From the above equation, it can be seen that as the amount of coarse lactose and fine lactose are increased, they may lead to high fine particle fraction. This might be due to easy detachment of the drug from the coarse lactose due to its high adhesion onto the low adhesion sites of the coarse lactose. Thus lung deposition majorly depends on the optimum ratio of coarse and file lactose as well as mixing time or lactose with drug.
The contour plots and the overlay plot with the design space has been shown in Fig. 3.
Scanning electron microscopy
The SEM studies of preblend of coarse and fine lactose were done to see whether the fine lactose occupies the high adhesion sites of coarse lactose or not. The SEM
images as shown in Fig. 4 show that the fine lactose has covered majority of the high adhesion sites of the coarse lactose.
In vitro deposition studies of optimized batch using eight stage nonviable cascade impactor
22.214.171.124 Mass balance and in vitro
The mass balance study of the optimized batch was done prior to in vitro deposition studies. The mass balance was 98.63% which was within the acceptable range of 85-115%, showing no drug loss in the system. Cascade impactor is the best tool for the in vitro evaluation of the inhalation products due to several merits. It helps in the determination of mass median aerodynamic diameter which plays a significant role in determining the
Figure 3. Response surface plots of design batches and overlay curve
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Table 4 Mass balance and fine particle fraction of the optimized batch
||Mass Balance (%)
||Fine particle fraction (%)
||Mass median aerodynamic diameter (µm)
||98.63 ± 3.41
||8.99 ± 3.71
||3.40 ± 0.02
Figure 4. SEM image of dry powder inhaler blend (optimized batch)
Figure 5. Amount of drug deposited on various stages of cascade impactor and image of S1 plate
66 INHALED FLUTICASONE PROPIONATE DRY POWDER FOR THE EFFECTIVE MANAGEMENT…
deposition of the drug in several parts of the lungs. It also helps to determine the
bronchitis, asthma and pulmonary emphysema. Am Rev Respir Dis
fine particle fraction of the drug.
consists of eight stages with a cut-off diameter ranging between 0.7 and 10 µm. The mass median aerodynamic diameter as well as fine particle fraction of the optimized batch has been shown in Table 4 and the amount of drug deposited at various stages has been shown in Fig.5.
The fluticasone propionate dry powder formulation was prepared and evaluated systematically. The optimized formulation showed mass median aerodynamic diameter between 1-5 µm and fine particle fraction of 8.99% using Breezhaler® device. This represents the effectiveness of the dry powder inhalation formulation in the efficient delivery of fluticasone propionate into the lungs which can be useful for the successful treatment of severe disease such as asthma.
The authors would thank Institute of Pharmacy, Nirma University for providing all the facilities for carrying out our research work. We also thank Meggle Germany and DFE Pharma for providing us inhalable lactose grades.
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