CN103732216A - 无机基质和有机聚合物组合用于制备稳定的无定形分散体的用途 - Google Patents

无机基质和有机聚合物组合用于制备稳定的无定形分散体的用途 Download PDF

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Publication number
CN103732216A
CN103732216A CN201280039578.7A CN201280039578A CN103732216A CN 103732216 A CN103732216 A CN 103732216A CN 201280039578 A CN201280039578 A CN 201280039578A CN 103732216 A CN103732216 A CN 103732216A
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amorphous
hydrochloride
drug products
cellulose
drug
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CN201280039578.7A
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Chinese (zh)
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J.希金斯
D.C.迪博斯特
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Merck Sharp and Dohme LLC
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Schering Corp
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    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K31/275—Nitriles; Isonitriles
    • A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
    • 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
    • A61K31/403—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 carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate 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
    • A61K9/143—Intimate 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 inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate 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
    • A61K9/145—Intimate 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 compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate 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
    • A61K9/146—Intimate 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN201280039578.7A 2011-08-16 2012-08-10 无机基质和有机聚合物组合用于制备稳定的无定形分散体的用途 Pending CN103732216A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161524033P 2011-08-16 2011-08-16
US61/524,033 2011-08-16
PCT/US2012/050221 WO2013025449A1 (en) 2011-08-16 2012-08-10 Use of inorganic matrix and organic polymer combinations for preparing stable amorphous dispersions

Publications (1)

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CN103732216A true CN103732216A (zh) 2014-04-16

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US (1) US20140206717A1 (https=)
EP (1) EP2744481A4 (https=)
JP (1) JP2014521745A (https=)
CN (1) CN103732216A (https=)
AU (1) AU2012295397A1 (https=)
CA (1) CA2844827A1 (https=)
IN (1) IN2014CN00827A (https=)
WO (1) WO2013025449A1 (https=)

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CN105943536A (zh) * 2016-05-06 2016-09-21 杭州容立医药科技有限公司 一种固体分散体的制备方法及其应用
CN108883190A (zh) * 2016-03-31 2018-11-23 宝丽制药股份有限公司 无定形化剂、包含无定形化剂而成的无定形的组合物及其使用
CN109152842A (zh) * 2016-04-29 2019-01-04 罗赛洛公司 用于活性药物成分的基于蛋白质的赋形剂
CN112023124A (zh) * 2019-06-03 2020-12-04 上海微创医疗器械（集团）有限公司 结晶型涂层及其制备方法和应用
CN112300086A (zh) * 2019-08-02 2021-02-02 江苏恩华药业股份有限公司 氯氮平与富马酸喹硫平共无定型物及其制备方法
CN113271978A (zh) * 2018-11-07 2021-08-17 创新材料制药公司 包括基本上无定形的介孔碳酸镁的新型无定形活性药物成分
CN113490492A (zh) * 2019-03-04 2021-10-08 日本烟草产业株式会社 吡唑酰胺化合物的非晶质固体分散体
CN116831989A (zh) * 2022-03-25 2023-10-03 天津市中西医结合医院（天津市南开医院） 一种用于评价难溶性固体分散体溶出的产品
CN117017922A (zh) * 2023-07-03 2023-11-10 青岛大学 一种克拉霉素掩味固体分散体及其制备方法

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US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
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Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108883190B (zh) * 2016-03-31 2022-07-01 宝丽制药股份有限公司 无定形化剂、包含无定形化剂而成的无定形的组合物及其使用
CN108883190A (zh) * 2016-03-31 2018-11-23 宝丽制药股份有限公司 无定形化剂、包含无定形化剂而成的无定形的组合物及其使用
CN109152842A (zh) * 2016-04-29 2019-01-04 罗赛洛公司 用于活性药物成分的基于蛋白质的赋形剂
US12582717B2 (en) 2016-04-29 2026-03-24 Dispersome Ip Aps Protein based excipient for active pharmaceutical ingredients
CN109152842B (zh) * 2016-04-29 2022-10-28 罗赛洛公司 用于活性药物成分的基于蛋白质的赋形剂
CN105943536A (zh) * 2016-05-06 2016-09-21 杭州容立医药科技有限公司 一种固体分散体的制备方法及其应用
US12459829B2 (en) 2018-11-07 2025-11-04 Disruptive Pharma Ab Amorphous active pharmaceutical ingredients comprising substantially amorphous mesoporous magnesium carbonate
CN113271978A (zh) * 2018-11-07 2021-08-17 创新材料制药公司 包括基本上无定形的介孔碳酸镁的新型无定形活性药物成分
CN113490492A (zh) * 2019-03-04 2021-10-08 日本烟草产业株式会社 吡唑酰胺化合物的非晶质固体分散体
CN112023124A (zh) * 2019-06-03 2020-12-04 上海微创医疗器械（集团）有限公司 结晶型涂层及其制备方法和应用
CN112300086B (zh) * 2019-08-02 2022-03-15 苏州恩华生物医药科技有限公司 氯氮平与富马酸喹硫平共无定型物及其制备方法
CN112300086A (zh) * 2019-08-02 2021-02-02 江苏恩华药业股份有限公司 氯氮平与富马酸喹硫平共无定型物及其制备方法
CN116831989A (zh) * 2022-03-25 2023-10-03 天津市中西医结合医院（天津市南开医院） 一种用于评价难溶性固体分散体溶出的产品
CN116831989B (zh) * 2022-03-25 2025-11-21 天津市中西医结合医院（天津市南开医院） 一种用于评价难溶性固体分散体溶出的产品
CN117017922A (zh) * 2023-07-03 2023-11-10 青岛大学 一种克拉霉素掩味固体分散体及其制备方法

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AU2012295397A1 (en) 2014-02-20
US20140206717A1 (en) 2014-07-24
JP2014521745A (ja) 2014-08-28
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CA2844827A1 (en) 2013-02-21
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