Aim: To compare the in vitro characteristics of fluticasone/ salmeterol HFA pMDI with an actuator having a dose indicator (Test Product) to the Reference Product. Methods: Two critical tests that qualify the performance of the product are Delivered dose uniformity and Aerodynamic particle size distribution. Delivered dose uniformity ensures that the total amount of drug emitted from the drug device and hence available to the user is consistent. The sampling apparatus used for determining the amount of delivered dose is the Dosage unit sampling apparatus manufactured by Copley scientific. Aerodynamic particle size distribution (APSD) of an aerosol cloud defines where the particles in that cloud are likely to deposit following inhalation. The APSD was performed on the Test Product (Cipla Ltd, India) and the Reference Product (Seretide Evohaler, UK) using an Anderson cascade impactor manufactured by Copley scientific. The fine particle dose was also estimated (i.e., the amount of the drug which is deposited into the lower airways of the lung during inhalation). Results: The delivered dose uniformity was within the acceptance criteria of 75% to 125% of delivered dose and the fine particle dose by cascade impactor is within the 15% for the test product compared with the reference product. Conclusion: These data confirmed that there were no significant differences in these critical quality performance attributes between the test product (fluticasone/ salmeterol HFA pMDI with an actuator having a dose indicator) and the reference product. These data further suggest that the in vivo performance of the test and reference product will be comparable.
Malhotra et al. (Mon,) studied this question.