Development and characterisation of soluble polymeric particles for pulmonary peptide delivery

European Journal of Pharmaceutical Sciences

Volumn 41, Issue 2, 2010, Pages 337-352

  Tewes, F ^a   Tajber, L ^a   Corrigan, O I ^a   Ehrhardt, C ^a   Healy, A M ^a  

^a TRINITY COLLEGE DUBLIN   (Ireland)

Author keywords

Microparticles; PEG; Peptide; Pulmonary inhalation; Spray drying

Indexed keywords

ACETONE; MACROGOL; POVIDONE; SALCATONIN;

ARTICLE; BIOLOGICAL ACTIVITY; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG ACTIVITY; DRUG DELIVERY SYSTEM; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IN VITRO STUDY; MELTING POINT; PARTICLE SIZE; PRIORITY JOURNAL; SPRAY DRYING; THERMOGRAVIMETRY; WETTABILITY; X RAY DIFFRACTION;

CALORIMETRY, DIFFERENTIAL SCANNING; LUNG; PARTICLE SIZE; POLYMERS; SOLUBILITY; SURFACE TENSION; THERMOGRAVIMETRY; X-RAY DIFFRACTION;

EID: 77955843806     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2010.07.001     Document Type: Article

References (46)

1. Agrawal A.M., Manek R.V., Kolling W.M., Neau S.H. Water distribution studies within microcrystalline cellulose and chitosan using differential scanning calorimetry and dynamic vapor sorption analysis. Journal of Pharmaceutical Sciences 2004, 93:1766-1779.
2. Alvarez-Lorenzo C., Gómez-Amoza J.L., Martínez-Pacheco R., Souto C., Concheiro A. Interactions between hydroxypropylcelluloses and vapour/liquid water. European Journal of Pharmaceutics and Biopharmaceutics 2000, 50:307-318.
3. Bailon P., Berthold W. Polyethylene glycol-conjugated pharmaceutical proteins. Pharmaceutical Science and Technology Today 1998, 1:352-356.
4. Bosquillon C., Rouxhet P.G., Ahimou F., Simon D., Culot C., Préat V., Vanbever R. Aerosolization properties, surface composition and physical state of spray-dried protein powders. Journal of Controlled Release 2004, 99:357-367.
5. Brandrup J., Immergut E.H., Grulke E.A. Polymer Handbook 1999.
6. Bravo-Osuna I., Ferrero C., Jiménez-Castellanos M.R. Water sorption-desorption behaviour of methyl methacrylate-starch copolymers: effect of hydrophobic graft and drying method. European Journal of Pharmaceutics and Biopharmaceutics 2005, 59:537-548.
7. Buckton G., Darcy P. The use of gravimetric studies to assess the degree of crystallinity of predominantly crystalline powders. International Journal of Pharmaceutics 1995, 123:265-271.
8. Cesteros L.C., Quintana J.R., Fernandez J.A., Katime I.A. Miscibility of poly(ethylene oxide) with poly(N-vinyl pyrrolidone). DMTA and DTA studies. Journal of Polymer Science, Part B: Polymer Physics. 1989, 27:2567-2576.
9. Chan H.K., Clark A.R., Feeley J.C., Kuo M.C., Lehrman S.R., Pikal-Cleland K., Miller D.P., Vehring R., Lechuga-Ballesteros D. Physical stability of salmon calcitonin spray-dried powders for inhalation. Journal of Pharmaceutical Sciences 2004, 93:792-804.
10. Cheng W., Lim L.-Y. Lipeo-sCT: a novel reversible lipidized salmon calcitonin derivative, its biophysical properties and hypocalcemic activity. European Journal of Pharmaceutical Sciences 2009, 37:151-159.
11. Chow A.H.L., Tong H.H.Y., Chattopadhyay P., Shekunov B.Y. Particle engineering for pulmonary drug delivery. Pharmaceutical Research 2007, 24:411-437.
