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The Bioavailability of Intranasal Salmon Calcitonin in Healthy Volunteers with and Without a Permeation Enhancer
Authors:Lee  William A.  Ennis  Richard D.  Longenecker  John P.  Bengtsson  Per
Affiliation:(1) Gilead Sciences, Inc., 353 Lakeside Drive, Foster City, California, 94404;(2) DepoTech Corporation, La Jolla, California;(3) Karo Bio AB, Stockholm, Sweden
Abstract:
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%.
Keywords:calcitonin  nasal delivery  peptide delivery  osteoporosis
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