經(jīng)腸內(nèi)飼管給藥的口服藥品的需求增多，但以往對此研究不夠深入細致，監(jiān)管力度也不大。為確保這種給藥方式安全有效，美國食品藥品管理局（FDA）于2021年6月發(fā)布了“經(jīng)腸內(nèi)飼管給藥的口服藥品：體外試驗和說明書建議”供企業(yè)用的指導(dǎo)原則。提出了臨床前體外試驗的具體而詳細的建議，建議的試驗類型包括回收率試驗、沉降量和再分散性試驗、在指定分散介質(zhì)中的使用穩(wěn)定性試驗、粒度分布研究、腸溶衣藥品的耐酸性試驗和緩釋制劑溶出度試驗。還提出了這類給藥方式藥品說明書的撰寫建議，特別是給藥說明的詳細建議并列舉了示例。我國目前還沒有類似的指導(dǎo)原則，詳細介紹FDA該指導(dǎo)原則，供我國這方面的研究和監(jiān)管人員參考。以期將經(jīng)腸內(nèi)飼管給藥的口服藥品的體外試驗和說明書的撰寫落到實處。

The demand for oral administration of drugs via enteral feeding tube is increasing, but the previous research on this is not deep and detailed, and the supervision is not strong. In order to ensure the safety and effectiveness of this administration method, FDA issued the Oral Drug Products Administered Via Enteral Feeding Tube:In Vitro Testing and Labeling Recommendations Guidance for Industry in June 2021. Specific and detailed recommendations for preclinical in vitro testing are put forward. The recommended testing types include recovery testing, sedimentation volume and redispersibility testing, in-use stability in designated dispersion media, particle size distribution study, acid resistance testing for dug products with an enteric coating and dissolution testing for extended-release drug products. It also puts forward recommendations on the writing of drug product labelings for this kind of administration, especially the detailed recommendations for administration instructions, and lists examples. At present, there is no similar guidance in China. This guidance of FDA is introduced in detail for the reference of researchers and regulators in this field. It is expected that the in vitro testing of oral drug products administered via enteral feeding tube and the writing of the drug product labeling will be implemented.

R951