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- Withdrawn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 (enExample) | 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 (enExample) |
| EP (1) | EP2934492A4 (enExample) |
| JP (1) | JP2016503803A (enExample) |
| KR (1) | KR20150111918A (enExample) |
| CN (1) | CN104869983A (enExample) |
| AU (1) | AU2013361053A1 (enExample) |
| BR (1) | BR112015014095A2 (enExample) |
| CA (1) | CA2895359A1 (enExample) |
| EA (1) | EA201591188A1 (enExample) |
| HK (2) | HK1214523A1 (enExample) |
| IL (1) | IL239280A0 (enExample) |
| MX (1) | MX2015007678A (enExample) |
| SG (1) | SG11201504422XA (enExample) |
| WO (1) | WO2014100639A1 (enExample) |
| ZA (1) | ZA201505049B (enExample) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2627669T3 (pl) | 2010-10-11 | 2017-02-28 | Teva Pharmaceutical Industries Ltd. | Biomarkery cytokinowe jako biomarkery prognostyczne odpowiedzi klinicznej na octan glatirameru |
| EP2765857A4 (en) | 2011-10-10 | 2015-12-09 | Teva Pharma | SIMPLE NUCLEOTIDE POLYMORPHISMS USEFUL FOR PREDICTING CLINICAL RESPONSE TO GLATIRAMERATE ACETATE |
| 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 |
| WO2017138645A1 (ja) * | 2016-02-12 | 2017-08-17 | テイカ製薬株式会社 | 乾式造粒物及び該乾式造粒物を含有する固形製剤並びにそれらの製造方法 |
| WO2019002228A1 (en) | 2017-06-26 | 2019-01-03 | Institut Pasteur | TREATMENTS TO REMOVE HIV RESERVOIRS AND REDUCE VIRAL LOAD |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ZA200206457B (en) * | 2000-02-18 | 2003-08-13 | Yeda Res & Dev | Oral, nasal and pulmonary dosage formulations of copolymer 1. |
| EP1261361B1 (en) * | 2000-02-18 | 2006-06-14 | Yeda Research And Development Company, Ltd. | Oral, nasal and pulmonary dosage formulations of copolymer 1 (glatiramer acetate) |
| IL159715A0 (en) * | 2001-07-10 | 2004-06-20 | Teva Pharma | Drug delivery system for zero order, zero order-biphasic, ascending or descending drug delivery |
| PT1848415E (pt) * | 2005-02-17 | 2013-06-27 | Teva Pharma | Terapia de combinação com acetato de glatirâmero e rasagilina para o tratamento da esclerose múltipla |
| CN101312714A (zh) * | 2005-11-22 | 2008-11-26 | 特瓦制药工业有限公司 | 替米沙坦的药用组合物 |
| WO2007074472A2 (en) * | 2005-12-27 | 2007-07-05 | Jubilant Organosys Limited | Mouth dissolving pharmaceutical composition and process for preparing the same using a high amount of silicon dioxide |
| EA018573B1 (ru) * | 2006-09-22 | 2013-09-30 | Фармасайкликс, Инк. | Ингибиторы тирозинкиназы брутона |
| ES2329327B1 (es) * | 2008-03-19 | 2010-09-17 | Proyecto De Biomedicina Cima, S.L. | Combinaciones sinergicas de 5'-metiltioadenosina. |
-
2013
- 2013-12-20 US US14/653,022 patent/US20160193276A1/en not_active Abandoned
- 2013-12-20 SG SG11201504422XA patent/SG11201504422XA/en unknown
- 2013-12-20 JP JP2015549792A patent/JP2016503803A/ja not_active Withdrawn
- 2013-12-20 HK HK16102544.9A patent/HK1214523A1/zh unknown
- 2013-12-20 EP EP13865051.0A patent/EP2934492A4/en not_active Withdrawn
- 2013-12-20 WO PCT/US2013/077034 patent/WO2014100639A1/en not_active Ceased
- 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 AU AU2013361053A patent/AU2013361053A1/en not_active Abandoned
- 2013-12-20 EA EA201591188A patent/EA201591188A1/ru unknown
- 2013-12-20 KR KR1020157019729A patent/KR20150111918A/ko not_active Withdrawn
- 2013-12-20 HK HK16102020.2A patent/HK1214134A1/zh unknown
- 2013-12-20 CA CA2895359A patent/CA2895359A1/en not_active Abandoned
- 2013-12-20 MX MX2015007678A patent/MX2015007678A/es unknown
-
2015
- 2015-06-08 IL IL239280A patent/IL239280A0/en unknown
- 2015-07-14 ZA ZA2015/05049A patent/ZA201505049B/en unknown
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