AU2021207284B2 - Dosage form with sustained release melatonin pellets - Google Patents

Dosage form with sustained release melatonin pellets

Info

Publication number
AU2021207284B2
AU2021207284B2 AU2021207284A AU2021207284A AU2021207284B2 AU 2021207284 B2 AU2021207284 B2 AU 2021207284B2 AU 2021207284 A AU2021207284 A AU 2021207284A AU 2021207284 A AU2021207284 A AU 2021207284A AU 2021207284 B2 AU2021207284 B2 AU 2021207284B2
Authority
AU
Australia
Prior art keywords
melatonin
carrier material
coating
aqueous carrier
dosage form
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
AU2021207284A
Other languages
English (en)
Other versions
AU2021207284A1 (en
Inventor
Daniel HASSAN
Syed M. Shah
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.)
Societe des Produits Nestle SA
Original Assignee
Societe des Produits Nestle SA
Nestle SA
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 Societe des Produits Nestle SA, Nestle SA filed Critical Societe des Produits Nestle SA
Publication of AU2021207284A1 publication Critical patent/AU2021207284A1/en
Application granted granted Critical
Publication of AU2021207284B2 publication Critical patent/AU2021207284B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • 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
    • A61K9/5073—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
    • 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)
AU2021207284A 2020-01-17 2021-01-15 Dosage form with sustained release melatonin pellets Active AU2021207284B2 (en)

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

Publications (2)

Publication Number Publication Date
AU2021207284A1 AU2021207284A1 (en) 2022-06-09
AU2021207284B2 true AU2021207284B2 (en) 2026-02-12

Family

ID=74285447

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021207284A Active AU2021207284B2 (en) 2020-01-17 2021-01-15 Dosage form with sustained release melatonin pellets

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 (3)

* 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
KR20040026374A (ko) * 2002-09-24 2004-03-31 한국화학연구원 다층 코팅법을 이용한 멜라토닌 함유 타게팅 약물 전달 기구
US20140171478A1 (en) * 2011-01-28 2014-06-19 Zx Pharma, Llc Controlled-release melatonin compositions and related methods

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4641696B2 (ja) * 1999-09-30 2011-03-02 大塚製薬株式会社 消化管下部溶解性コーティング製剤
GB0025208D0 (en) * 2000-10-13 2000-11-29 Euro Celtique Sa Delayed release pharmaceutical formulations
IL149377A (en) * 2002-04-28 2012-10-31 Neurim Pharma 1991 Pharmaceutical formulation comprising melatonin for the potentiation of the effect of hypnotic compounds
US20070298117A1 (en) * 2006-06-23 2007-12-27 The Procter & Gamble Company Compositions and kits comprising a melatonin component and a chondroprotective component
US20070299127A1 (en) * 2006-06-23 2007-12-27 The Procter & Gamble Company Compositions and kits comprising a melatonin component and an omega-3-fatty acid component
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
US20120315337A1 (en) 2011-06-07 2012-12-13 Shah Syed Multiparticulate 5-htp compositions and related methods
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.
CA3013472A1 (en) * 2016-02-11 2017-08-17 Biogen Ma Inc. Pharmaceutical bead formulations comprising dimethyl fumarate
WO2017192843A1 (en) * 2016-05-06 2017-11-09 Physician's Seal, LLC Valerian composition and related methods
GR1009541B (el) 2018-02-26 2019-06-07 Λαμδα Φαρμακευτικα Εργαστηρια Εφαρμοσμενης Ερευνας & Αναπτυξης Α.Ε. Ποσιμα φαρμακευτικα διαλυματα που περιλαμβανουν μελατονινη
CN113490491A (zh) * 2019-01-18 2021-10-08 雀巢产品有限公司 固体微粉化褪黑激素组合物

Patent Citations (3)

* 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
KR20040026374A (ko) * 2002-09-24 2004-03-31 한국화학연구원 다층 코팅법을 이용한 멜라토닌 함유 타게팅 약물 전달 기구
US20140171478A1 (en) * 2011-01-28 2014-06-19 Zx Pharma, Llc Controlled-release melatonin compositions and related methods

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
JP2023510223A (ja) 2023-03-13
BR112022012199A2 (pt) 2022-09-13
CA3163378A1 (en) 2021-07-22
CN114901256A (zh) 2022-08-12

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