LYOPHILIZATED COMPOSITION FOR TRANSPULMONARY ADMINISTRATION AND USE THEREOF (VARIANTS), PROCESS FOR THE PRODUCTION OF POWDER PREPARATION FOR TRANSPULMONARY ADMINISTRATION, POWDER INHALATION SYSTEM, METHOD OF TRANSPULMONARY ADMINISTRATION

摘要

It is intended to provide a novel dry powder inhalation system for transpulmonary administration which is suitable for transpulmonary administration. This novel dry powder inhalation system for transpulmonary administration comprises : (1) a container having a freeze-dried composition for transpulmonary administration which is prepared by freeze-drying a liquid composition containing a component in an undissolved state and has the following properties (i) to (iii): (i) being in the form of a non-powdery cake; (ii) having a disintegration index of 0.05 or more; and (iii) upon an air impact of an air speed of at least 1m/sec and an air flow rate of at least 17ml/sec, being disintegrated into fine particles having an average particle diameter (an aerodynamic particle diameter) of 10 mm or less or an effective particle rate of 10% or more; combined with (2) a means of applying the above-described air impact to the freeze-dried composition in the above-described container, and a means of discharging the powdery freeze-dried composition having been, disintegrated into fine particles.