CN113164473A - 一种维拉佐酮固体分散体及其制备方法 - Google Patents

一种维拉佐酮固体分散体及其制备方法 Download PDF

Info

Publication number
CN113164473A
CN113164473A CN201980080366.5A CN201980080366A CN113164473A CN 113164473 A CN113164473 A CN 113164473A CN 201980080366 A CN201980080366 A CN 201980080366A CN 113164473 A CN113164473 A CN 113164473A
Authority
CN
China
Prior art keywords
vilazodone
solid dispersion
carrier material
surfactant
dispersion according
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.)
Pending
Application number
CN201980080366.5A
Other languages
English (en)
Inventor
方代龙
范露露
黄心
游劲松
黄芳芳
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.)
Sunshine Lake Pharma Co Ltd
Guangdong HEC Pharmaceutical
Original Assignee
Sunshine Lake Pharma 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 Sunshine Lake Pharma Co Ltd filed Critical Sunshine Lake Pharma Co Ltd
Publication of CN113164473A publication Critical patent/CN113164473A/zh
Pending legal-status Critical Current

Links

Images

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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/34Macromolecular 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
    • 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
    • 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
    • A61K47/44Oils, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

本发明涉及一种维拉佐酮固体分散体及其制备方法和用途,所述维拉佐酮固体分散体包含活性成分维拉佐酮、水溶性聚合物载体材料和表面活性剂。所述水溶性聚合物载体材料选自聚维酮、共聚维酮、羟丙基甲基纤维素中的至少一种。所述固体分散体中,维拉佐酮以非结晶态存在于固体分散体中,该固体分散稳定性好,显著提高维拉佐酮的溶解度和体外溶出度,从而显著增加其口服生物利用度。所述维拉佐酮固体分散体可用于制备维拉佐酮相关制剂。

Description

PCT国内申请,说明书已公开。

Claims (30)

  1. PCT国内申请,权利要求书已公开。
CN201980080366.5A 2018-12-13 2019-12-11 一种维拉佐酮固体分散体及其制备方法 Pending CN113164473A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2018115230432 2018-12-13
CN201811523043 2018-12-13
PCT/CN2019/124429 WO2020119698A1 (zh) 2018-12-13 2019-12-11 一种维拉佐酮固体分散体及其制备方法

Publications (1)

Publication Number Publication Date
CN113164473A true CN113164473A (zh) 2021-07-23

Family

ID=71075886

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201980080366.5A Pending CN113164473A (zh) 2018-12-13 2019-12-11 一种维拉佐酮固体分散体及其制备方法
CN201980080339.8A Active CN113164394B (zh) 2018-12-13 2019-12-11 一种维拉佐酮固体分散体及其制备方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201980080339.8A Active CN113164394B (zh) 2018-12-13 2019-12-11 一种维拉佐酮固体分散体及其制备方法

Country Status (3)

Country Link
US (1) US20220071993A1 (zh)
CN (2) CN113164473A (zh)
WO (2) WO2020119698A1 (zh)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202348231A (zh) * 2022-03-25 2023-12-16 大陸商深圳市藥欣生物科技有限公司 非晶形固體分散液及包含其之醫藥組合物
CN115581678B (zh) * 2022-11-04 2023-09-12 北京鑫开元医药科技有限公司 一种瑞派替尼片组合物及其制备方法
CN117257804A (zh) * 2023-10-17 2023-12-22 深圳市新阳唯康科技有限公司 达拉非尼药物组合物及其制备方法和应用

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013078361A1 (en) * 2011-11-23 2013-05-30 Assia Chemical Industries Ltd. Solid state forms of vilazodone and vilazodone hydrochloride
CN103211751A (zh) * 2013-03-30 2013-07-24 北京万全德众医药生物技术有限公司 含维拉唑酮的药物组合物及其制备方法
WO2013168126A1 (en) * 2012-05-11 2013-11-14 Dr.Reddys Laboratories Limited Crystalline forms of vilazodone hydrochloride and vilazodone free base
US20130324554A1 (en) * 2012-06-05 2013-12-05 Symed Labs Limited Amorphous form of vilazodone hydrochloride substantially free of crystalline forms
CN104116741A (zh) * 2013-04-24 2014-10-29 江苏先声药物研究有限公司 盐酸维拉佐酮组合物及其制备方法
IN2013MU03458A (zh) * 2013-10-31 2015-07-17 Lupin Ltd
CN106540266A (zh) * 2015-09-18 2017-03-29 天津市汉康医药生物技术有限公司 一种维拉佐酮药物组合物及其制备方法
CN106580914A (zh) * 2017-02-27 2017-04-26 佛山市弘泰药物研发有限公司 一种盐酸维拉佐酮软胶囊及其制备方法
CN106580895A (zh) * 2016-12-07 2017-04-26 万全万特制药(厦门)有限公司 含盐酸维拉佐酮固体分散体的口腔崩解片及其制备方法
WO2018127088A1 (en) * 2017-01-06 2018-07-12 Sunshine Lake Pharma Co., Ltd. Lurasidone solid dispersion and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2009217865A1 (en) * 2008-02-28 2009-09-03 Bial - Portela & Ca., S.A. Pharmaceutical composition for poorly soluble drugs
CN104523620A (zh) * 2014-12-14 2015-04-22 天津市康瑞药业有限公司 维拉佐酮滴丸及其制备方法
CN108078934B (zh) * 2017-12-26 2020-08-28 南京工业大学 一种盐酸齐拉西酮固体分散片及其热熔挤出方法

