CA2477516C - Pharmaceutical formulation comprising melatonin - Google Patents
Pharmaceutical formulation comprising melatonin Download PDFInfo
- Publication number
- CA2477516C CA2477516C CA2477516A CA2477516A CA2477516C CA 2477516 C CA2477516 C CA 2477516C CA 2477516 A CA2477516 A CA 2477516A CA 2477516 A CA2477516 A CA 2477516A CA 2477516 C CA2477516 C CA 2477516C
- Authority
- CA
- Canada
- Prior art keywords
- melatonin
- zolpidem
- sleep
- sustained release
- placebo
- 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.)
- Expired - Lifetime
Links
- DRLFMBDRBRZALE-UHFFFAOYSA-N melatonin Chemical compound COC1=CC=C2NC=C(CCNC(C)=O)C2=C1 DRLFMBDRBRZALE-UHFFFAOYSA-N 0.000 title claims abstract description 133
- YJPIGAIKUZMOQA-UHFFFAOYSA-N Melatonin Natural products COC1=CC=C2N(C(C)=O)C=C(CCN)C2=C1 YJPIGAIKUZMOQA-UHFFFAOYSA-N 0.000 title claims abstract description 132
- 229960003987 melatonin Drugs 0.000 title claims abstract description 131
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 16
- ZAFYATHCZYHLPB-UHFFFAOYSA-N zolpidem Chemical compound N1=C2C=CC(C)=CN2C(CC(=O)N(C)C)=C1C1=CC=C(C)C=C1 ZAFYATHCZYHLPB-UHFFFAOYSA-N 0.000 claims description 90
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- GBBSUAFBMRNDJC-MRXNPFEDSA-N (5R)-zopiclone Chemical compound C1CN(C)CCN1C(=O)O[C@@H]1C2=NC=CN=C2C(=O)N1C1=CC=C(Cl)C=N1 GBBSUAFBMRNDJC-MRXNPFEDSA-N 0.000 claims description 7
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
-
- 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
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
-
- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
-
- 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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Indole Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IL149377 | 2002-04-08 | ||
| IL149377A IL149377A (en) | 2002-04-28 | 2002-04-28 | Pharmaceutical formulation comprising melatonin for the potentiation of the effect of hypnotic compounds |
| PCT/IL2003/000240 WO2003086352A1 (en) | 2002-04-08 | 2003-03-20 | Pharmaceutical formulation comprising melatonin |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2477516A1 CA2477516A1 (en) | 2003-10-23 |
| CA2477516C true CA2477516C (en) | 2012-12-11 |
Family
ID=29227410
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2477516A Expired - Lifetime CA2477516C (en) | 2002-04-08 | 2003-03-20 | Pharmaceutical formulation comprising melatonin |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US20050175692A1 (enExample) |
| EP (1) | EP1494650B1 (enExample) |
| JP (1) | JP2005527583A (enExample) |
| KR (1) | KR101000624B1 (enExample) |
| CN (1) | CN100386070C (enExample) |
| AR (1) | AR039232A1 (enExample) |
| AT (1) | ATE507831T1 (enExample) |
| AU (1) | AU2003227304B2 (enExample) |
| BR (1) | BR0308762A (enExample) |
| CA (1) | CA2477516C (enExample) |
| DE (1) | DE60336999D1 (enExample) |
| DK (1) | DK1494650T3 (enExample) |
| EA (1) | EA007954B1 (enExample) |
| ES (1) | ES2366116T3 (enExample) |
| GT (1) | GT200300064A (enExample) |
| HN (1) | HN2003000115A (enExample) |
| IL (1) | IL149377A (enExample) |
| IS (1) | IS2858B (enExample) |
| MX (1) | MXPA04009893A (enExample) |
| NO (1) | NO332525B1 (enExample) |
| NZ (1) | NZ536298A (enExample) |
| PE (1) | PE20040161A1 (enExample) |
| PL (1) | PL209922B1 (enExample) |
| PT (1) | PT1494650E (enExample) |
| TW (1) | TW200305404A (enExample) |
| UA (1) | UA86924C2 (enExample) |
| UY (1) | UY27753A1 (enExample) |
| WO (1) | WO2003086352A1 (enExample) |
| ZA (1) | ZA200407563B (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1696959A2 (en) * | 2003-12-24 | 2006-09-06 | Sepracor, Inc. | Melatonin combination therapy for improving sleep quality |
| TW200626137A (en) * | 2004-12-13 | 2006-08-01 | Takeda Pharmaceuticals Co | Preventive or therapeutic agent for sleep disorder |
| US20060198872A1 (en) * | 2005-03-07 | 2006-09-07 | Chioma Ikonte | Plant based dietary supplement for improving the duration and quality of sleep |
| KR20070070307A (ko) * | 2005-08-24 | 2007-07-04 | 에스에스 세야쿠 가부시키 가이샤 | 수면 개선 의약 조성물 |
| CN1299680C (zh) * | 2005-08-29 | 2007-02-14 | 陈彦方 | 一种治疗失眠的黑白制剂 |
| AR056076A1 (es) * | 2005-09-20 | 2007-09-19 | Takeda Pharmaceutical | Agente profilactico o terapeutico para el desorden de sueno |
| CN102018681A (zh) * | 2010-12-10 | 2011-04-20 | 荣港生技医药科技（北京）有限公司 | 一种美乐托宁缓释剂、其制备方法及其应用 |
| WO2012103411A2 (en) | 2011-01-28 | 2012-08-02 | Zx Pharma, Llc | Controlled-release melatonin composition and related methods |
