The bioavailability of intranasal salmon calcitonin in healthy volunteers with and without a permeation enhancer.
Serum levels of radioimmunoactive salmon calcitonin (sCT) were determined in 10 healthy volunteers after intranasal administration (IN) of 100-, 205-, and 450-IU of sCT with 0.5% sodium tauro-24,25-dihydrofusidate (STDHF), a 200-IU commercial IN formulation, and a 100-IU intramuscular (IM) formulation. Relative to the IM dose, the bioavailabilities of the IN formulations containing 0.5% STDHF were 3.9, 7.9, and 7.4%, respectively. The 200-IU commercial formulation resulted in serum levels above the limit of detection in only 5 of 10 patients, with an average bioavailability of 1.6%.
Lee
W A
WA
Gilead Sciences, Inc., Foster City, California 94404.
Ennis
R D
RD
Longenecker
J P
JP
Bengtsson
P
P
D000277:Adjuvants, Pharmaceutic; D000281:Administration, Intranasal; D000328:Adult; D001682:Biological Availability; D002116:Calcitonin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D005672:Fusidic Acid / Q000031:analogs & derivatives / Q000494:pharmacology; D006801:Humans; D008297:Male; D011863:Radioimmunoassay
D000277:Adjuvants, Pharmaceutic; D005672:Fusidic Acid; C053824:tauro-24,25-dihydrofusidate; C028815:salmon calcitonin; D002116:Calcitonin