JP2012531442A5 - - Google Patents
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- Publication number
- JP2012531442A5 JP2012531442A5 JP2012517802A JP2012517802A JP2012531442A5 JP 2012531442 A5 JP2012531442 A5 JP 2012531442A5 JP 2012517802 A JP2012517802 A JP 2012517802A JP 2012517802 A JP2012517802 A JP 2012517802A JP 2012531442 A5 JP2012531442 A5 JP 2012531442A5
- Authority
- JP
- Japan
- Prior art keywords
- liquid composition
- composition according
- botulinum toxin
- group
- range
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000203 mixture Substances 0.000 claims 55
- 239000007788 liquid Substances 0.000 claims 53
- 108030001720 Bontoxilysin Proteins 0.000 claims 26
- 229940053031 botulinum toxin Drugs 0.000 claims 23
- 239000008247 solid mixture Substances 0.000 claims 19
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical class CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 15
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 15
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 15
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 13
- 239000002736 nonionic surfactant Substances 0.000 claims 12
- 150000003839 salts Chemical class 0.000 claims 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 9
- 150000002840 non-reducing disaccharides Chemical class 0.000 claims 9
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims 8
- 239000000945 filler Substances 0.000 claims 8
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical class OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims 8
- 238000000034 method Methods 0.000 claims 8
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 8
- 239000000872 buffer Substances 0.000 claims 7
- 150000001413 amino acids Chemical group 0.000 claims 6
- 108090000765 processed proteins & peptides Proteins 0.000 claims 6
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims 5
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 5
- 229930006000 Sucrose Natural products 0.000 claims 5
- 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 5
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims 5
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical class O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims 5
- 238000001035 drying Methods 0.000 claims 5
- 239000011976 maleic acid Substances 0.000 claims 5
- 239000000546 pharmaceutical excipient Substances 0.000 claims 5
- 239000005720 sucrose Substances 0.000 claims 5
- 239000011975 tartaric acid Substances 0.000 claims 5
- 235000002906 tartaric acid Nutrition 0.000 claims 5
- 150000004043 trisaccharides Chemical class 0.000 claims 5
- 108010088751 Albumins Proteins 0.000 claims 4
- 102000009027 Albumins Human genes 0.000 claims 4
- 230000015572 biosynthetic process Effects 0.000 claims 4
- 239000013078 crystal Substances 0.000 claims 4
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 3
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 3
- 229920001213 Polysorbate 20 Polymers 0.000 claims 3
- 229920001219 Polysorbate 40 Polymers 0.000 claims 3
- 229920001214 Polysorbate 60 Polymers 0.000 claims 3
- MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 claims 3
- NWGKJDSIEKMTRX-AAZCQSIUSA-N Sorbitan monooleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O NWGKJDSIEKMTRX-AAZCQSIUSA-N 0.000 claims 3
- HVUMOYIDDBPOLL-XWVZOOPGSA-N Sorbitan monostearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O HVUMOYIDDBPOLL-XWVZOOPGSA-N 0.000 claims 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 3
- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 claims 3
- IJCWFDPJFXGQBN-RYNSOKOISA-N [(2R)-2-[(2R,3R,4S)-4-hydroxy-3-octadecanoyloxyoxolan-2-yl]-2-octadecanoyloxyethyl] octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@@H](OC(=O)CCCCCCCCCCCCCCCCC)[C@H]1OC[C@H](O)[C@H]1OC(=O)CCCCCCCCCCCCCCCCC IJCWFDPJFXGQBN-RYNSOKOISA-N 0.000 claims 3
- LWZFANDGMFTDAV-BURFUSLBSA-N [(2r)-2-[(2r,3r,4s)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl] dodecanoate Chemical compound CCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O LWZFANDGMFTDAV-BURFUSLBSA-N 0.000 claims 3
- 238000004108 freeze drying Methods 0.000 claims 3
- 239000003349 gelling agent Substances 0.000 claims 3
- 239000008363 phosphate buffer Substances 0.000 claims 3
- 229920001983 poloxamer Polymers 0.000 claims 3
- 229960000502 poloxamer Drugs 0.000 claims 3
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 3
