Authors: A. Sawant1, V. Salvi1, V. Naik2, S. Chhowala2, M. Lopez2, R. Hegde2, J. Gogtay2
Affiliations: 1 Integrated Product Development, Cipla Ltd, Vikhroli, Mumbai, India 2 Medical Affairs Cipla Ltd, Mumbai Central, Mumbai, India
Performance of a device is critical to determining optimal deposition of drugs in the lungs, which in turn impacts treatment outcomes.
To evaluate the in-vitro performance of two valved holding chambers with mask – the Huf Puf Kit© and the Transpacer VM, using budesonide 100 mcg (Budecort, Cipla Ltd) pressurized metered dose inhaler (pMDI).
The fine particle mass (FPM) of budesonide pMDI when used with the Huf Puf Kit© (Cipla Ltd) and Transpacer VM (Lupin) was evaluated using the Anderson cascade impactor (flow rate 28.3 liters/min ± 5%) to simulate human breathing when inhaling through a spacer. Analysis was done on three samples each of Huf Puf Kit© and Transpacer VM using budesonide pMDI. The amount of drug deposited in the cascade impactor was calculated using high performance liquid chromatography.
The mean FPM for budesonide pMDI with Transpacer VM was 7-fold lower than that with the Huf Puf Kit© (6.19 mcg Vs 41.46 mcg). The individual FPM values for three samples of Transpacer VM were 6.09, 6.78 and 5.72 mcg and that for Huf Puf Kit© were 41.2, 41.2 and 42 mcg, using budesonide pMDI.
In vitro evaluation of Transpacer VM showed significantly lower performance in terms of FPM compared to Huf Puf Kit©. This may be because of the static material of construction for Transpacer VM compared to the anti-static material used for Huf Puf Kit©.
Indian Journal of Pediatric Respirology 2019;1(1):25.