Percutaneous ibuprofen therapy with Trauma-Dolgit gel: bioequivalence studies.
The plasma and tissue kinetics of ibuprofen after topical application of 5% Trauma-Dolgit gel were determined in two bioequivalence studies. In eight patients, high ibuprofen concentrations, largely within the therapeutic range, were found in subcutaneous tissue, tendon, muscles and joint capsule. In plasma, however, very low concentrations (decimal exponents below the therapeutically relevant plasma ibuprofen level even after repeated application) were found in nine volunteers. Based upon the comparison of oral and topical ibuprofen forms, the test preparation was found to be bioequivalent and, from a kinetic viewpoint, safe and effective.
Berner
G
G
Research Laboratories, Dolorgiet, St. Augustin/Bonn, FRG.
Engels
B
B
Vögtle-Junkert
U
U
D000279:Administration, Cutaneous; D000287:Administration, Topical; D000368:Aged; D005260:Female; D005782:Gels; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013810:Therapeutic Equivalency; D014018:Tissue Distribution
D005782:Gels; D007052:Ibuprofen