Serum growth hormone (GH) profiles after nasally administered GH in normal subjects and GH deficient patients

Abstract

Nasally administered GH is absorbed to a significant degree from the nasal mucosa without obvious untoward effects in the short term. These data encourage further studies with nasal GH administration.

Clinical pharmacological aspects of growth hormone administration

“…Reasonable C max values were obtained, but bioavailability was very low, as judged by an AUC of only 1.6-3% of that obtained with a sc dose [227]. In other studies didecanoyl-L L -alpha-phosphatidylcholine (DDPC) has been used as enhancer [207,228,229]. In a double blinded randomized study in healthy subjects the impact of concentration of DDPC was examined [228].…”

“…Thus, no typical dose response relationship was apparent. Intranasal GH administration was well-tolerated in acute studies in man [207,[227][228][229]. However, high doses of DDPC have been reported to induce serious damage to the ciliated cells of the nasal mucosa in rabbits [230], suggesting that the trans-cellular transport may have been fascilitated by mucosal damage.…”

“…[69,139,[143][144][145]207,208,221,228,229,272,284]) was to provide clinical pharmacological data to enable an optimized treatment with GH. The studies have focussed on practical therapeutic problems associated with parenteral administration of GH, and in particular the interface between pharmacokinetics and pharmacodynamics have been addressed.…”

“…Administration of a total intranasal GH dose of 6 IU/m 2 to GHD subjects resulted in supraphysiological peak GH values of 56 mU/L 45 min after delivery [229]. Using the elimination constant, k, an apparent half-life of 119 min could be calculated [229].…”

“…Using the elimination constant, k, an apparent half-life of 119 min could be calculated [229]. The obtained serum GH profiles were intermediates of those achieved following iv and sc administration.…”