AU2016426598C1 - Melatonin mini-tablets and method of manufacturing the same - Google Patents

Melatonin mini-tablets and method of manufacturing the same Download PDF

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Publication number
AU2016426598C1
AU2016426598C1 AU2016426598A AU2016426598A AU2016426598C1 AU 2016426598 C1 AU2016426598 C1 AU 2016426598C1 AU 2016426598 A AU2016426598 A AU 2016426598A AU 2016426598 A AU2016426598 A AU 2016426598A AU 2016426598 C1 AU2016426598 C1 AU 2016426598C1
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AU
Australia
Prior art keywords
melatonin
mini
tablet
release
patient
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Application number
AU2016426598A
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English (en)
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AU2016426598A1 (en
AU2016426598B2 (en
Inventor
Moshe Laudon
Nava Zisapel
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Neurim Pharmaceuticals 1991 Ltd
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Neurim Pharmaceuticals 1991 Ltd
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Application filed by Neurim Pharmaceuticals 1991 Ltd filed Critical Neurim Pharmaceuticals 1991 Ltd
Publication of AU2016426598A1 publication Critical patent/AU2016426598A1/en
Application granted granted Critical
Publication of AU2016426598B2 publication Critical patent/AU2016426598B2/en
Priority to AU2019200479A priority Critical patent/AU2019200479B2/en
Priority to AU2019101470A priority patent/AU2019101470B4/en
Priority to AU2021200268A priority patent/AU2021200268A1/en
Priority to AU2023202003A priority patent/AU2023202003A1/en
Publication of AU2016426598C1 publication Critical patent/AU2016426598C1/en
Priority to AU2025234204A priority patent/AU2025234204A1/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
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Anesthesiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2016426598A 2016-10-31 2016-11-29 Melatonin mini-tablets and method of manufacturing the same Active AU2016426598C1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU2019200479A AU2019200479B2 (en) 2016-10-31 2019-01-24 Melatonin mini-tablets and method of manufacturing the same
AU2019101470A AU2019101470B4 (en) 2016-10-31 2019-11-28 Melatonin mini-tablets and method of manufacturing the same
AU2021200268A AU2021200268A1 (en) 2016-10-31 2021-01-18 Melatonin mini-tablets and method of manufacturing the same
AU2023202003A AU2023202003A1 (en) 2016-10-31 2023-03-31 Melatonin mini-tablets and method of manufacturing the same
AU2025234204A AU2025234204A1 (en) 2016-10-31 2025-09-18 Melatonin mini-tablets and method of manufacturing the same

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662415014P 2016-10-31 2016-10-31
US62/415,014 2016-10-31
PCT/IB2016/057190 WO2018078429A1 (en) 2016-10-31 2016-11-29 Melatonin mini-tablets and method of manufacturing the same

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2019200479A Division AU2019200479B2 (en) 2016-10-31 2019-01-24 Melatonin mini-tablets and method of manufacturing the same

Publications (3)

Publication Number Publication Date
AU2016426598A1 AU2016426598A1 (en) 2018-05-17
AU2016426598B2 AU2016426598B2 (en) 2018-11-01
AU2016426598C1 true AU2016426598C1 (en) 2024-02-08

Family

ID=57482481

Family Applications (6)

Application Number Title Priority Date Filing Date
AU2016426598A Active AU2016426598C1 (en) 2016-10-31 2016-11-29 Melatonin mini-tablets and method of manufacturing the same
AU2019200479A Active AU2019200479B2 (en) 2016-10-31 2019-01-24 Melatonin mini-tablets and method of manufacturing the same
AU2019101470A Expired AU2019101470B4 (en) 2016-10-31 2019-11-28 Melatonin mini-tablets and method of manufacturing the same
AU2021200268A Abandoned AU2021200268A1 (en) 2016-10-31 2021-01-18 Melatonin mini-tablets and method of manufacturing the same
AU2023202003A Pending AU2023202003A1 (en) 2016-10-31 2023-03-31 Melatonin mini-tablets and method of manufacturing the same
AU2025234204A Pending AU2025234204A1 (en) 2016-10-31 2025-09-18 Melatonin mini-tablets and method of manufacturing the same

Family Applications After (5)

Application Number Title Priority Date Filing Date
AU2019200479A Active AU2019200479B2 (en) 2016-10-31 2019-01-24 Melatonin mini-tablets and method of manufacturing the same
AU2019101470A Expired AU2019101470B4 (en) 2016-10-31 2019-11-28 Melatonin mini-tablets and method of manufacturing the same
AU2021200268A Abandoned AU2021200268A1 (en) 2016-10-31 2021-01-18 Melatonin mini-tablets and method of manufacturing the same
AU2023202003A Pending AU2023202003A1 (en) 2016-10-31 2023-03-31 Melatonin mini-tablets and method of manufacturing the same
AU2025234204A Pending AU2025234204A1 (en) 2016-10-31 2025-09-18 Melatonin mini-tablets and method of manufacturing the same

