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WO2014207664A3 - Stable pharmaceutical composition of asenapine - Google Patents

Stable pharmaceutical composition of asenapine Download PDF

Info

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
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/IB2014/062575
Other languages
French (fr)
Other versions
WO2014207664A2 (en
Inventor
Veerababu Ramabrahmmam Taduri
Viral Ramesh VAIDYA
Jigar Rameshchandra LALANI
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.)
Alembic Pharmaceuticals Ltd
Original Assignee
Alembic Pharmaceuticals 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 Alembic Pharmaceuticals Ltd filed Critical Alembic Pharmaceuticals Ltd
Publication of WO2014207664A2 publication Critical patent/WO2014207664A2/en
Publication of WO2014207664A3 publication Critical patent/WO2014207664A3/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
    • 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
    • A61K31/40—Heterocyclic 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
    • A61K31/407—Heterocyclic 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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

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

The present invention relates to a stable pharmaceutical composition for sublingual and/or buccal administration comprising asenapine or pharmaceutically acceptable salt thereof, antioxidant. water-soluble polymer, water soluble diluent, disintegrant and optionally one or more pharmaceutically acceptable excipient having improved bioavailability or is bioequivalent to marketed product Saphris®, Sycrest® and process for preparation of same.
PCT/IB2014/062575 2013-06-28 2014-06-25 Stable pharmaceutical composition of asenapine Ceased WO2014207664A2 (en)

Applications Claiming Priority (2)

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

Publications (2)

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

Family

ID=52142775

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/062575 Ceased WO2014207664A2 (en) 2013-06-28 2014-06-25 Stable pharmaceutical composition of asenapine

Country Status (2)

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

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10898449B2 (en) 2016-12-20 2021-01-26 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine
US11033512B2 (en) 2017-06-26 2021-06-15 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine and silicone acrylic hybrid polymer
US11337932B2 (en) 2016-12-20 2022-05-24 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine and polysiloxane or polyisobutylene
US11648213B2 (en) 2018-06-20 2023-05-16 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine
US12329862B2 (en) 2018-06-20 2025-06-17 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine
US12485099B2 (en) 2016-12-20 2025-12-02 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine and polysiloxane or polyisobutylene

Families Citing this family (5)

* 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
CN109288800A (en) * 2018-10-30 2019-02-01 天津仁生医药科技有限公司 Maleic acid asenapine piece and preparation method thereof
CN109330984A (en) * 2018-11-20 2019-02-15 天津仁生医药科技有限公司 A kind of Maleic acid asenapine sublingual tablet and preparation method thereof
KR102883506B1 (en) * 2019-10-28 2025-11-12 히사미쓰 세이야꾸 가부시키가이샤 Methods for inhibiting the production of asenapine-N-oxide

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 (en) * 2011-03-11 2012-09-20 Medichem S.A. NEW CRYSTAL FORMS OF THE SALT OF TRANS-5-CHLORO-2-METHYL-2,3,3A,12b-TETRAHYDRO-1H-DIBENZO[2,3:6,7]OXEPINO[4,5-c]PYRROLE WITH MALEIC ACID

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 (en) * 2011-03-11 2012-09-20 Medichem S.A. NEW CRYSTAL FORMS OF THE SALT OF TRANS-5-CHLORO-2-METHYL-2,3,3A,12b-TETRAHYDRO-1H-DIBENZO[2,3:6,7]OXEPINO[4,5-c]PYRROLE WITH MALEIC ACID

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10898449B2 (en) 2016-12-20 2021-01-26 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine
US10980753B2 (en) 2016-12-20 2021-04-20 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine
US11337932B2 (en) 2016-12-20 2022-05-24 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine and polysiloxane or polyisobutylene
US12138353B2 (en) 2016-12-20 2024-11-12 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine
US12485099B2 (en) 2016-12-20 2025-12-02 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine and polysiloxane or polyisobutylene
US11033512B2 (en) 2017-06-26 2021-06-15 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine and silicone acrylic hybrid polymer
US11648213B2 (en) 2018-06-20 2023-05-16 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine
US12329862B2 (en) 2018-06-20 2025-06-17 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system containing asenapine

Also Published As

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

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