Abstract
The aerosol properties of dry powder inhaler formulations of micronized and milled nedocromil sodium were investigated. Milled and micronized drug, alone or with a carrier (α-lactose monohydrate) were filled into hard gelatin capsules. These were placed into a proprietary dry powder inhaler device, the Rotahaler. The powders were liberated into a twin impinger operated at 60L min−1, and the drug deposited within the impinger and remaining in the device, was assayed. The results indicate that the α-lactose monohydrate carrier was necessary for optimal liberation of nedocromil sodium from the device and deposition in the lower stage of the impinger. Micronized drug (median size = 1.6 μm) was less efficiently delivered to the lower stage than milled drug (median size = 7-2 μm). Size reduction of nedocromil sodium, by micronization, to produce particles of optimal size for deep lung penetration, may alter the properties of the particles, such that they are more cohesive and adhesive and may consequently be delivered less effectively as dry powder aerosols than larger particles.
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