In vitro aerosol characterization of Staccato(®) Loxapine.

Medicinal aerosol products (metered dose and dry powder inhalers) require characterization testing over a wide range of use and pre-operating stress scenarios in order to ensure robust product performance and support submissions for regulatory approval. Aerosol characterization experiments on Staccato(®) Loxapine for inhalation (Staccato Loxapine) product (emitted dose, particle size, and purity) were assessed at different operating settings (flow rates, ambient temperature and humidity, altitude, and orientation) and at nominal test conditions following exposure to various stresses on the device (mechanical shock, vibration, drop, thermal cycling, and light exposure). Emitted dose values were approximately 90% of the coated dose at every condition, meeting target specifications in each case.

In vitro aerosol deposition in the oropharyngeal region for Staccato loxapine.

Background: The Staccato system employs a thermal vaporization technology to generate pure drug aerosols with a particle size optimized for alveolar deposition, leading to rapid absorption of the drug into the systemic circulation. Unlike most traditional aerosol-generation techniques, the particle size of the thermally generated aerosols is significantly affected by the airflow rate going through the device. The objective of this study was to determine the effects of flow rate and other operating conditions on predicted oropharyngeal and lung deposition when using the Staccato system.