| US9532952B2 (en) * | 2011-01-28 | 2017-01-03 | Physician's Seal, LLC | Controlled-release compositions of melatonin combined with sedative and/or analgesic ingredients |
| EP2570126B1 (en) * | 2011-09-16 | 2014-03-26 | Darius Rassoulian | Use of melatonin for treating acute alcohol intoxication |
| US10849856B2 (en) | 2016-10-31 | 2020-12-01 | Neurim Pharmaceuticals Ltd. | Melatonin mini-tablets and method of manufacturing the same |
| MX386987B (es) * | 2016-10-31 | 2025-03-19 | Neurim Pharma 1991 | Mini-tabletas de melatonina y métodos de fabricación de las mismas. |
| CN109364031A (zh) * | 2018-10-07 | 2019-02-22 | 威海贯标信息科技有限公司 | 一种盐酸曲唑酮片剂组合物 |
| US20230045118A1 (en) * | 2020-01-17 | 2023-02-09 | Societe Des Produits Nestle S.A. | Dosage form with sustained release melatonin pellets |
Family Cites Families (12)
| 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 |
| US5707652A (en) * | 1990-12-04 | 1998-01-13 | State Of Oregon | Methods of treating circadian rhythm phase disorders |
| IT1251544B (it) * | 1991-05-13 | 1995-05-17 | Gabriele Biella | Composizioni farmaceutiche attive nella terapia dei disturbi del sonno comprendenti melatonina o un suo derivato in associazione con un derivato benzodiazepinico |
| FR2718020B1 (fr) * | 1994-04-01 | 1996-05-31 | Biotec Centre Sa | Composition galénique mucoadhésive hétérofonctionnelle. |
| JP4516159B2 (ja) * | 1995-02-01 | 2010-08-04 | ニューリム ファーマシューティカルズ（１９９１）リミテッド | 薬物嗜癖患者の治療のためのメラトニンの使用 |
| KR100494214B1 (ko) * | 1996-03-08 | 2005-11-25 | 다케다 야쿠힌 고교 가부시키가이샤 | 삼환화합물,그의제조방법및용도 |
| US5849338A (en) * | 1996-04-10 | 1998-12-15 | Chronorx Llc | Unit dosage forms for treatment of vasoconstriction and related conditions |
| DE69728883T2 (de) * | 1996-07-17 | 2005-04-07 | Merck & Co., Inc. | Änderung des zirkadischen rhythmus mit nicht-peptidischen neurokinin-1 rezeptor antagonisten |
| EP1100508B8 (en) * | 1998-06-09 | 2004-01-07 | Takeda Chemical Industries, Ltd. | Pharmaceutical combination comprising a tricyclic compound and at least one of zolpidem, zopiclone and brotizolam for treating or preventing sleep disorders |
| CN1131030C (zh) * | 1999-03-18 | 2003-12-17 | 胡秀云 | 一种由褪黑素和安定制成的调节睡眠的组合物 |
| AU3910700A (en) * | 1999-03-22 | 2000-10-09 | Immugen Pharmaceuticals, Inc. | Treatment of immune diseases |
| 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 |
-
2002
- 2002-04-28 IL IL149377A patent/IL149377A/en active IP Right Grant
-
2003
- 2003-03-17 GT GT200300064A patent/GT200300064A/es unknown
- 2003-03-20 MX MXPA04009893A patent/MXPA04009893A/es active IP Right Grant
- 2003-03-20 DK DK03746393.2T patent/DK1494650T3/da active
- 2003-03-20 PT PT03746393T patent/PT1494650E/pt unknown
- 2003-03-20 CN CNB038075644A patent/CN100386070C/zh not_active Expired - Lifetime
- 2003-03-20 KR KR1020047015934A patent/KR101000624B1/ko not_active Expired - Lifetime
- 2003-03-20 JP JP2003583375A patent/JP2005527583A/ja active Pending
- 2003-03-20 WO PCT/IL2003/000240 patent/WO2003086352A1/en not_active Ceased
- 2003-03-20 UA UA20041008558A patent/UA86924C2/ru unknown
- 2003-03-20 EA EA200401331A patent/EA007954B1/ru not_active IP Right Cessation
- 2003-03-20 DE DE60336999T patent/DE60336999D1/de not_active Expired - Lifetime
- 2003-03-20 AU AU2003227304A patent/AU2003227304B2/en not_active Expired
- 2003-03-20 ES ES03746393T patent/ES2366116T3/es not_active Expired - Lifetime
- 2003-03-20 CA CA2477516A patent/CA2477516C/en not_active Expired - Lifetime
- 2003-03-20 NZ NZ536298A patent/NZ536298A/en not_active IP Right Cessation
- 2003-03-20 EP EP03746393A patent/EP1494650B1/en not_active Expired - Lifetime
- 2003-03-20 AT AT03746393T patent/ATE507831T1/de active
- 2003-03-20 US US10/510,625 patent/US20050175692A1/en not_active Abandoned
- 2003-03-20 PE PE2003000278A patent/PE20040161A1/es not_active Application Discontinuation
- 2003-03-20 PL PL372867A patent/PL209922B1/pl unknown
- 2003-03-20 BR BR0308762-0A patent/BR0308762A/pt not_active Application Discontinuation
- 2003-04-01 TW TW092107377A patent/TW200305404A/zh unknown
- 2003-04-02 AR ARP030101156A patent/AR039232A1/es not_active Application Discontinuation
- 2003-04-07 UY UY27753A patent/UY27753A1/es not_active Application Discontinuation
- 2003-04-07 HN HN2003000115A patent/HN2003000115A/es unknown
-
2004
- 2004-08-27 NO NO20043576A patent/NO332525B1/no not_active IP Right Cessation
- 2004-09-21 ZA ZA2004/07563A patent/ZA200407563B/en unknown
- 2004-10-07 IS IS7492A patent/IS2858B/is unknown
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| EEER | Examination request | ||
| MKEX | Expiry |
Effective date: 20230320 |