An investigation into water interactions with amorphous and milled salbutamol sulphate: The development of predictive models for uptake and recrystallization

International Journal of Pharmaceutics

Volumn 422, Issue 1-2, 2012, Pages 220-228

  Grisedale, Louise C ^a   Belton, Peter S ^a   Jamieson, Matthew J ^b   Barker, Susan A ^a   Craig, Duncan Q M ^a  

^a UNIVERSITY OF EAST ANGLIA   (United Kingdom)

^b Medicines Research Centre   (United Kingdom)

Author keywords

Calorimetry; Crystallization; Glass transition; Plasticizer; Salbutamol sulphate; Thermal analysis

Indexed keywords

SALBUTAMOL SULFATE;

ARTICLE; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG STABILITY; DRUG STORAGE; ENVIRONMENTAL FACTOR; GLASS TRANSITION TEMPERATURE; MOLECULAR DYNAMICS; PRIORITY JOURNAL; PROCESS MODEL; WATER TRANSPORT;

ALBUTEROL; BRONCHODILATOR AGENTS; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DESICCATION; DRUG STABILITY; DRUG STORAGE; HUMIDITY; MICROSCOPY, ELECTRON, SCANNING; MODELS, CHEMICAL; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; SURFACE PROPERTIES; TECHNOLOGY, PHARMACEUTICAL; THERMOGRAVIMETRY; TIME FACTORS; TRANSITION TEMPERATURE; WATER;

EID: 84655160870     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.10.055     Document Type: Article

References (25)

1. A.M. Abdul-Fattah, V. Truong-Le, L. Yee, L. Nguyen, D.S. Kalonia, M.T. Cicerone, and M.J. Pikal Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on stability (I): stability of a monoclonal antibody J. Pharm. Sci. 96 2007 1983 2008 (Pubitemid 47280096)
2. S.M. Aharoni Increased glass transition temperature in motionally constrained semicrystalline polymers Polym. Adv. Technol. 9 1998 169 201 (Pubitemid 128606534)
3. C. Ahlneck, and G. Alderborn Moisture adsorption and tabletting 1. Effect on volume reduction properties and tablet strength for some crystalline materials Int. J. Pharm. 54 1989 131 141 (Pubitemid 19205238)
4. C. Ahlneck, and G. Zografi The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state Int. J. Pharm. 62 1990 87 95 (Pubitemid 20261777)
5. P.R. Couchman, and F.E. Karasz A classical thermodynamic discussion of the effect of composition on glass-transition temperatures Macromolecules 11 1978 117 119
6. T.G. Fox The influence of diluent and of copolymer composition on the glass temperature of a polymer system Bull. Am. Phys. Soc. 1 1956 123
7. M. Gordon, and J.S. Taylor Ideal copolymers and the second-order transitions of synthetic rubber. I. Non-crystalline copolymers J. Appl. Chem. 2 1952 493 500
8. L. Grisedale, M. Jamieson, P.S. Belton, S.A. Barker, and D.Q.M. Craig The effect of milling on the physical structure and properties of salbutamol sulphate: a thermal, spectroscopic and water vapour sorption study J. Pharm. Sci. 100 2011 3114 3129
9. B.C. Hancock, and G. Zografi The relationship between the glass-transition temperature and the water content of amorphous pharmaceutical solids Pharm. Res. 11 1994 471 477 (Pubitemid 24144434)
10. B.C. Hancock, S.L. Shamblin, and G. Zografi Molecular mobility of amorphous pharmaceutical solids below their glass-transition temperatures Pharm. Res. 12 1995 799 806
11. J. Kern Sears, and J.R. Darby The Technology of Plasticizers 1982 John Wiley and Sons New York
12. T.K. Kwei The effect of hydrogen bonding on the glass transition temperatures of polymer mixtures J. Polym. Sci. 22 1984 307 313 (Pubitemid 14622322)
13. T.K. Kwei, E.M. Pearce, J.R. Pennacchia, and M. Charton Correlation between the glass transition temperatures of polymer mixtures and intermolecular force parameters Macromolecules 189 1987 1174 1176
14. R. Lefort, A. De Gusseme, J.E. Willart, F. Danede, and M. Descamps Solid state NMR and DSC methods for quantifying the amorphous content in solid dosage forms: an application to ball-milling of trehalose Int. J. Pharm. 280 2004 209 219 (Pubitemid 38950917)
15. J.E.G. Lipson, and S.T. Milner Multiple glass transitions and local composition effects on polymer solvent mixtures J. Polym. Sci. Part B: Polym. Phys. 44 2006 3528 3545 (Pubitemid 46052421)
16. A. Marcilla, and M. Beltran Handbook of Plasticizers 2004 Chem. Tech. Publishing Toronto, Canada
17. P.M. Mehl Observations of multiple glass transitions in the system water/1,3-butanediol. Effect on ice crystallisation Thermochim. Acta 284 1996 191 212 (Pubitemid 126316422)
18. N. Passerini, and D.Q.M. Craig An investigation into the effects of residual water on the glass transition temperature of polylactide microspheres using modulated temperature DSC J. Control. Rel. 73 2001 111 115 (Pubitemid 32406105)
19. S. Qi, I. Weuts, S. De Cort, S. Stokbroekx, R. Leemans, M. Reading, P. Belton, and D.Q.M. Craig An investigation into the crystallisation behaviour of an amorphous cryomilled pharmaceutical material above and below the glass transition temperature J. Pharm. Sci. 99 2010 196 208
20. P.G. Royall, D.Q.M. Craig, and C. Doherty Characterisation of moisture uptake effects on the glass transitional behaviour of an amorphous drug using modulated temperature DSC Int. J. Pharm. 192 1999 39 46
21. R. Simha, and R.F. Boyer On a general relation involving the glass temperature and coefficients of expansion of polymers J. Appl. Phys. 37 1962 1003 1007
22. M. Sugisaki, H. Suga, and S. Seki Calorimetric study of the glassy state. IV. Heat capacities of glass water and cubic ice Bull. Chem. Soc. Jpn. 41 1968 2591 2599
23. R. Surana, A. Pyne, and R. Suryanarayanan Effect of preparation method on physical properties of amorphous trehalose Pharm. Res. 21 2004 1167 1176 (Pubitemid 38960768)
24. B. Wunderlich Reversible crystallization and the rigid-amorphous phase in semicrystalline macromolecules Prog. Polym. Sci. 28 2003 383 450 (Pubitemid 35452387)
25. M. Yoshioka, B.C. Hancock, and G. Zografi Crystallization of indomethacin from the amorphous state below and above its glass-transition temperature J. Pharm. Sci. 83 1994 1700 1705