吸入给药的剂型选择和等效性验证

Selection of dosage form and evaluation of therapeutic equivalence for inhaled medical products

目前临床常用吸入给药的剂型包括定量吸入气雾剂(metered dose inhaler,MDI)、吸入粉雾剂/干粉吸入剂(Dry powder inhaler,DPI)和吸入喷雾剂(Nebulizer),这3种吸入给药剂型各有特点。如何正确选择所研发的药物的剂型,如何正确验证相同制剂间是否等效有其特殊性。本文结合吸入给药的药物吸收特点、各剂型特点及国外有关考虑,重点探讨了如何正确选择所研发的药物的剂型及如何正确验证相同制剂间是否等效。

The dosage forms of inhaled drugs include metered dose inhaler （MDI） , dry powder inhaler （DPI） and nebulizer. These dosage forms have different properties. In selecting a dosage form, the absorption of inhaled drugs is especially important. In this article, we focus on the development of dosage forms, and on the validation of therapeutic equivalence for the same medical products.