AR099751A1 - Formulaciones basadas en melatonina para administración parenteral - Google Patents
Formulaciones basadas en melatonina para administración parenteralInfo
- Publication number
- AR099751A1 AR099751A1 ARP150100759A ARP150100759A AR099751A1 AR 099751 A1 AR099751 A1 AR 099751A1 AR P150100759 A ARP150100759 A AR P150100759A AR P150100759 A ARP150100759 A AR P150100759A AR 099751 A1 AR099751 A1 AR 099751A1
- Authority
- AR
- Argentina
- Prior art keywords
- melatonin
- nanoparticles
- phospholipids
- combination
- organic solvent
- Prior art date
Links
- YJPIGAIKUZMOQA-UHFFFAOYSA-N Melatonin Natural products COC1=CC=C2N(C(C)=O)C=C(CCN)C2=C1 YJPIGAIKUZMOQA-UHFFFAOYSA-N 0.000 title abstract 8
- DRLFMBDRBRZALE-UHFFFAOYSA-N melatonin Chemical compound COC1=CC=C2NC=C(CCNC(C)=O)C2=C1 DRLFMBDRBRZALE-UHFFFAOYSA-N 0.000 title abstract 8
- 229960003987 melatonin Drugs 0.000 title abstract 8
- 239000000203 mixture Substances 0.000 title abstract 3
- 238000007911 parenteral administration Methods 0.000 title abstract 2
- 239000002105 nanoparticle Substances 0.000 abstract 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 5
- 239000003960 organic solvent Substances 0.000 abstract 4
- 150000003904 phospholipids Chemical class 0.000 abstract 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 abstract 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 abstract 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 2
- 239000012296 anti-solvent Substances 0.000 abstract 2
- 239000002577 cryoprotective agent Substances 0.000 abstract 2
- 239000000787 lecithin Substances 0.000 abstract 2
- 235000010445 lecithin Nutrition 0.000 abstract 2
- 238000004519 manufacturing process Methods 0.000 abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 2
- 150000008105 phosphatidylcholines Chemical class 0.000 abstract 2
- 150000008104 phosphatidylethanolamines Chemical class 0.000 abstract 2
- 229940067605 phosphatidylethanolamines Drugs 0.000 abstract 2
- 150000003905 phosphatidylinositols Chemical class 0.000 abstract 2
- 150000008106 phosphatidylserines Chemical class 0.000 abstract 2
- 238000001556 precipitation Methods 0.000 abstract 2
- 239000003381 stabilizer Substances 0.000 abstract 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 abstract 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 239000004471 Glycine Substances 0.000 abstract 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000008101 lactose Substances 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
Classifications
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- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61K9/51—Nanocapsules; 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
- A61K9/48—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
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5107—Excipients; Inactive ingredients
- A61K9/5123—Organic compounds, e.g. fats, sugars
-
- 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
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5192—Processes
-
- 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
- A61P39/00—General protective or antinoxious agents
- A61P39/06—Free radical scavengers or antioxidants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Optics & Photonics (AREA)
- Nanotechnology (AREA)
- Physics & Mathematics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biochemistry (AREA)
- Toxicology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
Abstract
Formulación de melatonina que es apropiada para una administración parenteral en neonatos. Reivindicación 1: Una formulación farmacéutica que ha de dispersarse en agua, caracterizada porque comprende (i) nanopartículas que consisten en melatonina como ingrediente activo, en combinación con uno o más fosfolípidos que se seleccionan del grupo que consiste en las fosfatidilcolinas, los fosfatidilgliceroles, las fosfatidilserinas, las fosfatidiletanolaminas, el fosfatidilinositol y las lecitinas, y opcionalmente en combinación con un agente estabilizador, donde al menos uno de los fosfolípidos se adsorbe en la superficie de la melatonina; y (ii) un agente crioprotector que se selecciona entre el manitol, el glicerol, el propilenglicol, la glicina, la sacarosa, la lactosa, la trehalosa y las mezclas de éstos. Reivindicación 11: Un proceso para preparar una formulación farmacéutica de acuerdo con cualquiera de las reivindicaciones 1 a 10, caracterizado porque comprende (i) disolver la melatonina y uno o más excipientes en un solvente orgánico; (ii) generar nanoparticulas por medio de una precipitación controlada, en presencia de agua como anti-solvente, mediante el uso de una tecnología basada en reactores a chorro en miniatura; (iii) agregar el agente crioprotector; y (iv) eliminar el solvente orgánico y el agua residuales. Reivindicación 13: Nanopartículas caracterizadas porque consisten en melatonina como ingrediente activo, en combinación con uno o más fosfolípidos que se seleccionan del grupo que consiste en las fosfatidilcolinas, los fosfatidilgliceroles, las fosfatidilserinas, las fosfatidiletanolaminas, el fosfatidilinositol y las lecitinas, y opcionalmente en combinación con un agente estabilizador, donde al menos uno de los fosfolípidos se adsorbe en la superficie de la melatonina. Reivindicación 14: Un proceso para preparar las nanopartículas de acuerdo con la reivindicación 13, caracterizado porque comprende (i) disolver la melatonina y uno o más excipientes en un solvente orgánico; (ii) generar nanopartículas por medio de una precipitación controlada, en presencia de agua como anti-solvente, mediante el uso de una tecnología basada en reactores a chorro en miniatura; y (iii) eliminar el solvente orgánico y el agua residuales.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14159326 | 2014-03-13 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR099751A1 true AR099751A1 (es) | 2016-08-17 |
