Effects of Process Variables on the Properties of Spray-Dried Mannitol and Mannitol/Disodium Cromoglycate Powders Suitable for Drug Delivery by Inhalation

Abstract

Understanding the influence of process conditions on the properties of pharmaceutical products is critical to their optimal and cost-effective design and manufacture. The aim of this study was to investigate the effect of changing processing variables on the physical properties of spray-dried mannitol and co-spray-dried mannitol/disodium cromoglycate (DSCG) formulations intended for therapeutic inhalation. A 2 4 full factorial design was performed to assess the consequences of altering the following spray-drying parameters: feed flow rate, nozzle gas flow rate, drying gas inlet temperature, and aspirator capacity (drying gas flow rate). Aqueous solutions of mannitol and mannitol/DSCG were spray-dried using a laboratory-scale spray dryer, and the products were characterized in terms of particle size distribution, powder yield, and particle morphology. These physical properties were found to be affected mainly by two processing variables: nozzle gas flow rate and drying gas inlet temperature. In addition, optimal conditions for the production of inhalable mannitol powders were obtained, generating a yield of 90% by weight of round and smooth particles with a volume median diameter of 4.28 μm. Mannitol/DSCG formulations co-spray-dried in the same conditions had similar characteristics. The results of this study can be applied to controlled formulation of various spray-dried powders for inhalation.

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“…liquid solution or suspension), as well as of the drying parameters are decisive in obtaining powders with the desired particle size and shape (Nandiyanto A.B.D. and Okuyama K., 2011;Kramek-Romanowska K. et al, 2011). Fig.…”

Preparation and Characterization of Biocompatible Polymer Particles as Potential Nanocarriers for Inhalation Therapy

“…Two process parameters were adjusted: the flow rate and the inlet temperature of the drying air in . These parameters were selected as decisive based on our previous studies related to use of spray drying for preparing of inhalable powders [20,22]. Experimental settings of the drying are listed in Table 1.…”

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Dynamic tensiometry studies on interactions of novel therapeutic inhalable powders with model pulmonary surfactant at the air–water interface

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