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013078361A1 (en) * 2011-11-23 2013-05-30 Assia Chemical Industries Ltd. Solid state forms of vilazodone and vilazodone hydrochloride
WO2013168126A1 (en) * 2012-05-11 2013-11-14 Dr.Reddys Laboratories Limited Crystalline forms of vilazodone hydrochloride and vilazodone free base
US20130324554A1 (en) * 2012-06-05 2013-12-05 Symed Labs Limited Amorphous form of vilazodone hydrochloride substantially free of crystalline forms
CN103211751A (zh) * 2013-03-30 2013-07-24 北京万全德众医药生物技术有限公司 含维拉唑酮的药物组合物及其制备方法
CN104116741A (zh) * 2013-04-24 2014-10-29 江苏先声药物研究有限公司 盐酸维拉佐酮组合物及其制备方法
IN2013MU03458A (zh) * 2013-10-31 2015-07-17 Lupin Ltd
CN106540266A (zh) * 2015-09-18 2017-03-29 天津市汉康医药生物技术有限公司 一种维拉佐酮药物组合物及其制备方法
CN106580895A (zh) * 2016-12-07 2017-04-26 万全万特制药(厦门)有限公司 含盐酸维拉佐酮固体分散体的口腔崩解片及其制备方法
WO2018127088A1 (en) * 2017-01-06 2018-07-12 Sunshine Lake Pharma Co., Ltd. Lurasidone solid dispersion and preparation method thereof
CN106580914A (zh) * 2017-02-27 2017-04-26 佛山市弘泰药物研发有限公司 一种盐酸维拉佐酮软胶囊及其制备方法

Also Published As

Publication number Publication date
CN113164394B (zh) 2023-06-23
US20220071993A1 (en) 2022-03-10
WO2020119698A1 (zh) 2020-06-18
CN113164394A (zh) 2021-07-23
WO2020119701A1 (zh) 2020-06-18

Similar Documents

Publication Publication Date Title
US7923026B2 (en) Embedded micellar nanoparticles
AU2021277731B2 (en) Improved formulations of deferasirox and methods of making the same
RU2351316C2 (ru) Лекарственные формы с замедленным высвобождением зипразидона
AU2007312233B2 (en) Micellar nanoparticles of chemical substances
WO2017042607A2 (en) Compositions comprising meloxicam-cyclodextrin inclusion complexes and methods of treating acute pain
CN113164473A (zh) 一种维拉佐酮固体分散体及其制备方法
US8663698B2 (en) Solid dispersion preparation
JP2011530532A (ja) 固体分子分散物中のhcvプロテアーゼインヒビターの薬学的処方物
EP2278957A2 (en) Oral pharmaceutical compositions in a solid dispersion comprising preferably posaconazole and hpmcas
US20070248682A1 (en) Solid preparation comprising enteric solid dispersion
CN115025048A (zh) 一种阿瑞匹坦的三元固体分散体
CN114533735A (zh) 盐酸鲁拉西酮药物组合物及其制备方法
US20100317642A1 (en) Pharmaceutical composition of orlistat
CN114948960A (zh) 一种维拉佐酮的组合物及其制备方法
WO2020225738A1 (en) Pharmaceutical composition comprising venetoclax
Vasconcelos Development of a Resveratrol Drug Delivery System Presenting Enhanced Bioavailability
CN113081970A (zh) 一种环孢素固体分散体及其片剂制备方法
Pushparaj Solubility Enhancement of BCS Class II Drug By Solid Dispersion Technique–Fabrication and Evaluation.

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
CB02 Change of applicant information

Address after: 523808 No.1, Gongye North Road, Songshanhu Park, Dongguan City, Guangdong Province

Applicant after: Guangdong Dongyangguang Pharmaceutical Co.,Ltd.

Address before: 523808 Songshan Lake Science and Technology Industrial Park, Dongguan City, Guangdong Province

Applicant before: SUNSHINE LAKE PHARMA Co.,Ltd.

CB02 Change of applicant information