HRP20230032T1 - Farmaceutski oblici koji sadrže kortikosteroide za topikalnu primjenu - Google Patents
Farmaceutski oblici koji sadrže kortikosteroide za topikalnu primjenu Download PDFInfo
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- HRP20230032T1 HRP20230032T1 HRP20230032TT HRP20230032T HRP20230032T1 HR P20230032 T1 HRP20230032 T1 HR P20230032T1 HR P20230032T T HRP20230032T T HR P20230032TT HR P20230032 T HRP20230032 T HR P20230032T HR P20230032 T1 HRP20230032 T1 HR P20230032T1
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- liquid oil
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- pharmaceutical composition
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- 239000008194 pharmaceutical composition Substances 0.000 title claims 11
- 239000003246 corticosteroid Substances 0.000 title claims 8
- 229960001334 corticosteroids Drugs 0.000 title 1
- 238000011200 topical administration Methods 0.000 title 1
- 239000007788 liquid Substances 0.000 claims 19
- 239000003921 oil Substances 0.000 claims 19
- -1 dicarboxylic acid ester Chemical class 0.000 claims 9
- 239000000825 pharmaceutical preparation Substances 0.000 claims 4
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 claims 3
- KSCKTBJJRVPGKM-UHFFFAOYSA-N octan-1-olate;titanium(4+) Chemical compound [Ti+4].CCCCCCCC[O-].CCCCCCCC[O-].CCCCCCCC[O-].CCCCCCCC[O-] KSCKTBJJRVPGKM-UHFFFAOYSA-N 0.000 claims 3
- 229950008396 ulobetasol propionate Drugs 0.000 claims 3
- BDSYKGHYMJNPAB-LICBFIPMSA-N ulobetasol propionate Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@H](C)[C@@](C(=O)CCl)(OC(=O)CC)[C@@]2(C)C[C@@H]1O BDSYKGHYMJNPAB-LICBFIPMSA-N 0.000 claims 3
- UYWQUFXKFGHYNT-UHFFFAOYSA-N Benzylformate Chemical compound O=COCC1=CC=CC=C1 UYWQUFXKFGHYNT-UHFFFAOYSA-N 0.000 claims 2
- 201000004624 Dermatitis Diseases 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 239000002480 mineral oil Substances 0.000 claims 2
- 235000010446 mineral oil Nutrition 0.000 claims 2
- HBTAOSGHCXUEKI-UHFFFAOYSA-N 4-chloro-n,n-dimethyl-3-nitrobenzenesulfonamide Chemical compound CN(C)S(=O)(=O)C1=CC=C(Cl)C([N+]([O-])=O)=C1 HBTAOSGHCXUEKI-UHFFFAOYSA-N 0.000 claims 1
- 206010012438 Dermatitis atopic Diseases 0.000 claims 1
- 206010012442 Dermatitis contact Diseases 0.000 claims 1
- PYGXAGIECVVIOZ-UHFFFAOYSA-N Dibutyl decanedioate Chemical compound CCCCOC(=O)CCCCCCCCC(=O)OCCCC PYGXAGIECVVIOZ-UHFFFAOYSA-N 0.000 claims 1
- WJOHZNCJWYWUJD-IUGZLZTKSA-N Fluocinonide Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)COC(=O)C)[C@@]2(C)C[C@@H]1O WJOHZNCJWYWUJD-IUGZLZTKSA-N 0.000 claims 1
- 206010058898 Hand dermatitis Diseases 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 241000159243 Toxicodendron radicans Species 0.000 claims 1
- 201000008937 atopic dermatitis Diseases 0.000 claims 1
- 208000010668 atopic eczema Diseases 0.000 claims 1
- 229960001102 betamethasone dipropionate Drugs 0.000 claims 1
- CIWBQSYVNNPZIQ-XYWKZLDCSA-N betamethasone dipropionate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O CIWBQSYVNNPZIQ-XYWKZLDCSA-N 0.000 claims 1
- 229960004703 clobetasol propionate Drugs 0.000 claims 1
- CBGUOGMQLZIXBE-XGQKBEPLSA-N clobetasol propionate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CCl)(OC(=O)CC)[C@@]1(C)C[C@@H]2O CBGUOGMQLZIXBE-XGQKBEPLSA-N 0.000 claims 1
- 208000010247 contact dermatitis Diseases 0.000 claims 1
- 229940031954 dibutyl sebacate Drugs 0.000 claims 1
- 229940031578 diisopropyl adipate Drugs 0.000 claims 1
- 229960000785 fluocinonide Drugs 0.000 claims 1
- XUGNVMKQXJXZCD-UHFFFAOYSA-N isopropyl palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC(C)C XUGNVMKQXJXZCD-UHFFFAOYSA-N 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 208000017520 skin disease Diseases 0.000 claims 1
- 208000024891 symptom Diseases 0.000 claims 1
- 229940125379 topical corticosteroid Drugs 0.000 claims 1
- 230000000699 topical effect Effects 0.000 claims 1
Classifications
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- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (13)
1. Farmaceutski pripravak za topikalnu primjenu na kožu pojedinca koji sadrži:
kortikosteroid izabran iz skupine koja se sastoji od halobetazol propionata, klobetazol propionata, betametazon dipropionata, diflorazon diacetata u koncentraciji manjoj od 0,05 % (w/w) i fluocinonida u koncentraciji manjoj od 0,1 % (w/w);
i
tekuću uljnu komponentu koja sadrži ester dikarboksilne kiseline koji sadrži dietil sebakat, diizopropil adipat ili dibutil sebakat, u kome je koncentracija tekuće uljne komponente između 1,5 i 3 puta veća od one koja je potrebna za potpuno otapanje količine kortikosteroida u pripravku na temperaturi od 22 °C ± 2 °C, i gdje je koncentracija estera dikarboksilne kiseline u tekućoj uljnoj komponenti najmanje 10 % koncentracije tekuće uljne komponente u pripravku.
