RU2020101742A - Растворяющаяся во рту лекарственная форма мелатонина с подкисляющей добавкой, которая делает мелатонин растворимым в слюне - Google Patents
Растворяющаяся во рту лекарственная форма мелатонина с подкисляющей добавкой, которая делает мелатонин растворимым в слюне Download PDFInfo
- Publication number
- RU2020101742A RU2020101742A RU2020101742A RU2020101742A RU2020101742A RU 2020101742 A RU2020101742 A RU 2020101742A RU 2020101742 A RU2020101742 A RU 2020101742A RU 2020101742 A RU2020101742 A RU 2020101742A RU 2020101742 A RU2020101742 A RU 2020101742A
- Authority
- RU
- Russia
- Prior art keywords
- dosage form
- saliva
- acid
- composition
- disintegrant
- Prior art date
Links
- 239000002552 dosage form Substances 0.000 title claims 46
- YJPIGAIKUZMOQA-UHFFFAOYSA-N Melatonin Natural products COC1=CC=C2N(C(C)=O)C=C(CCN)C2=C1 YJPIGAIKUZMOQA-UHFFFAOYSA-N 0.000 title claims 9
- DRLFMBDRBRZALE-UHFFFAOYSA-N melatonin Chemical compound COC1=CC=C2NC=C(CCNC(C)=O)C2=C1 DRLFMBDRBRZALE-UHFFFAOYSA-N 0.000 title claims 9
- 229960003987 melatonin Drugs 0.000 title claims 9
- 239000000654 additive Substances 0.000 title 1
- 230000000996 additive effect Effects 0.000 title 1
- 210000003296 saliva Anatomy 0.000 claims 30
- 239000000203 mixture Substances 0.000 claims 29
- 239000002253 acid Substances 0.000 claims 22
- 239000007884 disintegrant Substances 0.000 claims 16
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 15
- 239000011159 matrix material Substances 0.000 claims 6
- 239000006190 sub-lingual tablet Substances 0.000 claims 6
- 229940098466 sublingual tablet Drugs 0.000 claims 6
- 239000006189 buccal tablet Substances 0.000 claims 5
- 229940046011 buccal tablet Drugs 0.000 claims 5
- 150000001735 carboxylic acids Chemical class 0.000 claims 4
- 229920000642 polymer Polymers 0.000 claims 4
- 239000000843 powder Substances 0.000 claims 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 3
- 239000007936 buccal or sublingual tablet Substances 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 239000003826 tablet Substances 0.000 claims 2
- 229920003169 water-soluble polymer Polymers 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 210000000214 mouth Anatomy 0.000 claims 1
- 229940092969 oral strip Drugs 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
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
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- 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)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Zoology (AREA)
- Anesthesiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762522473P | 2017-06-20 | 2017-06-20 | |
| US62/522,473 | 2017-06-20 | ||
| PCT/US2018/037698 WO2018236678A1 (en) | 2017-06-20 | 2018-06-15 | Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2020101742A true RU2020101742A (ru) | 2021-07-20 |
Family
ID=64656010
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2020101742A RU2020101742A (ru) | 2017-06-20 | 2018-06-15 | Растворяющаяся во рту лекарственная форма мелатонина с подкисляющей добавкой, которая делает мелатонин растворимым в слюне |
Country Status (13)
| Country | Link |
|---|---|
| US (4) | US10500280B2 (https=) |