12. Corrigan D.O., Corrigan O.I., Healy A.M. Predicting the physical state of spray dried composites: salbutamol sulphate/lactose and salbutamol sulphate/polyethylene glycol co-spray dried systems. International Journal of Pharmaceutics 2004, 273:171-182.
13. Corrigan D.O., Healy A.M., Corrigan O.I. The effect of spray drying solutions of polyethylene glycol (PEG) and lactose/PEG on their physicochemical properties. International Journal of Pharmaceutics 2002, 235:193-205.
14. D'souza A.J.M., Schowen R.L., Topp E.M. Polyvinylpyrrolidone-drug conjugate: synthesis and release mechanism. Journal of Controlled Release 2004, 94:91-100.
15. De Boer A., Hagedoorn P., Schellekens R., Rottier B., Bocca G., Duiverman E., Frijlink H. Can systemic drug delivery via the pulmonary route be achieved effectively with a dry powder inhaler?. Lessons Learned from Exubera, Drug Delivery to the Lungs 2008, 19:27-30.
16. Edwards D.A., Dunbar C. Bioengineering of therapeutic aerosols. Annual Review of Biomedical Engineering 2002, 4:93-107.
17. Fee C.J. Size comparison between proteins PEGylated with branched and linear poly(ethylene glycol) molecules. Biotechnology and Bioengineering 2007, 98:725-731.
18. Filpula D., Zhao H. Releasable PEGylation of proteins with customized linkers. Advanced Drug Delivery Reviews 2008, 60:29-49.
19. Finlay W.H., Stapleton K.W., Zuberbuhler P. Fine particle fraction as a measure of mass depositing in the lung during inhalation of nearly isotonic nebulized aerosols. Journal of Aerosol Science 1997, 28:1301-1309.
20. Frijlink H.W., De Boer A.H. Dry powder inhalers for pulmonary drug delivery. Expert Opinion on Drug Delivery 2004, 1:67-86.
21. Ghosh P., Siddhanta S.K., Chakrabarti A. Characterization of poly(vinyl pyrrolidone) modified polyaniline prepared in stable aqueous medium. European Polymer Journal 1999, 35:699-710.
22. Haaf F., Sanner A., Straub F. Polymers of N-vinylpyrrolidone: synthesis, characterization and uses. Polymer Journal 1984, 17:143-152.
23. Haddadine-Rahmoun N., Amrani F., Arrighi V., Cowie J.M.G. Interpolymer complexation and thermal behaviour of poly(styrene-co-maleic acid)/poly(vinyl pyrrolidone) mixtures. Thermochimica Acta 2008, 475:25-32.
24. Healy A.M., Mcdonald B.F., Tajber L., Corrigan O.I. Characterisation of excipient-free nanoporous microparticles (NPMPs) of bendroflumethiazide. European Journal of Pharmaceutics and Biopharmaceutics 2008, 69:1182-1186.
25. IUPAC Reporting physisorption data for gas/solid systems with special reference to the determination of surface area and porosity. Pure and Applied Chemistry 1986, 57:603-619.
26. Janssens S., Novoa De Armas H., Roberts C.J., Van Den Mooter G. Characterization of ternary solid dispersions of itraconazole, PEG 6000, and HPMC 2910 E5. Journal of Pharmaceutical Sciences 2008, 97:2110-2120.
27. Jirgensons B. Solubility and fractionation of polyvinylpyrrolidone. Journal of Polymer Science 1952, 8:519-527.
28. Kachrimanis K., Noisternig M.F., Griesser U.J., Malamataris S. Dynamic moisture sorption and desorption of standard and silicified microcrystalline cellulose. European Journal of Pharmaceutics and Biopharmaceutics 2006, 64:307-315.
29. Kompella U.B., Lee V.H.L. Delivery systems for penetration enhancement of peptide and protein drugs: design considerations. Advanced Drug Delivery Reviews 2001, 46:211-245.
