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Intranasal delivery of recombinant human growth hormone (somatropin) in sheep using chitosan-based powder formulations

The effectiveness of chitosan in promoting the intranasal bioavailability of recombinant human growth hormone (hGH) has been evaluated. hGH was formulated with chitosan to produce a powder blend (Formulation A) and granules (Formulation B) for intranasal administration. The in vivo pharmacokinetic p...

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Bibliographic Details
Published in:European journal of pharmaceutical sciences 2005-09, Vol.26 (1), p.9-15
Main Authors: Cheng, Yu-Hui, Dyer, A. Margaret, Jabbal-Gill, Inderjit, Hinchcliffe, Michael, Nankervis, Richard, Smith, Alan, Watts, Peter
Format: Article
Language:English
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Summary:The effectiveness of chitosan in promoting the intranasal bioavailability of recombinant human growth hormone (hGH) has been evaluated. hGH was formulated with chitosan to produce a powder blend (Formulation A) and granules (Formulation B) for intranasal administration. The in vivo pharmacokinetic performance of the formulations was evaluated in a group of six sheep in a randomised crossover study. A subcutaneous injection of hGH solution was administered as a control. The intranasal and subcutaneous doses of hGH were 0.3 and 0.03 mg/kg, respectively. The intranasal formulations appeared to be well tolerated. Mean bioavailabilities of hGH from Formulations A and B were 14 and 15%, respectively relative to subcutaneous injection. It is concluded that chitosan-based intranasal powder formulations may provide a practical means for non-injectable delivery of hGH and, potentially, other therapeutic protein molecules.
ISSN:0928-0987
1879-0720
DOI:10.1016/j.ejps.2005.03.014