RU2018127191A - Оромукозальные фармацевтические препараты с высокой биодоступностью на основе циклодекстрина и сукралозы - Google Patents
Оромукозальные фармацевтические препараты с высокой биодоступностью на основе циклодекстрина и сукралозы Download PDFInfo
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- RU2018127191A RU2018127191A RU2018127191A RU2018127191A RU2018127191A RU 2018127191 A RU2018127191 A RU 2018127191A RU 2018127191 A RU2018127191 A RU 2018127191A RU 2018127191 A RU2018127191 A RU 2018127191A RU 2018127191 A RU2018127191 A RU 2018127191A
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- Prior art keywords
- composite
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- api
- sucralose
- hpβcd
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- 229920000858 Cyclodextrin Polymers 0.000 title claims 7
- 239000004376 Sucralose Substances 0.000 title claims 7
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 title claims 7
- 235000019408 sucralose Nutrition 0.000 title claims 7
- 229940079593 drug Drugs 0.000 title 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 title 1
- 239000002131 composite material Substances 0.000 claims 11
- 239000008186 active pharmaceutical agent Substances 0.000 claims 10
- 238000000034 method Methods 0.000 claims 6
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 RJKFOVLPORLFTN-LEKSSAKUSA-N 0.000 claims 4
- MUMGGOZAMZWBJJ-DYKIIFRCSA-N Testostosterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 MUMGGOZAMZWBJJ-DYKIIFRCSA-N 0.000 claims 4
- 239000008365 aqueous carrier Substances 0.000 claims 4
- 239000000203 mixture Substances 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 238000004090 dissolution Methods 0.000 claims 2
- 239000000186 progesterone Substances 0.000 claims 2
- 229960003387 progesterone Drugs 0.000 claims 2
- 150000003431 steroids Chemical class 0.000 claims 2
- 229960003604 testosterone Drugs 0.000 claims 2
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000010408 film Substances 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 239000000499 gel Substances 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 229940088597 hormone Drugs 0.000 claims 1
- 239000005556 hormone Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000008185 minitablet Substances 0.000 claims 1
- 239000006187 pill Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 238000001694 spray drying Methods 0.000 claims 1
- 239000003270 steroid hormone Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims 1
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- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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Claims (19)
1. Композит, состоящий из: гидроксипропил-β-циклодекстрина (HPβCD), сукралозы, активного фармацевтического ингредиента (АФИ), необязательно водного носителя, и при этом указанный АФИ находится в комплексе с указанным HPβCD, где композит имеет молярное соотношение НРβCD:сукралоза от 1:0,05 до 1:0,8 и АФИ представляет собой стероид.
2. Композит по п. 1, имеющий молярное соотношение АФИ:НРβСБ от 1:1 до 1:4.
3. Композит по любому из пп. 1, 2, имеющий молярное соотношение АФИ:сукралоза от 1:0,05 до 1:2.
4. Композит по любому из пп. 1-3, в котором указанный стероид выбран из тестостерона, прогестерона и их производных.
5. Способ получения композита по любому из пп. 1-4, включающий образование комплекса АФИ в HPβCD в присутствии сукралозы.
6. Способ по п. 5, включающий следующие стадии:
a. растворение HPβCD (или сукралозы) в водном носителе.
b. растворение сукралозы (или HPβCD) в растворе, полученном на стадии а.
c. добавление АФИ в раствор, полученный на стадии b.
d. необязательно удаление водного носителя.
7. Способ по любому из пп. 5-6, в котором на стадии d. водный носитель удаляют лиофильной сушкой или распылительной сушкой.
8. Способ по любому из пп. 5-7, в котором продукт, полученный на стадии (d) представляет собой аморфное твердое вещество.
9. Композит, полученный способом по любому из пп. 5-8.
10. Фармацевтическая композиция, содержащая композит по любому из пп. 1-4, 9.
11. Фармацевтическая композиция по п. 10, походящая для оромукозального введения.
12. Фармацевтическая композиция по любому из пп. 10, 11, выбранная из: порошка, гранулята, таблетки, минитаблетки, пилюли, геля, пленки.
13. Композит или композиция по любому из пп. 1-4, 9-12 для применения в способе лечения, характеризующемся оромукозальным введением.
14. Композит или композиция для применения по п. 13, где указанный АФИ представляет собой стероидный гормон, и указанное лечение направлено на заболевание, характеризующееся снижением продуцирования указанного гормона.
