WO2023134641A1 - Système d'administration par voie transdermique d'olanzapine, son procédé de préparation et son utilisation - Google Patents

Système d'administration par voie transdermique d'olanzapine, son procédé de préparation et son utilisation Download PDF

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Publication number
WO2023134641A1
WO2023134641A1 PCT/CN2023/071410 CN2023071410W WO2023134641A1 WO 2023134641 A1 WO2023134641 A1 WO 2023134641A1 CN 2023071410 W CN2023071410 W CN 2023071410W WO 2023134641 A1 WO2023134641 A1 WO 2023134641A1
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WO
WIPO (PCT)
Prior art keywords
olanzapine
layer
delivery system
adhesive
acid
Prior art date
Application number
PCT/CN2023/071410
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English (en)
Chinese (zh)
Inventor
唐俭生
Original Assignee
新领医药技术(深圳)有限公司
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Publication date
Application filed by 新领医药技术(深圳)有限公司 filed Critical 新领医药技术(深圳)有限公司
Priority to CN202380008874.9A priority Critical patent/CN116829131B/zh
Publication of WO2023134641A1 publication Critical patent/WO2023134641A1/fr

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    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics

Abstract

La présente invention concerne un système d'administration par voie transdermique d'olanzapine, son procédé de préparation et son utilisation. De l'olanzapine, ou un sel pharmaceutiquement acceptable correspondant, dans le système d'administration par voie transdermique est dispersée dans un état amorphe dans une couche de matrice, permettant une libération de médicament stable.
PCT/CN2023/071410 2022-01-12 2023-01-09 Système d'administration par voie transdermique d'olanzapine, son procédé de préparation et son utilisation WO2023134641A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202380008874.9A CN116829131B (zh) 2022-01-12 2023-01-09 奥氮平透皮给药系统及其制备方法和用途

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202210031805.7 2022-01-12
CN202210031805 2022-01-12

Publications (1)

Publication Number Publication Date
WO2023134641A1 true WO2023134641A1 (fr) 2023-07-20

Family

ID=87280086

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2023/071410 WO2023134641A1 (fr) 2022-01-12 2023-01-09 Système d'administration par voie transdermique d'olanzapine, son procédé de préparation et son utilisation

Country Status (2)

Country Link
CN (1) CN116829131B (fr)
WO (1) WO2023134641A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210244679A1 (en) * 2020-01-13 2021-08-12 Starton Therapeutics, Inc. Treatment of vomiting and nausea with minimum dose of olanzapine
US20220040194A1 (en) * 2018-12-17 2022-02-10 Starton Therapeutics, Inc. Use of olanzapine for treatment of parp-inhibitor-induced nausea
WO2022066987A1 (fr) * 2020-09-25 2022-03-31 Starton Therapeutics, Inc. Traitement des vomissements et de la nausée par une dose minimale d'olanzapine

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5891461A (en) * 1995-09-14 1999-04-06 Cygnus, Inc. Transdermal administration of olanzapine
EP1684734A2 (fr) * 2003-11-18 2006-08-02 3M Innovative Properties Company Compositions d'administration medicamenteuse transdermique renfermant de l'olanzapine
WO2012084969A1 (fr) * 2010-12-22 2012-06-28 Hexal Ag Composition adhésive contenant de la rotigotine et système thérapeutique transdermique comprenant la composition adhésive
DE102012013439A1 (de) * 2012-07-03 2014-01-23 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Transdermales therapeutisches System umfassend Rotigotin und Kristallisationsinhibitor
DE102011090178A1 (de) * 2011-12-30 2013-07-04 Lts Lohmann Therapie-Systeme Ag Transdermales therapeutisches System mit geringer Neigung zur Spontankristallisation
CN106361728B (zh) * 2015-07-22 2021-03-26 广东东阳光药业有限公司 经皮吸收制剂及制备经皮吸收制剂的方法
WO2019243452A1 (fr) * 2018-06-20 2019-12-26 Lts Lohmann Therapie-Systeme Ag Système thérapeutique transdermique contenant de l'asénapine

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220040194A1 (en) * 2018-12-17 2022-02-10 Starton Therapeutics, Inc. Use of olanzapine for treatment of parp-inhibitor-induced nausea
US20210244679A1 (en) * 2020-01-13 2021-08-12 Starton Therapeutics, Inc. Treatment of vomiting and nausea with minimum dose of olanzapine
WO2022066987A1 (fr) * 2020-09-25 2022-03-31 Starton Therapeutics, Inc. Traitement des vomissements et de la nausée par une dose minimale d'olanzapine

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
AGGARWAL GEETA, DHAWAN SANJU, L. HARIKUMAR S.: "Natural Oils as Skin Permeation Enhancers for Transdermal Delivery of Olanzapine: In Vitro and In Vivo Evaluation", CURRENT DRUG DELIVERY, BENTHAM SCIENCE PUBLISHERS, HILVERSUM, NL, vol. 9, no. 2, 1 March 2012 (2012-03-01), NL , pages 172 - 181, XP055872569, ISSN: 1567-2018, DOI: 10.2174/156720112800234567 *
LI NING; QUAN PENG; WAN XIAOCAO; LIU CHAO; LIU XIAOCHANG; FANG LIANG: "Mechanistic insights of the enhancement effect of sorbitan monooleate on olanzapine transdermal patch both in release and percutaneous absorption processes", EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, ELSEVIER AMSTERDAM, NL, vol. 107, 8 July 2017 (2017-07-08), NL , pages 138 - 147, XP085151551, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2017.07.006 *
MENG-SI LIU, HAN HONG-CAN; SUN CHUN-MENG;: "The application of non-oral modified release preparation in the treatment of schizophrenia and general consideration for its research and development", THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY, vol. 37, no. 10, 28 May 2021 (2021-05-28), pages 1255 - 1265, XP093078693 *
ZHIRONG LI, CHEN YONGSHUN, DU SHIMING, JIANG HUAJUN: "Effect of Matrixes and Different Penetration Enhancers on Transdermal Permeability of Olanzapine in vitro", CHINA PHARMACIST, vol. 16, no. 7, 5 July 2013 (2013-07-05), pages 1017 - 1020, XP093078691 *

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Publication number Publication date
CN116829131B (zh) 2024-05-07
CN116829131A (zh) 2023-09-29

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