Abstract
Characterization of the solid-state form (hydrate or polymorph) of a pharmaceutical active is a key scientific and regulatory requirement during development of and prior to seeking approval for marketing of the drug product. A variety of analytical methods are available to perform this task. By nature of the fundamental information it provides, TG-DTA offers advantages over other methods in regards to monitoring and quantitation of hydration state changes. In a single experiment with only a few milligrams of sample, TG-DTA perceives minor changes in phase, quantitates total water content and percent conversion, and illustrates hydrate type. All of this is accomplished without the necessity of generating time-consuming standard curves representing the differing ratios of hydrated to anhydrous forms. This study describes the use of TG-DTA to monitor and quantitate humidity induced solid–solid phase conversion of nitrofurantoin and risedronate. Percent conversion was qualitatively observed by both TG and DTA signals and quantitated by the TG.
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References
HG Brittain et al. (1999) Polymorphism in Pharmaceutical Solids, Vol. 95 Marcel Decker Inc. New York
SR Vippagunta HG Brittain DJW Grant (2001) Adv. Drug Deliv. Rev. 48 3 Occurrence Handle1:CAS:528:DC%2BD3MXivFejsrs%3D Occurrence Handle10.1016/S0169-409X(01)00097-7
GGZ Zhang D Law EA Schmitt Y Qiu (2004) Adv. Drug Deliv. Rev. 56 371 Occurrence Handle1:CAS:528:DC%2BD2cXhtV2msro%3D Occurrence Handle10.1016/j.addr.2003.10.009
D Singhal W Curatolo (2004) Adv. Drug Deliv. Rev. 56 335 Occurrence Handle1:CAS:528:DC%2BD2cXhtV2msr4%3D Occurrence Handle10.1016/j.addr.2003.10.008
RK Khankari DJW Grant (1995) Thermochim. Acta 248 61 Occurrence Handle1:CAS:528:DyaK2MXivVOrtrw%3D Occurrence Handle10.1016/0040-6031(94)01952-D
D Giron Ch Goldburnn M Mutz S Pfeffer Ph Piechon Ph Schwab (2002) J. Therm. Anal. Cal. 68 453 Occurrence Handle1:CAS:528:DC%2BD38XkvFegsrw%3D Occurrence Handle10.1023/A:1016031517430
D Giron M Mutz S Garnier (2004) J. Therm. Anal. Cal. 77 709 Occurrence Handle1:CAS:528:DC%2BD2cXmvFSmtLo%3D Occurrence Handle10.1023/B:JTAN.0000039005.51343.33
HG Brittain et al. (1995) Physical Characterization of Pharmaceutical Solids, Vol. 70 Marcel Decker Inc. New York
SS Leung BE Padden EJ Munson DJW Grant (1998) J. Pharm. Sci. 87 501 Occurrence Handle1:CAS:528:DyaK1cXhs1Chsrk%3D Occurrence Handle10.1021/js970249n
GA Stephenson RS Forbes SM Ruetzel-Edens (2001) Adv. Drug Deliv. Rev. 48 67 Occurrence Handle1:CAS:528:DC%2BD3MXivFejsrY%3D Occurrence Handle10.1016/S0169-409X(01)00099-0
M Blanco D Valdes IL Lorente M Bayod (2005) J. Pharm. Sci. 94 1336 Occurrence Handle1:CAS:528:DC%2BD2MXkvF2qtb8%3D Occurrence Handle10.1002/jps.20362
IM Vitéz (2004) J. Therm. Anal. Cal. 78 33 Occurrence Handle10.1023/B:JTAN.0000042151.60566.0f
N Redman-Furey M Dicks A Bigalow-Kern RT Cambron G Lubey C Lester D Vaughn (2005) J. Pharm. Sci. 94 893 Occurrence Handle1:CAS:528:DC%2BD2MXjtFCju7o%3D Occurrence Handle10.1002/jps.20308
N. Redman-Furey, M. Dicks, J. Godlewski, D. Vaughn and W. Collins, Journal of ASTM International, 2005, 2, paper ID JAI12971.
N. Redman-Furey, M. Dicks, J. Godlewski, D. Vaughn and W. Collins, Journal of ASTM International, 2005, 2, paper ID JAI12972.
EM van der Merwe CA Strydom (2004) J. Therm. Anal. Cal. 76 149 Occurrence Handle1:CAS:528:DC%2BD2cXjvFSku7k%3D Occurrence Handle10.1023/B:JTAN.0000027814.93703.0c
IA Ibrahim HH ElSersy MF Abadir (2004) J. Therm. Anal. Cal. 76 713 Occurrence Handle1:CAS:528:DC%2BD2cXkvFGgtbg%3D Occurrence Handle10.1023/B:JTAN.0000032255.58397.4b
ASTM E104-02, Standard Practice for Maintaining Constant Relative Humidity by Means of Aqueous Salt Solutions, 2002.
N Garti F Tibika (1980) Drug Dev. Ind. Pharm. 6 379 Occurrence Handle1:CAS:528:DyaL3MXjs1aiuw%3D%3D
PV Marshall P York (1989) Int. J. Pharm. 55 257 Occurrence Handle1:CAS:528:DyaL1MXmtF2hs7k%3D Occurrence Handle10.1016/0378-5173(89)90049-5
EW Pienaar MR Caira AP Lötter (1993) J. Crystallogr. Spectr. Res. 23 739 Occurrence Handle1:CAS:528:DyaK2cXht1Witb0%3D Occurrence Handle10.1007/BF01187276
MR Caira EW Pienaar AP Lötter (1996) Mol. Cryst. Liq. Cryst. 279 241 Occurrence Handle1:CAS:528:DyaK28XjtVKksLw%3D
M Otsuka R Teraoka Y Matsuda (1991) Pharm. Res. 8 1066 Occurrence Handle1:CAS:528:DyaK3MXlsVaisbc%3D Occurrence Handle10.1023/A:1015825628530
M Otsuka Y Matsuda (1993) J. Pharm. Pharmacol. 45 406 Occurrence Handle1:CAS:528:DyaK3sXktlChtr4%3D
M Otsuka Y Matsuda (1994) Chem. Pharm. Bull. 42 156 Occurrence Handle1:CAS:528:DyaK2cXisFehtr8%3D
M Otsuka M Ishii Y Matsuda (2002) Colloids Surf. B: Biointerf. 23 73 Occurrence Handle1:CAS:528:DC%2BD3MXovVChs74%3D Occurrence Handle10.1016/S0927-7765(01)00210-7
N. Redman-Furey, W. Collins and M. Burgin, Proceedings of the 30th North American Thermal Analysis Society Conference, 2003, pp. 733–738.
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Poiesz, K.B., Grundner, C.L. & Redman-Furey, N.L. Monitoring hydration state conversion by TG-DTA. J Therm Anal Calorim 85, 79–86 (2006). https://doi.org/10.1007/s10973-005-7350-z
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DOI: https://doi.org/10.1007/s10973-005-7350-z