JP2023510223A - 徐放性メラトニンペレットを含む剤形 - Google Patents

徐放性メラトニンペレットを含む剤形 Download PDF

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Publication number
JP2023510223A
JP2023510223A JP2022540995A JP2022540995A JP2023510223A JP 2023510223 A JP2023510223 A JP 2023510223A JP 2022540995 A JP2022540995 A JP 2022540995A JP 2022540995 A JP2022540995 A JP 2022540995A JP 2023510223 A JP2023510223 A JP 2023510223A
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Japan
Prior art keywords
melatonin
coating
carrier material
aqueous carrier
dosage form
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Pending
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JP2022540995A
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English (en)
Japanese (ja)
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JP2023510223A5 (https=
Inventor
サイド， エム シャー，
ダニエル ハッサン，
Original Assignee
ソシエテ・デ・プロデュイ・ネスレ・エス・アー
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Publication of JP2023510223A publication Critical patent/JP2023510223A/ja
Publication of JP2023510223A5 publication Critical patent/JP2023510223A5/ja
Priority to JP2025134129A priority Critical patent/JP2025169319A/ja
Pending legal-status Critical Current

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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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2022540995A 2020-01-17 2021-01-15 徐放性メラトニンペレットを含む剤形 Pending JP2023510223A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025134129A JP2025169319A (ja) 2020-01-17 2025-08-12 徐放性メラトニンペレットを含む剤形

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062962574P 2020-01-17 2020-01-17
US62/962,574 2020-01-17
PCT/EP2021/050770 WO2021144403A1 (en) 2020-01-17 2021-01-15 Dosage form with sustained release melatonin pellets

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025134129A Division JP2025169319A (ja) 2020-01-17 2025-08-12 徐放性メラトニンペレットを含む剤形

Publications (2)

Publication Number Publication Date
JP2023510223A true JP2023510223A (ja) 2023-03-13
JP2023510223A5 JP2023510223A5 (https=) 2024-01-15

Family

ID=74285447

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2022540995A Pending JP2023510223A (ja) 2020-01-17 2021-01-15 徐放性メラトニンペレットを含む剤形
JP2025134129A Pending JP2025169319A (ja) 2020-01-17 2025-08-12 徐放性メラトニンペレットを含む剤形

Family Applications After (1)

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JP2025134129A Pending JP2025169319A (ja) 2020-01-17 2025-08-12 徐放性メラトニンペレットを含む剤形

Country Status (8)

Country Link
US (2) US11723862B2 (https=)
EP (1) EP4090315A1 (https=)
JP (2) JP2023510223A (https=)
CN (1) CN114901256A (https=)
AU (1) AU2021207284B2 (https=)
BR (1) BR112022012199A2 (https=)
CA (1) CA3163378A1 (https=)
WO (1) WO2021144403A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024079125A1 (en) 2022-10-14 2024-04-18 Société des Produits Nestlé S.A. Sustained release melatonin compositions
CN116172979B (zh) * 2023-02-15 2024-10-15 浙江贝灵生物医药有限公司 一种褪黑素缓释小丸及其制备方法

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995003043A1 (en) * 1993-07-26 1995-02-02 State Of Oregon, Acting By And Through The Oregon State Board Of Higher Education On Behalf Of The Oregon Health Sciences University Sustained release oral compositions containing melatonin
WO2001023000A1 (fr) * 1999-09-30 2001-04-05 Otsuka Pharmaceutical Company, Limited Preparations d'enrobage solubles dans le tube digestif inferieur
KR20040026374A (ko) * 2002-09-24 2004-03-31 한국화학연구원 다층 코팅법을 이용한 멜라토닌 함유 타게팅 약물 전달 기구
JP2005527583A (ja) * 2002-04-28 2005-09-15 ヌリム・ファーマスーティカルズ・（１９９１）・リミテッド メラトニンを含む医薬製剤
JP2009539967A (ja) * 2006-06-23 2009-11-19 ザ プロクター アンド ギャンブル カンパニー メラトニン成分及び軟骨保護剤成分を含む組成物及びキット
JP2009539968A (ja) * 2006-06-23 2009-11-19 ザ プロクター アンド ギャンブル カンパニー メラトニン成分及びオメガ−３−脂肪酸成分を含む組成物及びキット
JP2010150271A (ja) * 2000-10-13 2010-07-08 Euro Celtique Sa 遅延放出医薬製剤
WO2012103411A2 (en) * 2011-01-28 2012-08-02 Zx Pharma, Llc Controlled-release melatonin composition and related methods
WO2012170611A1 (en) * 2011-06-07 2012-12-13 Zx Pharma, Llc Multiparticulate 5-htp compositions and related methods
JP2019504859A (ja) * 2016-02-11 2019-02-21 バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． フマル酸ジメチルを含む医薬ビーズ製剤
JP2019514977A (ja) * 2016-05-06 2019-06-06 フィジシャンズ シール，エルエルシー バレリアン組成物及び関連方法
EP3530289A1 (en) * 2018-02-26 2019-08-28 Lamda Laboratories S.A. Oral pharmaceutical solutions comprising melatonin
JP2022534159A (ja) * 2019-01-18 2022-07-28 ソシエテ・デ・プロデュイ・ネスレ・エス・アー 微細化した固形メラトニン組成物

