Patient Acceptance of Nordiject: A New Drug Delivery System for Growth Hormone

Abstract

Twenty-seven children, aged 5-20 years, with growth retardation were enrolled in an open study to evaluate the acceptability of a new injection pen (Nordiject 24, Novo Nordisk A/S) for administration of recombinant human growth hormone (r-hGH). Prior to this study, 17 of the patients had been receiving treatment with r-hGH administered via syringes and vials; their experiences with this conventional technique have been used for comparison with Nordiject. The injection pen is provided with a replaceable 27-gauge needle and a cartridge containing 24 IU of reconstituted r-hGH (12 IU/mL). A benzyl alcohol 0.9% solution is used as the solvent for the reconstitution. The pen can be regulated for doses from 0.5 to 8 IU per injection; regulation is accomplished by a turning movement. The patients had no problems with the dissolving procedure or handling the pen. Nearly two-thirds of the patients experienced less injection pain with the pen as compared with the syringe. Special attention was paid to local tolerability, which was reported to be good. The thigh was the preferred injection site. The residual contents from 68 cartridges returned by the patients were analyzed for microbial contamination. Contamination was detected in only one cartridge, which could not be confirmed in a repeated test. Because of the simplification of the injection procedure afforded by the injection pen, 20 of 27 patients were able to perform the injections themselves and hence assume a more active role in their treatment. The patients who previously had been using conventional syringes strongly preferred the pen, and all patients wished to continue using the device.