2. Farmaceutski pripravak patentnog zahtjeva 1, u kome je koncentracija kortikosteroida 0,04 % (w/w) ili manja.
3. Farmaceutski pripravak patentnog zahtjeva 1 ili 2, u kome je koncentracija kortikosteroida 0,025 % (w/w) ili manja, posebice pri čemu je koncentracija kortikosteroida 0,01 % (w/w) ili manja.
4. Farmaceutski pripravak bilo kojeg patentnog zahtjeva od 1 do 3, u kome je koncentracija tekuće uljne komponente između 1,75 i 2,75 puta veća od one koja je potrebna za potpuno otapanje količine kortikosteroida u pripravku na temperaturi od 22 °C ± 2 °C.
5. Farmaceutski pripravak bilo kojeg patentnog zahtjeva od 1 do 4, u kome koncentracija estera dikarboksilne kiseline u tekućoj uljnoj komponenti iznosi najmanje 30 % koncentracije tekuće uljne komponente u pripravku,
posebice u kome koncentracija estera dikarboksilne kiseline u tekućoj uljnoj komponenti iznosi najmanje 50 % koncentracije tekuće uljne komponente u pripravku,
posebice u kome koncentracija estera dikarboksilne kiseline u tekućoj uljnoj komponenti iznosi najmanje 70 % koncentracije tekuće uljne komponente u pripravku,
posebice u kome koncentracija estera dikarboksilne kiseline u tekućoj uljnoj komponenti iznosi najmanje 90 % koncentracije tekuće uljne komponente u pripravku,
posebice u kome koncentracija estera dikarboksilne kiseline u tekućoj uljnoj komponenti iznosi 100 % koncentracije tekuće uljne komponente u pripravku.
6. Farmaceutski pripravak bilo kojeg patentnog zahtjeva od 1 do 5, u kome tekuća uljna komponenta sadrži dietil sebakat.
7. Farmaceutski pripravak bilo kojeg patentnog zahtjeva od 1 do 6, u kome je tekuća uljna komponenta nadalje sadrži ester monokarboksilne kiseline odabran iz skupine koja se sastoji od izopropil miristata, izopropil palmitata i benzil formata, posebice pri čemu je ester monokarboksilne kiseline izopropil miristat.
8. Farmaceutski pripravak patentnog zahtjeva 1, u kome tekuća uljna komponenta sadrži dietil sebakat i izopropil miristat.
9. Farmaceutski pripravak bilo kojeg patentnog zahtjeva od 1 do 8, u kome tekuća uljna komponenta nadalje sadrži mineralno ulje ili lagano tretirano mineralno ulje.
10. Farmaceutski pripravak bilo kojeg patentnog zahtjeva od 1 do 9, u kome je kortikosteroid halobetazol propionat.
11. Farmaceutski pripravak patentnog zahtjeva 10, u kome je koncentracija halobetazol propionata oko 0,035 % (w/w).
12. Farmaceutski pripravak patentnog zahtjeva od 1 do 11 za upotrebu u liječenju poremećaja kože koji je podložan liječenju lokalnim kortikosteroidom, a liječenje se sastoji od davanja farmaceutskog pripravka i primjene izvjesne količine na kožu koja je učinkovita u ublažavanju znakova ili simptoma poremećaja.
