Pulmonary delivery of beclomethasone liposome aerosol in volunteers: Tolerance and safety

Chest

Volumn 111, Issue 2, 1997, Pages 316-323

  Waldrep, J Clifford ^a   Gilbert, Brian E ^a   Knight, Caroline M ^a   Black, Melanie B ^a   Scherer, Peter W ^b   Knight, Vernon ^a   Eschenbacher, William ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

aerosols; bechlomethasone dipropionate (Bec); deposition; dilauroylphosphatidylcholine (DPLC); liposomes; nebulizers; safety; tolerance

Indexed keywords

BECLOMETASONE; DILAUROYLPHOSPHATIDYLCHOLINE; LIPOSOME;

ADULT; ARTICLE; ASTHMA; CLINICAL PROTOCOL; CLINICAL TRIAL; CORTICOSTEROID THERAPY; DOSE RESPONSE; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; HUMAN EXPERIMENT; INHALATIONAL DRUG ADMINISTRATION; MALE; NEBULIZATION; NORMAL HUMAN; PRIORITY JOURNAL;

EID: 0031029186     PISSN: 00123692     EISSN: None     Source Type: Journal    
DOI: 10.1378/chest.111.2.316     Document Type: Article

References (35)

1. Reed CE. Aerosol steroids as primary treatment of mild asthma. N Engl J Med 1991; 325:425-26
2. Szefler SJ. Glucocorticoid therapy for asthma: clinical pharmacology. J Allergy Clin Immunol 1991; 88:147-65
3. Toogood JH. Making better and safer use of inhaled steroids. J Respir Dis 1993; 14:221-38
4. Pavord I. Knox A. Pharmacokinetic optimization of inhaled steroid therapy in asthma, Clin Pharmacokinet 1993; 25: 126-35
5. Konig P. Spacer devices used with metered dose inhalers: breakthrough or gimmick. Chest 1985; 88:276-84
6. Salzman GA, Pyszcynski DR. Oropharyngeal candidiasis in patients treated with beclomethasone dipropionate delivered by metered dose inhaler alone and with Aerochamber. J Allergy Clin Immunol 1988; 81:424-28
7. Kim CS, Eldridge MA, Sacker MA. Oropharyngeal deposition and delivery aspects of metered dose inhaler aerosols. Am Rev Respir Dis 1987; 135:135-37
8. Kim CS, Trujillo D, Sackner MA. Size aspects of metered dose inhaler aerosols. Am Rev Respir Dis 1985; 131:132-37
9. Waldrep JC, Keyhani K, Black M, et al. Operating characteristics of 18 different continuous-flow jet nebulizers with beclomethasone dipropionate liposome aerosol. Chest 1994; 105:106-10
10. Waldrep JC, Seherer PW, Hess GD, et al. Nebulized glucocorticoids in liposomes: aerosol characteristics and human dose estimates. J Aerosol Med 1994; 7:135-45
11. Webb MSC, Milner AD, Hiller EJ, et al. Nebulized beclomethasone dipropionate suspension. Arch Dis Child 1986; 61: 1108-10
12. O'Callaghan C. Particle size of beclomethasone dipropionate by two nebulizers and two spacing devices. Thorax 1990; 45:109-11
13. Storr J, Lenney CA, Lenney W. Nebulized beclomethasone dipropionate in presehool asthma. Arch Dis Child 1986; 61:270-73
14. Niven RW, Schreier H. Nebulization of liposomes: I. Effects of lipid composition. Pharmacent Res 1990; 7:1127-33
15. Schreier H, Gonzalez-Rothi RJ, Stecenko AA. Pulmonary delivery of liposomes. J Controlled Release 1993; 24:209-23
16. Cronimelin DJA, Grit M, Talsma H, et al. Liposomes as carriers for drugs and antigens: approaches to preserve their long-term stability. Drug Dev Ind Pharm 1994; 20:547-56
17. Gonzalez-Rothi RJ, Schreier H. Pulmonary delivery of liposome encapsulated drugs in asthma therapy. Clin Immunother 1995; 4:331-37
18. 99mTechnetium as a marker of liposomal deposition and clearance in the human lung. Int J Pharm 1985; 26:303-16
19. 99mtechnetium-labelled beclomethasone dipropionate dilauroylphosphatidylcholine liposome aerosol in normal volunteers. Int J Pharm 1995; 115:209-16
20. Gruber SA, Venkataram S, Canafax DM, et al. Liposomal formulation eliminates acute toxicity and pump incompatibility of parenteral cyclosporine. Pharm Res 1989; 6:601-07
21. Freise CE, Liu T, Hong K, et al. The increased efficacy and decreased nephrotoxicity of a cyclosporine liposome. Transplant 1994; 57:928-32
22. Wyde PR, Six HR, Wilson SZ, et al. Activity against rhinoviruses, toxicity, and delivery in aerosol of enviroxime in liposomes. Antimicrob Agents Chemother 1988; 32:890-95
23. Clark JM, Whinety RR, Olsen SJ, et al. Amphotericin B lipid complex therapy of experimental fungal infections in mice. Antimicrob Agents Chemother 1991; 35:615-21
24. Gondal JA, Swarz RP, Rahman A. Therapeutic evaluation of free and liposome-encapsulated amphotericin B in the treatment of systemic candidiasis in mice. Antimicrob Agents Chemother 1989; 33:1544-48
25. Lopez-Berestein G, Fainstein V, Hopfer R, et al. Liposomal amphotericin B for the treatment of systemic fungal infections in patients with cancer: a preliminary study. J Infect Dis 1985; 151:704-10
26. Lopez-Berestein G, Mehta R, Hopfer RL, et al. Treatment and prophylaxis of disseminated infection due to Candida albicans in mice with liposome-encapsulated amphotericin B. J Infect Dis 1983; 147:939-45
27. Gilbert BE, Wyde PR, Lopez-Berestein G, et al. Aerosolized amphotericin B-liposomes for treatment of systemic Candida infections in mice. Antimicrob Agents Chemother 1994; 38:356-59
28. Smaldone GC, Fuhrer J, Steigbigel RT, et al. Factors determining pulmonary deposition of aerosolized pentamidine in patients with human immunodeficiency virus infection. Am Rev Respir Dis 1991; 143:727-37
29. Hofmann W. Mathematical model for the postnatal growth of the human lung. Respir Physiol 1982; 49:115-29
30. Radford EP Jr, Ferris BG Jr, Kriete BC. Clinical use of a nomogram to estimate proper ventilation during artificial respiration. N Engl J Med 1954; 251:877-84
31. Persons DD, Hess GD, Muller WM, et al. Airway deposition of hygroscopic heterodispersed aerosols: results of a computer calculation. J Appl Physiol 1987; 63:1195-1204
32. Thomas DA, Myers MA, Wichert B, et al. Acute effects of liposome aerosol inhalation on pulmonary function in healthy human volunteers. Chest 1991; 99:1268-70
33. Taylor KMPG, Taylor G, Kellaway IW, et al. The influence of liposomal encapsulation on sodium cromoglycate pharmacokinetics in man. Pharm Res 1989; 6:633-36
34. Martin F. Development of liposomes for aerosol delivery: recent preclinical and clinical results. J Liposome Res 1990; 1:407-29
35. Gilbert BE, Six HR, Wilson SZ, et al. Small particle aerosols of enviroxime containing liposomes. Antiviral Res 1988; 9:355-65