KR102167190B1 - 멜라토닌 소형 정제 및 이의 제조방법 - Google Patents

멜라토닌 소형 정제 및 이의 제조방법 Download PDF

Info

Publication number
KR102167190B1
KR102167190B1 KR1020187035251A KR20187035251A KR102167190B1 KR 102167190 B1 KR102167190 B1 KR 102167190B1 KR 1020187035251 A KR1020187035251 A KR 1020187035251A KR 20187035251 A KR20187035251 A KR 20187035251A KR 102167190 B1 KR102167190 B1 KR 102167190B1
Authority
KR
South Korea
Prior art keywords
melatonin
release
small
small tablet
tablet
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
KR1020187035251A
Other languages
English (en)
Korean (ko)
Other versions
KR20190014512A (ko
Inventor
모시 라우돈
나바 지사펠
Original Assignee
뉴림 파머슈티칼스(1991) 리미티드
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=57482481&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR102167190(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 뉴림 파머슈티칼스(1991) 리미티드 filed Critical 뉴림 파머슈티칼스(1991) 리미티드
Publication of KR20190014512A publication Critical patent/KR20190014512A/ko
Application granted granted Critical
Publication of KR102167190B1 publication Critical patent/KR102167190B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • A61K9/20—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
    • 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
    • A61K9/28—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

Landscapes

  • 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)
KR1020187035251A 2016-10-31 2016-11-29 멜라토닌 소형 정제 및 이의 제조방법 Active KR102167190B1 (ko)

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

Publications (2)

Publication Number Publication Date
KR20190014512A KR20190014512A (ko) 2019-02-12
KR102167190B1 true KR102167190B1 (ko) 2020-10-19

Family

ID=57482481

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020187035251A Active KR102167190B1 (ko) 2016-10-31 2016-11-29 멜라토닌 소형 정제 및 이의 제조방법

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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0518468A1 (en) 1991-05-09 1992-12-16 Neurim Pharmaceuticals (1991) Limited Melatonin containing compositions
EP0724878A2 (en) 1995-02-01 1996-08-07 Neurim Pharmaceuticals (1991) Limited Use of melatonin for treating patients suffering from drug dependencies
WO2001049286A1 (en) 2000-01-05 2001-07-12 Neurim Pharmaceuticals (1991) Ltd. Method and formulation for treating resistance to antihypertensives and related conditions
WO2003086352A1 (en) 2002-04-08 2003-10-23 Neurim Pharmaceuticals (1991) Ltd. Pharmaceutical formulation comprising melatonin

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4600723A (en) 1983-05-18 1986-07-15 Monash University Method for minimizing disturbances in circadian rhythms of bodily performance and function
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
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
RU2488388C1 (ru) * 2012-05-24 2013-07-27 Ооо "Валента Интеллект" Фармацевтическая композиция для профилактики и лечения психических, поведенческих, когнитивных расстройств
DK2949322T3 (en) 2014-05-28 2018-07-23 Valpharma S P A FORMULATION FOR ORAL ADMINISTRATION COMPREHENSIVE MELATONIN IN STABLE FORM AND PROCEDURE FOR PREPARING THEREOF

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0518468A1 (en) 1991-05-09 1992-12-16 Neurim Pharmaceuticals (1991) Limited Melatonin containing compositions
EP0724878A2 (en) 1995-02-01 1996-08-07 Neurim Pharmaceuticals (1991) Limited Use of melatonin for treating patients suffering from drug dependencies
KR100425045B1 (ko) * 1995-02-01 2004-09-01 뉴림 파머슈티칼스 (1991) 리미티드 약물중독의치료를위한멜라토닌함유약학적조성물
WO2001049286A1 (en) 2000-01-05 2001-07-12 Neurim Pharmaceuticals (1991) Ltd. Method and formulation for treating resistance to antihypertensives and related conditions
WO2003086352A1 (en) 2002-04-08 2003-10-23 Neurim Pharmaceuticals (1991) Ltd. Pharmaceutical formulation comprising melatonin

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
AU2016426598C1 (en) 2024-02-08
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
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

Similar Documents

Publication Publication Date Title
AU2023202003A1 (en) Melatonin mini-tablets and method of manufacturing the same
US20150352084A1 (en) Compositions and methods for treating middle-of-the-night insomnia
US20060281783A1 (en) Compositions and methods of treating middle-of-the night insomnia
US20120034300A1 (en) Stabilized zolpidem pharmaceutical compositions
US10849856B2 (en) Melatonin mini-tablets and method of manufacturing the same
HK40120004A (en) Melatonin mini-tablets and method of manufacturing the same
CN104906063A (zh) 一种新型复方安眠控释制剂的释放方式及其制备方法
HK40008154B (zh) 褪黑素小片剂及其制备方法
HK40008154A (en) Melatonin mini-tablets and method of manufacturing the same
TW202037368A (zh) 治療精神疾病之控釋藥物組合物和方法
KR20180101539A (ko) 수면장애를 예방 및 치료하기 위한 약제학적 조성물

Legal Events

Date Code Title Description
A201 Request for examination
E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

PN2301 Change of applicant

St.27 status event code: A-3-3-R10-R13-asn-PN2301

St.27 status event code: A-3-3-R10-R11-asn-PN2301

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

St.27 status event code: A-1-2-D10-D22-exm-PE0701

GRNT Written decision to grant
PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 4

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 5

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 6