[ Pobierz całość w formacie PDF ]
070336.pdf.
30. Kashchiev D, Verdoes D, van Rosmalen GM. 1991. Induction
9. FDA/ICH 2006. Guidance for industry. Q8 pharmaceu-
time and metastability limit in new phase formation. J Cryst
tical development. Accessed August 10, 2010, at: http://
Growth 110:373 380.
www.fda.gov/downloads/RegulatoryInformation/Guidances/
31. Lyczko N, Espitalier F, Louisnard O, Schwartzentruber J.
ucm128029.pdf.
2002. Effect of ultrasound on the induction time and the
10. FDA/ICH 2009. Q8(R2) pharmaceutical development re-
metastable zone widths of potassium sulphate. Chem Eng J
vision 2. Accessed August 10, 2010, at: http://www.fda.gov/
86:233 241.
downloads/Drugs/GuidanceComplianceRegulatoryInformation/
32. Barata PA, Serrano ML. 1996. Salting-out precipitation
Guidances/ucm073507.pdf.
of potassium dihydrogen phosphate (KDP). I. Precipitation
11. Varon V, Bhugra C, Pikal MJ. 2010. Prediction of onset of
mechanism. J Cryst Growth 160:361 369.
crystallization in amorphous pharmaceutical systems: Pheno-
33. Anda JCD, Wang XZ, Lai X, Roberts KJ. 2005. Real-time prod-
barbital, nifedipine/PVP, and phenobarbital/PVP. J Pharm Sci
uct morphology monitoring in crystallization using imaging
99(9):3887 900.
technique. AIChE J 51:1406 1413.
12. Eerdenbrugh BV, Baird JA, Taylor LS. 2010. Crystallization
34. Hu X, Cunningham JC, Winstead D. 2008. Study growth ki-
tendency of active pharmaceutical ingredients following rapid
netics in fluidized bed granulation with at-line FBRM. Int J
solvent evaporation classification and comparison with crys-
Pharm 347:54 61.
tallization tendency from undercooled melts. J Pharm Sci
35. Kougoulos E, Jones AG, Jennings KH, Wood-Kaczmar MW.
99(9):3826 3838.
2005. Use of focused beam reflectance measurement (FBRM)
13. Söhnel O, Mullin JW. 1988. Interpretation of crystallization
and process video imaging (PVI) in a modified mixed sus-
induction periods. J Colloid Interface Sci 123:43 50.
pension mixed product removal (MSMPR) cooling crystallizer.
14. Yosjihashi Y, Yonemochi E, Maeda Y, Terada K. 2010. Pre-
J Cryst Growth 273:529 534.
diction of the induction period of crystallization of naproxen
36. Su M, Wang L, Sun H, Wang J. 2009. FBRM and PVM in-
in solid dispersion using differential scanning calorimetry.
vestigations of the double feed semi-batch crystallization of
J Therm Anal Calorim 99:15 19.
6-aminopenicillanic acid. Frontiers of Chemical Engineering
15. Söhnel O, Mullin JW. 1978. A method for the determination of
in China 3(3):282 288.
precipitation induction periods. J Cryst Growth 44:377 382.
37. Greaves D, Boxall J, Mulligan J, Montesi A, Creek J, Sloan
16. Van Der Leeden MC, Kashchiev D, Van Rosmalen GM. 1992.
ED, Koh CA. 2008. Measuring the particle size of a known
Precipitation of barium sulfate: Induction time and the effect
DOI 10.1002/jps JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 100, NO. 5, MAY 2011
1986 WU AND KHAN
distribution using the focused beam reflectance measurement and tetrahydrofuran studied by the ultrasonic, volumetic and
technique. Chem Eng Sci 63:5410 5419. viscometric methods. J Mol Liq 141:8 16.
38. Kail N, Marquardt W, Briesen H. 2009. Estimation of parti- 44. Wu H, Lyon RC, Hussain AS, Drenene JD, Das-Gupta D,
cle size distributions from focused beam reflectance measure- Voytilla RJ, Bejic L. 2003. Application of principal compo-
ments based on an optical model. Chem Eng Sci 64:984 1000. nent analysis in assessing pharmaceutical formulation design:
39. Zidan AS, Rahman Z, Habib MJ, Khan MA. 2010.Online mon- Exploring the casual links between the tablet processing con-
itoring of PLGA microparticles formation using lasentec fo- ditions and drug dissolution rate. In: Proceedings of sympo-
cused beam reflectance (FBRM) and particle video microscope sium on innovations in pharmaceutical and biotechnology de-
(PVM). AAPS J 12(3):254 262. velopment and manufacturing, 2003 AIChE Annual Meeting
40. Chacron M, L Heureux I. 1999. A new model of periodic pre- [TE001], San Francisco, CA, Nov. 17 21, 2003, pp 635 642.
cipitation incorporating nucleation, growth and ripening. Phys 45. Burns DA, Ciurczak EW. 2001. Handbook of near-infrared
Lett A 263:70 77. analysis. 2nd edNew York: Marcel Dekker, pp 95 95 .
41. Vippagunta SR, Brittain HG, Grant DJW. 2001. Crystalline 46. Wu H, Heilweil EJ, Hussain AS, Khan MA. 2008. Process an-
solids. Adv Drug Deliv Rev 48:3 26. alytical technology (PAT): Quantification approaches in tera-
42. Zhang GGZ, Law D, Schmitt EA, Qiu Y. 2004. Phase transfor- hertz spectroscopy for pharmaceutical application. J Pharm
[ Pobierz całość w formacie PDF ]