JP2016503803A5 - - Google Patents
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- Publication number
- JP2016503803A5 JP2016503803A5 JP2015549792A JP2015549792A JP2016503803A5 JP 2016503803 A5 JP2016503803 A5 JP 2016503803A5 JP 2015549792 A JP2015549792 A JP 2015549792A JP 2015549792 A JP2015549792 A JP 2015549792A JP 2016503803 A5 JP2016503803 A5 JP 2016503803A5
- Authority
- JP
- Japan
- Prior art keywords
- weight percent
- amount
- glatiramer acetate
- oral tablet
- hydroxypropylcellulose
- 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.)
- Withdrawn
Links
- 229940096978 oral tablet Drugs 0.000 claims description 72
- 239000007935 oral tablet Substances 0.000 claims description 72
- 108010072051 Glatiramer Acetate Proteins 0.000 claims description 46
- FHEAIOHRHQGZPC-KIWGSFCNSA-N acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid Chemical compound CC(O)=O.C[C@H](N)C(O)=O.NCCCC[C@H](N)C(O)=O.OC(=O)[C@@H](N)CCC(O)=O.OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 FHEAIOHRHQGZPC-KIWGSFCNSA-N 0.000 claims description 45
- 229960003776 glatiramer acetate Drugs 0.000 claims description 45
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 29
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 29
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 29
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 26
- 229920002125 Sokalan® Polymers 0.000 claims description 26
- 229960001631 carbomer Drugs 0.000 claims description 26
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 24
- 229930195725 Mannitol Natural products 0.000 claims description 22
- 239000000594 mannitol Substances 0.000 claims description 22
- 235000010355 mannitol Nutrition 0.000 claims description 22
- 239000003826 tablet Substances 0.000 claims description 22
- 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 description 20
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims description 20
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims description 20
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims description 18
- 229920001661 Chitosan Polymers 0.000 claims description 16
- 239000000314 lubricant Substances 0.000 claims description 16
- 239000000499 gel Substances 0.000 claims description 15
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 11
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 9
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 8
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 8
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 229910021485 fumed silica Inorganic materials 0.000 claims description 6
- 229940105329 carboxymethylcellulose Drugs 0.000 claims description 5
- 239000008194 pharmaceutical composition Substances 0.000 claims description 5
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 4
- 239000001856 Ethyl cellulose Substances 0.000 claims description 4
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 4
- 108010010803 Gelatin Proteins 0.000 claims description 4
- 229920000084 Gum arabic Polymers 0.000 claims description 4
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 4
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 4
- 241000978776 Senegalia senegal Species 0.000 claims description 4
- 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 description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- 235000010489 acacia gum Nutrition 0.000 claims description 4
- 239000000205 acacia gum Substances 0.000 claims description 4
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 4
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 4
- 229920001249 ethyl cellulose Polymers 0.000 claims description 4
- 239000008273 gelatin Substances 0.000 claims description 4
- 229920000159 gelatin Polymers 0.000 claims description 4
- 235000019322 gelatine Nutrition 0.000 claims description 4
- 235000011852 gelatine desserts Nutrition 0.000 claims description 4
- IPCSVZSSVZVIGE-UHFFFAOYSA-N hexadecanoic acid Chemical compound CCCCCCCCCCCCCCCC(O)=O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 claims description 4
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 229920000609 methyl cellulose Polymers 0.000 claims description 4
- 239000001923 methylcellulose Substances 0.000 claims description 4
