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txalex木蟲 (正式寫手)
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[求助]
硫酸氫氯吡格雷制劑專利問(wèn)題
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最近開始接手這個(gè)項(xiàng)目，有關(guān)專利問(wèn)題還不是很確定：現(xiàn)在歐盟那邊有一篇制劑專利，國(guó)內(nèi)也有一篇。我對(duì)于這兩篇專利具體保護(hù)的內(nèi)容有些拿不準(zhǔn)，求高手幫忙。 這幾篇專利在第一條主權(quán)利要求中都列舉了處方中用到的一些輔料并且全部對(duì)其使用量進(jìn)行了限制，我想問(wèn)下我是不是就不可以使用該專利里列舉的輔料？還是我可以使用但是不能完全按照專利里面的輔料種類和用量來(lái)使用？有一點(diǎn)差別就可以了？ 以下為歐盟專利的前幾條： Summary of the Invention [0007] One general aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a clopidogrel salt; lactose; stearic acid; and one or more of other pharmaceutically acceptable excipients; wherein clopidogrel salt is hydrobromide or hydrochloride. [0008] Another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a clopidogrel salt; lactose and microcrystalline cellulose; stearic acid; and one or more of other pharmaceutically acceptable excipients wherein clopidogrel salt is hydrobromide or hydrochloride. [0009] Yet another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a clopidogrel salt; lactose; stearic acid and hydrogenated castor oil; and one or more of other pharmaceutically acceptable excipients; wherein clopidogrel salt is hydrobromide or hydrochloride. [0010] Another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a clopidogrel salt; lactose and microcrystalline cellulose; stearic acid and hydrogenated castor oil; and one or more of other pharmaceutically acceptable excipients; wherein clopidogrel salt is hydrobromide or hydrochloride. [0011] Another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a clopidogrel salt, prepared by process comprising the steps of (a) blending the clopidogrel salt with the one or more of the diluents and other pharmaceutically acceptable excipients; (b) mixing one or more of the lubricants with the blend of step (a); and (c) compressing the final blend of step (b) into tablet; wherein the clopidogrel salt is hydrobromide or hydrochloride. [0012] A further aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a clopidogrel salt, prepared by process comprising the steps of (a) blending the clopidogrel salt with lactose and other pharmaceutically acceptable excipients; (b) mixing stearic acid with the blend of step (a); and (c) compressing the final blend of step (b) into tablet; wherein the clopidogrel salt is hydrobromide or hydrochloride. [0013] Another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a clopidogrel salt, prepared by process comprising the steps of (a) blending the clopidogrel salt with lactose and microcrystalline cellulose and optionally other pharmaceutically acceptable excipients; (b) mixing stearic acid with the blend of step (a); and (c) compressing the final blend of step (b) into tablet; |
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本內(nèi)容由用戶自主發(fā)布，如果其內(nèi)容涉及到知識(shí)產(chǎn)權(quán)問(wèn)題，其責(zé)任在于用戶本人，如對(duì)版權(quán)有異議，請(qǐng)聯(lián)系郵箱：xiaomuchong@tal.com - 附件 1 : 200610063151-氯吡格雷硫酸鹽的...-審定授權(quán).pdf
- 附件 2 : 200710047897-氯吡格雷氫溴酸鹽...-審定授權(quán).pdf
- 附件 3 : 201010252488-一種氯吡格雷或其...-審定授權(quán).pdf
- 附件 4 : EP1970054A2.pdf
- 附件 5 : 200810305453-氯吡格雷的固體制...-審定授權(quán).pdf
2012-06-15 10:02:44, 395.85 K
2012-06-15 10:02:46, 527.83 K
2012-06-15 10:02:49, 242.19 K
2012-06-15 10:02:52, 83.64 K
2012-06-15 10:03:14, 1.68 M
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plc88
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3樓2012-06-15 15:00:19
txalex
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