Development of inhalable dry powder formulation of basic fibroblast growth factor

International Journal of Pharmaceutics

Volumn 385, Issue 1-2, 2010, Pages 66-72

  Ibrahim, Basma M ^a   Jun, Seoung Wook ^b   Lee, Mee Yong ^b   Kang, Soo Hyung ^b   Yeo, Yoon ^a,c  

^a PURDUE UNIVERSITY   (United States)

^b Dong A Pharmaceutical Company   (South Korea)

^c PURDUE UNIVERSITY   (United States)

Author keywords

Basic fibroblast growth factor; Dry powder; Inhalable formulation; Protein stability; Spray drying

Indexed keywords

ALBUMIN; ALCOHOL; BASIC FIBROBLAST GROWTH FACTOR; EXCIPIENT; LACTOSE; LEUCINE; PHOSPHOLIPID;

AQUEOUS SOLUTION; ARTICLE; CONTROLLED STUDY; DISPERSION; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG STABILITY; DRY POWDER; INHALATIONAL DRUG ADMINISTRATION; PARTICLE SIZE; PRIORITY JOURNAL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SCANNING ELECTRON MICROSCOPY; SPRAY DRYING;

ADMINISTRATION, INHALATION; AEROSOLS; CHEMISTRY, PHARMACEUTICAL; DRUG CARRIERS; DRUG STABILITY; ETHANOL; EXCIPIENTS; FIBROBLAST GROWTH FACTOR 2; LACTOSE; LEUCINE; PARTICLE SIZE; PHOSPHOLIPIDS; POWDERS; PROTEIN STABILITY; RESPIRATORY SYSTEM AGENTS; SERUM ALBUMIN; SURFACE PROPERTIES; TECHNOLOGY, PHARMACEUTICAL;

EID: 72149126106     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2009.10.029     Document Type: Article

References (43)

