The Development Of Eltrombopag Olamine Tablets

The pharmaceutical industry is related to a key industry people's livelihood in China,the original research development of new drugs is a capital,time-consuming huge project,but also bear the potential risk of failure due to the strength of the gap between business,the world's drug discovery focused on foreign large pharmaceutical companies,domestic pharmaceutical companies with a higher proportion of generics research and development,the original drug research and development accounted for relatively small.Since the drug development project in the world is gradually reduced,a large number of drug patent is about to expire,including foreign pharmaceutical companies,including the short cycle,low risk,profitable generic drug development as a key.GlaxoSmithKline R&D production of the original drug Eltrombopag Olamine,approved by the FDA in 2008 after the listing in the United States have approved for marketing in more than ninety countries.Primarily for the treatment of chronic hepatitis C associated thrombocytopenia,the treatment of chronic idiopathic thrombocytopenic purpura,so that patients can be started and maintained with standard interferon-based hepatitis C therapy,the treatment of severe aplastic anemia.Eltrombopag Olamine is the first song poise Pa human oral non-peptide thrombopoietin receptor agonist class of small molecules.Eltrombopag Olamine wide range of application,can be a safe and effective treatment of various thrombocytopenia,can significantly increase the platelet count and reduce bleeding events,improve quality of life,increase vitality,improve activities of daily living,reduce fatigue.Based on the nature of Eltrombopag Olamine,as a reference to the original drug research,study of the original drug release properties of the melt,stability,and other related pharmaceutical properties.Comprehensive survey of the use of materials at home and abroad,domestic and foreign manufacturers and different materials performance differences in the formulation application,through materials compatibility test materials were selected for the formulation.Final selection of low-cost,quality and performance can be achieved in the original research materials,the choice of microcrystalline cellulose,povidone K30,mannitol,sodium carboxymethyl starch,magnesium stearate as excipients.Mannitol were investigated with microcrystalline cellulose filler ratio,select the amount of binder and the amount of drug particle size,disintegrating agents and added way,the choice of the original research article closest to the final six prescription prescription,that song Ai Popa Tablets contain eltrombopag 31.9mg,mannitol 93mg,microcrystalline cellulose(PH 101)192mg,carboxymethyl starch sodium 13mg,,magnesium stearate 4mg.of eltrombopag prescription enlargement process development,small scale production from the laboratory to industrial scale production.Identified as wet granulation process,disintegrating agents added to the applied combination ho main process step,raw materials mixed to prepare a soft material,screened granulation,drying temperature,mixing,tableting,coating and the like.