RU2012124262A - Микрокапсулы фексофенадина и содержащие их композиции - Google Patents
Микрокапсулы фексофенадина и содержащие их композиции Download PDFInfo
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- RU2012124262A RU2012124262A RU2012124262/15A RU2012124262A RU2012124262A RU 2012124262 A RU2012124262 A RU 2012124262A RU 2012124262/15 A RU2012124262/15 A RU 2012124262/15A RU 2012124262 A RU2012124262 A RU 2012124262A RU 2012124262 A RU2012124262 A RU 2012124262A
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- microcapsules
- pharmaceutical composition
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- fexofenadine
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- 239000003094 microcapsule Substances 0.000 title claims abstract 34
- 239000000203 mixture Substances 0.000 title claims abstract 10
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 25
- 229920003176 water-insoluble polymer Polymers 0.000 claims abstract 12
- 229960003592 fexofenadine Drugs 0.000 claims abstract 11
- RWTNPBWLLIMQHL-UHFFFAOYSA-N fexofenadine Chemical compound C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RWTNPBWLLIMQHL-UHFFFAOYSA-N 0.000 claims abstract 11
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims abstract 11
- 239000005414 inactive ingredient Substances 0.000 claims abstract 7
- RRJFVPUCXDGFJB-UHFFFAOYSA-N Fexofenadine hydrochloride Chemical group Cl.C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RRJFVPUCXDGFJB-UHFFFAOYSA-N 0.000 claims abstract 6
- 229960000354 fexofenadine hydrochloride Drugs 0.000 claims abstract 6
- 239000011248 coating agent Substances 0.000 claims abstract 5
- 238000000576 coating method Methods 0.000 claims abstract 5
- 239000011118 polyvinyl acetate Substances 0.000 claims abstract 4
- 229920002689 polyvinyl acetate Polymers 0.000 claims abstract 4
- 239000007788 liquid Substances 0.000 claims abstract 3
- 239000004094 surface-active agent Substances 0.000 claims abstract 3
- 239000001856 Ethyl cellulose Substances 0.000 claims abstract 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical group CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims abstract 2
- 229920002301 cellulose acetate Polymers 0.000 claims abstract 2
- 229920006217 cellulose acetate butyrate Polymers 0.000 claims abstract 2
- 229920001577 copolymer Polymers 0.000 claims abstract 2
- 229920001249 ethyl cellulose Polymers 0.000 claims abstract 2
- 235000019325 ethyl cellulose Nutrition 0.000 claims abstract 2
- 238000000034 method Methods 0.000 claims 10
- 239000003960 organic solvent Substances 0.000 claims 7
- 206010061218 Inflammation Diseases 0.000 claims 2
- 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 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 230000004054 inflammatory process Effects 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 238000005191 phase separation Methods 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 239000000230 xanthan gum Substances 0.000 claims 2
- 229920001285 xanthan gum Polymers 0.000 claims 2
- 229940082509 xanthan gum Drugs 0.000 claims 2
- 235000010493 xanthan gum Nutrition 0.000 claims 2
- 208000035285 Allergic Seasonal Rhinitis Diseases 0.000 claims 1
- 208000036284 Rhinitis seasonal Diseases 0.000 claims 1
- 201000010105 allergic rhinitis Diseases 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 208000030949 chronic idiopathic urticaria Diseases 0.000 claims 1
- 206010072757 chronic spontaneous urticaria Diseases 0.000 claims 1
- 208000024376 chronic urticaria Diseases 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 230000000887 hydrating effect Effects 0.000 claims 1
- 239000000411 inducer Substances 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 208000017022 seasonal allergic rhinitis Diseases 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K9/48—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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
- A61K9/48—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
- A61K9/5089—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- 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
- A61P17/04—Antipruritics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- 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
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- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
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- Bioinformatics & Cheminformatics (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Pulmonology (AREA)
- Dermatology (AREA)
- Immunology (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
