JP7444775B2 - 活性薬を高装薬した経口薄フィルム剤 - Google Patents
活性薬を高装薬した経口薄フィルム剤 Download PDFInfo
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- JP7444775B2 JP7444775B2 JP2020530650A JP2020530650A JP7444775B2 JP 7444775 B2 JP7444775 B2 JP 7444775B2 JP 2020530650 A JP2020530650 A JP 2020530650A JP 2020530650 A JP2020530650 A JP 2020530650A JP 7444775 B2 JP7444775 B2 JP 7444775B2
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- 239000010409 thin film Substances 0.000 title claims description 72
- 239000003814 drug Substances 0.000 title claims description 6
- 229940079593 drug Drugs 0.000 title 1
- 239000000203 mixture Substances 0.000 claims description 48
- 239000013543 active substance Substances 0.000 claims description 33
- 238000009472 formulation Methods 0.000 claims description 31
- 229920002678 cellulose Polymers 0.000 claims description 19
- 239000001913 cellulose Substances 0.000 claims description 19
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 14
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 13
- 238000002360 preparation method Methods 0.000 claims description 12
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 10
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 10
- VCMGMSHEPQENPE-ZOWNYOTGSA-N esketamine hydrochloride Chemical compound [Cl-].C=1C=CC=C(Cl)C=1[C@@]1([NH2+]C)CCCCC1=O VCMGMSHEPQENPE-ZOWNYOTGSA-N 0.000 claims description 6
- 238000004519 manufacturing process Methods 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 5
- 239000002671 adjuvant Substances 0.000 claims description 4
- 239000000796 flavoring agent Substances 0.000 claims description 3
- 239000000243 solution Substances 0.000 claims description 3
- 239000000725 suspension Substances 0.000 claims description 3
- 208000020401 Depressive disease Diseases 0.000 claims description 2
- 239000003963 antioxidant agent Substances 0.000 claims description 2
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 239000007900 aqueous suspension Substances 0.000 claims description 2
- 239000003086 colorant Substances 0.000 claims description 2
- 239000003995 emulsifying agent Substances 0.000 claims description 2
- 235000003599 food sweetener Nutrition 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 238000003892 spreading Methods 0.000 claims description 2
- 230000007480 spreading Effects 0.000 claims description 2
- 239000003765 sweetening agent Substances 0.000 claims description 2
- 239000000080 wetting agent Substances 0.000 claims description 2
- -1 corrigents Substances 0.000 claims 2
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 239000003623 enhancer Substances 0.000 claims 1
- 235000019634 flavors Nutrition 0.000 claims 1
- YQEZLKZALYSWHR-ZDUSSCGKSA-N (S)-ketamine Chemical group C=1C=CC=C(Cl)C=1[C@@]1(NC)CCCCC1=O YQEZLKZALYSWHR-ZDUSSCGKSA-N 0.000 description 8
- YQEZLKZALYSWHR-UHFFFAOYSA-N Ketamine Chemical compound C=1C=CC=C(Cl)C=1C1(NC)CCCCC1=O YQEZLKZALYSWHR-UHFFFAOYSA-N 0.000 description 8
- 229960003299 ketamine Drugs 0.000 description 7
- 150000003839 salts Chemical class 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 239000010408 film Substances 0.000 description 3
- 210000002200 mouth mucosa Anatomy 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 230000000202 analgesic effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 235000013355 food flavoring agent Nutrition 0.000 description 2
- 238000002695 general anesthesia Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 210000004400 mucous membrane Anatomy 0.000 description 2
- 229920005615 natural polymer Polymers 0.000 description 2
- 229920001059 synthetic polymer Polymers 0.000 description 2
- YQEZLKZALYSWHR-CYBMUJFWSA-N (R)-(+)-ketamine Chemical compound C=1C=CC=C(Cl)C=1[C@]1(NC)CCCCC1=O YQEZLKZALYSWHR-CYBMUJFWSA-N 0.000 description 1
