Chemical stability study of vitamins thiamine, riboflavin, pyridoxine and ascorbic acid in parenteral nutrition for neonatal use

<p>Abstract</p> <p>Background</p> <p>The objective of this work was to study the vitamins B₁, B₂, B₆and C stability in a pediatric formulation containing high amounts of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulfate, pediatric vitamins and trace elements under different conditions using developed and validated analytical methods.</p> <p>Methods</p> <p>The study was carried out during 72 h with formulations packaged in recommended storage temperature (4°C) and 25°C, with and without photoprotection.</p> <p>Results</p> <p>The results showed that the methodologies used for assessing the chemical stability of vitamins B₁, B₂, B₆and C in the formulation were selective, linear, precise and accurate. The vitamins could be considered stable in the formulation during the three days of study if stored at 4°C. When stored at 25°C vitamin C presented instability after 48 h.</p> <p>Conclusion</p> <p>The pediatric formulation containing high amount of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulphate, pediatric vitamins and trace elements packaged in bag-type trilaminate presented a shelf life of the 72 h, when maintained under refrigeration, between 2°C and 8°C. This shelf life was measured considering the vitamins studied. Further studies are needed including all the vitamins present in this formulation.</p

HUMAN-IGM MONOCLONAL-ANTIBODY 16.88 - PHARMACOKINETICS AND DISTRIBUTION IN MOUSE AND MAN

Human IgM monoclonal antibody (MAb) 16.88 recognizes an antigen strongly expressed by colon cancer tissue. We used 131I-labelled 16.88 for biodistribution and pharmacokinetic studies in nude mice bearing WiDr or NIH:OVCAR-3 xenografts. Serum half-life was 8 h. Maximum tumour uptake was between 1 and 8 h after administration and amounted to, respectively, 3% and 1% of the injected dose g-1 for WiDr and NIH:OVCAR-3 tumours. Half-lives in these tumours were approximately 24 h. Tumour to normal colon uptake ratios increased from 2.3 at 24 h to 17 at 5 days after injection. Simultaneously, pharmacokinetic studies were performed in patients with advanced colon cancer reactive with 16.88. They were injected with 5 mCi 131I-16.88 by intravenous infusion over 2 h. Serum half-life was 20 h with greater than 90% of the 131I bound to 16.88. Within 40 h 50% of the injected dose was excreted as free 131I in the urine. In one patient an accelerated clearance was found, possibly caused by pre-existing antibodies reacting with 16.88. None of the patients showed an immune response against 16.88 antibody. Immunoscintigraphy showed positive tumour localization in the majority of the patients, best visualized at later days. We conclude that 16.88 has tumour localization properties while its human origin accounts for the lack of immunogenicity

TUMOR-LOCALIZATION WITH I-131-LABELED HUMAN-IGM MONOCLONAL-ANTIBODY 16.88 IN ADVANCED COLORECTAL-CANCER PATIENTS

Human IgM monoclonal antibody 16.88 recognised an intracellular antigen strongly expressed in colorectal cancer tissue in 51% of our patients. Tumour localisation was carried out with 185 MBq I-131-16.88 (8 mg) in 20 of these patients with advanced disease. In 16 patients (80%) immunoscintigraphy was positive in at least one organ site with disease. Of all sites, 55% could be visualised. In general, lesions <3 cm could not be detected. Sequential immunoscintigrams of liver metastases showed variable patterns. Initial "cold" lesions corresponded to liver metastases with poor blood supply as indicated by Tc-99m-sulphur-colloid and Tc-99m-HMPAO scintigraphy, respectively. The mean (S.D.) biological half-life (whole body clearance of radioactivity) was 37.6 (5.0) h. A second infusion of I-131-16.88 with the addition of high doses of unlabelled 16.88 could be done safely, but did not result in better visualisation of tumour lesions or affect radioactivity clearance from the body

[Mondiale verandering en duurzame ontwikkeling: een modelperspectief voor de komende tien jaar.]

In this study the totality of changes on planet Earth, including all human interventions and alterations, is considered as constituting global change, a concept which is therefore broader than the concept of global environmental change. The latter only refers to the human-induced biophysical changes in the dynamics of the Earth system, while global change refers to changes in both the biophysical and the human system. In practice, the concept of global environmental change is a general umbrella term for a whole range of mutually dependent global environmental problems. Within the context of this research programme global change is, in contrast to earlier studies, considered from an integrated perspective. In this study the starting point is to consider the common causes, mechanisms and impacts of a number of coherent themes, functions and scales, and to translate this in terms of Pressure, State, Impact and Response (P-S-I-R approach). This is more in line with the universal principle of approaching environmentally related problems, which assumes that many of those problems are generic in nature