Inhaler air sampler FP/S

Overview
Equipment and methods described here reflect the FP/S (Fluticasone Propionate/Salmeterol) inhalation aerosol monograph requirements used for product release and comparability testing. The configurations combine specialised sampling for Delivered Dose Uniformity (DDU) and modified impactor accessories for Aerodynamic Particle Size Distribution (APSD) to align with original product development methods.

Delivered Dose Uniformity (DDU)
The FP/S monograph specifies DDU measurement using a dedicated glass Sample Collection Apparatus. This glass sampling system is used to collect and quantify the delivered dose from FP/S aerosols in accordance with compendial requirements.

Products featured for DDU

• Sample Collection Apparatus for FP/Salmeterol aerosols (glass sampling apparatus)

Aerodynamic Particle Size Distribution (APSD)
APSD is measured using an Andersen Cascade Impactor (ACI) configured at 28.3 L/min (Stages 0–7 plus filter). The monograph requires a specially modified induction port common to aerosols and powders; for aerosols a modified inlet cone is used while a preseparator is applied for powders. These configurations ensure reproducible APSD results comparable to the compendial method.

Products featured for APSD

• Andersen Cascade Impactor (ACI), 28.3 L/min (Stages 0–7 plus filter)
• FP/Salmeterol Induction Port (specially modified induction port)
• ACI Inlet Cone for FP/Salmeterol aerosols (modified inlet cone)

Notes
Monograph-driven methods call for specialised sampling and impactor accessories to match original development methods. Equipment choices include glass sampling apparatus for DDU and modified impactor components for APSD to ensure method conformance and comparable results.

Technical specifications

• Monograph target: Fluticasone Propionate / Salmeterol inhalation aerosol (FP/S)
• DDU sampling: Specific glass Sample Collection Apparatus for FP/Salmeterol aerosols
• APSD measurement: Andersen Cascade Impactor (ACI), 28.3 L/min configuration (Stages 0–7 plus filter stage)
• APSD accessories: specially modified induction port common to aerosols and powders; modified inlet cone for aerosols; preseparator for powders
• Method note: although other powder methods may specify 60 L/min, the FP/S monograph requires the 28.3 L/min ACI for APSD to align with original development methods
• Approach: use of equipment and methods based on original product development to meet USP/Ph. Eur. monograph requirements
• Featured items: Sample Collection Apparatus for FP/Salmeterol aerosols; Andersen Cascade Impactor (ACI); FP/Salmeterol Induction Port; ACI Inlet Cone for FP/Salmeterol aerosols