- 206010010144 Completed suicide Diseases 0.000 description 1
- 230000021736 acetylation Effects 0.000 description 1
- 238000006640 acetylation reaction Methods 0.000 description 1
- 230000003444 anaesthetic effect Effects 0.000 description 1
- 125000000129 anionic group Chemical group 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 125000002091 cationic group Chemical group 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000006203 ethylation Effects 0.000 description 1
- 238000006200 ethylation reaction Methods 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 230000000977 initiatory effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 238000002690 local anesthesia Methods 0.000 description 1
- 239000002609 medium Substances 0.000 description 1
- 230000011987 methylation Effects 0.000 description 1
- 238000007069 methylation reaction Methods 0.000 description 1
- 210000000214 mouth Anatomy 0.000 description 1
- 230000004677 mucosal permeability Effects 0.000 description 1
- 238000006396 nitration reaction Methods 0.000 description 1
- 238000009828 non-uniform distribution Methods 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006277 sulfonation reaction Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Images
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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
- 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
- A61K9/70—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
- A61P25/24—Antidepressants
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Inorganic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Zoology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
a) 少なくとも1種のセルロース誘導体および少なくとも1種の薬学的に活性な薬剤を含む水性懸濁液または溶液を製造する工程、および
b) 工程a)で得られた懸濁液または溶液を広げて乾燥させて、約50~300g/m2の単位面積当たりの質量を有する薄フィルムを得る工程であり、工程a)で得られた懸濁液または溶液が乾燥される温度は約50℃~90℃である工程
を含む。
1分当たりのストローク数:29~32
媒体:水
温度:37℃±2℃
終点検出:視覚的
終点:フィルム剤の完全崩壊
Claims (5)
- 少なくとも1種のセルロース誘導体および少なくとも1種の薬学的に活性な薬剤を含む経口薄フィルム剤であって、
該少なくとも1種のセルロース誘導体は、2012年からの米国薬局方規格<911>方法1により測定される異なる粘度を有する2種のヒドロキシプロピルメチルセルロースの混合物を含み、
該少なくとも1種の薬学的に活性な薬剤は、(S)ケタミン・HClを含み、
該経口薄フィルム剤は、40~45wt%の(S)ケタミン・HCl、35~40wt%の、粘度が1~5mPasのヒドロキシプロピルメチルセルロース、5~15wt%の、粘度が40~60mPasのヒドロキシプロピルメチルセルロース、および、0.1~10wt%の量で少なくとも1種の補助剤を含むことを特徴とする、前記経口薄フィルム剤。 - 少なくとも1種の補助剤は、着色剤、香味剤、甘味剤、矯味剤、乳化剤、向上剤、pH調節剤、湿潤剤、保存剤および/または酸化防止剤を含む群から選択されることを特徴とする、請求項1に記載の経口薄フィルム剤。
- 単位面積当たりの質量は50~300g/m2であることを特徴とする、請求項1又は2に記載の経口薄フィルム剤。
- a) 2012年からの米国薬局方規格<911>方法1により測定される異なる粘度を有する2種のヒドロキシプロピルメチルセルロースの混合物、および(S)ケタミン・HClを含み、経口薄フィルム剤の合計重量に対して、40~45wt%の(S)ケタミン・HCl、35~40wt%の、粘度が1~5mPasのヒドロキシプロピルメチルセルロース、5~15wt%の、粘度が40~60mPasのヒドロキシプロピルメチルセルロース、および0.1~10wt%の少なくとも1種の補助剤を含む、水性懸濁液または溶液を製造する工程、
および
b) 工程a)で得られた懸濁液または溶液を広げて乾燥させて、50~300g/m2
の単位面積当たりの質量を有する薄フィルムを得る工程であり、工程a)で得られた懸濁液または溶液が乾燥される温度は50℃~90℃である工程
を含む、請求項1~3のいずれか1項に記載の経口薄フィルム剤を製造する方法。 - 特に鬱病の処置において使用するための、請求項1~3のいずれか1項に記載の経口薄フィルム剤を含む医薬。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102017129012.5A DE102017129012A1 (de) | 2017-12-06 | 2017-12-06 | Oraler Dünnfilm mit hoher Wirkstoffbeladung |
DE102017129012.5 | 2017-12-06 | ||
PCT/EP2018/083781 WO2019110727A1 (de) | 2017-12-06 | 2018-12-06 | Oraler Dünnfilm mit hoher Wirkstoffbeladung |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2021516212A JP2021516212A (ja) | 2021-07-01 |
JP7444775B2 true JP7444775B2 (ja) | 2024-03-06 |
Family
ID=64746523
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Application Number | Title | Priority Date | Filing Date |
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JP2020530650A Active JP7444775B2 (ja) | 2017-12-06 | 2018-12-06 | 活性薬を高装薬した経口薄フィルム剤 |
Country Status (12)
Country | Link |
---|---|
US (1) | US20200383936A1 (ja) |
EP (1) | EP3720419A1 (ja) |
JP (1) | JP7444775B2 (ja) |
KR (1) | KR102378847B1 (ja) |
CN (1) | CN111447920A (ja) |
AU (1) | AU2018380864B2 (ja) |
