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Preparation and characterization of amorphous solid dispersion obtained via spray drying technology

Drying is perhaps the oldest, most common and most diverse of chemical engineering unit operations. Over four hundred types of dryers have been reported in the literature while over one hundred distinct types are commonly available [1]. Spray drying, amongst other technologies, is a well‐established technology for the production of amorphous products. It offers the possibility to modify powder characteristics such as particle size, particle morphology, crystallinity and the amount of residual solvent [2]. In this work, the possibility of obtaining a stable amorphous solid dispersion of 5‐(4‐(4‐(5‐ Cyano‐1H‐indol‐3‐yl)butyl)piperazin‐1‐yl)benzofuran‐2‐carboxamide hydrochloride and hydroxypropyl methylcellulose in a spray‐dryer was examined. Taking into account solubility of all ingredients, their crystallization and chemical stability, influence of material of construction on their stability, optimal system for spray drying process was chosen. A solution of the hydrochloride crystalline structure of the active pharmaceutical ingredient and polymer in a mixture of water and acetonitrile was dried at different temperatures, nozzle configurations and flow rates of nitrogen used for atomization, as well as the flow rates of the solution. The influence of the process conditions on the properties of the product was analyzed. The final dried products were characterized and identified with a variety of analytical and physical methods. The results showed that a stable amorphous solid dispersion of the high purity active pharmaceutical ingredient is obtained with a spray drying, and that the optimal conditions of the process are defined.

amorphous solid dispersion, characterization, spray drying

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