymer
KR20210022656A (ko) 2018-06-20 2021-03-03 에르테에스 로만 테라피-시스테메 아게 아세나핀을 함유하는 경피 치료 시스템
CN109288800A (zh) * 2018-10-30 2019-02-01 天津仁生医药科技有限公司 马来酸阿塞那平片及其制备方法
CN109330984A (zh) * 2018-11-20 2019-02-15 天津仁生医药科技有限公司 一种马来酸阿塞那平舌下片及其制备方法
JP7170124B2 (ja) * 2019-10-28 2022-11-11 久光製薬株式会社 アセナピン-n-オキシドの生成を抑制する方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5763476A (en) * 1994-03-02 1998-06-09 Akzo Noble N.V. Sublingual or buccal pharmaceutical composition
WO2012123325A1 (fr) * 2011-03-11 2012-09-20 Medichem S.A. Nouvelles formes cristallines du sel de trans-5-chloro-2-méthyl-2,3,3a,12b-tétrahydro-1h-dibenzo[2,3:6,7] oxépino[4,5-c]pyrrole avec l'acide maléique

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5763476A (en) * 1994-03-02 1998-06-09 Akzo Noble N.V. Sublingual or buccal pharmaceutical composition
WO2012123325A1 (fr) * 2011-03-11 2012-09-20 Medichem S.A. Nouvelles formes cristallines du sel de trans-5-chloro-2-méthyl-2,3,3a,12b-tétrahydro-1h-dibenzo[2,3:6,7] oxépino[4,5-c]pyrrole avec l'acide maléique

Also Published As

Publication number Publication date
WO2014207664A2 (fr) 2014-12-31
IN2013MU02206A (fr) 2015-06-12

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