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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題
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最近開始接手這個項目，有關(guān)專利問題還不是很確定：現(xiàn)在歐盟那邊有一篇制劑專利，國內(nèi)也有一篇。我對于這兩篇專利具體保護的內(nèi)容有些拿不準，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其使用量進行了限制，我想問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使用？有一點差別就可以了？ 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)容涉及到知識產(chǎn)權(quán)問題，其責任在于用戶本人，如對版權(quán)有異議，請聯(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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txalex
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2樓2012-06-15 10:04:02
plc88
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3樓2012-06-15 15:00:19
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