- 235000010981 methylcellulose Nutrition 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- 239000000230 xanthan gum Substances 0.000 claims description 4
- 235000010493 xanthan gum Nutrition 0.000 claims description 4
- 229920001285 xanthan gum Polymers 0.000 claims description 4
- 229940082509 xanthan gum Drugs 0.000 claims description 4
- 241000206575 Chondrus crispus Species 0.000 claims description 3
- 239000005720 sucrose Substances 0.000 claims description 3
- GNWCZBXSKIIURR-UHFFFAOYSA-N (2-docosanoyloxy-3-hydroxypropyl) docosanoate Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(CO)OC(=O)CCCCCCCCCCCCCCCCCCCCC GNWCZBXSKIIURR-UHFFFAOYSA-N 0.000 claims description 2
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 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 description 2
- 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 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 2
- 235000021314 Palmitic acid Nutrition 0.000 claims description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
- WMGSQTMJHBYJMQ-UHFFFAOYSA-N aluminum;magnesium;silicate Chemical compound [Mg+2].[Al+3].[O-][Si]([O-])([O-])[O-] WMGSQTMJHBYJMQ-UHFFFAOYSA-N 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- 229910000019 calcium carbonate Inorganic materials 0.000 claims description 2
- 239000001506 calcium phosphate Substances 0.000 claims description 2
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 2
- 235000011010 calcium phosphates Nutrition 0.000 claims description 2
- 239000000378 calcium silicate Substances 0.000 claims description 2
- 229910052918 calcium silicate Inorganic materials 0.000 claims description 2
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 claims description 2
- 239000008121 dextrose Substances 0.000 claims description 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 2
- 239000000194 fatty acid Substances 0.000 claims description 2
- 229930195729 fatty acid Natural products 0.000 claims description 2
- 150000004665 fatty acids Chemical class 0.000 claims description 2
- 230000002209 hydrophobic effect Effects 0.000 claims description 2
- 239000000905 isomalt Substances 0.000 claims description 2
- 235000010439 isomalt Nutrition 0.000 claims description 2
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims description 2
- 239000008101 lactose Substances 0.000 claims description 2
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims description 2
- 239000001095 magnesium carbonate Substances 0.000 claims description 2
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims description 2
- 239000000395 magnesium oxide Substances 0.000 claims description 2
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims description 2
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims description 2
- -1 nosyl mannitol Chemical compound 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- 239000000843 powder Substances 0.000 claims description 2
- 159000000000 sodium salts Chemical class 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 2
- 229960004793 sucrose Drugs 0.000 claims 2
- 235000010418 carrageenan Nutrition 0.000 claims 1
- 239000000679 carrageenan Substances 0.000 claims 1
- 229920001525 carrageenan Polymers 0.000 claims 1
- 229940113118 carrageenan Drugs 0.000 claims 1
- 235000013681 dietary sucrose Nutrition 0.000 claims 1
- 229960001031 glucose Drugs 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- 229960001855 mannitol Drugs 0.000 claims 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims 1
- 238000000034 method Methods 0.000 description 10
- 239000006190 sub-lingual tablet Substances 0.000 description 4
- 229940098466 sublingual tablet Drugs 0.000 description 4
- 238000007908 dry granulation Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 210000004303 peritoneum Anatomy 0.000 description 2
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 description 1
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 229940038717 copaxone Drugs 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229960004667 ethyl cellulose Drugs 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 229940014259 gelatin Drugs 0.000 description 1
- 210000004195 gingiva Anatomy 0.000 description 1
- 229940071826 hydroxyethyl cellulose Drugs 0.000 description 1