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 claims 3
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 claims 3
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 claims 3
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 claims 3
- 229940068977 polysorbate 20 Drugs 0.000 claims 3
- 229940101027 polysorbate 40 Drugs 0.000 claims 3
- 229940113124 polysorbate 60 Drugs 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 229940068968 polysorbate 80 Drugs 0.000 claims 3
- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose 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[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 claims 3
- 235000011067 sorbitan monolaureate Nutrition 0.000 claims 3
- 235000011078 sorbitan tristearate Nutrition 0.000 claims 3
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 3
- 229940095064 tartrate Drugs 0.000 claims 3
- 229940074410 trehalose Drugs 0.000 claims 3
- 125000000647 trehalose group Chemical group 0.000 claims 3
- DPVHGFAJLZWDOC-PVXXTIHASA-N (2r,3s,4s,5r,6r)-2-(hydroxymethyl)-6-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-3,4,5-triol;dihydrate Chemical compound O.O.O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 DPVHGFAJLZWDOC-PVXXTIHASA-N 0.000 claims 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 239000013504 Triton X-100 Substances 0.000 claims 2
- 229920004890 Triton X-100 Polymers 0.000 claims 2
- 239000006172 buffering agent Substances 0.000 claims 2
- 229940126600 bulk drug product Drugs 0.000 claims 2
- 229920000136 polysorbate Polymers 0.000 claims 2
- 229950008882 polysorbate Drugs 0.000 claims 2
- 239000000843 powder Substances 0.000 claims 2
- -1 sorbitan ester Chemical class 0.000 claims 2
- 230000001225 therapeutic effect Effects 0.000 claims 2
- 229940074409 trehalose dihydrate Drugs 0.000 claims 2
- 238000001291 vacuum drying Methods 0.000 claims 2
- 239000004034 viscosity adjusting agent Substances 0.000 claims 2
- 239000004475 Arginine Substances 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 239000004952 Polyamide Substances 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 229920002125 Sokalan® Polymers 0.000 claims 1
- 229920001938 Vegetable gum Polymers 0.000 claims 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 239000004584 polyacrylic acid Substances 0.000 claims 1
- 229920002647 polyamide Polymers 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 230000006641 stabilisation Effects 0.000 claims 1
- 238000011105 stabilization Methods 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US22043309P | 2009-06-25 | 2009-06-25 | |
| US61/220,433 | 2009-06-25 | ||
| PCT/US2010/040104 WO2010151840A2 (en) | 2009-06-25 | 2010-06-25 | Albumin-free botulinum toxin formulations |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2012531442A JP2012531442A (ja) | 2012-12-10 |
| JP2012531442A5 true JP2012531442A5 (enExample) | 2013-08-08 |
| JP6043627B2 JP6043627B2 (ja) | 2016-12-14 |
Family
ID=43381023
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012517802A Expired - Fee Related JP6043627B2 (ja) | 2009-06-25 | 2010-06-25 | アルブミン非含有ボツリヌス毒素製剤 |
Country Status (13)
| Country | Link |
|---|---|
| US (6) | US9340587B2 (enExample) |
| EP (1) | EP2445521A4 (enExample) |
| JP (1) | JP6043627B2 (enExample) |
| KR (5) | KR20210141783A (enExample) |
| CN (1) | CN102869373B (enExample) |
| AU (1) | AU2010265888A1 (enExample) |
| BR (1) | BRPI1015938A2 (enExample) |
| CA (1) | CA2766521C (enExample) |
| CO (1) | CO6491076A2 (enExample) |
| IL (2) | IL268980B (enExample) |
| MX (3) | MX344583B (enExample) |
| SG (1) | SG177357A1 (enExample) |
| WO (1) | WO2010151840A2 (enExample) |
Families Citing this family (36)
| Publication number | Priority date | Publication date | Assignee | Title |
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| AU2005251676B2 (en) * | 2004-03-03 | 2011-09-29 | Revance Therapeutics, Inc. | Compositions and methods for topical diagnostic and therapeutic transport |
| US9211248B2 (en) | 2004-03-03 | 2015-12-15 | Revance Therapeutics, Inc. | Compositions and methods for topical application and transdermal delivery of botulinum toxins |
| BRPI0513850A (pt) * | 2004-07-26 | 2008-05-20 | Merz Pharma Gmbh & Co Kgaa | composição terapêutica com uma neurotoxina botulìnica |
| BRPI0608249A2 (pt) * | 2005-03-03 | 2009-12-08 | Revance Therapeutics Inc | formulação, método para aplicação tópica e kit para distribuição transdérmica de toxina botulìnica |
