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Combination of an HMG-CoA reductase inhibitor and a colloidal clay, and method for the preparation thereof
专利权人:
PHARMATHEN S.A.
发明人:
KARAVAS, EVANGELOS,KOUTRIS, EFTHIMIOS,IOANNIDOU, ELLI,SAMARA, VICKY,BIKIARIS, DIMITRIOS
申请号:
NZ58266707
公开号:
NZ582667A
申请日:
2007.06.25
申请国别(地区):
NZ
年份:
2012
代理人:
摘要:
Disclosed is a pharmaceutical composition for oral administration comprising Atorvastatin or a pharmaceutical acceptable salt thereof, as an active ingredient, and an effective amount of Attapulgite as a stabilizer to inhibit hydrolysis and/or isomerization and/or elimination and/or oxidation and/or re-, crystallization, wherein said composition is prepared with direct compression and said composition comprises 3% to 10% by weight of said Atorvastatin or salt thereof, wherein said composition does not comprise any buffering or alkaline agent. A process for the preparation of a solid dosage form for oral administration such as a tablet, capsule or sachet containing Atorvastatin, or a pharmaceutical acceptable salt thereof, as an active ingredient and an effective amount of Attapulgite as a stabilizer to inhibit isomerization and/or elimination and/or oxidation and/or re-crystallization wherein is said solid dosage form comprises 3% to 10% by weight of said Atorvastatin or salt thereof is also disclosed, wherein the process comprises the steps of:(a) forming a homogenous mixture by mixing the total quantity of said active ingredient with a portion of the total quantity of Attapulgite and at least one optional excipient such as a binder, a diluent, a disintegrant and/or a glidant and mixing until uniform(b) sieving the above mixture through a sieve (c) adding to the sieved mixture the total quantities of at least one optional excipient such as a binder, a diluent, a disintegrant and/or a glidant and mixing until uniform (d) admixing the remaining portion of the total quantity of Attapulgite and mixing until uniform (e) subsequently adding a lubricant and forming a homogenous mixture, and (f) formulating the resulting mixture in a solid dosage form either by compressing it into a desired tablet form or by filling capsules or sachets.
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中国工程科技知识中心
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