| EP (1) | EP3641759B1 (https=) |
| JP (1) | JP7297685B2 (https=) |
| KR (1) | KR20200018652A (https=) |
| CN (1) | CN110913853A (https=) |
| AU (1) | AU2018289284A1 (https=) |
| BR (2) | BR122021012549B8 (https=) |
| CA (1) | CA3067822C (https=) |
| ES (1) | ES2979335T3 (https=) |
| MX (1) | MX2019015733A (https=) |
| RU (1) | RU2020101742A (https=) |
| SG (1) | SG11201912172YA (https=) |
| WO (1) | WO2018236678A1 (https=) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG11201912172YA (en) | 2017-06-20 | 2020-01-30 | Physicians Seal Llc | Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva |
| US10828254B2 (en) | 2018-09-28 | 2020-11-10 | Intelgenx Corp. | Oral film formulation for modulating absorption profile |
| CN112426408B (zh) * | 2020-12-08 | 2023-12-19 | 广州帝奇医药技术有限公司 | 一种褪黑素组合物及其制备工艺 |
| WO2022170442A1 (en) * | 2021-02-12 | 2022-08-18 | Intelgenx Corp. | Novel tryptamine oral film formulation |
| CA3221463A1 (en) * | 2021-06-09 | 2022-12-15 | Agb-Pharma Ab | Melatonin formulation in solid dosage form |
| US12440472B2 (en) | 2021-06-16 | 2025-10-14 | Intelgenx Corp. | Stable tryptamine oral films |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030091629A1 (en) | 1998-03-27 | 2003-05-15 | Cima Labs Inc. | Sublingual buccal effervescent |
| US6730330B2 (en) | 2001-02-14 | 2004-05-04 | Gw Pharma Limited | Pharmaceutical formulations |
| WO2003074029A1 (en) * | 2002-03-07 | 2003-09-12 | Vectura Limited | Fast melt multiparticulate formulations for oral delivery |
| CA2551637A1 (en) | 2003-12-24 | 2005-07-14 | Sepracor Inc. | Melatonin combination therapy for improving sleep quality |
| JP5179757B2 (ja) | 2004-02-17 | 2013-04-10 | トランセプト ファーマシューティカルズ， インコーポレイティド | 口腔粘膜を介して催眠剤をデリバリーするための組成物及びその使用方法 |
| US20090047347A1 (en) | 2005-07-29 | 2009-02-19 | Aegis Therapeutics, Inc. | Compositions for Drug Administration |
| CA2582299A1 (en) | 2004-10-05 | 2006-04-13 | Altana Pharma Ag | Oral pharmaceutical preparation for proton pump antagonists |
| CN101132769A (zh) * | 2005-02-10 | 2008-02-27 | 奥瑞克索股份公司 | 用于药物的跨黏膜给药的药物组合物 |
| JP2009527504A (ja) | 2006-02-23 | 2009-07-30 | イオメディックス スリープ インターナショナル エスアールエル | 良質な睡眠の誘導および維持のための組成物および方法 |
| IL175338A0 (en) * | 2006-05-01 | 2006-09-05 | Biota Ltd | Orally administrable films and preparation thereof |
| US20080171085A1 (en) | 2007-01-11 | 2008-07-17 | Natrol, Inc. | Novel biphasic delivery system for a pharmaceutical or nutraceutical composition and method of administration |
| RU2485949C2 (ru) | 2007-04-11 | 2013-06-27 | Фармасьютикал Продакшнс Инк | Таблетка мелатонина и способы изготовления и применения |
| US20080260823A1 (en) * | 2007-04-20 | 2008-10-23 | Sciele Pharma, Inc. | Orally disintegrating tablet comprising glycopyrrolate for treating sialorrhea |
| CA2685591A1 (en) | 2007-05-01 | 2008-11-06 | Sigmoid Pharma Limited | Pharmaceutical nimodipine compositions |
| KR100905027B1 (ko) | 2007-10-03 | 2009-06-30 | (주)씨엘팜 | 식용 필름 |
| EP2265259A1 (en) * | 2008-04-25 | 2010-12-29 | Cadila Healthcare Limited | Rapidly disintegrating oral compositions of tramadol |
| US8691275B2 (en) * | 2011-01-28 | 2014-04-08 | Zx Pharma, Llc | Controlled-release melatonin compositions and related methods |