| US8168206B1 (en) * | 2005-10-06 | 2012-05-01 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
| HRP20180739T1 (hr) | 2008-12-31 | 2018-06-29 | Revance Therapeutics, Inc. | Injekcijske formulacije botulinskog toksina |
| CA2766521C (en) * | 2009-06-25 | 2020-07-21 | Revance Therapeutics, Inc. | Albumin-free botulinum toxin formulations |
| JP5951490B2 (ja) * | 2009-10-21 | 2016-07-13 | ルバンス セラピュティックス インク．Ｒｅｖａｎｃｅ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． | 非複合ボツリヌス神経毒素を精製するための方法およびシステム |
| HRP20171483T1 (hr) | 2011-01-07 | 2017-12-01 | Revance Therapeutics, Inc. | Topikalni pripravak koji se sastoji od botulinskog toksina i boje |
| MX2014011376A (es) | 2012-03-22 | 2014-10-14 | Revance Therapeutics Inc | Metodo de tratamiento de arrugas mediante agentes quimiodenervantes topicos. |
| US20140242110A1 (en) * | 2013-02-28 | 2014-08-28 | Dt Scimed, Llc | Dose, localization, and formulation of botulinum toxins in skin and muscle |
| MX369534B (es) * | 2013-09-08 | 2019-11-11 | Pfizer | Composiciones de neisseria meningitidis y sus metodos. |
| US9480731B2 (en) | 2013-12-12 | 2016-11-01 | Medy-Tox, Inc. | Long lasting effect of new botulinum toxin formulations |
| US9943576B2 (en) * | 2014-04-30 | 2018-04-17 | Allergan, Inc. | Formulations of biologics for intravesical instillation |
| JP6798993B2 (ja) | 2014-12-23 | 2020-12-09 | メルツ ファーマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディト ゲゼルシャフト アウフ アクティーン | ボツリヌス毒素プレフィルド容器 |
| WO2016124213A1 (en) * | 2015-02-03 | 2016-08-11 | Merz Pharma Gmbh & Co. Kgaa | Botulinum toxin prefilled container |
| SG10202004337WA (en) * | 2015-10-29 | 2020-06-29 | Revance Therapeutics Inc | Injectable botulinum toxin formulations and methods of use thereof having long duration of therapeutic or cosmetic effect |
| WO2018038301A1 (en) | 2016-08-26 | 2018-03-01 | Hugel Inc. | Stabilized liquid formulation of botulinum toxin and preparation method thereof |
| WO2018038585A1 (ko) * | 2016-08-26 | 2018-03-01 | 주식회사 에이비바이오 | 보툴리눔 독소 및 안정화제를 포함하는 액상 제형 및 이의 제조방법 |
| HUE046449T2 (hu) * | 2016-09-13 | 2020-03-30 | Allergan Inc | Stabilizált, nem fehérje eredetû, clostridiális toxin készítmények |
| US11311496B2 (en) * | 2016-11-21 | 2022-04-26 | Eirion Therapeutics, Inc. | Transdermal delivery of large agents |
| KR101744900B1 (ko) * | 2017-01-20 | 2017-06-08 | 주식회사 대웅 | 보툴리눔 독소를 포함하는 안정한 액상 조성물 |
| WO2018213710A1 (en) * | 2017-05-18 | 2018-11-22 | Revance Therapeutics, Inc. | Methods of treatment for cervical dystonia |
| EP3641746B1 (en) | 2017-06-19 | 2024-11-20 | President And Fellows Of Harvard College | Methods and compositions for treating a microbial infection |
| CA3068292A1 (en) * | 2017-06-26 | 2019-01-03 | Bonti, Inc. | Clostridial neurotoxin formulations and use |
| WO2019046311A1 (en) | 2017-08-28 | 2019-03-07 | Revance Therapeutics, Inc. | TRANSMUCOSAL COMPOSITIONS OF BOTULINUM TOXIN, KITS AND METHODS FOR TREATING BLADDER DISORDERS |
| MX2020005785A (es) * | 2017-12-04 | 2020-10-28 | Revance Therapeutics Inc | Formulaciones inyectables de toxina botulínica y métodos de uso de las mismas que tienen una alta tasa de respuesta y una larga duración del efecto. |
| KR102063475B1 (ko) * | 2018-02-22 | 2020-01-09 | 주식회사 에이비바이오 | 보툴리눔 독소, 안정화제, 및 국소마취제를 포함하는 액상 제형 및 이의 제조방법 |
| KR102324855B1 (ko) * | 2020-05-20 | 2021-11-11 | 오스템임플란트 주식회사 | 보툴리눔 독소를 포함하는 약제학적 액상 조성물 |
| KR102414997B1 (ko) * | 2020-09-29 | 2022-06-29 | 주식회사 엘지생활건강 | 안정성이 개선된 재조합 보툴리눔 독소 경쇄 단백질 조성물 |
| KR102710632B1 (ko) * | 2020-10-07 | 2024-09-27 | 주식회사 프로톡스 | 보툴리눔 독소의 진공 건조 방법 |
| WO2022131860A1 (ko) * | 2020-12-18 | 2022-06-23 | 주식회사 에이티지씨 | 보툴리눔 독소의 액상 제제를 장기 보관하기 위한 약제학적 조성물 |
| KR102427362B1 (ko) * | 2021-11-11 | 2022-08-01 | (주)이니바이오 | 보툴리눔 독소 제제의 건조 공정 |
| WO2025059665A1 (en) | 2023-09-15 | 2025-03-20 | Revance Therapeutics, Inc. | Serial treatment with botulinum toxin for cervical dystonia |
| WO2025064729A1 (en) | 2023-09-19 | 2025-03-27 | Revance Therapeutics, Inc. | Treatment with botulinum toxin in patients in need of a rapid onset cosmetic effect and smoother skin appearance |
| GB202318884D0 (en) * | 2023-12-11 | 2024-01-24 | Ipsen Biopharm Ltd | Formulation |
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- 2010-06-25 KR KR1020217037163A patent/KR20210141783A/ko not_active Withdrawn
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