Effect of storage conditions on the recrystallization of drugs in solid dispersions with crospovidone

Pharmaceutical Development and Technology

Volumn 19, Issue 4, 2014, Pages 468-474

  Shibata, Yusuke ^a   Fujii, Makiko ^b   Suzuki, Ayako ^b   Koizumi, Naoya ^b   Kanada, Ken ^a   Yamada, Masaki ^a   Watanabe, Yoshiteru ^b  

^a KISSEI PHARMACEUTICAL CO LTD   (Japan)

^b SHOWA PHARMACEUTICAL UNIVERSITY   (Japan)

Author keywords

Amorphous; Dipyridamole; Indomethacin; Interaction; Moisture; Nifedipine; Temperature

Indexed keywords

AMIDE; CARBONYL DERIVATIVE; CROSPOVIDONE; DIPYRIDAMOLE; INDOMETACIN; NIFEDIPINE;

ARTICLE; CRYSTALLIZATION; DISPERSION; DRUG STABILITY; GLASS BOTTLE; GLASS TRANSITION TEMPERATURE; HIGH TEMPERATURE; HUMIDITY; HYDROGEN BOND; MOISTURE; PRIORITY JOURNAL; RAMAN SPECTROMETRY; STORAGE;

CRYSTALLIZATION; DIPYRIDAMOLE; DRUG CARRIERS; DRUG STABILITY; HOT TEMPERATURE; HUMIDITY; INDOMETHACIN; NIFEDIPINE; POVIDONE;

EID: 84899975750     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450.2013.795168     Document Type: Article

References (25)

1. Sekiguchi K, Obi N. Studies on absorption of eutectic mixture. I. A comparison of the behavior of eutectic mixture of sulfathiazole and that of ordinary sulfatiazole in man. Chem Pharm Bull 1961;9:866-872.
2. Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 2000;50:47-60.
3. Ford JL, Stewart AF, Rubinstein MK. The assay and stability of chlorpropamide in solid dispersion with urea. J Pharm Pharmacol 1979;31:726-729.
4. Serajuddin ATM. Solid dispersion of poorly water-soluble drugs: early promises, subsequent problems, and recent breakthroughs. J Pharm Sci 1999;88:1058-1066.
5. Chiou WL, Riegelman S. Pharmaceutical applications of solid dispersion systems. J Pharm Sci 1971;60:1281-1302.
6. Taylor LS, Zografi G. Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions. Pharm Res 1997;14:1691-1698.
7. Miyazaki T, Yoshioka S, Aso Y, Kojima S. Ability of poly(vinylpyrrolidone) and polyacrylic acid to inhibit the crystallization of amorphous acetaminophen. J Pharm Sci 2004;93: 2710-2717.
8. Fujii M, Okada H, Shibata Y, et al. Preparation, characterization, and tableting of a solid dispersion of indomethacin with crospovidone. Int J Pharmaceut 2005;293:145-153.
9. Shibata Y, Fujii M, Sugawara Y, et al. The preparation of a powder solid dispersion of indomethacin with crospovidone prepared by a twin screw extruder or kneader. Int J Pharmaceut 2009;365:53-60.
10. Shibata Y, Fujii M, Okada H, et al. Evaluation of the compaction properties of a solid dispersion of indomethacin with crospovidone by tableting process analyzer. Chem Pharm Bull 2005;53:759-763.
11. Shibata Y, Fujii M, Noda S, et al. Fluidity and tableting characteristics of a powder solid dispersion of the low melting drugs ketoprofen and ibuprofen with crospovidone. Drug Dev Ind Pharm 2006;32:449-456.
12. Shibata Y, Fujii M, Sugamura Y, et al. Stability of amorphous indomethacin in a solid dispersion using crospovidone prepared by a twin-screw kneader or extruder and application of aqueous filmcoating to solid dispersion tablets. J Drug Deliv Sci Tech 2009;19: 205-210.
13. Shibata Y, Fujii M, Kokudai M, et al. Effect of characteristics of compounds on maintenance of an amorphous state in solid dispersion with crospovidone. J Pharm Sci 2007;96:1537-1547.
14. Imaizumi H, Nambu N, Nagai T. Stabilization of amorphous state of indomethacin by solid dispersion in polyvinypolypyrrolidone. Chem Pharm Bull 1983;31:2510-2512.
15. Oksanen CA, Zografi G. The relationship between the glass transition temperature and water vapor absorption by poly(vinylpyrrolidone). Pharm Res 1990;7:654-657.
16. Shamblin SL, Zografi G. The effects of absorbed water on the properties of amorphous mixtures containing sucrose. Pharm Res 1999;16:1119-1124.
17. Yoshioka M, Hancock BC, Zografi G. Inhibition of indomethacin crystallization in poly(vinylpyrrolidone). J Pharm Sci 1995;84: 983-986.
18. Yu L. Amorphous pharmaceutical solids: preparation, characterization and stabilization. Adv Drug Deliv Rev 2001;4:27-42.
19. Taylor LS, Langkilde FW. Evaluation of solid-state forms present in tablets by Raman spectroscopy. J Pharm Sci 2000;89:1342-1353.
20. Sugamura Y, Fujii M, Nakanishi S, et al. Effect of particle size of drug on conversion of crystals to an amorphous state in a solid dispersion with crospovidone. Chem Pharm Bull 2011;59:235-238.
21. Marsac PJ, Rumondor ACF, Nivens DE, et al. Effect of temperature and moisture on the miscibility of amorphous dispersions of felodipine and poly(vinyl pyrrolidone). J Pharm Sci 2010;99: 169-185.
22. Rumondor ACF, Marsac PJ, Stanford LA, Taylor LS. Phase behavior of ploy(vinylpyrrolidone) containing amorphous solid dispersions in the presence of moisture. Mol Pharm 2009;6:1492-1505.
23. Rumondor ACF, Stanford LA, Taylor LS. Effect of polymer type and storage relative humidity on the kinetics of felodipine crystallization from amorphous solid dispersions. Pharm Res 2009;26:2599-2606.
24. Bhugra C, Shmeis R, Krill SL, Pikal MJ. Prediction of onset of crystallization from experimental relaxation times. II. Comparison between predicted and experimental onset times. J Pharm Sci 2008; 97:455-472.
25. Patterson JE, James MB, Forster AH, et al. The influence of thermal and mechanical preparative techniques on the amorphous state of four poorly soluble compounds. J Pharm Sci 2005;94:1998-2012.