1. Ameri M., and Maa Y.-F. Spray drying of biopharmaceuticals: stability and process considerations. Drying Technol. 24 (2006) 763-768
2. Astafieva I.V., Eberlein G.A., and John Wang Y. Absolute on-line molecular mass analysis of basic fibroblast growth factor and its multimers by reversed-phase liquid chromatography with multi-angle laser light scattering detection. J. Chromatogr. A 740 (1996) 215-229
3. Barnes Peter J., and Kleinert S. COPD-a neglected disease. Lancet 364 (2004) 564-565
4. Ben-Jebria A., Chen D., Eskew M.L., Vanbever R., Langer R., and Edwards D.A. Large porous particles for sustained protection from carbachol-induced bronchoconstriction in guinea pigs. Pharm. Res. 16 (1999) 555-561
5. Bhuyan A.K. Protein stabilization by urea and guanidine hydrochloride. Biochemistry 41 (2002) 13386-13394
6. Bosquillon C., Lombry C., Preat V., and Vanbever R. Influence of formulation excipients and physical characteristics of inhalation dry powders on their aerosolization performance. J. Controlled Release 70 (2001) 329
7. Bosquillon C., Préat V., and Vanbever R. Pulmonary delivery of growth hormone using dry powders and visualization of its local fate in rats. J. Controlled Release 96 (2004) 233-244
8. Brunton S. Insulin delivery systems: reducing barriers to insulin therapy and advancing diabetes mellitus treatment. Am. J. Med. 121 (2008) S35-41
9. Caccia P., Nitti G., Cletini O., Pucci P., Ruoppolo M., Bertolero F., Valsasina B., Roletto F., Cristiani C., et al. Stabilization of recombinant human basic fibroblast growth factor by chemical modifications of cysteine residues. Eur. J. Biochem. 204 (1992) 649-655
10. Chew N.Y.K., Shekunov B.Y., Tong H.H.Y., Chow A.H.L., Savage C., Wu J., and Chan H.-K. Effect of amino acids on the dispersion of disodium cromoglycate powders. J. Pharm. Sci. 94 (2005) 2289-2300
11. Codrons V.R., Vanderbist F., Verbeeck R.K., Arras M., Lison D., Preat V., and Vanbever R. Systemic delivery of parathyroid hormone (1-34) using inhalation dry powders in rats. J. Pharm. Sci. 92 (2003) 938-950
12. Dunbar J., Yennawar H.P., Banerjee S., Luo J., and Farber G.K. The effect of denaturants on protein structure. Protein Sci. 6 (1997) 1727-1733
13. Edwards D.A., Hanes J., Caponetti G., Hrkach J., Ben-Jebria A., Eskew M.L., Mintzes J., Deaver D., Lotan N., and Langer R. Large porous particles for pulmonary drug delivery. Science (Washington, DC) 276 (1997) 1868-1871
14. Fanta C.H. Asthma. N. Engl. J. Med. 360 (2009) 1002-1014
15. Holgate S.T. Airway inflammation and remodeling in asthma: current concepts. Mol. Biotechnol. 22 (2002) 179-189
16. Jeon S.G., Lee C.G., Oh M.-H., Chun E.-Y., Gho Y.S., Cho S.-H., Kim J.-H., Min K.-U., Kim Y.-Y., Kim Y.-K., and Elias J.A. Recombinant basic fibroblast growth factor inhibits the airway hyperresponsiveness, mucus production, and lung inflammation induced by an allergen challenge. J. Allergy Clin. Immunol. 119 (2007) 831-837
17. Li H.-Y., Neill H., Innocent R., Seville P., Williamson I., and Birchall J.C. Enhanced dispersibility and deposition of spray-dried powders for pulmonary gene therapy. J. Drug Target. 11 (2003) 425-432
18. Li H.Y., Seville P.C., Williamson I.J., and Birchall J.C. The use of amino acids to enhance the aerosolisation of spray-dried powders for pulmonary gene therapy. J. Gene Med. 7 (2005) 343-353
19. Lipworth B.J. Targets for inhaled treatment. Resp. Med. 94 (2000) S13-S16
20. Lucas P., Anderson K., Potter U.J., and Staniforth J.N. Enhancement of small particle size dry powder aerosol formulations using an ultra low density additive. Pharm. Res. 16 (1999) 1643-1647
21. Maa Y.-F., and Hsu C.C. Effect of high shear on proteins. Biotechnol. Bioeng. 51 (1996) 458-465
22. Maa Y.-F., and Hsu C.C. Protein denaturation by combined effect of shear and air-liquid interface. Biotechnol. Bioeng. 54 (1997) 503-512
23. Maa Y.-F., and Hsu C.C. Feasibility of protein spray coating using a fluid-bed Wurster processor. Biotechnol. Bioeng. 53 (1997) 560-566
24. Maa Y.-F., Nguyen P.-A., and Hsu C.C. Spray-coating of rhDNase on lactose: effect of system design, operational parameters and protein formulation. Int. J. Pharm. 144 (1996) 47-59
25. May J.C., Wheeler R.M., Etz N., and Del Grosso A. Measurement of final container residual moisture in freeze-dried biological products. Dev. Biol. Standardization 74 (1992) 153-164
26. Morino S., Nakamura T., Toba T., Takahashi M., Kushibiki T., Tabata Y., and Shimizu Y. Fibroblast growth factor-2 induces recovery of pulmonary blood flow in canine emphysema models. Chest 128 (2005) 920-926
27. Nathan R.A. Beta-2 agonist therapy-oral versus inhaled delivery. J. Asthma 29 (1992) 49-54
28. Newman S.P. Dry powder inhalers for optimal drug delivery. Exp. Opin. Biol. Ther. 4 (2004) 23-33
29. Nugent M.A., and Iozzo R.V. Fibroblast growth factor-2. Int. J. Biochem. Cell Biol. 32 (2000) 115-120
30. Osterman K., Carlholm M., Ekelund J., Kiviloog J., Nikander K., Nilholm L., Salomonsson P., Strand V., Venge P., and Zetterstrom O. Effect of 1 year daily treatment with 400 μg budesonide (Pulmicort Turbuhaler) in newly diagnosed asthmatics. Eur. Resp. J. 10 (1997) 2210-2215
31. Park T.G., Lee H.Y., and Nam Y.S. A new preparation method for protein loaded poly(lactic-co-glycolic acid) microspheres and protein release mechanism study. J. Controlled Release 55 (1998) 181-191
32. Patton J.S., and Byron P.R. Inhaling medicines: delivering drugs to the body through the lungs. Nat. Rev. Drug Discov. 6 (2007) 67-74
33. Pleasants R.A. Asthma and Chronic Obstructive Pulmonary Disease. Comprehensive Pharmacy Review (2006), Lippincott Williams & Wilkins
34. Qian F., Mathias N., Moench P., Chi C., Desikan S., Hussain M., and Smith R.L. Pulmonary delivery of a GLP-1 receptor agonist, BMS-686117. Int. J. Pharm. 366 (2009) 218-220
35. Seville P.C., Learoyd T.P., Li H.Y., Williamson I.J., and Birchall J.C. Amino acid-modified spray-dried powders with enhanced aerosolization properties for pulmonary drug delivery. Powder Technol. 178 (2007) 40-50
36. Shur J., Nevell T.G., Ewen R.J., Price R., Smith A., Barbu E., Conway J.H., Carroll M.P., Shute J.K., and Smith J.R. Cospray-dried unfractionated heparin with l-leucine as a dry powder inhaler mucolytic for cystic fibrosis therapy. J. Pharm. Sci. 97 (2008) 4857-4868
37. Towns J.K. Moisture content in proteins: its effects and measurement. J. Chromatogr. A 705 (1995) 115-127
38. Tsifansky M.D., Yeo Y., Evgenov O.V., Bellas E., Benjamin J., and Kohane D.S. Microparticles for inhalational delivery of antipseudomonal antibiotics. AAPS J. (2008)
39. Vehring R. Pharmaceutical particle engineering via spray drying. Pharm. Res. 25 (2008) 999-1022
40. Wang J., Hong A., Ren J.S., Sun F.Y., Shi Y.J., Liu K., Xie Q.L., Dai Y., Li Z.Y., and Chen Y. Biochemical properties of C78SC96S rhFGF-2: a double point-mutated rhFGF-2 increases obviously its activity. J. Biotechnol. 121 (2006) 442-447
41. Wills-Karp M., Luyimbazi J., Xu X., Schofield B., Neben T.Y., Karp C.L., and Donaldson D.D. Interleukin-13: central mediator of allergic asthma. Science (Washington, DC) 282 (1998) 2258-2261
42. Yu L.-C., Chen S.-C., Chang W.-C., Huang Y.-C., Lin K.M., Lai P.-H., and Sung H.-W. Stability of angiogenic agents, ginsenoside Rg1 and Re, isolated from Panax ginseng: in vitro and in vivo studies. Int. J. Pharm. 328 (2007) 168-176
43. Zhou X.J., Hines P., and Borer M.W. Moisture determination in hygroscopic drug substances by near infrared spectroscopy. J. Pharm. Biomed. Anal. 17 (1998) 219-225