[ Pobierz całość w formacie PDF ]
lation and lyophilization cycle design: Prevention of damage 6:94 99.
due to freeze-concentration induced phase separation. Biotech- 28. Janik H, Palys B, Petrovic ZS. 2003. Multiphase-separated
nol Bioeng 63:166 174. polyurethanes studied by micro-Raman spectroscopy. Macro-
9. Heller MC, Carpenter John F, Randolph Theodore W. 1999. mol Rapid Commun 24:265 268.
Conformational stability of lyophilized PEGylated proteins in a 29. Sammon C, Mura C, Eaton P, Yarwood J. 2000. Raman micro-
phase-separating system. J Pharm Sci 88:58 64. scopic studies of polymer surfaces and interfaces. Analusis
10. Izutsu K-I, Kojima S. 2000. Freeze-concentration separates 28:30 34.
proteins and polymer excipients into different amorphous 30. Huan S, Lin W, Sato H, Yang H, Jiang J, Ozaki Y, Wu H, Yu R.
phases. Pharm Res 17:1316 1322. 2007. Direct characterization of phase behavior and compat-
DOI 10.1002/jps JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 100, NO. 1, JANUARY 2011
222 PADILLA ET AL.
ibility in PET/HDPE polymer blends by confocal Raman map- rolidone-dextran solutions induced by freeze-concentration.
ping. J Raman Spectrosc 38:260 270. J Chem Soc, Faraday Trans 94:411 417.
31. Turrell G, Delhaye M, Dhamelincourt P. 1996. Characteristics 47. Krause S. 1986. Polymer-polymer miscibility. Pure Appl Chem
of Raman microscopy. In: Turrell G, Corset J, editors. Raman 58:1553 1560.
microscopy: Developments and applications. Academic Press: 48. Sperling LH. 1992. Introduction to physical polymer science.
San Diego, CA; pp. 27 49. John Wiley and Sons, Inc.: New York, NY.
32. Tu AT. 1982. Raman spectroscopy in biology: Principles and 49. Elliott SR. 1990. Physics of amorphous materials. Longman
applications. John Wiley and Sons. New York, NY. Scientific and Technical: Essex, England.
33. Docoslis A, Huszarik KL, Papageorgiou GZ, Bikiaris D, 50. Shamblin SL, Taylor LS, Zografi G. 1998. Mixing behavior of
Stergiou A, Georgarakis E. 2007. Characterization of the dis- colyophilized binary systems. J Pharm Sci 87:694 701.
tribution, polymorphism, and stability of nimodipine in its solid 51. Tolstoguzov V. 1989. Some physicochemical and technological
dispersions in polyethylene glycol by micro-Raman spectro- aspects of interactions in protein multicomponent systems.
scopy and powder X-ray diffraction. AAPS J 9:361 370. Abhandlungen der Akademie der Wissenschaften der
34. Bates S, Zografi G, Engers D, Morris K, Crowley K, Newman A. DDR, Abteilung Mathematik, Naturwissenschaften, Technik
2006. Analysis of amorphous and nanocrystalline solids from (1N, Interact. Protein Syst), 1N, Interact. Protein Syst
their X-ray diffraction patterns. Pharm Res 23:2333 2349. 53 64.
35. Nollenberger K, Gryczke A, Meier C, Dressman J, Schmidt MU, 52. Taylor LS. 2001. Raman spectroscopy as a tool to probe solid
Brühne S. 2009. Pair distribution function X-ray analysis state form of tablets. Am Pharm Rev 4:60 67.
explains dissolution characteristics of felodipine melt extrusion 53. Zhang L, Henson MJ, Sekulic SS. 2005. Multivariate data
products. J Pharm Sci 98:1476 1486. analysis for Raman imaging of a model pharmaceutical tablet.
36. Proffen T. 2000. Analysis of occupational and displacive dis- Anal Chim Acta 545:262 278.
order using atomic pair distribution function: A systematic 54. Pudney PDA, Hancewicz TM, Cunningham DG, Gray C. 2003.
investigation. Z Kristallogr 215:1 8. A novel method for measuring concentrations of phase sepa-
37. Proffen T, Billinge SJL, Egami T, Louca D. 2003. Structural rated biopolymers: The use of confocal Raman spectroscopy
analysis of complex materials using the atomic pair distribu- with self-modelling curve resolution. Food Hydrocolloids
tion function A practical guide. Z Kristallogr 218:132 143. 17:345 353.
38. Warren BE. 1969. X-ray diffraction. Dover Publications. 55. Durrani CM, Donald AM. 1995. Compositional mapping of
Mineola, NY. mixed gels using FTIR microspectroscopy. Carbohydrate
39. Warren BE. 1937. X-ray determination of the structure of Polym 297 303.
liquids and glass. J Appl Phys 8:645 654. 56. Koenig JL. 1998. Microspectroscopic imaging of polymers.
40. Newman A, Engers D, Bates S, Ivanisevic I, Kelly RC, Zografi American Chemical Society: Washington, D.C.
G. 2008. Characterization of amorphous API:Polymer mixtures 57. Weber WH, Merlin R, editors. 2000. Raman scattering in
using X-ray powder diffraction. J Pharm Sci 97:4840 4856. materials science. Springer-Verlag: Berlin, Germany.
41. Windig W, Guilment J. 1991. Interactive self-modeling mixture 58. Giles JH, Gilmore DA, Denton MB. 1999. Quantitative analysis
analysis. Anal Chem 63:1425 1432. using Raman spectroscopy without spectral standardization. J
42. Moore MD, Cogdill RP, Wildfong PLD. 2009. Evaluation of Raman Spectrosc 30:767 771.
chemometric algorithms in quantitative X-ray powder diffrac- 59. Krause S, Iskandar M. 1977. Phase separation in styrene-a-
tion (XRPD) of intact multi-component consolidated samples. J methyl styrene block copolymers. Polym Sci Technol 100:231
Pharm Biomed Sci 49:619 626. 243.
43. Ivanisevic I, Bates S, Chen P. 2009. Novel methods for the 60. Pikal MJ, Rigsbee D, Roy ML, Galreath D, Kovach K, Wang B,
assessment of miscibility of amorphous drug-polymer disper- Carpenter JF, Cicerone MT. 2008. Solid state chemistry of
sions. J Pharm Sci 98:3373 3386. proteins: II. The correlation of storage stability of freeze-dried
44. Barnes RJ, Dhanoa MS, Lister S. 1989. Standard normal human growth hormone (hGH) with structure and dynamics in
variate transformation and de-trending of near-infrared diffuse the glassy solid. J Pharm Sci 97:5106 5121.
reflectance spectra. Appl Spectrosc 43:772 777. 61. Clarke FC, Jamieson MJ, Clark DA, Hammond SV, Jee RD,
45. Brent RP. 1973. Algorithms for minimization without deriva- Moffat AC. 2001. Chemical image fusion. The synergy of FT-
tives. Prentice-Hall: Englewood Cliffs, NJ. NIR and Raman mapping microscopy to enable a more com-
46. Izutsu K-I, Heller MC, Randolph TW, Carpenter JF. 1998. plete visualization of pharmaceutical formulations. Anal Chem
Effect of salts and sugars on phase separation of polyvinylpyr- 73:2213 2220.
JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 100, NO. 1, JANUARY 2011 DOI 10.1002/jps
[ Pobierz całość w formacie PDF ]