[Doxycycline pellets: a suitable formulation with guaranteed bioequivalence].
Basing on the physico-chemical properties of doxycycline relevant to an optimisation of the administration of this drug a new formulation (pellets) was developed. The bioavailability and tolerability of this formulation were studied in normal subjects in a cross-over design. The drug liberation profile of the new product excludes the risk of oesophageal irritation. The gastric tolerance of the pellet formulation is significantly better than that of the comparative product. No statistically significant differences were observed in the plasma AUC, indicating bioequivalence of the dosage forms. The values for plasma peak levels did not differ significantly, and were in agreement with the results of other studies on doxycycline bioavailability. Using the experimental data, a pharmacokinetic computer simulation of the doxycycline plasma levels for multiple-dose treatment was carried out: During the usual therapeutic dosage regimen the plasma levels are maintained above the MIC value.
D000328:Adult; D001681:Biological Assay; D004318:Doxycycline / Q000008:administration & dosage* / Q000097:blood; D005260:Female; D006801:Humans; D007700:Kinetics; D008297:Male; D008954:Models, Biological; D013607:Tablets; D013810:Therapeutic Equivalency
D013607:Tablets; D004318:Doxycycline
Doxycyclin-Pellets: eine wirkstoffgerechte Darreichungsform mit gesicherter Bioäquivalenz.