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- W2086224770 abstract "Abstract The in vitro deposition pattern of disodium cromoglycate (DSCG) from a unit dose dry powder inhaler device (Microhaler ® ) was investigated using the Twin Impinger. Four excipients with differing particle sizes, two α-lactose monohydrate grades (Pharmatose 325 M, x 50 = 56.3 μ m and Granulac 220, x 50 =15.6 μ m) and two dextrose monohydrate grades (Roferose FF, x 50 = 102.8 μ m and Roferose SF, x 50 = 37.4 μ m), were mixed with DSCG in the ratio 1 plus 1 and 1 plus 4 at low relative humidity. Loose spherical agglomerates were formed in a rotating drum and then the mixtures were filled into hard gelatin capsules size 3 and stored at 33 and 55% RH, respectively. The deposition pattern was investigated using the Twin Impinger at a flow rate of 60 l/min. The amount of DSCG deposited in the lower impingement chamber, corresponding to a particle size of ≤ 6.4 μm, was markedly influenced by the humidity level during storage. In all experiments, the fine particle fraction from mixtures stored at 33% RH was higher compared to those stored at 55% RH. Mixtures containing 1 part DSCG plus 1 part excipient showed higher deposition rates than the 4 + 1 mixtures. Excipients with a smaller mean particle diameter gave a higher DSCG deposition in the lower impingement chamber. Best results were obtained with the 1 + 1 mixtures of DSCG and fine lactose (Granulac 220) with 41% and DSCG and fine glucose (Roferose SF) with 38%, respectively. The results indicate that dry powder inhalations can be optimized by appropriate selection of the excipient, because its particle size distribution and its proportion in a formulation in combination with the storage humidity are important factors determining the inhalation fraction of a formulation." @default.
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- W2086224770 date "1996-06-17" @default.
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- W2086224770 title "Influence of excipients and storage humidity on the deposition of disodium cromoglycate (DSCG) in the Twin Impinger" @default.
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- W2086224770 doi "https://doi.org/10.1016/0378-5173(95)04337-3" @default.
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