Family
ID=50241261
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP150100759A AR099751A1 (es) | 2014-03-13 | 2015-03-12 | Formulaciones basadas en melatonina para administración parenteral |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US9468626B2 (es) |
| EP (1) | EP3116482B1 (es) |
| KR (1) | KR102239761B1 (es) |
| CN (2) | CN112754997A (es) |
| AR (1) | AR099751A1 (es) |
| CA (1) | CA2942111C (es) |
| ES (1) | ES2687484T3 (es) |
| HR (1) | HRP20181968T1 (es) |
| RU (1) | RU2685698C2 (es) |
| WO (1) | WO2015135997A1 (es) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016058985A1 (en) * | 2014-10-13 | 2016-04-21 | Therapicon S.R.L. | Anydrous liquid melatonin composition |
| WO2018167162A1 (en) * | 2017-03-17 | 2018-09-20 | Chiesi Farmaceutici S.P.A. | Therapeutic dosage and regimen for melatonin |
| US10507199B2 (en) * | 2017-05-08 | 2019-12-17 | The Brigham And Women's Hospital, Inc. | Molecules in the tryptophan-5-hydroxytryptophan-serotonin-NAS-melatonin/6-hydroxymelatonin sulfate-melatonin receptor 1A pathway in neurological diseases |
| WO2019038586A1 (en) | 2017-08-19 | 2019-02-28 | Ftf Pharma Private Limited | PHARMACEUTICAL COMPOSITION OF MELATONIN |
| AU2020339867A1 (en) | 2019-08-30 | 2022-04-14 | Vijayendrakumar Virendrakumarji Redasani | Liquid pharmaceutical compositions of melatonin for oral and parenteral administration |
| EP4087533B1 (en) * | 2020-01-08 | 2024-01-31 | Worphmed Srl | Soluble melatonin tripartate adduct for the prevention and treatment of rare and severe eye sight-threatening conditions and neuro-ophthalmic disorders |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5336507A (en) | 1992-12-11 | 1994-08-09 | Sterling Winthrop Inc. | Use of charged phospholipids to reduce nanoparticle aggregation |
| HUP0202032A2 (hu) | 2002-06-19 | 2004-10-28 | D. Endre Radics | Nanoemulziós formulációban található bioaktív anyagok emberi szervezetbe való bevitele a szájüreg nyálkahártyáján keresztül, mechanikus pumpájú spray által. |
| SI1585548T1 (sl) * | 2002-12-09 | 2018-11-30 | Abraxis Bioscience, Llc | Sestave in metode odmerjanja farmakoloških sredstev |
| EP1701718A4 (en) | 2003-12-23 | 2009-06-24 | Abraxis Bioscience Llc | SUBSTITUTED MELATONIN DERIVATIVES, METHOD FOR THE PRODUCTION THEREOF AND METHOD OF ADMINISTRATION |
| ITMI20061918A1 (it) | 2006-10-06 | 2008-04-07 | Nanovector S R L | Formulazioni adatte ad essere somministrate per via transdermica contenenti principi attivi incorporati in sln |
| DE102009008478A1 (de) | 2009-02-11 | 2010-08-19 | PHAST Gesellschaft für pharmazeutische Qualitätsstandards mbH | Vorrichtung und Verfahren zur Herstellung pharmazeutisch hochfeiner Partikel sowie zur Beschichtung solcher Partikel in Mikroreaktoren |
| KR101651915B1 (ko) * | 2009-09-14 | 2016-08-29 | 한화케미칼 주식회사 | 금속 나노입자 수계 분산액의 제조방법 |
| BRPI1002601E2 (pt) * | 2010-06-01 | 2020-06-30 | Embrapa Pesquisa Agropecuaria | composição nanoestruturada de uso veterinário para administração de fármacos |
| US8790704B2 (en) * | 2010-06-10 | 2014-07-29 | Monosol Rx, Llc | Combination peptide-nanoparticles and delivery systems incorporating same |
| 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. |
-
2015
- 2015-03-10 US US14/642,795 patent/US9468626B2/en active Active
- 2015-03-11 CA CA2942111A patent/CA2942111C/en active Active
- 2015-03-11 EP EP15712818.2A patent/EP3116482B1/en active Active
- 2015-03-11 KR KR1020167022645A patent/KR102239761B1/ko active IP Right Grant
- 2015-03-11 RU RU2016136327A patent/RU2685698C2/ru active
- 2015-03-11 ES ES15712818.2T patent/ES2687484T3/es active Active
- 2015-03-11 CN CN202110101172.8A patent/CN112754997A/zh active Pending
- 2015-03-11 WO PCT/EP2015/055092 patent/WO2015135997A1/en active Application Filing
- 2015-03-11 CN CN201580012135.2A patent/CN106102721A/zh active Pending
- 2015-03-12 AR ARP150100759A patent/AR099751A1/es not_active Application Discontinuation
-
2018
- 2018-11-23 HR HRP20181968TT patent/HRP20181968T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3116482B1 (en) | 2018-08-29 |
| EP3116482A1 (en) | 2017-01-18 |
| CA2942111A1 (en) | 2015-09-17 |
| US20150258064A1 (en) | 2015-09-17 |
| US9468626B2 (en) | 2016-10-18 |
| HRP20181968T1 (hr) | 2019-02-08 |
| CA2942111C (en) | 2022-06-21 |
| RU2685698C2 (ru) | 2019-04-23 |
| WO2015135997A1 (en) | 2015-09-17 |
| RU2016136327A (ru) | 2018-04-13 |
| ES2687484T3 (es) | 2018-10-25 |
| KR20160132380A (ko) | 2016-11-18 |
| KR102239761B1 (ko) | 2021-04-14 |
| CN112754997A (zh) | 2021-05-07 |
| RU2016136327A3 (es) | 2018-06-19 |
| CN106102721A (zh) | 2016-11-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Refusal |