A comparison of the pulmonary bioavailability of powder and liquid aerosol formulations of salmon calcitonin

Pharmaceutical Research

Volumn 25, Issue 7, 2008, Pages 1583-1590

  Clark, Andrew ^a   Kuo, Mei Chang ^a   Newman, Stephen ^b,c   Hirst, Peter ^b,d   Pitcairn, Gary ^b,e   Pickford, Matt ^a,b  

^a NEKTAR THERAPEUTICS   (United States)

^b PHARMACEUTICAL PROFILES LTD   (United Kingdom)

^c Vectura Group plc ^*

^d PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^e ASTRAZENECA   (United Kingdom)

Author keywords

Aerosol; Bioavailability; Deposition; Dry powder; Nebulizer; Salmon calcitonin

Indexed keywords

CITRATE SODIUM; CITRIC ACID; MANNITOL; SALCATONIN; SERUM ALBUMIN;

ADULT; AEROSOL; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSIMETER; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRY POWDER; FEMALE; FLOW RATE; GAMMA SCINTIGRAPHY; HUMAN; LIQUID; MALE; MEDICAL NEBULIZER; NORMAL HUMAN; PARTICLE SIZE; PH MEASUREMENT; POWDER INHALER; PRIORITY JOURNAL; RADIOIMMUNOASSAY;

ADULT; AEROSOLS; ANTI-ASTHMATIC AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CALCITONIN; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; HYDROGEN-ION CONCENTRATION; INJECTIONS, SUBCUTANEOUS; LUNG; MALE; PARTICLE SIZE; POWDERS;

EID: 44749083577     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-008-9547-x     Document Type: Article

References (22)

1. H. Folkesson, B. Westrom, and B. Karlsson. Permeability of the respiratory tract to different sized macromolecules after intratracheal instillation in young and adult rats. Acta Physiol. Scand 139:347-354 (1990).
2. R. Niven, F. Lott, A. Ip, and J. Cribbs. Pulmonary delivery of powders and solutions containing recombinant human granulocyte colony-stimulating factor (rhG-CSF) to the rabbit. Pharm. Res 11(8):1101-1109 (1994).
3. S. Kobayashi, S. Kondo, and K. Juni. Pulmonary delivery of salmon calcitonin dry powders containing absorption enhancers in rats. Pharm. Res 13(1):80-83 (1996).
4. S. Kobayashi, S. Kondo, and K. Juni. Study on pulmonary delivery of salmon calcitonin in rats: effects of protease inhibitors and absorption enhancers. Pharm. Res 11(9):1239-1243 (1994).
5. 1,7)-eel calcitonin by various protease inhibitors in rats. Pharm. Res 11(6):909-913 (1994).
6. S. White, D. B. Bennett, S. Cheu, S. P. Conley, D. B. Guzek, S. Gray, J. Howard, R. Malcolmson, J. M. Parker, P. Roberts, N. Sadrzadeh, J. D. Schumacher, S. Seshadri, G. W. Sluggett, C. L. Stevenson, and N. J. Harper. Exubera: pharmaceutical development of a novel product for pulmonary delivery of insulin. Diabetes Technol. Ther 7:896-906 (2005).
7. J. Patton. Mechanisms of macromolecule absorption by the lungs. Adv. Drug Deliv. Rev 19:3-36 (1996).
8. J. D. Burr, J. M. Anthony, G. S. Axford, J. W. Etter, and A. E. Smith. Apparatus and methods for dispersing dry powder medicaments. US Patent 6(089):228 (2000).
9. A. R. Clark, C. B. Chambers, D. Muir, M. T. Newhouse, S. Paboojian, and C. Schuler. The effect of biphasic flow profiles on the deposition and clearance of coarse (6.5 mm) bolus aerosols. J. Aerosol. Med 20(1):75-82 (2007).
10. E. Berg, J. Svensson, and L. Asking. Determination of nebulizer droplet size distribution: A method based on impactor refrigeration. J. Aerosol. Med 20(2):97-104 (2007).
11. A. R. Clark. The use of laser diffraction for the evaluation of the aerosol clouds generated by medical nebulizers. Int. J. Pharm 115:69-78 (1995).
12. USP/NF, Physical tests and determinations: Aerosols, Vol 20 US XVII. US Pharmacopeia, Rockville, MD: US Pharmacopeial conventions, Inc. 1992, pp. 3158-3178
13. G. R. Pitcairn, and S. P. Newman. Radiolabelling of dry powder formulations. In R. N. Dalby, P. R. Byron, and S. J. Farr (eds.), Respiratory drug delivery VI, Interpharm Press, Buffalo Grove, 1998, pp. 397-399.
14. M. T. Newhouse, P. Hirst, S. Duddu, Y. Walter, T. Tarara, A. Clark, and J. Weers. Inhalation of a dry powder tobramycin Pulmosphere formulation in healthy volunteers. Chest 124:360-366 (2003).
15. S. P. Newman, A. R. Clark, N. Talaee, and S. W. Clarke. Pressurised aerosol deposition in the human lung with and without an "open" spacer. Thorax 44:706-710 (1989).
16. G. R. Pitcairn, and S. P. Newman. Tissue attenuation corrections in gamma scintigraphy. J. Aerosol. Med 10:187-198 (1997).
17. S. P. Newman, P. R. Hirst, G. R. Pitcairn, and A. R. Clark. Understanding regional lung deposition in gamma scintigraphy. In R. N. Dalby, P. R. Byron, and S. J. Farr (eds.), Respiratory Drug Delivery VI, Interpharm Press, Buffalo Grove, 1998, pp. 9-15.
18. F. Komada, S. Iwakawa, N. Yamamoto, H. Sakakibara, and K. Okumura. Intratracheal delivery of peptide and protein agents: absorption from solution and dry powder by rat lung. J. Pharm. Sci 83(6):863-867 (1994).
19. L. Heinemann, and T. Heise. Current status of the development of inhaled insulin. Br. J. Diab. Vac. Dis 4(5):295-301 (2004).
20. K. Okumura, S. Iwaka, Y. Tsuguchika, S. Toshimitsu, and F. Komada. Intratracheal delivery of insulin absorption from solution an aerosol by rat. Int. J. Pharm 88:63-73 (1992).
21. S. J. Farr, I. Gonda, and V. Licko. Physicochemical and physiological factors influence the effectiveness of inhaled insulin. In R. N. Dalby, P. R. Byron, and S. J. Farr (eds.), Respiratory Drug Delivery VI, Interpharm Press, Buffalo Grove, 1998, pp. 25-33.
22. J. S. Patton, J. G. Bukar, and M. A. Eldon. Clinical pharmacokinetics and pharmacokinetics of inhaled insulin. Clin. Pharmacokinet 43(12):781-801 (2004).