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Pharmacokinetics of Recombinant Human Growth Hormone (rhGH) in Beagles by ELISA

Author(s):

Yueyue Qian, Qing Shao, Quanyu Xu and Hongqun Qiao*   Pages 1 - 9 ( 9 )

Abstract:


Background: Somatropin is recombinant human growth (GH) used for the treatment of growth failure in children and GH deficiency in adults. At present, rhGH marketed in China is mostly freeze-dried powder injection. As the lyophilization process is unstable, time-consuming and costly, rhGH has been prepared into an aqueous solution for administering directly.

Introduction: In this study, the pharmacokinetics of two dosage forms of rhGH in beagle dogs after single subcutaneous administration was determined by enzyme-linked immunosorbent assay (ELISA).

Method: Twelve healthy beagles (male, 6:female, 6) were used for the pharmacokinetic study and were equally divided into two groups. Subcutaneous injection of 0.2 IU/kg with rhGH in the two formulations. The blood samples were taken from forearms, 0, 0.033, 0.083, 0.25, 0.5, 1, 2, 3, 4, 7, 10, 24 h and collected the beagle plasma on time. The pharmacokinetic parameters of rhGH after subcutaneous (s.c.) injection were determined experimentally on beagles. Primary PK endpoints were area under the serum concentration-time curve (AUC0-t) and maximum serum concentration (Cmax). Serum rhGH level was determined by enzyme-linked immunosorbent assay.

Results: The calibration curves obtained were linear over the concentration range of 25 to 1600 ng/ml for recombinant human growth. The results of the intra- and inter-day precision and accuracy studies were well within the acceptable limits. The analysis samples were stable under different storage conditions and temperature.

sions: The developed ELISA method has been successfully applied to the studies of pharmacokinetic of recombinant human growth hormone in beagles.

Keywords:

Recombinant human growth hormone (rhGH), Pharmacokinetic, ELISA, beagles, dosage form, subcutaneous injection.

Affiliation:

School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing 211816, School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing 211816, Jiangsu Provincial Institute Of Materia Medica, Nanjing 211816, School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing 211816



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