Use of solution calorimetry to determine the extent of crystallinity of drugs and excipients

International Journal of Pharmaceutics

Volumn 151, Issue 2, 1997, Pages 183-192

  Gao, Daneben ^a,b   Rytting, J Howard ^a  

^a UNIVERSITY OF KANSAS   (United States)

^b ABBOTT LABORATORIES   (United States)

Author keywords

Crystallinity; Heat of solution; Solid state stability; Solution calorimetry; Sucrose; Warfarin sodium

Indexed keywords

EXCIPIENT; SUCROSE; WARFARIN;

ARTICLE; CALORIMETRY; CRYSTAL STRUCTURE; DISSOLUTION; DRUG STABILITY; HUMIDITY; PHASE TRANSITION; PRIORITY JOURNAL; SOLID STATE; TECHNIQUE;

EID: 0030918424     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-5173(97)04895-3     Document Type: Article

References (33)

1. Ahmed, H., Buckton, G. and Rowlins, D.A., The use of isothermal microncalorimetry in the study of small degrees of amorphous content of a hydrophobic powder. Int. J. Pharm., 130 (1996) 195-201.
2. Beezer, A.E. (Ed.), Biological Microcalorimetry, Academic Press, London, 1980, p. 456.
3. Briggner, L., Buckton, G., Bystrom, K. and Darcy, P., The use of isothermal microcalorimetry in the study of changes in crystallinity induced during the processing of powders. Int. J. Pharm., 105 (1994) 125-135.
4. Buckton, G., Darcy, P., Greenleaf, D. and Holbrook, P.A., The use of isothermal microcalorimetry in the study of changes in crystallinity of spray-dried salbutamol sulphate. Int. J. Pharm., 116 (1995) 113-118.
5. Buckton, G., Darcy, P. and Mackellar B., A.J., The use of isothermal microcalorimetry in the study of small degrees of amorphous content of powders. Int. J. Pharm., 117 (1995) 253-256.
6. Carstensen, J.T. and Van Scoik, K., Amorphous-to-crystalline transformation of sucrose. Pharm. Res., 7(12) (1990) 1278-1281.
7. Craig, D.Q.M. and Newton, J.M., Characterization of polyethylene glycol solid dispersions using differential scanning calorimetry and solution calorimetry. Int. J. Pharm., 76 (1991a) 17-24.
8. Craig, D.Q.M. and Newton, J.M., Characterization of polyethylene glycols using solution calorimetry. Int. J. Pharm., 74 (1991b) 43-48.
9. Erb, D.M., Solution Calorimetry - An Alternative Method for the Quantitation of the Solid State Properties of Drugs, Ph.D. Thesis, The University of Iowa, Iowa City, 1984.
10. Filisko, F.E. and Raghava, R.S., Amorphous structure heat: molecular mechanisms from solution heats of poly(2,6-dimethyl-p-phenylene oxide) in orthodichlorobenzene, J. Appl. Phys., 45 (1974) 4151-4154.
11. Franks, F., Water - A Comprehensive Treatise, Vol. 2, Plenum Press, New York, 1972, pp. 351.
12. Fukuoka, E., Makita, M. and Yamamura, S., Preferred orientation of crystallites in tablets. III. Variations of crystallinity and crystallite size of pharmaceuticals with compression. Chem. Pharm. Bull., 41(3) (1993) 595-598.
13. Guillory, J.K. and Erb, D.M., Using solution calorimetry to quantitate binary mixtures of three crystalline forms of sulfamethoxazole. Pharm. Manuf., Sept. (1985) 28-33.
14. Hiskey, C.F. and Melnitchenko, V., Clathrate of warfarin sodium. J. Pharm. Sci., 54(9) (1965) 1298-1302.
15. Hunt, D.K. and Hsu, A.C.T., Heat effects in the amorphous-crystalline transformation of basic copper carbonate. J. Colloid Interface Sci., 48 (1974) 105-109.
16. Kaelble, E.F. Handbook of X-rays for Diffraction, Emission, Absorption, and Microscopy, McGraw-Hill, New York, 1967, pp. 21-5-21-9.
17. Kishimoto, K., Suga, H. and Seki, S., Calorimetric study of the glassy state. VIII. Heat capacity and relaxational phenomena of isopropylbenzene. Bull. Chem. Soc. Jpn., 46 (1973) 3020-3031.
18. Lieberman, H.A. and Lachman, L.A., Pharmaceutical Dosage Forms: Tablets, Vol. 1, Marcel Dekker, New York, 1980a, p. 81.
19. Lieberman, H.A. and Lachman, L. (Eds.) Pharmaceutical Dosage Forms: Tablets, Vol. 1, Marcel Dekker, New York, 1980b, p. 117.
20. Lindenbaum, S. and McGraw, S.E., The identification and characterization of polymorphism in drug solids by solution calorimetry. Pharm. Manuf., Jan., (1985) 26-30.
21. Mathews, A.G., Schram, C.J. amd Minty, D., Crystallization of penicillin in the solid phase. Nature, 211 (1966) 959.
22. Miller, M.L., Encyclopedia of Polymer Science and Technology, Vol. 4, Interscience, New York, 1966, p. 449.
23. Miller, The Structure of Polymers, Reinhold, New York, 1966, Chap. 10.
24. Motooka, I., Hashizume, G. and Kobayshi, M., Studies of the grinding of condensed phosphates. VI. The effect of grinding on the heat of solution of sodium trimetaphosphate. J. Phys. Chem., 73 (1969) 3012-3013.
25. Nyqvist, H., Saturated salt solutions for maintaining specified relative humidities. J. Pharm. Tech. Prod. Manuf., 4(2) (1983) 47-48.
26. Palmer, K.J., Dye, W.B. and Black, D., X-ray diffractometer and microscopic investigation of crystallization of amorphous sucrose. Agric. Food Chem., 4(1) (1956) 77-81.
27. Pikal, M.J., Lukes, A.L., Lang, J.E. and Gaines, K., Quantitative crystallinity determinations for β-lactam antibiotics by solution calorimetry: correlation with stability. J. Pharm. Sci., 67(6) (1978) 767-772.
28. Roos, Y. and Karel, M., Differential scanning calorimetry study of phase transitions affecting the quality of dehydrated materials. Biotechnol. Prog., 6 (1990) 159-163.
29. Roos, Y. and Karel, M., Phase transition of amorphous sucrose and frozen sucrose solutions. J. Food Sci., 56(1) (1991) 266-267.
30. Sebhatu, T., Angberg, M. and Ahlneck, C., Assessment of the degree of disorder in crystalline solid by isothermal microcalorimetry. Int. J. Pharm., 104 (1994) 135-144.
31. te Booy, M.P.W.M., de Ruiter, R.A. and de Meere, A.L.J., Evaluation of the physical stability of freeze-dried sucrose-containing formulations by differential scanning calorimetry. Pharm. Res., 9(1) (1992) 109-113.
32. Temple, M.P. and Zarzycki, M.J., Chimie physique, C. R. Acad. Sci. Paris (Sect. C), 280 (1975) 1443-1446.
33. Tong, W.Q., Lach, J.L., Chin, T. and Guillory, J.K., Structural effects on the binding of amine drugs with diphenyimethyl functionality to cyclodextrine. I. A microcalorimetric study, Pharm. Res., 8 (1991) 951-957.