Country Status (25)

Country Link
US (2) US10722494B2 (enExample)
EP (3) EP4474012A3 (enExample)
JP (1) JP6830156B2 (enExample)
KR (1) KR102167190B1 (enExample)
CN (1) CN109922795B (enExample)
AU (6) AU2016426598C1 (enExample)
CA (1) CA3040027C (enExample)
CY (1) CY1123449T1 (enExample)
DK (2) DK3337462T3 (enExample)
ES (2) ES3009413T3 (enExample)
FI (1) FI3777842T3 (enExample)
HR (2) HRP20250166T1 (enExample)
HU (2) HUE051362T2 (enExample)
IL (1) IL262537B (enExample)
LT (2) LT3777842T (enExample)
MX (1) MX386987B (enExample)
NZ (1) NZ747702A (enExample)
PL (2) PL3337462T3 (enExample)
PT (2) PT3337462T (enExample)
RS (2) RS66471B1 (enExample)
SG (1) SG11201903829PA (enExample)
SI (2) SI3777842T1 (enExample)
SM (2) SMT202500046T1 (enExample)
TW (1) TWI787164B (enExample)
WO (1) WO2018078429A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220125733A1 (en) * 2020-10-23 2022-04-28 Atoz Pharmaceuticals Pvt Ltd Nongranulated compressed tablets of mesalamine, and process of preparation thereof
KR20230017814A (ko) * 2020-10-26 2023-02-06 일동제약(주) 옥수수불검화추출물을 포함하는 소형화된 경구투여 제제의 제조방법 및 이에 따라 제조된 소형화 제제
CN120076789A (zh) 2022-10-14 2025-05-30 雀巢产品有限公司 缓释褪黑激素组合物

Citations (2)

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Publication number Priority date Publication date Assignee Title
EP0724878A2 (en) * 1995-02-01 1996-08-07 Neurim Pharmaceuticals (1991) Limited Use of melatonin for treating patients suffering from drug dependencies
WO2003086352A1 (en) * 2002-04-08 2003-10-23 Neurim Pharmaceuticals (1991) Ltd. Pharmaceutical formulation comprising melatonin

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US4600723A (en) 1983-05-18 1986-07-15 Monash University Method for minimizing disturbances in circadian rhythms of bodily performance and function
ES2134789T3 (es) 1991-05-09 1999-10-16 Neurim Pharma 1991 Composiciones que contienen melatonina.
ATE141051T1 (de) 1992-04-07 1996-08-15 Neurim Pharma 1991 Verwendung von melatonin zur herstellung eines arzneimittels zur behandlung der gutartigen prostatahyperplasie
US5449683A (en) 1992-10-01 1995-09-12 Massachussetts Institute Of Technology Methods of inducing sleep using melatonin
AU7550994A (en) * 1993-07-26 1995-02-20 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
PL183148B1 (pl) * 1995-02-01 2002-05-31 Neurim Pharma 1991 Zastosowanie melatoniny do wytwarzania leku do leczenia zależności, nałogu stosowania lub tolerancji na benzodiazepiny oraz zastosowanie melatoniny do wytwarzania leku do zapobiegania zależności, nałogu stosowania lub tolerancji na benzodiazepiny
FR2762513B1 (fr) * 1997-04-23 2003-08-22 Permatec Pharma Ag Comprimes bioadhesifs
CA2346001C (en) 1998-10-01 2003-12-30 Elan Pharma International, Limited Controlled release nanoparticulate compositions
EP1064938A1 (en) * 1999-06-28 2001-01-03 Sanofi-Synthelabo Pharmaceutical dosage forms for controlled release producing at least a timed pulse
CN1414851A (zh) * 2000-01-05 2003-04-30 纽里姆药品(1991)有限公司 用于治疗对抗高血压药的抗药性和相关病症的方法和制剂
US6458384B2 (en) * 2000-02-23 2002-10-01 Impetus Ag Pharmaceutical with predetermined activity profile
IL144900A (en) 2001-08-14 2013-12-31 Neurim Pharma 1991 Melatonin and drugs containing it for use in the treatment of primary insomnia, and the manufacture of those drugs
KR20030016215A (ko) * 2002-07-05 2003-02-26 뉴림 파머슈티칼스 (1991) 리미티드 항고혈압제에 대한 내성 및 관련 질환의 치료를 위한 방법및 제형
EP1592453A1 (en) * 2003-01-28 2005-11-09 Collegium Pharmaceutical, Inc. Multiparticulate compositions of milnacipran for oral administration
IL155666A (en) 2003-04-29 2013-12-31 Neurim Pharma 1991 Insomnia treatment
JP2007517040A (ja) 2003-12-24 2007-06-28 セプレイコー インコーポレイテッド 睡眠の質を改善するためのメラトニン併用療法
FR2889811B1 (fr) * 2005-08-19 2009-10-09 Sanofi Aventis Sa Association d'un agent hypnotique a duree d'action longue et d'un agent hypnotique a duree d'action courte, composition pharmaceutique la contenant et son application en therapeutique.
DE102006006532B4 (de) 2006-02-10 2007-11-08 Biogenerics Pharma Gmbh Pharmazeutische Zubereitung
WO2008148015A1 (en) 2007-05-24 2008-12-04 The Trustees Of Columbia University In The City Of New York Sustained release formulation of melatonin
US20100159001A1 (en) * 2008-12-19 2010-06-24 Cardinal John R Extended-Release Pharmaceutical Formulations
US9532952B2 (en) 2011-01-28 2017-01-03 Physician's Seal, LLC Controlled-release compositions of melatonin combined with sedative and/or analgesic ingredients
US8691275B2 (en) 2011-01-28 2014-04-08 Zx Pharma, Llc Controlled-release melatonin compositions and related methods
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Publication number Priority date Publication date Assignee Title
EP0724878A2 (en) * 1995-02-01 1996-08-07 Neurim Pharmaceuticals (1991) Limited Use of melatonin for treating patients suffering from drug dependencies
WO2003086352A1 (en) * 2002-04-08 2003-10-23 Neurim Pharmaceuticals (1991) Ltd. Pharmaceutical formulation comprising melatonin

