Influence of protein on mannitol polymorphic form produced during co-spray drying

International Journal of Pharmaceutics

Volumn 382, Issue 1-2, 2009, Pages 67-72

  Hulse, Wendy L ^a   Forbes, Robert T ^a   Bonner, Michael C ^a   Getrost, Matthias ^b  

^a UNIVERSITY OF BRADFORD   (United Kingdom)

^b Merck Biosciences Ltd   (United Kingdom)

Author keywords

Directing effect; Mannitol; Polymorphic behaviour; Protein; Solid form; Spray drying

Indexed keywords

LYSOZYME; MANNITOL; TRYPSIN;

ARTICLE; CHEMICAL STRUCTURE; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG STABILITY; DRUG STORAGE; HUMIDITY; INFRARED SPECTROSCOPY; PRIORITY JOURNAL; SPRAY DRYING; TEMPERATURE MEASUREMENT; THERMOGRAVIMETRY; X RAY POWDER DIFFRACTION;

CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; CRYSTALLOGRAPHY, X-RAY; DESICCATION; DRUG COMPOUNDING; ENZYME STABILITY; EXCIPIENTS; FOURIER ANALYSIS; HUMIDITY; MANNITOL; MURAMIDASE; POWDER DIFFRACTION; SPECTRUM ANALYSIS, RAMAN; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; THERMOGRAVIMETRY; TRYPSIN;

EID: 70350202527     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2009.08.007     Document Type: Article

References (40)

