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The aim of this study was to assess the use of an automatic filling system (Siframix M31 and M32 system) to prepare pediatric parenteral nutrition. Volumetric accuracy was measured for each siframix system loads cells (< 5% for 5 ml with the Siframix M32 and < 5% for 9 ml with the Siframix M31) with sterile water for injection. The minimal 20 ml of flushing sterile water of the common tubulure of the Siframix M32 (p = 0.211 for 20 ml and p = 0.75 for 500 ml), the use of viscous solutions (70% dextrose) on the Siframix M31 (p = 0.28 for 20 ml and p = 0.12 for 500 ml) and the use of a special tubulure for using E.V.A. Luer-lock bags (p = 0.89 for 20 ml and p = 0.103 for 500 ml) do not modify the accuracy. Changing bags or bottles during the filling operation modify the accuracy (p = 0.004 for 20 ml and p = 0.009 for 500 ml). A flushing operation is necessary to lower the risk of electrolytic pollution for the filling of little bags. The filling speed for each module was also measured (the maximal filling speed was five liters per minute). The Siframix system allows one to prepare pediatric parenteral nutrition bags when volumes are above 4 ml and with adapted source solutions in terms of concentration and conditioning volumes.

The microencapsulation of essential oils offers protection against oxidation and evaporation, and allows the concurrent utilization of several vegetable extracts. Complex coacervation methods have been described for essential oils. Even though microencapsulation involves wrapping the essential oils in shells, some difficulties arise in the process of stabilizing the essential oils: oil may be lost by evaporation and partial dissolution in the water-gelatin phase and this will vary with the type of essential oil being encapsulated. In order to investigate the efficacy of the gelatin-polyphosphate methods we analysed their essential oil microcapsules peppermint and rosemary, in particular their granulometric size distribution, oil content (%) and encapsulation yield (%). In addition the essential oils were analysed by GC before and after microencapsulation so as to investigate the loss of their components during the process.

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We studied four granulation methods on the same quantitative and qualitative formula: wet massing by forced agglomeration (Lödige) and free agglomeration (Glatt); and dry massing by slugging and roller compaction technique. Three different particle sizes of nitrofurantoin (bioinequivalent drug) were used. The nitrofurantoin particle size has a very low influence on the physical characteristics of the granules. The granulating process influenced the binding of the particles. Granules processed using the wet granulating method were harder than those made by dry process. Lödige granules were more bonded than Glatt granules. Granules prepared by dry massing presented broken particles. The surface area and the porosity of Glatt granules were the most important parameters. Dissolution studies must be effected to make a correlation between the physical results and the dissolution rates. It is necessary to effect a new validation and a comparison of the results when a new granulating apparatus is used.