1. Фармацевтическая композиция, содержащая микрокапсулы, выбранные из микрокапсул немедленного высвобождения с замаскированным вкусом или совместно гранулированных микрокапсул немедленного высвобождения с замаскированным вкусом и их смесей, где указанные микрокапсулы содержат фексофенадин и нерастворимое в воде полимерное покрытие.2. Фармацевтическая композиция по п.1, где указанные микрокапсулы являются совместно гранулированными микрокапсулами немедленного высвобождения с замаскированным вкусом.3. Фармацевтическая композиция по пп.1 и 2, где указанный фексофенадин представляет собой фексофенадина гидрохлорид.4. Фармацевтическая композиция по п.1, где указанный нерастворимый в воде полимер выбирают из группы, включающей этилцеллюлозу, поливинилацетат, ацетилцеллюлозу, ацетилцеллюлозы бутират, поливинилацетат, сополимеры аммония и метакрилата и их смеси.5. Фармацевтическая композиция по п.1, где вес нерастворимого в воде полимера указанных микрокапсул составляет от приблизительно 2% до приблизительно 40%.6. Фармацевтическая композиция по п.3, где указанная композиция высвобождает по меньшей мере приблизительно 60% указанного фексофенадина гидрохлорида в течение 15 мин в жидкости с рН 6,8 по 2-му изданию фармакопеи Японии.7. Фармацевтическая композиция по п.1, где указанные микрокапсулы дополнительно содержат поверхностно-активное вещество.8. Фармацевтическая композиция по п.7, где указанные микрокапсулы дополнительно содержат средство, способствующее скольжению, или средство, уменьшающее липкость.9. Фармацевтическая композиция по п.1, дополнительно содержащая по меньшей мере один неактивный ингредиент,
Claims (23)
1. Фармацевтическая композиция, содержащая микрокапсулы, выбранные из микрокапсул немедленного высвобождения с замаскированным вкусом или совместно гранулированных микрокапсул немедленного высвобождения с замаскированным вкусом и их смесей, где указанные микрокапсулы содержат фексофенадин и нерастворимое в воде полимерное покрытие.
2. Фармацевтическая композиция по п.1, где указанные микрокапсулы являются совместно гранулированными микрокапсулами немедленного высвобождения с замаскированным вкусом.
3. Фармацевтическая композиция по пп.1 и 2, где указанный фексофенадин представляет собой фексофенадина гидрохлорид.
4. Фармацевтическая композиция по п.1, где указанный нерастворимый в воде полимер выбирают из группы, включающей этилцеллюлозу, поливинилацетат, ацетилцеллюлозу, ацетилцеллюлозы бутират, поливинилацетат, сополимеры аммония и метакрилата и их смеси.
5. Фармацевтическая композиция по п.1, где вес нерастворимого в воде полимера указанных микрокапсул составляет от приблизительно 2% до приблизительно 40%.
6. Фармацевтическая композиция по п.3, где указанная композиция высвобождает по меньшей мере приблизительно 60% указанного фексофенадина гидрохлорида в течение 15 мин в жидкости с рН 6,8 по 2-му изданию фармакопеи Японии.
7. Фармацевтическая композиция по п.1, где указанные микрокапсулы дополнительно содержат поверхностно-активное вещество.
8. Фармацевтическая композиция по п.7, где указанные микрокапсулы дополнительно содержат средство, способствующее скольжению, или средство, уменьшающее липкость.
9. Фармацевтическая композиция по п.1, дополнительно содержащая по меньшей мере один неактивный ингредиент, который является необязательно гранулированным, и/или по меньшей мере одно вспомогательное вещество.
10. Фармацевтическая композиция по п.1, где указанная композиция находится в форме таблетки, капсул или саше.
11. Фармацевтическая композиция по п.1, где совместно гранулированные микрокапсулы содержат микрокапсулы немедленного высвобождения с замаскированным вкусом, ксантановую камедь и сахарозу, где весовое соотношение микрокапсул к (ксантановая камедь+сахароза) составляет 1:7.
12. Фармацевтическая композиция по п.9, где соотношение совместно гранулированных микрокапсул к гранулированному неактивному ингредиенту составляет 1:1.
13. Способ получения фармацевтической композиции по п.1, где фармацевтическая композиция содержит микрокапсулы немедленного высвобождения с замаскированным вкусом, содержащие фексофенадин, покрытый нерастворимым в воде полимером, где указанный способ включает этапы: (а) растворения нерастворимого в воде полимера в органическом растворителе; (b) супендирования фексофенадина в указанном органическом растворителе; (с) нанесение покрытия указанного нерастворимого в воде полимера на указанный фексофенадин с помощью разделения фаз; и (d) отделение указанных микрокапсул от указанного органического растворителя.
14. Способ по п.13, где указанный фексофенадин представляет собой фексофенадина гидрохлорид.
