Skip to main content
Log in

The Bioavailability of Intranasal Salmon Calcitonin in Healthy Volunteers with and Without a Permeation Enhancer

  • Published:
Pharmaceutical Research Aims and scope Submit manuscript

Abstract

Serum levels of radioimmunoactive salmon calcitonin (sCT) were determined in 10 healthy volunteers after intranasal administration (IN) of 100-, 205-, and 450-IU of sCT with 0.5% sodium tauro-24,25-dihydrofusidate (STDHF), a 200-IU commercial IN formulation, and a 100-IU intramuscular (IM) formulation. Relative to the IM dose, the bioavailabilities of the IN formulations containing 0.5% STDHF were 3.9, 7.9, and 7.4%, respectively. The 200-IU commercial formulation resulted in serum levels above the limit of detection in only 5 of 10 patients, with an average bioavailability of 1.6%.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

REFERENCES

  1. L. A. Austin and H. Heath. Calcitonin: physiology and pathophysiology. N. Engl. J. Med. 304:269–278 (1980).

    Google Scholar 

  2. D. J. Hosking. Treatment of severe hypercalcemia with calcitonin. Metab. Bone Dis. Relat. Res. 2:207–212 (1980).

    Google Scholar 

  3. J. DeRose, F. R. Singer, A. Avramides, A. Flores, R. Dzaiadiw, R. K. Baker, and S. Wallach. Response of Paget's disease to porcine and salmon calcitonins. Effects of long-term treatment. Am. J. Med. 56:858–866 (1974).

    Google Scholar 

  4. V. Fatourechi and H. Hunter. Salmon calcitonin in the treatment of postmenopausal osteoporosis. Ann. Intern. Med. 107:923–925 (1987).

    Google Scholar 

  5. H. W. Gruber, J. L. Ivey, D. J. Baylink, M. Matthews, W. B. Nelp, K. Sisom, and C. H. Chesnut. Long-term calcitonin therapy in postmenopausal osteoporosis. Metabolism 33:295–303 (1984).

    Google Scholar 

  6. W. A. Lee and J. P. Longenecker. Intranasal delivery of proteins and peptides. Biopharm Manuf. 1:30–37 (1988).

    Google Scholar 

  7. C. McMartin, L. E. F. Hutchinson, R. Hyde, and G. E. Peters. Analysis of structural requirements for the absorption of drugs and macromolecules from the nasal cavity. J. Pharm. Sci. 76:535–540 (1987).

    Google Scholar 

  8. J. Y. Reginster, D. Denis, A. Albert, and P. Franchimont. Assessment of the biological effectiveness of nasal synthetic salmon calcitonin (SSCT) by comparison with intramuscular (i.m.) or placebo injection in normal subjects. Bone Miner. 2:133–140 (1987).

    Google Scholar 

  9. J. Y. Reginster, A. Albert, and P. Franchimont. Salmon-calcitonin nasal spray in Paget's disease of bone: Preliminary results in five patients. Calcif. Tissue Int. 37:577–580 (1985).

    Google Scholar 

  10. K. Overgaard, B. J. Riis, C. Christiansen, J. Podenphant, and J. S. Johansen. Nasal calcitonin for treatment of established osteoporosis. Clin. Endocrinol. 30:435–442 (1989).

    Google Scholar 

  11. M. Hanson, G. Gazdick, J. Cahill, and M. Augustine. Intranasal delivery of the peptide, salmon calcitonin. In S. S. Davis, L. Illum, and E. Tomlinson (eds.), Delivery Systems for Peptide Drugs, Plenum Press, New York, 1986, pp. 233–241.

    Google Scholar 

  12. H. R. D'Agostino, C. A. Barnett, X. J. Zielinski, and G. S. Gordon. Intranasal salmon calcitonin treatment of Paget's disease of bone. Clin. Ortho. Relat. Res. 230:223–228 (1988).

    Google Scholar 

  13. J. F. Habner, F. R. Singer, L. J. Deftos, and J. T. Potts. Endocrinology 90:1102–1106 (1972).

    Google Scholar 

  14. P. A. Baldwin, C. K. Klingbeil, C. J. Grimm, and J. P. Longenecker. The effect of tauro-24,25-dihydrofusidate on the nasal absorption of human growth hormone in three animal models. Pharm. Res. 7:547–552 (1990).

    Google Scholar 

  15. R. E. Stratford and V. H. L. Lee. Aminopeptidase activity in homogenates of various absorptive mucosae in the albino rabbit: Implications in peptide delivery. Int. J. Pharm. 30:73–82 (1986).

    Google Scholar 

  16. R. D. Ennis. Unpublished results.

  17. W. A. Lee and P. A. Baldwin. Nasal membrances—structure and permeability. In H. Junginger (ed.), Drug Targeting and Delivery, Ellis Horwood, Chichester, 1993, pp. 219–232.

    Google Scholar 

  18. M. Azria and T. Cavanak. Calcitonin inhalation compositions. UK Pat. Appl. GB 2127689 A (1984).

  19. M. S. Nolte, C. Taboga, E. Salamon, A. Moses, J. P. Longenecker, J. Flier, and J. H. Karam. Biological activity of nasally administered insulin in normal subjects. Horm. Metabol. Res. 7:547–552 (1990).

    Google Scholar 

  20. L. Hedin, M. Diczfalusy, B. Olsson, S. Rosberg, A. S. Pettersson, and K. Albertsson-Wikland. Nasal delivery of human growth hormone (hGH)—a new route of hormone administration in the treatment of GH-deficiency. Workshop on Current Trends in Growth Related Research, Haifa, Israel, Oct. 24–27 (1989).

  21. G. Thamsborg, T. L. Storm, E. Brinch, R. Sykulski, N. Fogh-Andersen, S. N. Holmegaard, and O. H. Sorensen. The effect of different doses of nasal salmon calcitonin on plasma cyclic AMP and serum ionized calcium. Calcif. Tissue Int. 46:5–8 (1990).

    Google Scholar 

  22. T. Buclin, J. P. Randin, A. F. Jacquet, M. Azria, M. Attinger, F. Gomez, and P. Burckhardt. The effect of rectal and nasal administration of salmon calcitonin in normal subjects. Calcif. Tissue Int. 41:252–258 (1987).

    Google Scholar 

  23. J. Y. Reginster and P. Franchimont. Side effects of synthetic salmon calcitonin given by intranasal spray compared with intramuscular injection. Clin. Exp. Rheum. 3:155–157 (1985).

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Lee, W.A., Ennis, R.D., Longenecker, J.P. et al. The Bioavailability of Intranasal Salmon Calcitonin in Healthy Volunteers with and Without a Permeation Enhancer. Pharm Res 11, 747–750 (1994). https://doi.org/10.1023/A:1018992716621

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/A:1018992716621

Navigation