CN113784703A - 经鼻施予用粉末制剂及其制造方法 - Google Patents

经鼻施予用粉末制剂及其制造方法 Download PDF

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Publication number
CN113784703A
CN113784703A CN202080032083.6A CN202080032083A CN113784703A CN 113784703 A CN113784703 A CN 113784703A CN 202080032083 A CN202080032083 A CN 202080032083A CN 113784703 A CN113784703 A CN 113784703A
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Prior art keywords
composite particles
water
active ingredient
insoluble polysaccharide
powder formulation
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Pending
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CN202080032083.6A
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English (en)
Chinese (zh)
Inventor
治田俊志
园田阳
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Shin Nippon Biomedical Laboratories Ltd
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Shin Nippon Biomedical Laboratories Ltd
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Publication of CN113784703A publication Critical patent/CN113784703A/zh
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    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/0043—Nose
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/422—Oxazoles not condensed and containing further heterocyclic rings
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • 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
    • A61K31/658—Medicinal preparations containing organic active ingredients o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Otolaryngology (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN202080032083.6A 2019-05-16 2020-05-01 经鼻施予用粉末制剂及其制造方法 Pending CN113784703A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2019093150 2019-05-16
JP2019-093150 2019-05-16
PCT/JP2020/018456 WO2020230676A1 (ja) 2019-05-16 2020-05-01 経鼻投与用の粉末製剤及びその製造方法

Publications (1)

Publication Number Publication Date
CN113784703A true CN113784703A (zh) 2021-12-10

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CN202080032083.6A Pending CN113784703A (zh) 2019-05-16 2020-05-01 经鼻施予用粉末制剂及其制造方法

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US (1) US12478581B2 (https=)
EP (1) EP3970696A4 (https=)
JP (2) JPWO2020230676A1 (https=)
KR (1) KR20220009407A (https=)
CN (1) CN113784703A (https=)
AU (1) AU2020273810B2 (https=)
BR (1) BR112021021841A2 (https=)
CA (1) CA3138846A1 (https=)
MX (1) MX2021013442A (https=)
WO (1) WO2020230676A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117503703A (zh) * 2023-11-09 2024-02-06 广州新济药业科技有限公司 一种左旋多巴鼻喷雾剂及其制备方法及应用

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* Cited by examiner, † Cited by third party
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US20250270471A1 (en) * 2022-04-21 2025-08-28 Merck Sharp & Dohme Llc Process for preparing agglomerated crystalline medium-chain fatty acid sodium salts
WO2025225629A1 (ja) * 2024-04-23 2025-10-30 株式会社メディラボRfp 経鼻投与用組成物

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09291025A (ja) * 1996-02-28 1997-11-11 Teijin Ltd 粉末状経鼻投与組成物
CN1491114A (zh) * 2001-07-05 2004-04-21 ��ҵ���о���ʽ���� 胰岛素的经鼻给药用组合物
CN101428009A (zh) * 2008-04-09 2009-05-13 上海医药工业研究院 胰岛素经鼻吸入粉雾剂
CN101668544A (zh) * 2006-12-26 2010-03-10 株式会社新日本科学 经鼻投用制剂
CN102905717A (zh) * 2010-03-19 2013-01-30 第一三共株式会社 经鼻投与用组合物及其制造方法
WO2017223566A1 (en) * 2016-06-24 2017-12-28 Opiant Pharmaceuticals, Inc. Compositions, devices, and methods for the treatment of alcohol use disorder

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JP3634380B2 (ja) * 1996-02-27 2005-03-30 帝人株式会社 粉末状経鼻投与組成物
JP3197221B2 (ja) * 1996-02-27 2001-08-13 帝人株式会社 吸収性が改善された粉末状経鼻投与組成物
JP3197223B2 (ja) * 1996-02-28 2001-08-13 帝人株式会社 即効性と持続性を兼ね備えた粉末状経鼻投与用組成物
JP2001055323A (ja) * 1999-08-12 2001-02-27 Teijin Ltd 粉末状経鼻投与用組成物
JP4711520B2 (ja) * 2000-03-21 2011-06-29 日本ケミカルリサーチ株式会社 生理活性ペプチド含有粉末
WO2006016530A1 (ja) 2004-08-10 2006-02-16 Translational Research, Ltd. 速効性でかつ高い吸収性を可能とする経鼻投与用組成物
JPWO2006064906A1 (ja) 2004-12-17 2008-06-12 小野薬品工業株式会社 非晶質性組成物
JP2006176461A (ja) * 2004-12-24 2006-07-06 Dai Ichi Seiyaku Co Ltd 粒状物
ITRM20050443A1 (it) 2005-08-12 2007-02-13 Opocrin Spa Preparati oftalmici a base di polisaccaridi mucoadesivi con capacita' riepitelizzante della cornea.
CA2672134C (en) * 2006-12-07 2015-02-10 Daiichi Sankyo Company, Limited Solid medicinal preparation containing mannitol or lactose
WO2009135646A2 (en) 2008-05-05 2009-11-12 Farmaprojects, Sa Stable pharmaceutical compositions and their processes for preparation suitable for industrial scale
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JP2017036214A (ja) * 2013-12-10 2017-02-16 株式会社ダイセル 炭酸塩を含む口腔内崩壊錠剤用組成物及び口腔内崩壊錠剤
EP3493789A2 (en) * 2016-08-05 2019-06-12 Shin Nippon Biomedical Laboratories, Ltd. Intranasal pharmaceutical powder compositions
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Publication number Priority date Publication date Assignee Title
JPH09291025A (ja) * 1996-02-28 1997-11-11 Teijin Ltd 粉末状経鼻投与組成物
CN1491114A (zh) * 2001-07-05 2004-04-21 ��ҵ���о���ʽ���� 胰岛素的经鼻给药用组合物
CN101668544A (zh) * 2006-12-26 2010-03-10 株式会社新日本科学 经鼻投用制剂
CN101428009A (zh) * 2008-04-09 2009-05-13 上海医药工业研究院 胰岛素经鼻吸入粉雾剂
CN102905717A (zh) * 2010-03-19 2013-01-30 第一三共株式会社 经鼻投与用组合物及其制造方法
WO2017223566A1 (en) * 2016-06-24 2017-12-28 Opiant Pharmaceuticals, Inc. Compositions, devices, and methods for the treatment of alcohol use disorder

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117503703A (zh) * 2023-11-09 2024-02-06 广州新济药业科技有限公司 一种左旋多巴鼻喷雾剂及其制备方法及应用
CN117503703B (zh) * 2023-11-09 2024-11-22 广州新济药业科技有限公司 一种左旋多巴鼻喷雾剂及其制备方法及应用
WO2025098365A1 (zh) * 2023-11-09 2025-05-15 广州新济药业科技有限公司 一种左旋多巴鼻喷雾剂及其制备方法及应用

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Publication number Publication date
JP2024111203A (ja) 2024-08-16
EP3970696A4 (en) 2023-03-01
EP3970696A1 (en) 2022-03-23
US12478581B2 (en) 2025-11-25
BR112021021841A2 (pt) 2022-01-04
US20220183971A1 (en) 2022-06-16
JPWO2020230676A1 (https=) 2020-11-19
MX2021013442A (es) 2022-01-06
AU2020273810A1 (en) 2021-11-18
WO2020230676A1 (ja) 2020-11-19
AU2020273810B2 (en) 2025-10-09
KR20220009407A (ko) 2022-01-24
CA3138846A1 (en) 2020-11-19

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