30. Lechuga-Ballesteros D., Charan C., Stults C.L.M., Stevenson C.L., Miller D.P., Vehring R., Tep V., Kuo M.C. Trileucine improves aerosol performance and stability of spray-dried powders for inhalation. Journal of Pharmaceutical Sciences 2008, 97:287-302.
31. Lucas P., Anderson K., Staniforth J.N. Protein deposition from dry powder inhalers: fine particle multiplets as performance modifiers. Pharmaceutical Research 1998, 15:562-569.
32. Mitri J., Pittas A.G. Inhaled insulin-what went wrong. Nature Clinical Practice Endocrinology and Metabolism 2009, 5:24-25.
33. Nolan L.M., Tajber L., Mcdonald B.F., Barham A.S., Corrigan O.I., Healy A.M. Excipient-free nanoporous microparticles of budesonide for pulmonary delivery. European Journal of Pharmaceutical Sciences 2009, 37:593-602.
34. Patton J. Breathing life into protein drugs. Nature Biotechnology 1998, 16:141-143.
35. Pean J.M., Boury F., Venier-Julienne M.C., Menei P., Proust J.E., Benoit J.P. Why does PEG 400 co-encapsulation improve NGF stability and release from PLGA biodegradable microspheres?. Pharmaceutical Research 1999, 16:1294-1299.
36. Pharmacopoeia Appendix XII C: Aerodynamic Assessment of Fine Particles-Fine Particle Dose and Particle Size Distribution. British Pharmacopoeia. IV 2009.
37. Reddy R., Chang L., Luthra S., Collins G., Lopez C., Shamblin S.L., Pikal M.J., Gatlin L.A., Shalaev E.Y. The glass transition and sub-Tg-relaxation in pharmaceutical powders and dried proteins by thermally stimulated current. Journal of Pharmaceutical Sciences 2009, 98:81-93.
38. Ryan S.M., Wang X., Mantovani G., Sayers C.T., Haddleton D.M., Brayden D.J. Conjugation of salmon calcitonin to a combed-shaped end functionalized poly(poly(ethylene glycol) methyl ether methacrylate) yields a bioactive stable conjugate. Journal of Controlled Release 2009.
39. Seville P.C., Li H.Y., Learoyd T.P. Spray-dried powders for pulmonary drug delivery. Critical Reviews in Therapeutic Drug Carrier Systems 2007, 24:307-360.
40. Verheyen S., Augustijns P., Kinget R., Van Den Mooter G. Melting behavior of pure polyethylene glycol 6000 and polyethylene glycol 6000 in solid dispersions containing diazepam or temazepam: a DSC study. Thermochimica Acta 2001, 380:153-164.
41. Verheyen S., Blaton N., Kinget R., Van Den Mooter G. Mechanism of increased dissolution of diazepam and temazepam from polyethylene glycol 6000 solid dispersions. International Journal of Pharmaceutics 2002, 249:45-58.
42. Vicent M.J., Duncan R. Polymer conjugates: nanosized medicines for treating cancer. Trends in Biotechnology 2006, 24:39-47.
43. Yoshioka S., Aso Y., Miyazaki T. Negligible contribution of molecular mobility to the degradation rate of insulin lyophilized with poly(vinylpyrrolidone). Journal of Pharmaceutical Sciences 2006, 95:939-943.
44. Youn Y.S., Jung J.Y., Oh S.H., Yoo S.D., Lee K.C. Improved intestinal delivery of salmon calcitonin by Lys18-amine specific PEGylation: stability, permeability, pharmacokinetic behavior and in vivo hypocalcemic efficacy. Journal of Controlled Release 2006, 114:334-342.
45. Youn Y.S., Kwon M.J., Na D.H., Chae S.Y., Lee S., Lee K.C. Improved intrapulmonary delivery of site-specific PEGylated salmon calcitonin: optimization by PEG size selection. Journal of Controlled Release 2008, 125:68-75.
46. Zografi G., Kontny M.J. The interactions of water with cellulose- and starch-derived pharmaceutical excipients. Pharmaceutical Research 1986, 3:187-194.