AU2020273810B2 - Powder formulation for intranasal administration, and manufacturing method thereof - Google Patents

Powder formulation for intranasal administration, and manufacturing method thereof

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Publication number
AU2020273810B2
AU2020273810B2 AU2020273810A AU2020273810A AU2020273810B2 AU 2020273810 B2 AU2020273810 B2 AU 2020273810B2 AU 2020273810 A AU2020273810 A AU 2020273810A AU 2020273810 A AU2020273810 A AU 2020273810A AU 2020273810 B2 AU2020273810 B2 AU 2020273810B2
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AU
Australia
Prior art keywords
water
composite particles
formulation
granulation
cellulose
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.)
Active
Application number
AU2020273810A
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English (en)
Other versions
AU2020273810A1 (en
Inventor
Shunji Haruta
Yo SONODA
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.)
Shin Nippon Biomedical Laboratories Ltd
Original Assignee
Shin Nippon Biomedical Laboratories 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
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Application filed by Shin Nippon Biomedical Laboratories Ltd filed Critical Shin Nippon Biomedical Laboratories Ltd
Publication of AU2020273810A1 publication Critical patent/AU2020273810A1/en
Application granted granted Critical
Publication of AU2020273810B2 publication Critical patent/AU2020273810B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • 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
    • A61K9/0012—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
    • 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

Landscapes

  • 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)
AU2020273810A 2019-05-16 2020-05-01 Powder formulation for intranasal administration, and manufacturing method thereof Active AU2020273810B2 (en)

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 (2)

Publication Number Publication Date
AU2020273810A1 AU2020273810A1 (en) 2021-11-18
AU2020273810B2 true AU2020273810B2 (en) 2025-10-09

Family

ID=73290206

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020273810A Active AU2020273810B2 (en) 2019-05-16 2020-05-01 Powder formulation for intranasal administration, and manufacturing method thereof

Country Status (10)

Country Link
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=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20250270471A1 (en) * 2022-04-21 2025-08-28 Merck Sharp & Dohme Llc Process for preparing agglomerated crystalline medium-chain fatty acid sodium salts
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
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 (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09291026A (ja) * 1996-02-28 1997-11-11 Teijin Ltd 即効性と持続性を兼ね備えた粉末状経鼻投与用組成物
JPH1059841A (ja) * 1996-02-27 1998-03-03 Teijin Ltd 吸収性が改善された粉末状経鼻投与組成物
JP2002187852A (ja) * 2000-03-21 2002-07-05 Jcr Pharmaceuticals Co Ltd 生理活性ペプチド含有粉末
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
WO2017223566A1 (en) * 2016-06-24 2017-12-28 Opiant Pharmaceuticals, Inc. Compositions, devices, and methods for the treatment of alcohol use disorder
WO2018025089A2 (en) * 2016-08-05 2018-02-08 Shin Nippon Biomedical Laboratories, Ltd. Pharmaceutical compositions
WO2018124062A1 (ja) * 2016-12-26 2018-07-05 塩野義製薬株式会社 含量均一性を改善した製剤の製造方法
WO2019065673A1 (en) * 2017-09-26 2019-04-04 Shin Nippon Biomedical Laboratories, Ltd. INTRANASAL DELIVERY DEVICES

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WO1993012818A1 (fr) * 1991-12-27 1993-07-08 Daiichi Pharmaceutical Co., Ltd. Preparation pharmaceutique pour application topique
JP3634380B2 (ja) * 1996-02-27 2005-03-30 帝人株式会社 粉末状経鼻投与組成物
JP3197222B2 (ja) 1996-02-28 2001-08-13 帝人株式会社 粉末状経鼻投与組成物
JP2001055323A (ja) * 1999-08-12 2001-02-27 Teijin Ltd 粉末状経鼻投与用組成物
KR20030027108A (ko) * 2001-07-05 2003-04-03 트렌스레셔널 리서치 가부시키가이샤 인슐린의 경비 투여용 조성물
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
US8337817B2 (en) * 2006-12-26 2012-12-25 Shin Nippon Biomedical Laboratories, Ltd. Preparation for transnasal application
CN101428009B (zh) * 2008-04-09 2013-01-09 上海医药工业研究院 胰岛素经鼻吸入粉雾剂
WO2009135646A2 (en) 2008-05-05 2009-11-12 Farmaprojects, Sa Stable pharmaceutical compositions and their processes for preparation suitable for industrial scale
WO2010131486A1 (en) * 2009-05-15 2010-11-18 Shin Nippon Biomedical Laboratories, Ltd. Intranasal pharmaceutical compositions with improved pharmacokinetics
ES2663335T3 (es) 2010-03-19 2018-04-12 Daiichi Sankyo Company, Limited Composición para administración transnasal y método para prepararla

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH1059841A (ja) * 1996-02-27 1998-03-03 Teijin Ltd 吸収性が改善された粉末状経鼻投与組成物
JPH09291026A (ja) * 1996-02-28 1997-11-11 Teijin Ltd 即効性と持続性を兼ね備えた粉末状経鼻投与用組成物
JP2002187852A (ja) * 2000-03-21 2002-07-05 Jcr Pharmaceuticals Co Ltd 生理活性ペプチド含有粉末
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
WO2017223566A1 (en) * 2016-06-24 2017-12-28 Opiant Pharmaceuticals, Inc. Compositions, devices, and methods for the treatment of alcohol use disorder
WO2018025089A2 (en) * 2016-08-05 2018-02-08 Shin Nippon Biomedical Laboratories, Ltd. Pharmaceutical compositions
WO2018124062A1 (ja) * 2016-12-26 2018-07-05 塩野義製薬株式会社 含量均一性を改善した製剤の製造方法
WO2019065673A1 (en) * 2017-09-26 2019-04-04 Shin Nippon Biomedical Laboratories, Ltd. INTRANASAL DELIVERY DEVICES

Also Published As

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
CN113784703A (zh) 2021-12-10
MX2021013442A (es) 2022-01-06
AU2020273810A1 (en) 2021-11-18
WO2020230676A1 (ja) 2020-11-19
KR20220009407A (ko) 2022-01-24
CA3138846A1 (en) 2020-11-19

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DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE INVENTION TITLE TO READ POWDER FORMULATION FOR INTRANASAL ADMINISTRATION, AND MANUFACTURING METHOD THEREOF

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