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080171085A1 (en) * 2007-01-11 2008-07-17 Natrol, Inc. Novel biphasic delivery system for a pharmaceutical or nutraceutical composition and method of administration
WO2011160003A1 (en) * 2010-06-17 2011-12-22 Antioxidant Superfoods, Inc. Improved health characteristic chewy or gummy candy confection
ITMI20112042A1 (it) * 2011-11-10 2013-05-11 Eratech S R L Polvere da ricostituire prima dell'uso comprendente melatonina e preparazione iniettabile ottenibile da tale polvere.

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995003043A1 (en) * 1993-07-26 1995-02-02 State Of Oregon, Acting By And Through The Oregon State Board Of Higher Education On Behalf Of The Oregon Health Sciences University Sustained release oral compositions containing melatonin
WO2001023000A1 (fr) * 1999-09-30 2001-04-05 Otsuka Pharmaceutical Company, Limited Preparations d'enrobage solubles dans le tube digestif inferieur
JP2010150271A (ja) * 2000-10-13 2010-07-08 Euro Celtique Sa 遅延放出医薬製剤
JP2005527583A (ja) * 2002-04-28 2005-09-15 ヌリム・ファーマスーティカルズ・（１９９１）・リミテッド メラトニンを含む医薬製剤
KR20040026374A (ko) * 2002-09-24 2004-03-31 한국화학연구원 다층 코팅법을 이용한 멜라토닌 함유 타게팅 약물 전달 기구
JP2009539967A (ja) * 2006-06-23 2009-11-19 ザ プロクター アンド ギャンブル カンパニー メラトニン成分及び軟骨保護剤成分を含む組成物及びキット
JP2009539968A (ja) * 2006-06-23 2009-11-19 ザ プロクター アンド ギャンブル カンパニー メラトニン成分及びオメガ−３−脂肪酸成分を含む組成物及びキット
WO2012103411A2 (en) * 2011-01-28 2012-08-02 Zx Pharma, Llc Controlled-release melatonin composition and related methods
WO2012170611A1 (en) * 2011-06-07 2012-12-13 Zx Pharma, Llc Multiparticulate 5-htp compositions and related methods
JP2019504859A (ja) * 2016-02-11 2019-02-21 バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． フマル酸ジメチルを含む医薬ビーズ製剤
JP2019514977A (ja) * 2016-05-06 2019-06-06 フィジシャンズ シール，エルエルシー バレリアン組成物及び関連方法
EP3530289A1 (en) * 2018-02-26 2019-08-28 Lamda Laboratories S.A. Oral pharmaceutical solutions comprising melatonin
JP2022534159A (ja) * 2019-01-18 2022-07-28 ソシエテ・デ・プロデュイ・ネスレ・エス・アー 微細化した固形メラトニン組成物

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 188, JPN7024005541, 15 October 1999 (1999-10-15), pages 71 - 80, ISSN: 0005497517 *

Also Published As

Publication number Publication date
US20210220264A1 (en) 2021-07-22
US11723862B2 (en) 2023-08-15
AU2021207284A1 (en) 2022-06-09
EP4090315A1 (en) 2022-11-23
WO2021144403A1 (en) 2021-07-22
US20230045118A1 (en) 2023-02-09
US12558310B2 (en) 2026-02-24
JP2025169319A (ja) 2025-11-12
BR112022012199A2 (pt) 2022-09-13
CA3163378A1 (en) 2021-07-22
AU2021207284B2 (en) 2026-02-12
CN114901256A (zh) 2022-08-12

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