Wet granulation of co-amorphous indomethacin systems.

The feasibility of co-amorphous systems to be wet granulated together with microcrystalline cellulose (MCC) was investigated. Solid state and molecular interactions were analysed for various co-amorphous drug-amino acid formulations of indomethacin with tryptophan and arginine, respectively, via XRPD, DSC and FTIR. The co-amorphous binary systems were produced by ball-milling for 90 min at different molar ratios followed by wet granulation with MCC and water in a miniaturised scale. Tryptophan containing systems showed crystalline reflections in their XRPD diffractograms and endothermal events in their DSC analyses, and were therefore excluded from upscaling attempts. The systems containing arginine were found to be remain amorphous for at least ten months and were upscaled for production in a high-shear blender under application of two different parameter settings. Under the harsher instrument settings, a composition with a low MCC ratio experienced recrystallisation during wet granulation, while all other compositions could be successfully processed via wet granulation and stayed stable for a storage period of at least twelve weeks, indicating that wet granulation of co-amorphous systems can be feasible.

Non-Targeted LC-MS Metabolomics Approach towards an Authentication of the Geographical Origin of Grain Maize (Zea mays L.) Samples.

Safety along the food and feed supply chain is an emerging topic and closely linked to the ability to analytical trace the geographical origin of food or feed. In this study, ultra-performance liquid chromatography coupled with electrospray ionization quadrupole-time-of-flight mass spectrometry was used to trace back the geographical origin of 151 grain maize (Zea mays L.) samples from seven countries using a high resolution non-targeted metabolomics approach. Multivariate data analysis and univariate statistics were used to identify promising marker features related to geographical origin. Classification using only 20 selected markers with the Random Forest algorithm led to 90.5% correctly classified samples with 100 times repeated 10-fold cross-validation. The selected markers were assigned to the class of triglycerides, diglycerides and phospholipids. The marker set was further evaluated for its ability to separate between one sample class and the rest of the dataset, yielding accuracies above 89%. This demonstrates the high potential of the non-polar metabolome to authenticate the geographic origin of grain maize samples. Furthermore, this suggests that focusing on only a few lipids with high potential for grain maize authentication could be a promising approach for later transfer of the method to routine analysis.

Cobalamin is produced by Acetobacter pasteurianus DSM 3509.

Only a few cobalamin-producing bacterial species are known which are suitable for food fermentations. The strain of Acetobacter pasteurianus DSM 3509 was found to have the capability to synthesize cobalamin. A survival test and a preliminary genetic study of the gene of uroporphyrinogen-III synthase indicated the ability to synthesize cobalamin. By a modified microbiological assay based on Lactobacillus delbrueckii ssp. lactis DSM 20355, 4.57 ng/mL of cyanocorrinoids and 0.75 ng/mL of noncorrinoid growth factors were detected. The product extracted and isolated by immunoaffinity chromatography in its cyanide form had the similar UV spectrum as standard cyanocobalamin and Coα-[α-(7-adenyl)]-(Coß-cyano) cobamide also known as pseudovitamin B12 produced by Lactobacillus reuteri DSM 20016. The chromatographically separated product of A. pasteurianus was subjected to mass spectrometrical analysis. There, its fragmentation pattern turned out to be equivalent to that of cyanocobalamin also produced by Propionibacterium freudenreichii ssp. freudenreichii DSM 20271 and clearly differs from pseudovitamin B12. Due to the presence of this species in several food applications, there might be cobalamin residues in food fermented with these bacteria.