Spray Drying of Biopharmaceuticals: Stability and Process Considerations

REFERENCES

• Tracy , M.A. Development and scale-up of a microsphere protein delivery system . Biotechnology Progress 1998 , 14 , 108 – 115 . [INFOTRIEVE] [CSA]
   PubMed Web of Science ®Google Scholar
• Maa , Y.F. ; Nguyen , P.A. ; Sweeney , T.D. ; Shire , S.J. ; Hsu , C.C. Protein inhalation powder: Spray drying vs . spray freeze drying. Pharmaceutical Research 1999 , 16 , 249 – 254 . [CSA]
   PubMed Web of Science ®Google Scholar
• Chen , D. ; Maa , Y.F. ; Haynes , J. Needle-free epidermal powder immunizations . Expert Vaccine Review 2002 , 1 , 265 – 276 . [CSA] [CROSSREF]
   PubMedGoogle Scholar
• Broadhead , J. ; Rouan , S. ; Rhodes , C. The spray drying of pharmaceuticals . Drug Development and Industrial Pharmacy 1992 , 18 , 1169 – 1206 . [CSA]
   Web of Science ®Google Scholar
• Labrude , P. ; Rasolomanana , M. ; Vigneron , C. ; Thirion , C. ; Chaillot , B. Protective effect of sucrose on spray drying of oxyhemoglobin . Journal of Pharmaceutical Sciences 1989 , 78 , 223 – 229 . [INFOTRIEVE] [CSA]
   PubMed Web of Science ®Google Scholar
• Broadhead , J. ; Rouan , S. ; Hau , I. ; Rhodes , C. The effect of process and formulation variables on the properties of spray dried b-galactosidase . Journal of Pharmacy and Pharmacology 1994 , 46 , 458 – 467 . [INFOTRIEVE] [CSA]
   PubMed Web of Science ®Google Scholar
• Tzannis , S.T. ; Prestrelski , S.J. Activity-stability considerations of trypsinogen during spray drying: Effects of sucrose . Journal of Pharmaceutical Sciences 2000 , 88 , 351 – 358 . [CSA] [CROSSREF]
   Web of Science ®Google Scholar
• Tzannis , S.T. ; Prestrelski , S.J. Moisture effects on protein - excipient interactions in spray-dried powders . Nature of destabilizing effects of sucrose. Journal of Pharmaceutical Sciences 2000 , 88 , 360 – 370 . [CSA]
   Web of Science ®Google Scholar
• Masters , K. Spray Drying Handbook ; John Wiley and Sons : New York , 1991 .
   Google Scholar
• Maa , Y.F. ; Costantino , H.R. ; Nguyen , P.A. ; Hsu , C.C. The effect of operating and formulation variables on the morphology of spray-dried protein particles . Pharmaceutical Development and Technology 1997 , 2 , 213 – 223 . [INFOTRIEVE] [CSA]
   PubMed Web of Science ®Google Scholar
• Tzannis , S.T. ; Meyer , J.D. ; Prestrelski , S.J. Secondary structure consideration during protein spray drying . Presented at 213th ACS National Meeting, BIOT-297, April 13–17, 1997 , San Francisco , CA .
   Google Scholar
• Costantino , R.H. ; Nguyen , T.H. ; Hsu , C.C. Fourier transform infrared spectroscopy demonstrates that lyophilization alters the secondary structure of recombinant human growth hormone . Journal of Pharmaceutical Science 1996 , 2 , 229 – 232 . [CSA]
   Google Scholar
• Prestrelski , S.J. ; Pikal , K.A. ; Arakawa , T. Optimization of lyophilization conditions for recombinant human interlukin-2 by dried-state conformational analysis using fourier transform infrared spectroscopy . Pharmaceutical Research 1995 , 12 , 250 – 1259 . [CSA] [CROSSREF]
   Web of Science ®Google Scholar
• Carpenter , J.F. ; Crowe , J.H. An infrared spectroscopic study of interactions of carbohydrates with dried proteins . Biochemistry 1989 , 28 , 3916 – 3922 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Arakawa , T. ; Timsheff , S.N. Stabilization of protein structure by sugars . Biochemistry 1982 , 21 , 6536 – 6544 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Sarciaux , J.M.E. ; Hageman , M. Effect of bovine somatotropin (rbSt) concentration at different moisture levels on the physical stability of sucrose in freeze-dried rbSt/sucrose mixture . Journal of Pharmaceutical Sciences 1997 , 86 , 365 – 371 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Maa , Y.F. ; Hsu , C.C. Effect of high shear on proteins . Biotechnology and Bioengineering 1996 , 51 , 458 – 465 . [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Maa , Y.F. ; Hsu , C.C. Protein denaturation by combined effect of shear and air-liquid interface . Biotechnology and Bioengineering 1997 , 54 , 503 – 512 . [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Adler , M. ; Lee , G. Stability and surface activity of lactate dehydrogenase in spray-dried trehalose . Journal of Pharmaceutical Sciences 1999 , 88 , 99 – 208 . [CSA]
   Web of Science ®Google Scholar
• Faldt , P. ; Berganstahl , B. The surface composition of spray-dried protein-lactose powders . Colloids and Surfaces 1994 , 90 , 183 – 190 . [CSA] [CROSSREF]
   Google Scholar
• MacRichie , F. Proteins at interfaces . Advances in Protein Chemistry 1978 , 32 , 283 – 311 . [CSA]
   PubMedGoogle Scholar
• Thurow , H. ; Geisen , K. Stabilization of dissolved proteins against denaturation at hydrophobic interfaces . Diabetologia 1984 , 27 , 212 – 218 . [INFOTRIEVE] [CSA]
   PubMed Web of Science ®Google Scholar
• Maa , Y.F. ; Nguyen , P.A. ; Hsu , C.C. Spray drying of air-sensitive recombinant human growth hormone . Journal of Pharmaceutical Sciences 1998 , 87 , 152 – 159 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Hageman , M.J. The role of moisture on protein stability . Drug Development and Industrial Pharmacy 1988 , 14 , 2047 – 2070 . [CSA]
   Web of Science ®Google Scholar
• Bell , L.N. ; Hageman , M.J. ; Muraoka , L.M. Thermally induced denaturation of lyophilized bovine somatotropin and lysozyme as impacted by moisture and excipients . Journal of Pharmaceutical Sciences 1995 , 84 , 707 – 712 . [INFOTRIEVE] [CSA]
   PubMed Web of Science ®Google Scholar
• Hageman , M.J. Chemical and physical pathways of protein degradation . In Stability of Protein Pharmaceuticals ; Ahern , T.J. , Manning , M.C. , Eds.; Plenum Press : New York , 1994 ; 273 – 309 .
   Google Scholar
• Maa , Y.F. ; Nguyen , P.A. ; Andya , J.D. ; Dasovich , N. ; Sweeney , T.D. ; Shire , S.J. ; Hsu , C.C. Effect of spray drying and subsequent processing conditions on residual moisture content and physical/biochemical stability of protein inhalation powders . Pharmaceutical Research 1998 , 15 , 768 – 775 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar