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Extra resources for Advanced Drug Formulation Design to Optimize Therapeutic Outcomes
In particular, a cursory review of the literature reveals that there have been developments in marketed multiple dose devices such as Chiesi’s Pulvinal and Innovata’s ClickhalerÒ (11). Often such devices are based on the principles of the first generation products but have evolved to include patient friendly features such as dose counting, for example, in the Turbuhaler, the Clickhaler and the TwisthalerÒ. In addition, the concept of replenishable single dose capsule formulations has been extended to multiple dose DPIs with the marketing of the NovolizerÒ, which has a replaceable multi-dose cartridge.
For example, materials such as magnesium stearate (25,26,52,53,56) and leucine (54) are reported to improve the aerosolization efficiency of carrier based system by modification of the adhesive forces between the drug and the carrier. 5 (29 and 102 mg doses for the smoothed and magnesium stearate treated lactose carriers, respectively) (26). 5) (from a 112 Â 10-9 nJ to 32 Â 10-9 nJ for magnesium stearate treated systems). More recent work by Iida et al. (52,57), has reported similar improvements, and, improved performance after storage of lactosemagnesium based formulations at elevated humidities.
The most obvious commercial example of API spray drying is the recent ExuberaÒ formulation (13). By modifying the drug solution concentration and operating conditions it becomes possible to, with relative ease, alter the particle size or morphology of the final product. This has obvious implications, as reported by Chew et al. (79), where the altering of the spray drying conditions resulted in the control of the degree of particle corrugation of an serum albumin (BSA), and thus, the aerosolization efficiency.