PMID: 8587058Nov 1, 1995Paper

Utility of pharmacodynamic measures for assessing the oral bioavailability of peptides. 1. Administration of recombinant salmon calcitonin in rats

Journal of Pharmaceutical Sciences
P J SinkoJ P Gilligan

Abstract

Salmon calcitonin (sCT) is a therapeutic peptide used in the treatment of Paget's Disease, postmenopausal osteoporosis, and hypercalcemia due to malignancy. In this study, recombinant sCT (rsCT) was administered intravenously (iv), subcutaneously (sc), and intraduodenally (id.) in rats to evaluate pharmacodynamic (PD) response as a measure of rsCT bioavailability (F) and to test the feasibility of delivering rsCT orally. rsCT pharmacokinetics were linear throughout the range of iv and sc doses studied. Following sc administration, F ranged from 11.2% to 23.1% and was linear. The absorption of rsCT after id. administration was low (0.022%); however, a significant lowering of serum calcium concentrations was observed. Serum calcium lowering was nonlinear and saturable after sc administration with the minimum dose required for maximum calcium lowering (Dmin/max) equal to 10.2 ng and a maximal response of 426.8 mg min/dL. Using Dmin/max as the reference dose, absolute Fs were recalculated using PD response after id. administration of 1 and 2 mg of rsCT and were 0.040% and 0.029%, respectively. Substantial overestimates of F were obtained when the reference dose was not properly selected. While the absorption of rsCT was low, the si...Continue Reading

References

Jul 1, 1989·Computer Methods and Programs in Biomedicine·D W Bourne
Nov 1, 1987·Calcified Tissue International·T BuclinP Burckhardt

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Citations

Oct 26, 2002·Journal of Controlled Release : Official Journal of the Controlled Release Society·Keon-Hyoung SongChang-Koo Shim
Mar 20, 2003·Journal of Controlled Release : Official Journal of the Controlled Release Society·Jeff WangWei-Chiang Shen
Aug 30, 2000·Advanced Drug Delivery Reviews·Y H Lee, P J Sinko
Aug 30, 2000·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Y Hee LeeP J Sinko
Jul 13, 2002·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Keon-Hyoung SongChang-Koo Shim
Dec 17, 2008·AAPS PharmSciTech·Meltem CetinKang Choon Lee
Jun 20, 2001·Biological & Pharmaceutical Bulletin·T OgisoT Wada
May 13, 2014·Expert Opinion on Drug Delivery·Alice L SmartAbdul W Basit
Aug 16, 2008·Journal of Pharmaceutical Sciences·Weiqiang Cheng, Lee-Yong Lim
Jan 6, 2004·Journal of Pharmaceutical Sciences·Hyuk Sang Yoo, Tae Gwan Park
Jan 29, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Signe Beck PetersenDavid J Brayden
Jul 6, 2011·International Journal of Pharmaceutics·Yating FanYan Liu
Sep 9, 2015·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Tanira A S AguirreDavid J Brayden
May 12, 2009·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Weiqiang Cheng, Lee-Yong Lim
Jun 28, 2005·Journal of Controlled Release : Official Journal of the Controlled Release Society·Keon-Hyoung SongChang-Koo Shim
Sep 24, 2005·Pharmaceutical Development and Technology·Saffar MansoorKang Choon Lee
Feb 21, 2009·Journal of Microencapsulation·Eliza GlowkaPhilippe Maincent
May 17, 2008·Molecular Pharmaceutics·Weiqiang Cheng, Lee-Yong Lim

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