- 229960002900 methylcellulose Drugs 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 229940071643 prefilled syringe Drugs 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261745226P | 2012-12-21 | 2012-12-21 | |
| US61/745,226 | 2012-12-21 | ||
| PCT/US2013/077034 WO2014100639A1 (en) | 2012-12-21 | 2013-12-20 | Transmucosal delivery of glatiramer acetate |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2016503803A JP2016503803A (ja) | 2016-02-08 |
| JP2016503803A5 true JP2016503803A5 (https=) | 2017-02-02 |
Family
ID=50979257
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015549792A Withdrawn JP2016503803A (ja) | 2012-12-21 | 2013-12-20 | 酢酸グラチラマーの経粘膜送達 |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US20160193276A1 (https=) |
| EP (1) | EP2934492A4 (https=) |
| JP (1) | JP2016503803A (https=) |
| KR (1) | KR20150111918A (https=) |
| CN (1) | CN104869983A (https=) |
| AU (1) | AU2013361053A1 (https=) |
| BR (1) | BR112015014095A2 (https=) |
| CA (1) | CA2895359A1 (https=) |
| EA (1) | EA201591188A1 (https=) |
| HK (2) | HK1214134A1 (https=) |
| IL (1) | IL239280A0 (https=) |
| MX (1) | MX2015007678A (https=) |
| SG (1) | SG11201504422XA (https=) |
| WO (1) | WO2014100639A1 (https=) |
| ZA (1) | ZA201505049B (https=) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ703122A (en) | 2010-10-11 | 2016-06-24 | Teva Pharma | Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate |
| KR20140101730A (ko) | 2011-10-10 | 2014-08-20 | 테바 파마슈티컬 인더스트리즈 리미티드 | 글라티라머 아세테이트에 대한 임상 반응을 예측하는 데 유용한 단일 뉴클레오티드 다형성 |
| UY35790A (es) | 2013-10-21 | 2015-05-29 | Teva Pharma | Marcadores genéticos que predicen la respuesta al acetato de glatiramer |
| WO2015140790A1 (en) | 2014-03-17 | 2015-09-24 | Mapi Pharma Ltd. | Sublingual delivery of glatiramer acetate |
| CN106924175B (zh) * | 2015-12-29 | 2020-07-03 | 深圳翰宇药业股份有限公司 | 一种治疗多发性硬化症的药物组合物 |
| HK1257053A1 (zh) * | 2016-02-12 | 2019-10-11 | 特一华制药株式会社 | 干法制粒物和含有该干法制粒物的固态制剂及它的制造方法 |
| JP2020525459A (ja) | 2017-06-26 | 2020-08-27 | アンスティテュ・パストゥール | Ｈｉｖリザーバーを排除し、ウイルス負荷を低減する処置 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7022663B2 (en) * | 2000-02-18 | 2006-04-04 | Yeda Research And Development Co., Ltd. | Oral, nasal and pulmonary dosage formulations of copolymer 1 |
| WO2001060392A1 (en) * | 2000-02-18 | 2001-08-23 | Yeda Research And Development Co., Ltd. At The Weizmann Institute Of Science | Oral, nasal and pulmonary dosage formualtions of copolymer 1 |
| IL159715A0 (en) * | 2001-07-10 | 2004-06-20 | Teva Pharma | Drug delivery system for zero order, zero order-biphasic, ascending or descending drug delivery |
| PL1848415T3 (pl) * | 2005-02-17 | 2013-10-31 | Teva Pharma | Terapia kombinowana obejmująca octan glatirameru oraz rasagilinę do leczenia stwardnienia rozsianego |
| WO2007061415A1 (en) * | 2005-11-22 | 2007-05-31 | Teva Pharmaceutical Industries Ltd. | Pharmaceutical compositions of telmisartan |
| JP2009521523A (ja) * | 2005-12-27 | 2009-06-04 | ジュビラント・オルガノシス・リミテッド | 口中溶解性医薬組成物およびその製造方法 |
| BRPI0622054B8 (pt) * | 2006-09-22 | 2021-05-25 | Oxford Amherst Llc | composto e composição farmacêutica |
| ES2329327B1 (es) * | 2008-03-19 | 2010-09-17 | Proyecto De Biomedicina Cima, S.L. | Combinaciones sinergicas de 5'-metiltioadenosina. |
-
2013
- 2013-12-20 JP JP2015549792A patent/JP2016503803A/ja not_active Withdrawn
- 2013-12-20 HK HK16102020.2A patent/HK1214134A1/zh unknown
- 2013-12-20 AU AU2013361053A patent/AU2013361053A1/en not_active Abandoned
- 2013-12-20 HK HK16102544.9A patent/HK1214523A1/zh unknown
- 2013-12-20 SG SG11201504422XA patent/SG11201504422XA/en unknown
- 2013-12-20 MX MX2015007678A patent/MX2015007678A/es unknown
- 2013-12-20 CN CN201380067083.XA patent/CN104869983A/zh active Pending
- 2013-12-20 BR BR112015014095A patent/BR112015014095A2/pt not_active IP Right Cessation
- 2013-12-20 EA EA201591188A patent/EA201591188A1/ru unknown
- 2013-12-20 EP EP13865051.0A patent/EP2934492A4/en not_active Withdrawn
- 2013-12-20 CA CA2895359A patent/CA2895359A1/en not_active Abandoned
- 2013-12-20 WO PCT/US2013/077034 patent/WO2014100639A1/en not_active Ceased
- 2013-12-20 US US14/653,022 patent/US20160193276A1/en not_active Abandoned
- 2013-12-20 KR KR1020157019729A patent/KR20150111918A/ko not_active Withdrawn
-
2015
- 2015-06-08 IL IL239280A patent/IL239280A0/en unknown
- 2015-07-14 ZA ZA2015/05049A patent/ZA201505049B/en unknown
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