| US20120213855A1 (en) | 2011-02-17 | 2012-08-23 | Cima Labs Inc. | Dosage forms for weakly ionizable compounds |
| US20120315337A1 (en) * | 2011-06-07 | 2012-12-13 | Shah Syed | Multiparticulate 5-htp compositions and related methods |
| US20130052234A1 (en) * | 2011-08-25 | 2013-02-28 | Purebrands LLC | Edible strips |
| ES2457718B1 (es) | 2012-09-24 | 2015-04-16 | Universidad De Granada | Composición farmacéutica bucodispersable de melatonina |
| US20140303227A1 (en) | 2013-03-14 | 2014-10-09 | Pharmaceutical Productions Inc. | Transmucosal hormone delivery system |
| EP3265140B1 (en) * | 2015-03-02 | 2021-05-12 | Medlab Clinical U.S., Inc. | Transmucosal and transdermal delivery systems |
| SG11201912172YA (en) * | 2017-06-20 | 2020-01-30 | Physicians Seal Llc | Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva |
-
2018
- 2018-06-15 SG SG11201912172YA patent/SG11201912172YA/en unknown
- 2018-06-15 MX MX2019015733A patent/MX2019015733A/es unknown
- 2018-06-15 BR BR122021012549A patent/BR122021012549B8/pt active IP Right Grant
- 2018-06-15 ES ES18820326T patent/ES2979335T3/es active Active
- 2018-06-15 CN CN201880041048.3A patent/CN110913853A/zh active Pending
- 2018-06-15 CA CA3067822A patent/CA3067822C/en active Active
- 2018-06-15 WO PCT/US2018/037698 patent/WO2018236678A1/en not_active Ceased
- 2018-06-15 JP JP2019570491A patent/JP7297685B2/ja active Active
- 2018-06-15 RU RU2020101742A patent/RU2020101742A/ru not_active Application Discontinuation
- 2018-06-15 KR KR1020207001344A patent/KR20200018652A/ko not_active Withdrawn
- 2018-06-15 EP EP18820326.9A patent/EP3641759B1/en active Active
- 2018-06-15 US US16/009,372 patent/US10500280B2/en active Active
- 2018-06-15 AU AU2018289284A patent/AU2018289284A1/en not_active Abandoned
- 2018-06-15 BR BR112019027286-0A patent/BR112019027286B1/pt active IP Right Grant
-
2019
- 2019-11-06 US US16/676,022 patent/US10960075B2/en active Active
-
2020
- 2020-05-13 US US15/931,029 patent/US11224657B2/en active Active
- 2020-05-13 US US15/931,135 patent/US11224658B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US10500280B2 (en) | 2019-12-10 |
| EP3641759B1 (en) | 2024-04-03 |
| JP7297685B2 (ja) | 2023-06-26 |
| CN110913853A (zh) | 2020-03-24 |
| KR20200018652A (ko) | 2020-02-19 |
| ES2979335T3 (es) | 2024-09-25 |
| US20200268887A1 (en) | 2020-08-27 |
| US11224658B2 (en) | 2022-01-18 |
| BR112019027286B1 (pt) | 2022-02-22 |
| US11224657B2 (en) | 2022-01-18 |
| BR122021012549B8 (pt) | 2022-10-25 |
| US20180360967A1 (en) | 2018-12-20 |
| WO2018236678A1 (en) | 2018-12-27 |
| CA3067822C (en) | 2022-08-30 |
| SG11201912172YA (en) | 2020-01-30 |
| EP3641759A1 (en) | 2020-04-29 |
| JP2020524162A (ja) | 2020-08-13 |
| CA3067822A1 (en) | 2018-12-27 |
| US20200268886A1 (en) | 2020-08-27 |
| BR112019027286A2 (pt) | 2020-07-21 |
| EP3641759A4 (en) | 2021-03-24 |
| BR122021012549B1 (pt) | 2022-02-22 |
| US10960075B2 (en) | 2021-03-30 |
| AU2018289284A1 (en) | 2020-01-16 |
| MX2019015733A (es) | 2020-02-20 |
| US20200069803A1 (en) | 2020-03-05 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA93 | Acknowledgement of application withdrawn (no request for examination) |
Effective date: 20210616 |