Fast-dissolving granules for pediatric practice: composition and technology
The authors have developed a technology for manufacturing pediatric drugs that are a mixture of granules and acid and carbonate ingredients that form a clear solution on dissolving. The patterns of a granulation process were investigated using model granulates. The samples obtained by granulating with 80% sorbitol solution show a higher overall yield due to less dusting on granulation, as well as a small percentage of a fine fraction, which is caused by the good agglutinant and plugging properties of the 80% sorbitol solution. These samples exhibit the best friability and the highest bulk weight; the surface of granules is planer. On sorbitol-induced granulation, the optimal consumption of the 80% sorbitol solution largely depends on the composition of dry components and their water solubility. It has been experimentally proven that the developed technology can be employed to make Fenibut and Ambroxol granules. The granules are packaged in single-dose containers or plastic jars. For their use, the granules are dissolved extempore in water; at the same time a clear solution with pleasant organoleptic properties is rapidly formed.