13. Farmaceutski pripravak za upotrebu prema patentnom zahtjevu 12, u kome je poremećaj psorijaza, atopijski dermatitis, kontaktni dermatitis, dermatitis ruku, ekcem ili dermatitis koji potiče od otrovnog bršljana.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US45833910P | 2010-11-22 | 2010-11-22 | |
| EP11850419.0A EP2643002B1 (en) | 2010-11-22 | 2011-11-09 | Pharmaceutical formulations containing corticosteroids for topical administration |
| PCT/US2011/059861 WO2012087443A1 (en) | 2010-11-22 | 2011-11-09 | Pharmaceutical formulations containing corticosteroids for topical administration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230032T1 true HRP20230032T1 (hr) | 2023-03-03 |
Family
ID=46064916
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230032TT HRP20230032T1 (hr) | 2010-11-22 | 2011-11-09 | Farmaceutski oblici koji sadrže kortikosteroide za topikalnu primjenu |
Country Status (20)
| Country | Link |
|---|---|
| US (3) | US8809307B2 (hr) |
| EP (2) | EP2643002B1 (hr) |
| JP (1) | JP6111007B2 (hr) |
| KR (2) | KR101967121B1 (hr) |
| CN (1) | CN103228281B (hr) |
| AU (1) | AU2011345240B2 (hr) |
| BR (1) | BR112013012476B1 (hr) |
| CA (2) | CA2817524C (hr) |
| ES (1) | ES2935814T3 (hr) |
| HR (1) | HRP20230032T1 (hr) |
| HU (1) | HUE061270T2 (hr) |
| IL (1) | IL226398B2 (hr) |
| LT (1) | LT2643002T (hr) |
| MX (1) | MX346961B (hr) |
| NZ (1) | NZ610659A (hr) |
| PL (1) | PL2643002T3 (hr) |
| PT (1) | PT2643002T (hr) |
| RU (1) | RU2568598C2 (hr) |
| SI (1) | SI2643002T1 (hr) |
| WO (1) | WO2012087443A1 (hr) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8809307B2 (en) * | 2010-11-22 | 2014-08-19 | Dow Pharmaceutical Sciences, Inc. | Pharmaceutical formulations containing corticosteroids for topical administration |
| US11957753B2 (en) | 2010-11-22 | 2024-04-16 | Bausch Health Ireland Limited | Pharmaceutical formulations containing corticosteroids for topical administration |
| CN103705441B (zh) * | 2012-10-08 | 2017-06-23 | 天津金耀集团有限公司 | 一种丙酸倍氯米松乳膏 |
| CN103705440B (zh) * | 2012-10-08 | 2017-05-10 | 天津金耀集团有限公司 | 一种哈西奈德乳膏 |
| US8962028B2 (en) | 2012-10-18 | 2015-02-24 | MiCal Pharmaceuticals LLC—H Series, a Series of MiCal Pharmaceuticals LLC, a Multi-Division Limited Liability Company | Topical steroid composition and method |
| US10111956B2 (en) | 2013-06-03 | 2018-10-30 | Tolmar, Inc. | Corticosteroid compositions |
| CN104095805B (zh) * | 2014-01-02 | 2016-08-24 | 江苏知原药业有限公司 | 地奈德乳膏及其制备方法 |
| US20160184431A1 (en) * | 2014-03-11 | 2016-06-30 | Promius Pharma Llc | Topical compositions comprising a corticosteroid |
| MX2017015990A (es) | 2015-06-18 | 2018-11-09 | Valeant Pharmaceuticals North America | Composiciones topicas que comprenden un corticosteroide y un retinoide para tratar psoriasis. |
| US20190133943A1 (en) * | 2015-06-18 | 2019-05-09 | Valeant Pharmaceuticals North America | Topical compositions and methods for treating skin diseases |
| CN106474052B (zh) * | 2016-12-16 | 2019-10-25 | 重庆华邦制药有限公司 | 二丙酸阿氯米松乳膏及其制备方法 |
| US11311482B2 (en) | 2017-05-12 | 2022-04-26 | Bausch Health Us, Llc | Topical compositions and methods for treating skin diseases |
| US10653656B2 (en) | 2018-04-05 | 2020-05-19 | Bausch Health Ireland Limited | Topical pharmaceutical compositions for treating skin conditions |
| CA3133174A1 (en) | 2019-03-14 | 2020-09-17 | Crescita Therapeutics Inc. | Rinse-off compositions and uses thereof for delivery of active agents |
| US20230057282A1 (en) * | 2020-02-11 | 2023-02-23 | Taro Pharmaceutical Industries Ltd. | Compositions comprising desoximetasone and tazarotene |
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