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

GH-deficient patients are at present treated with daily subcutaneous GH injections. Further improvements in patient compliance and effects of treatment may occur with nasal administration. We have examined the absorption of nasally administered GH in healthy subjects and in GH deficient patients in two separate studies.

Healthy subjects and GH deficient patient were examined in the morning after an overnight fast. Twelve IU of GH in a powder containing didecanoyl-L-alpha-phosphatidylcholine as enhancer were administered in the nostrils (6 IU in each nostril) at the beginning of the study in the healthy subjects. The GH deficient subjects received a total of 6 IU GH/m2 intranasally. Blood was frequently sampled for up to 4 hours. Before and after nasal application anterior rhinoscopy was performed.

Eight normal subjects and 7 GH deficient patients.

Serum GH.

(mean +/- SD) Mean maximum concentration (Cmax) in the normal group was 57.6 mU/l +/- 36.9 with a mean time to obtain Cmax (Tmax) of 65 +/- 47 min. In the GH deficient group Cmax was 56.1 +/- 26.1 mU/l with a mean Tmax of 45 +/- 15 min. The subjects did not report any major inconvenience during the study. Anterior rhinoscopy did not reveal changes.

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.