409
Views
25
CrossRef citations to date
0
Altmetric
Research Article

Formulation and process development of (recombinant human) deoxyribonuclease I as a powder for inhalation

, , , , , & show all
Pages 358-368 | Received 29 Jun 2008, Accepted 01 Dec 2008, Published online: 12 Mar 2009

References

  • Shak S. Aerosolized recombinant human DNase I for the treatment of cystic fibrosis. Chest 1995;107(2 Suppl.):65S–70.
  • Shak S, Capon DJ, Hellmiss R, Marsters SA, Baker CL. Recombinant human DNase I reduces the viscosity of cystic fibrosis sputum. Proc Natl Acad Sci USA 1990;87(23):9188–9192.
  • Lethem MI, James SL, Marriott C, Burke JF. The origin of DNA associated with mucus glycoproteins in cystic fibrosis sputum. Eur Respir J 1990;3(1):19–23.
  • Picot R, Das I, Reid L. Pus, deoxyribonucleic acid, and sputum viscosity. Thorax 1978;33(2):235–242.
  • Laube BL, Auci RM, Shields DE, et al. Effect of rhDNase on airflow obstruction and mucociliary clearance in cystic fibrosis. Am J Respir Crit Care Med 1996;153(2):752–760.
  • Zahm JM, Girod de Bentzmann S, Deneuville E, et al. Dose-dependent in vitro effect of recombinant human DNase on rheological and transport properties of cystic fibrosis respiratory mucus. Eur Respir J 1995;8(3):381–386.
  • Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. The Pulmozyme Study Group. N Engl J Med 1994;331(10):637–642.
  • Diot P, Palmer LB, Smaldone A, DeCelie-Germana J, Grimson R, Smaldone GC. RhDNase I aerosol deposition and related factors in cystic fibrosis. Am J Respir Crit Care Med 1997;156(5):1662–1668.
  • De Boer AH, Le Brun PPH, van der Woude HG, Hagedoorn P, Heijerman HG, Frijlink HW. Dry powder inhalation of antibiotics in cystic fibrosis therapy, part 1: Development of a powder formulation with colistin sulfate for a special test inhaler with an air classifier as de-agglomeration principle. Eur J Pharm Biopharm 2002;54(1):17–24.
  • Le Brun PPH, de Boer AH, Mannes GP, et al. Dry powder inhalation of antibiotics in cystic fibrosis therapy: part 2. Inhalation of a novel colistin dry powder formulation: a feasibility study in healthy volunteers and patients. Eur J Pharm Biopharm 2002;54(1):25–32.
  • Wagener JS, Rock MJ, McCubbin MM, Hamilton SD, Johnson CA, Ahrens RC. Aerosol delivery and safety of recombinant human deoxyribonuclease in young children with cystic fibrosis: a bronchoscopic study. Pulmozyme Pediatric Broncoscopy Study Group. J Pediatr 1998;133(4):486–491.
  • Diot P, Palmer LB, Smaldone A, DeCelie-Germana J, Grimson R, Smaldone GC. RhDNase I aerosol deposition and related factors in cystic fibrosis. Am J Respir Crit Care Med 1997;156(5):1662–1668.
  • Fiel SB, Fuchs HJ, Johnson C, Gonda I, Clark AR. Comparison of three jet nebulizer aerosol delivery systems used to administer recombinant human DNase I to patients with cystic fibrosis. The Pulmozyme rhDNase Study Group. Chest 1995;108(1):153–156.
  • Geller DE, Eigen H, Fiel SB, et al. Effect of smaller droplet size of dornase alfa on lung function in mild cystic fibrosis. Dornase Alfa Nebulizer Group. Pediatr Pulmonol 1998;25(2):83–87.
  • Chan HK, Clark A, Gonda I, Mumenthaler M, Hsu C. Spray dried powders and powder blends of recombinant human deoxyribonuclease (rhDNase) for aerosol delivery. Pharm Res 1997;14(4):431–437.
  • Costantino HR, Andya JD, Nguyen P-A, et al. Effect of mannitol crystallization on the stability and aerosol performance of spray-dried pharmaceutical protein, recombinant humanized anti-IgE monoclonal antibody. J Pharm Sci 1998;87:1406–1411.
  • Maa YF, Nguyen PA, Sweeney T, Shire SJ, Hsu CC. Protein inhalation powders: spray drying vs. spray freeze drying. Pharm Res 1999;16(2):249–254.
  • Maa YF, Nguyen PA, Hsu C. Spray-coating of rhDNase on lactose: effect of system design, operational parameters and protein formulation. Int J Pharm 1996(144):47–59.
  • Andya JD, Maa YF, Costantino HR, et al. The effect of formulation excipients on protein stability and aerosol performance of spray-dried powders of a recombinant humanized anti-IgE monoclonal antibody. Pharm Res 1999;16(3):350–358.
  • Colaco CALS, Smith CJS, Sen S, et al. Chemistry of protein stabilization by trehalose. ACS Symp Ser 1994;567:222–240.
  • Hinrichs WLJ, Prinsen MG, Frijlink HW. Inulin glasses for the stabilization of therapeutic proteins. Int J Pharm 2001;215(1–2):163–174.
  • Amorij JP, Meulenaar J, Hinrichs WL, et al. Rational design of an influenza subunit vaccine powder with sugar glass technology: preventing conformational changes of haemagglutinin during freezing and freeze-drying. Vaccine 2007;25(35):6447–6457.