BR (1) | BR112020010175A2 (ja) |
CA (1) | CA3085020C (ja) |
DE (1) | DE102017129012A1 (ja) |
MX (1) | MX2020005942A (ja) |
RU (1) | RU2754824C1 (ja) |
WO (1) | WO2019110727A1 (ja) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102019117870B3 (de) * | 2019-07-02 | 2020-11-26 | Lts Lohmann Therapie-Systeme Ag | Oraler Dünnfilm |
DE102019135432A1 (de) * | 2019-12-20 | 2021-06-24 | Lts Lohmann Therapie-Systeme Ag | Lösliche Rückschicht für OTF |
AU2021285083A1 (en) * | 2020-06-02 | 2023-01-19 | Ix Biopharma Limited | Methods for treating major depressive disorder and treatment-resistant depression |
GB2596592A (en) * | 2020-07-03 | 2022-01-05 | Alkaloid Ad Skopje | Pharmaceutical formulation |
US20230404914A1 (en) * | 2020-11-09 | 2023-12-21 | Lts Lohmann Thereapie-Systeme Ag | Oral thin film |
DE102021105268A1 (de) * | 2021-03-04 | 2022-09-08 | Lts Lohmann Therapie-Systeme Ag. | Oraler Dünnfilm |
DE102021130954A1 (de) * | 2021-11-25 | 2023-05-25 | Lts Lohmann Therapie-Systeme Ag. | Orales Micronadel Patch |
WO2023207728A1 (zh) * | 2022-04-26 | 2023-11-02 | 宜昌人福药业有限责任公司 | 艾司氯胺酮液体制剂及其用途 |
Citations (1)
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JP2017533231A (ja) | 2014-11-04 | 2017-11-09 | アキュコート エービー | デキサメタゾン口腔内フィルム |
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EP2717852B1 (en) * | 2011-06-08 | 2019-05-08 | LTS LOHMANN Therapie-Systeme AG | Edible oral strip or wafer dosage form containing ion exchange resin for taste masking |
WO2014020155A1 (en) * | 2012-08-02 | 2014-02-06 | Clinpharm Reform Gmbh | Oral transmucosal adminstration forms of s-ketamine |
US10413516B2 (en) * | 2013-05-09 | 2019-09-17 | Cure Pharmaceutical Corporation | Thin film with high load of active ingredient |
US11207316B2 (en) * | 2014-05-30 | 2021-12-28 | West Virginia University | Ketamine or dextromethorphan formulations and methods of use |
CN105997955B (zh) * | 2016-06-28 | 2017-09-12 | 力品药业(厦门)有限公司 | 一种帕洛诺司琼口腔膜剂及其制备方法 |
DE102017112527B4 (de) * | 2017-06-07 | 2019-01-03 | Lts Lohmann Therapie-Systeme Ag | Schnell zerfallende Schaumwafer mit hohem Flächengewicht |
-
2017
- 2017-12-06 DE DE102017129012.5A patent/DE102017129012A1/de active Pending
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2018
- 2018-12-06 WO PCT/EP2018/083781 patent/WO2019110727A1/de active Search and Examination
- 2018-12-06 CA CA3085020A patent/CA3085020C/en active Active
- 2018-12-06 MX MX2020005942A patent/MX2020005942A/es unknown
- 2018-12-06 KR KR1020207019262A patent/KR102378847B1/ko active IP Right Grant
- 2018-12-06 EP EP18822284.8A patent/EP3720419A1/de active Pending
- 2018-12-06 AU AU2018380864A patent/AU2018380864B2/en active Active
- 2018-12-06 RU RU2020122136A patent/RU2754824C1/ru active
- 2018-12-06 JP JP2020530650A patent/JP7444775B2/ja active Active
- 2018-12-06 BR BR112020010175-3A patent/BR112020010175A2/pt active Search and Examination
- 2018-12-06 US US16/770,501 patent/US20200383936A1/en active Pending
- 2018-12-06 CN CN201880078745.6A patent/CN111447920A/zh active Pending
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JP2017533231A (ja) | 2014-11-04 | 2017-11-09 | アキュコート エービー | デキサメタゾン口腔内フィルム |
Also Published As
Publication number | Publication date |
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MX2020005942A (es) | 2020-08-24 |
CA3085020A1 (en) | 2019-06-13 |
CA3085020C (en) | 2023-01-17 |
US20200383936A1 (en) | 2020-12-10 |
AU2018380864A1 (en) | 2020-06-11 |
KR102378847B1 (ko) | 2022-03-24 |
KR20200096804A (ko) | 2020-08-13 |
DE102017129012A1 (de) | 2019-06-06 |
AU2018380864B2 (en) | 2021-10-07 |
WO2019110727A1 (de) | 2019-06-13 |
EP3720419A1 (de) | 2020-10-14 |
CN111447920A (zh) | 2020-07-24 |
BR112020010175A2 (pt) | 2020-11-03 |
JP2021516212A (ja) | 2021-07-01 |
RU2754824C1 (ru) | 2021-09-07 |
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