15. Композит или композиция для применения по п. 14, где указанный АФИ выбран из тестостерона или прогестерона.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102016000019030 | 2016-02-24 | ||
| ITUB2016A001027A ITUB20161027A1 (it) | 2016-02-24 | 2016-02-24 | Preparazioni farmaceutiche oromucosali ad elevata biodisponibilita’ a base di ciclodestrina e sucralosio |
| PCT/EP2017/054274 WO2017144636A1 (en) | 2016-02-24 | 2017-02-24 | High bioavailability oromucosal pharmaceutical preparations based on cyclodextrin and sucralose |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2018127191A true RU2018127191A (ru) | 2020-03-24 |
| RU2018127191A3 RU2018127191A3 (ru) | 2020-05-27 |
| RU2736245C2 RU2736245C2 (ru) | 2020-11-12 |
Family
ID=56116500
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018127191A RU2736245C2 (ru) | 2016-02-24 | 2017-02-24 | Оромукозальные фармацевтические препараты с высокой биодоступностью на основе циклодекстрина и сукралозы |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US20190021986A1 (ru) |
| EP (1) | EP3419671B1 (ru) |
| CN (1) | CN108778342B (ru) |
| CA (1) | CA3013530A1 (ru) |
| IT (1) | ITUB20161027A1 (ru) |
| RU (1) | RU2736245C2 (ru) |
| WO (1) | WO2017144636A1 (ru) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR3041535B1 (fr) * | 2015-09-29 | 2019-01-25 | Galderma Research & Development | Mousse chimique non rincee contenant du trifarotene, et son utilisation dans le traitement de l'ichtyose. |
| WO2020223393A1 (en) * | 2019-04-30 | 2020-11-05 | Taka Usa, Inc. | METHODS FOR FORMING INCLUSION COMPLEXES WITH HYDROPHILIC β-CYCLODEXTRIN DERIVATIVES AND COMPOSITIONS THEREOF |
| PL3962455T3 (pl) * | 2020-05-18 | 2023-01-16 | Orexo Ab | Nowa kompozycja farmaceutyczna do dostarczania leku |
| WO2022181569A1 (ja) * | 2021-02-24 | 2022-09-01 | エーザイ・アール・アンド・ディー・マネジメント株式会社 | 口腔内崩壊性組成物、カプセル剤、フィルムコーティング錠、フィルム製剤及び口腔内崩壊性の向上方法 |
| IL313016A (en) | 2021-11-25 | 2024-07-01 | Orexo Ab | A pharmaceutical preparation that includes adrenaline |
| GB202117016D0 (en) | 2021-11-25 | 2022-01-12 | Orexo Ab | New pharmaceutical device |
| CN116869927B (zh) * | 2023-09-06 | 2023-11-10 | 中国医学科学院北京协和医院 | 一种用于治疗嗜酸性食管炎的食道温敏凝胶 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4596795A (en) * | 1984-04-25 | 1986-06-24 | The United States Of America As Represented By The Secretary, Dept. Of Health & Human Services | Administration of sex hormones in the form of hydrophilic cyclodextrin derivatives |
| US4971797A (en) * | 1988-12-22 | 1990-11-20 | Warner-Lambert Company | Stabilized sucralose complex |
| IT1241088B (it) * | 1990-03-27 | 1993-12-29 | Chiesi Farma Spa | Procedimento per la preparazione di complessi piroxicam/ciclodestrina,prodotti ottenuti e loro composizioni farmaceutiche |
| US20060120967A1 (en) * | 2004-12-07 | 2006-06-08 | Qpharma, Llc | Solution forms of cyclodextrins for nasal or throat delivery of essential oils |
| ITMI20071971A1 (it) * | 2007-10-10 | 2009-04-11 | Altergon Sa | Composizione farmaceutica per la somministrazione sublinguale di progesterone, e metodo per la sua preparazione |
| CN101559077A (zh) * | 2009-04-16 | 2009-10-21 | 官培龙 | 一种口腔炎症性疾病止痛用含漱液 |
| US9173860B2 (en) * | 2009-11-04 | 2015-11-03 | Susan Park Perrine | S isomers of α-methyl hydrocinnamic acid for the treatment of blood disorders |
| HK1161509A2 (en) * | 2010-06-04 | 2012-07-27 | 全球药物科技有限公司 | Oral meclizine aqueous formulations with taste flavoring agent |
| GB2482868A (en) | 2010-08-16 | 2012-02-22 | Franciscus Wilhelmus Henricus Maria Merkus | A testosterone liquid spray formulation for oromucosal administration |
| ITMI20122027A1 (it) * | 2012-11-28 | 2014-05-29 | Altergon Sa | Soluzioni acquose orali di ormoni steroidei e hp¿cd con biodisponibilità ottimizzata |
| CN103610659B (zh) * | 2013-12-06 | 2016-01-20 | 湖南中南大学湘雅口腔医院 | 一种大蒜素药物组合物及其制备方法 |
-
2016
- 2016-02-24 IT ITUB2016A001027A patent/ITUB20161027A1/it unknown
-
2017
- 2017-02-24 CN CN201780013106.7A patent/CN108778342B/zh not_active Expired - Fee Related
- 2017-02-24 RU RU2018127191A patent/RU2736245C2/ru active
- 2017-02-24 CA CA3013530A patent/CA3013530A1/en active Pending
- 2017-02-24 EP EP17710832.1A patent/EP3419671B1/en active Active
- 2017-02-24 WO PCT/EP2017/054274 patent/WO2017144636A1/en not_active Ceased
- 2017-02-24 US US16/072,909 patent/US20190021986A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| ITUB20161027A1 (it) | 2017-08-24 |
| RU2736245C2 (ru) | 2020-11-12 |
| CA3013530A1 (en) | 2017-08-31 |
| WO2017144636A1 (en) | 2017-08-31 |
| CN108778342B (zh) | 2021-11-16 |
| EP3419671A1 (en) | 2019-01-02 |
| US20190021986A1 (en) | 2019-01-24 |
| RU2018127191A3 (ru) | 2020-05-27 |
| CN108778342A (zh) | 2018-11-09 |
| EP3419671B1 (en) | 2021-02-17 |
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