15. Способ по п.14, дополнительно содержащий этап (е) сушки указанных отделенных микрокапсул.
16. Способ по п.15, дополнительно содержащий этап добавления средства-индуктора фаз к указанному органическому растворителю для стимулирования этапа (с).
17. Способ получения фармацевтической композиции немедленного высвобождения с замаскированным вкусом в форме саше, включающий следующие этапы: (а) растворения нерастворимого в воде полимера в органическом растворителе; (b) суспендирования фексофенадина в указанном органическом растворителе; (с) нанесения покрытия указанного нерастворимого в воде полимера на указанный фексофенадин помощью разделения фаз; (d) отделение указанных микрокапсул от указанного органического растворителя; (е) необязательного увлажнения микрокапсул; (f) совместной грануляции микрокапсул по меньшей мере с одним неактивным ингредиентом; (g) отдельной грануляции по меньшей мере одного неактивного ингредиента; h) смешивания совместного гранулята, полученного на этапе (f), вместе с гранулированным неактивным ингредиентом, полученным на этапе (g); (i) фасовки нефасованной смеси этапа (h) в саше.
18. Способ лечения состояния, связанного с воспалением, у индивидуума, включающий введение индивидууму, нуждающемуся в этом, фармацевтической композиции, содержащей микрокапсулы немедленного высвобождения с замаскированным вкусом или совместно гранулированные микрокапсулы немедленного высвобождения с замаскированным вкусом, где указанные микрокапсулы содержат фексофенадин и нерастворимое в воде полимерное покрытие.
19. Способ по п.18, где вес нерастворимого в воде полимера указанных микрокапсул составляет от приблизительно 2% до приблизительно 40%.
20. Способ по пп.18 и 19, где указанное состояние, связанное с воспалением, представляет собой сезонный аллергический ринит или хроническую идиопатическую крапивницу.
21. Способ по п.18, где указанная композиция высвобождает по меньшей мере приблизительно 80% указанного фексофенадина гидрохлорида в течение 15 мин в жидкости с рН 6,8 по 2-му изданию фармакопеи Японии.
22. Способ по п.18, где указанные микрокапсулы дополнительно содержат поверхностно-активное вещество.
23. Способ по п.18, дополнительно содержащий по меньшей мере один неактивный ингредиент, который является необязательно гранулированным, и/или по меньшей мере одно вспомогательное вещество.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US26582309P | 2009-12-02 | 2009-12-02 | |
| US61/265,823 | 2009-12-02 | ||
| US35457510P | 2010-06-14 | 2010-06-14 | |
| US61/354,575 | 2010-06-14 | ||
| PCT/IB2010/003196 WO2011067667A2 (en) | 2009-12-02 | 2010-12-01 | Fexofenadine microcapsules and compositions containing them |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2012124262A true RU2012124262A (ru) | 2014-01-20 |
| RU2563623C2 RU2563623C2 (ru) | 2015-09-20 |
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| RU2012124262/15A RU2563623C2 (ru) | 2009-12-02 | 2010-12-01 | Микрокапсулы фексофенадина и содержащие их композиции |
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| US (6) | US8580313B2 (ru) |
| EP (1) | EP2506836B1 (ru) |
| JP (3) | JP5309262B2 (ru) |
| KR (1) | KR101765357B1 (ru) |
| CN (2) | CN102958515A (ru) |
| AR (1) | AR079248A1 (ru) |
| AU (1) | AU2010325746B2 (ru) |
| CA (1) | CA2782285A1 (ru) |
| CL (1) | CL2012001451A1 (ru) |
| CO (1) | CO6541583A2 (ru) |
| ES (1) | ES2668203T3 (ru) |
| IL (1) | IL220085A (ru) |
| MX (1) | MX2012006240A (ru) |
| NZ (1) | NZ600256A (ru) |
| RU (1) | RU2563623C2 (ru) |
| SA (1) | SA110310896B1 (ru) |
| SG (1) | SG10201407965XA (ru) |
| TW (1) | TWI471146B (ru) |
| UY (1) | UY33076A (ru) |
| WO (1) | WO2011067667A2 (ru) |
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|---|---|---|---|---|
| CN102958515A (zh) | 2009-12-02 | 2013-03-06 | 阿普塔利斯制药有限公司 | 非索非那定微胶囊及含有非索非那定微胶囊的组合物 |
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