  • Shoyele SA, Cawthorne S. Particle engineering techniques for inhaled biopharmaceuticals. Adv Drug Deliv Rev 2006;58(9–10):1009–1029.
  • Quan CP, Wu S, Dasovich N, Hsu C, Patapoff T, Canova-Davis E. Susceptibility of rhDNase I to glycation in the dry-powder state. Anal Chem 1999;71(20):4445–4454.
  • Kishi K, Yasuda T, Takeshita H. DNase I: structure, function, and use in medicine and forensic science. Legal Med 2001;3:69–83.
  • Peterson GL. A simplification of the protein assay method of Lowry et al. which is more generally applicable. Analyt Biochem 1977;83(2):346–356.
  • Sinicropi D, Baker DL, Prince WS, Shiffer K, Shak S. Colorimetric determination of DNase I activity with a DNA-methyl green substrate. Anal Biochem 1994;222(2):351–358.
  • Miller GL. Use of dinitrosalycilic acid reagent for determination of reducing sugar. Anal Chem 1959;31:426–428.
  • Martins SIFS, Jongen WMF, Boekel vAJS. A review of the Maillard reaction in food and implications to kinetic modelling. Trends Food Sci Techn 2001;11:364–373.
  • Sampietro T, Lenzi S, Giampietro O, Cecchetti P, Masoni A, Navalesi R. A sensitive high performance liquid chromatographic method for determining small amounts of glycosylproteins. Clin Physiol Biochem 1987;5(1):49–56.
  • Cuzzoni MT, Stoppini G, Gazzani G, Mazza P. Influence of water activity and reaction temperature of ribose-lysine and glucose-lysine Maillard systems on mutagenicity, absorbance and content of furfurals. Food Chem Toxicol 1988;26(10):815–822.
  • Vanbever R, Mintzes JD, Wang J, et al. Formulation and physical characterization of large porous particles for inhalation. Pharm Res 1999;16(11):1735–1742.
  • Sanders NN, De Smedt SC, Van Rompaey E, Simoens P, De Baets F, Demeester J. Cystic fibrosis sputum: a barrier to the transport of nanospheres. Am J Respir Crit Care Med 2000;162(5):1905–1911.
  • Sanders NN, Van Rompaey E, De Smedt SC, Demeester J. Structural alterations of gene complexes by cystic fibrosis sputum. Am J Respir Crit Care Med 2001;164(3):486–493.
  • King M, Dasgupta B, Tomkiewicz RP, Brown NE. Rheology of cystic fibrosis sputum after in vitro treatment with hypertonic saline alone and in combination with recombinant human deoxyribonuclease I. Am J Respir Crit Care Med 1997;156(1):173–177.
  • Yoshioka S, Aso Y. Correlations between molecular mobility and chemical stability during storage of amorphous pharmaceuticals. J Pharm Sci 2007;96(5):960–981.
  • Maa YF, Costantino HR, Nguyen PA, Hsu CC. The effect of operating and formulation variables on the morphology of spray-dried protein particles. Pharm Dev Technol 1997;2(3):213–223.
  • Zijlstra GS, Hinrichs WLJ, Boer AHd, Frijlink HW. The role of particle engineering in relation to formulation and de-agglomeration principle in the development of a dry powder formulation for inhalation of cetrorelix. Eur J Pharm Sci 2004;23(2):139–149.
  • Usmani OS, Biddiscombe MF, Nightingale JA, Underwood SR, Barnes PJ. Effects of bronchodilator particle size in asthmatic patients using monodisperse aerosols. J Appl Physiol 2003;95(5):2106–2112.
  • Dickhoff BH, Ellison MJ, de Boer AH, Frijlink HW. The effect of budesonide particle mass on drug particle detachment from carrier crystals in adhesive mixtures during inhalation. Eur J Pharm Biopharm 2002;54(2):245–248.
  • De Boer AH, Hagedoorn P, Gjaltema D, Goede J, Frijlink HW. Air classifier technology (ACT) in dry powder inhalation: Part 1. Introduction of a novel force distribution concept (FDC) explaining the performance of a basic air classifier on adhesive mixtures. Int J Pharm 2003;260(2):187–200.
  • Chan HK, Gonda I. Solid state characterization of spray-dried powders of recombinant human deoxyribonuclease (rhDNase). J Pharm Sci 1998;87(5):647–654.
  • Jacquot J, Hayem A, Galabert C. Functions of proteins and lipids in airway secretions. Eur Respir J 1992;5(3):343–358.
  • List SJ, Findlay BP, Forstner GG, Forstner JF. Enhancement of the viscosity of mucin by serum albumin. Biochem J 1978;175(2):565–571.
  • Murty VL, Sarosiek J, Slomiany A, Slomiany BL. Effect of lipids and proteins on the viscosity of gastric mucus glycoprotein. Biochem Biophys Res Commun 1984;121(2):521–529.
  • Wine JJ. The genesis of cystic fibrosis lung disease. J Clin Invest 1999;103(3):309–312.
  • Zijlstra GS, Boersma C, Frijlink HW, Postma MJ. Pharmaco-economic review of Recombinant Human DNase (rhDNase) in the management of cystic fibrosis; with special reference to current developments in delivery systems. Expert Rev Pharmacoeconom Outcomes Res 2004;4(1):49–59.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.