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Practical,regulatory and clinical considerations for development of inhalation drug products 被引量:8
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作者 Shuguang Hou Jiangyue Wu +1 位作者 Xu Li Hong Shu 《Asian Journal of Pharmaceutical Sciences》 SCIE CAS 2015年第6期490-500,共11页
The formulation and device collectively constitute an inhalation drug product.Development of inhaled drugs must consider the compatibility between formulation and device in order to achieve the intended pharmaceutical... The formulation and device collectively constitute an inhalation drug product.Development of inhaled drugs must consider the compatibility between formulation and device in order to achieve the intended pharmaceutical performance and usability of the product to improve patient compliance with treatment instruction.From the points of formulation,device and patient use,this article summarizes the inhalation drugs,including pressurized metered dose inhaler(pMDI),dry powder inhaler(DPI),and nebulizer that are currently available in the US and UK markets.It also discusses the practical considerations for the development of inhalers and provides an update on the corresponding regulations of the FDA(U.S.Food and Drug Administration)and the EMA(European Medicines Agency). 展开更多
关键词 pressurized metered dose inhaler(pMDI) Dry powder inhaler(DPI) NEBULIZER FORMULATION Device Clinical application
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