Solubility of small-molecule crystals in polymers: D-Mannitol in PVP, indomethacin in PVP/VA, and nifedipine in PVP/VA

Pharmaceutical Research

Volumn 26, Issue 4, 2009, Pages 855-864

  Tao, Jing ^a   Sun, Ye ^a   Zhang, Geoff G Z ^b   Yu, Lian ^a  

^a UNIVERSITY OF WISCONSIN MADISON   (United States)

^b ABBOTT LABORATORIES   (United States)

Author keywords

Amorphous pharmaceuticals; Glass transition; Polymer dispersion; PVP; PVP VA; Solubility

Indexed keywords

INDOMETACIN; MANNITOL; NIFEDIPINE; POLYMER; POVIDONE;

ARTICLE; CONTROLLED STUDY; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG SOLUBILITY; DRUG STRUCTURE; GLASS TRANSITION TEMPERATURE; HYDROPHILICITY; PRIORITY JOURNAL; VALIDATION STUDY; X RAY DIFFRACTION;

CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; INDOMETHACIN; KINETICS; MANNITOL; NIFEDIPINE; POVIDONE; PYRROLIDINES; REPRODUCIBILITY OF RESULTS; SOLUBILITY; SOLVENTS; TECHNOLOGY, PHARMACEUTICAL; TRANSITION TEMPERATURE; VINYL COMPOUNDS; VISCOSITY;

EID: 61449135800     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-008-9784-z     Document Type: Article

References (24)

1. M. Vasanthavada W. Tong Y. Joshi M. S. Kislalioglu 2004 Phase behavior of amorphous molecular dispersions I: determination of the degree and mechanism of solid solubility Pharm. Res 21 1598 1606
2. M. Vasanthavada W. Tong Y. Joshi M. S. Kislalioglu 2004 Phase behavior of amorphous molecular dispersions II: role of hydrogen bonding in solid solubility and phase separation kinetics Pharm. Res 22 440 448
3. P. J. Marsac S. L. Shamblin L. S. Taylor 2006 Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility Pharm. Res 23 2417 2426
4. P. J. Marsac, T. Li, and L. S. Taylor. Estimation of drug-polymer miscibility and solubility in amorphous solid dispersions using experimentally determined interaction parameters. Pharm. Res. in press (2008).
5. R. Mohan H. Lorenz A. S. Myerson 2002 Solubility measurement using differential scanning calorimetry Ind. Eng. Chem. Res 41 4854 4862
6. K. Park J. M. B. Evans A. S. Myerson 2003 Determination of solubility of polymorphs using differential scanning calorimetry Cryst. Growth Des 3 991 995
7. R. Tamagawa W. Martins S. Derenzo A. Bernardo M. Rolemberg P. Carvan M. Giulietti 2006 Short-cut method to predict the solubility of organic molecules in aqueous and nonaqueous solutions by differential scanning calorimetry Cryst. Growth Des 6 313 320
8. V. Andronis G. Zografi 2000 Crystal nucleation and growth of indomethacin polymorphs from the amorphous state J. Non-Cryst. Solids 271 236 248
9. V. Andronis G. Zografi 1997 Molecular mobility of supercooled amorphous indomethacin, determined by dynamic mechanical analysis Pharm. Res 14 410 419
10. M. Yoshioka B. C. Hancock G. Zografi 1994 Crystallization of indomethacin from the amorphous state below and above its glass transition temperature J. Pharm. Sci 83 1700 1705
11. T. Wu L. Yu 2006 Origin of enhanced crystal growth kinetics near Tg probed with indomethacin polymorphs J. Phys. Chem. B 110 15694 15699
12. S. R. Vippagunta K. A. Maul S. Tallavajhala D. J. W. Grant 2002 Solid-state characterization of nifedipine solid dispersions Int. J. Pharm 236 111 123
13. N. Zajc A. Obreza M. Bele S. Srcic 2005 Physical properties and dissolution behaviour of nifedipine/mannitol solid dispersions prepared by hot melt method Int. J. Pharm 291 51 58
14. I. Sugimoto A. Kuchiki H. Nakagawa 1981 Stability of nifedipine- polyvinylpyrrolidone coprecipitate Chem. Pharm. Bull 29 1715 1723
15. H. Ishida T. Wu L. Yu 2007 Sudden rise of crystal growth rate of nifedipine near Tg without and with polyvinylpyrrolidone J. Pharm. Sci 96 1131 1138
16. L. S. Taylor G. Zografi 1997 Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions Pharm. Res 14 1691 1698
17. T. Matsumoto G. Zografi 1999 Physical properties of solid molecular dispersions of indomethacin with poly(vinylpyrrolidone) and poly(vinylpyrrolidone-co-vinyl-acetate) in relation to indomethacin crystallization Pharm. Res 16 1722 1728
18. T. Miyazaki S. Yoshioka Y. Aso S. Kojima 2004 Ability of polyvinylpyrrolidone and polyacrylic acid to inhibit the crystallization of amorphous acetaminophen J. Pharm. Sci 93 2710 2717
19. K. J. Crowley G. Zografi 2002 Cryogenic grinding of indomethacin polymorphs and solvates: assessment of amorphous phase formation and amorphous phase physical stability J. Pharm. Sci 91 492 507
20. L. Yu D. S. Mishra D. R. Rigsbee 1998 Determination of the glass properties of d-mannitol using sorbitol as an impurity J. Pharm. Sci 87 774 777
21. L. Yu J. Huang K. J. Jones 2005 Measuring free-energy difference between crystal polymorphs through eutectic melting J. Phys. Chem. B 109 19915 19922
22. L. Yu 2003 Nucleation of one polymorph by another J. Am. Chem. Soc 125 6380 6381
23. J. Tao L. Yu 2006 Kinetics of cross-nucleation between polymorphs J. Phys. Chem. B 110 7097 7101
24. M. K. Mapes S. F. Swallen M. D. Ediger 2006 Self-diffusion of supercooled o-terphenyl near the glass transition temperature J. Phys. Chem. B 110 507 511