[Pharmacokinetic parameters as criteria for clinical use of hydroxyethyl starch preparations]. / Pharmakokinetische Merkmale als Kriterien für den klinischen Einsatz von Hydroxyethylstärke.

Pharmacokinetic Parameters as Criteria for Clinical Use of Hydroxyethyl Starch Preparations In a study with volunteers (n = 2 x 6) pharmacokinetic data of two only marginally differing starch preparations were investigated. We were able to demonstrate that there exist significant differences in raw materials used which determined the pharmacokinetic data in humans. Newly implemented analyzing methods (LALLS) were used. In addition to the degree of substitution, further differences concerning the position of hydroxyethylization at the anhydroglucose molecule could be documented. The C2/C6 positions of hydroxyethylization at the molecule seem to be most essential. To classify and to differentiate starch preparations we propose to include these data in general informations for clinicians because these differences might determine clinical usage and efficacy.

[Significance and assessment of the compatibility of mixed solutions with fat emulsion components for parenteral nutrition]. / Bedeutung und Prüfung der Kompatibilität von Mischlösungen mit Fettemulsionskomponente für die parenterale Ernährung.

Combined solutions can greatly facilitate the carrying out of parenteral nutrition. The compatibility of their components as well as the stability of such solutions for the duration of clinical use are prerequisites for their application. The necessary and extensive tests of compatibility are illustrated on the basis of a combined solution that is easily produced in the clinic for peripheral and parenteral nutrition. The limits to the production of combined solutions are described.

[Effect of particle size and emulsifier on pharmacokinetic values of a parenterally administered fat emulsion]. / Uber den Einfluss von Teilchengrösse und Emulgator auf pharmakokinetische Kenndaten einer parenteral applizierten Fettemulsion.

To evaluate pharmacokinetic data during parenteral application of a fat emulsion a controlled study in healthy volunteers was performed. Another aim of the study was to investigate whether these kinetics could be changed by modification of the emulsion. For this purpose, 10 male medical students--free of any metabolic disorders--received modified batches of one fat emulsion (Lipovenös), differing with respect to particle size or emulsifier. The emulsions were applied using a pump-controlled continuous infusion technique. The dosage was calculated according to body weight: 0.1 g/kg B.W./h. There was a 7-10 day interval between one application and the following study period, again using the same volunteers. Thus every volunteer served as his own control. Routine laboratory parameters as well as parameters relating to fat metabolism were measured. While routine laboratory parameters were not statistically different between the groups, pharmacokinetic data showed differences according to the batches used. Highest triglyceride and free fatty acid levels i.s. were present after application of the emulsion with low medium particle size, while lowest levels were found after increasing the particle size to 380 nm. In addition, it could be documented that an increase in medium particle size resulted in higher elimination rate, transfer and pool size. The modified emulsifier led to an additional increase of these effects, thus inducing beneficial metabolic profiles. The results of the present investigation might perhaps enable us to adjust the profile of future fat emulsions, with the aim of optimizing or restoring metabolic hemostasis.