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专利详细信息
专利号
CN103338754A
专利标题 Highly stable compositions of orally active nucleotide analogues or orally active nucleotide analogue prodrugs
专利权人 Sigmapharm Lab Llc;
发明人
申请号 CN2011859661
申请日 2011/12/9
公开日 2013/10/2
优先权号
IPC A61K00920000;
专利类型
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Disclosed are highly stable compositions having outstanding storage stability and/or demonstrating exceptional resistance to aqueous degradation the composition including an orally active nucleotide analogue or an orally active nucleotide analogue prodrug which is orally bioavailable such as adefovir dipivoxil and tenofovir disoproxil. In particular molecular dispersions of adefovir dipivoxil in copovidone are disclosed. For example when a composition of the invention is stored for 1 month or for 18 months at 25 DEG C and 60% relative humidity its orally active nucleotide analogue or orally active nucleotide analogue prodrug degrades to provide a composition containing no more than 0. 2% or no more than 0. 7% by weight of a less orally bioavailable impurity respectively. Also disclosed are a container/closure package system including the composition and a package insert and methods of manufacturing the composition and treating a patient for a disease or condition for example a viral disease or cancer with the use of the composition.
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