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Also Published As

Publication number Publication date
SG11201903829PA (en) 2019-05-30
AU2016426598A1 (en) 2018-05-17
EP3777842B1 (en) 2024-12-11
ES2828034T3 (es) 2021-05-25
US10869857B2 (en) 2020-12-22
CN109922795A (zh) 2019-06-21
AU2019101470B4 (en) 2020-06-25
CY1123449T1 (el) 2022-03-24
TWI787164B (zh) 2022-12-21
AU2025234204A1 (en) 2025-10-09
RS66471B1 (sr) 2025-03-31
FI3777842T3 (fi) 2025-02-11
PL3337462T3 (pl) 2021-01-25
JP6830156B2 (ja) 2021-02-17
MX386987B (es) 2025-03-19
WO2018078429A1 (en) 2018-05-03
ES3009413T3 (en) 2025-03-26
EP4474012A3 (en) 2025-03-12
NZ747702A (en) 2022-08-26
MX2019004736A (es) 2019-06-17
AU2021200268A1 (en) 2021-03-18
HUE070190T2 (hu) 2025-05-28
CA3040027A1 (en) 2018-05-03
EP3337462A1 (en) 2018-06-27
IL262537B (en) 2021-03-25
SI3777842T1 (sl) 2025-03-31
LT3777842T (lt) 2025-04-10
EP4474012A2 (en) 2024-12-11
NZ782840A (en) 2025-02-28
AU2019101470A4 (en) 2020-01-16
DK3777842T3 (da) 2025-02-03
CA3040027C (en) 2023-08-15
EP3777842A1 (en) 2021-02-17
EP3337462B1 (en) 2020-09-30
KR20190014512A (ko) 2019-02-12
PL3777842T3 (pl) 2025-05-12
US20200306227A1 (en) 2020-10-01
AU2016426598B2 (en) 2018-11-01
PT3337462T (pt) 2020-10-30
US10722494B2 (en) 2020-07-28
SMT202500046T1 (it) 2025-03-12
AU2019200479A1 (en) 2019-02-14
IL262537A (en) 2018-12-31
TW201817418A (zh) 2018-05-16
JP2019533672A (ja) 2019-11-21
AU2019200479B2 (en) 2020-10-22
KR102167190B1 (ko) 2020-10-19
PT3777842T (pt) 2025-02-11
CN109922795B (zh) 2021-10-08
SMT202000575T1 (it) 2021-01-05
AU2023202003A1 (en) 2023-05-04
HUE051362T2 (hu) 2021-03-01
LT3337462T (lt) 2021-01-11
DK3337462T3 (da) 2020-10-12
HRP20201722T1 (hr) 2021-03-05
SI3337462T1 (sl) 2021-01-29
RS61024B1 (sr) 2020-12-31
HRP20250166T1 (hr) 2025-05-09
US20190060277A1 (en) 2019-02-28

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