1. Andya J.D., Maa Y.-F., Costantino H.R., Nguyen P.-A., Dasovich N., Sweeney T.D., Hsu C.C., and Shire S.J. 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. 16 (1999) 350-358
2. Bakaltcheva I., O'Sullivan A.M., Hmel P., and Ogbu H. Freeze-dried whole plasma: evaluating sucrose, trehalose, sorbitol, mannitol and glycine as stabilizers. Thromb. Res. 120 (2007) 105-116
3. Bonincontro A., De Francesco A., and Onori G. Influence of pH on lysozyme conformation revealed by dielectric spectroscopy. Coll. Surf. B: Bioint. 12 (1998) 1-5
4. Broadhead J., Rouan S.K.E., and Rhodes C.T. Spray drying of pharmaceuticals. Drug Dev. Ind. Pharm. 18 (1992) 1169-1206
5. Brunner H., and Sussner H. Raman scattering of native and thermally denatured lysozyme. Biochim. Biophys. Acta 271 (1972) 16-22
6. Burger A., Henck J., Hetz S., Rollinger J.M., Weissnicht A.A., and Stottner H. Energy temperature diagram and compression behaviour of the polymorphs of mannitol. J. Pharm. Sci. 89 (2000) 457-468
7. Careri G., Giansanti A., Gratton E., and Namprogetti S. Lysozyme film hydration events: an IR and gravimetric study. Biopolymers 18 (1979) 1187-1203
8. Corrigan O.I. Thermal analysis of spray dried products. Thermochim. Acta 248 (1995) 245-258
9. Costantino H.R., Andya J.D., Nguyen P.-A., Dasovich N., Sweeney T.D., Shire S.J., Hsu C.C., and Maa Y.-F. Effect of mannitol crystallization on the stability and aerosol performance of a spray-dried pharmaceutical protein, recombinant humanized anti-IgE monoclonal antibody. J. Pharm. Sci. 87 (1998) 1406-1411
10. Debord B., Lefebvre C., and Guyot-Hermann A.M. Study of the different crystalline forms of mannitol: comparative behaviour under compression. Drug Dev. Ind. Pharm. 13 (1987) 1533-1546
11. Elkordy A.A., Forbes R.T., and Barry B.W. The integrity of crystalline lysozyme exceeds that of a spray-dried form. Int. J. Pharm. 247 (2002) 79-90
12. Hubbard S.A. Comparative toxicology of borates. Biol. Trace Elem. Res. 66 (1998) 343-357
13. Hulse W.L., Forbes R.T., Bonner M.C., and Getrost M. Do Co-spray dried excipients offer better lysozyme stabilisation than single excipients?. Eur. J. Pharm. Sci. 33 (2008) 294-305
14. Izutsu K.-I., Ocheda S.O., Aoyagi N., and Kojima S. Effects of sodium tetraborate and boric acid on nonisothermal mannitol crystallization in frozen and freeze-dried solids. Int. J. Pharm. 273 (2004) 85-93
15. Izutsu K.-I., Yomota C., and Aoyagi N. Inhibition of mannitol crystallization in frozen solutions by sodium phosphates and citrates. Chem. Pharm. Bull. 55 (2007) 565-570
16. Jones F.T., and Lee K.S. The optical and crystallographic properties of three phases of mannitol. Microscope 18 (1970) 279-285
17. Kibbe A.E. Handbook of pharmaceutical excipients. 3rd ed. (2000), Pharmaceutical Press
18. Kim H.S., Jeffrey G.A., and Rosenstein R.D. The physical state of mannitol after freeze drying: effects of concentration and drying rate. Acta. Cryst. B 24 (1986) 1449-1455
19. Lord R.C., and Yu N.-T. Laser-excited Raman spectroscopy of biomolecules. 1. Native lysozyme and its constituent amino acids. J. Mol. Biol. 50 (1970) 509-524
20. Maa Y.-F., Nguyen P.-A., and Hsu S.W. Spray drying of air-liquid interface sensitive recombinant human growth hormone. J. Pharm. Sci. 87 (1997) 152-159
21. Maa Y.-F., Nguyen, Sit K., and Hsu C.C. Spray drying performance of a bench top spray dryer for protein aerosol powder preparation. Biotech. Bioeng. 60 (1998) 301-305
22. Makki F., and Durance T.D. Thermal inactivation of lysozyme as influenced by pH, sucrose and sodium chloride and inactivation and preservative effect in beer. Food Res. Int. 29 (1996) 635-645
23. Malzert A., Boury F., Robert P., Proust J.E., and Benoit J.P. Influence of some formulation parameters on lysozyme adsorption and on its stability in solution. Int. J. Pharm. 242 (2002) 405-409
24. Nguyen X.C., Herberger J.D., and Burke P.A. Protein powders for encapsulation: a comparison of spray-freeze drying and spray drying of darbepoetin alfa. Pharm. Res. 21 (2004) 507-514
25. Pyne A., Chatterjee K., and Suryanarayanan R. Solute crystallization in mannitol-glycine systems-implications on protein stabilization in freeze-dried formulations. J. Pharm. Sci. 92 (2003) 2272-2283
26. Roberts S.N.C., Williams A.C., Grimsey I.M., and Booth S.W. Quantitative analysis of mannitol polymorphs FT-Raman spectroscopy. J. Pharm. Biomed. Anal. 28 (2002) 1135-1147
27. Roxby R., and Tanford C. Hydrogen ion titration curve of lysozyme in 6 molar guanidine hydrochloride. Biochemistry 10 (1971) 3348
28. Schule S., Frieb W., Bechtold-Peters K., and Garidel P. Conformational analysis of protein secondary structure during spray-drying of antibody/mannitol formulations. Eur. J. Pharm. Biopharm. 65 (2007) 1-9
29. Sharma V.K., and Kalonia D.S. Effect of vacuum drying on protein-mannitol interactions: The physical state of mannitol and protein structure in the dried state. AAPS Pharmscitech. 5 (2004) (Article 10)
30. Sliwinski E.L., Lavrijsen B.M.W., Vollenbroek H.K., van Boekel M.A.J.S., and Wouters J.T.M. Effects of spray drying on physiochemical properties of milk protein-stabilised emulsions. Coll. Surf. B: Bioint. 31 (2004) 219-229
31. Ståhl K., Claesson M., Lilliehorn P., Linden H., and Bäckstrom K. The effect of process variables on the degradation and physical properties of spray dried insulin intended for inhalation. Int. J. Pharm. 233 (2002) 227-237
32. Telang C., Suryanarayanan R., and Yu L. Crystallization of d-mannitol in binary phase mixtures with NaCl: phase diagram and polymorphism. Pharm. Res. 20 (2003) 1939-1945
33. Taylor K. In: Aulton M.E. (Ed). Pharmaceutics. 2nd ed. (2002), Harcourt Publishers Ltd., London
34. Tomizawa H., Hidenori Y., Katsutoshi W., and Imoto T. Stabilization of lysozyme against irreversible inactivation by suppression of chemical reactions. J. Biochem. 117 (1995) 635-640
35. Torrado S., and Torrado S. Characterisation of the physical state of mannitol after freeze-drying-effect of acetylsalicylic acid as a second crystalline co-solute. Chem. Pharm. Bull. 50 (2002) 567-570
36. Tu A.T. Raman spectroscopy in biology: principals and applications (1982), John Wiley and Sons, New York
37. Vanbever R., Mintzes J.D., Wang J., Nice J., Chen D., Batycky R., Langer R., and Edwards D.A. Formulation and physical characterisation of large porous particles for inhalation. Pharm. Res. 16 (1999) 1735-1742
38. Voet D., Voet J.G., and Pratt C.W. Fundamentals of biochemistry (1999), John Wiley and Sons Inc., New York
39. Yoshinari T., Forbes R.T., York P., and Kawashima Y. Moisture induced polymorphic transition of mannitol and its morphological transformation. Int. J. Pharm. 247 (2002) 69-77
40. Yoshinari T., Forbes R.T., York P., and Kawashima Y. Crystallisation of amorphous mannitol is retarded using boric acid. Int. J. Pharm. 258 (2003) 109-120