Solid state NMR and DSC methods for quantifying the amorphous content in solid dosage forms: An application to ball-milling of trehalose

International Journal of Pharmaceutics

Volumn 280, Issue 1-2, 2004, Pages 209-219

  Lefort, R ^a   De Gusseme, A ^a   Willart, J F ^a   Danede F ^a   Descamps, M ^a  

^a UNIV LILLE   (France)

Author keywords

Amorphous quantification; Ball milling; DSC; Solid state NMR; Trehalose

Indexed keywords

TREHALOSE;

ACCURACY; ANALYTIC METHOD; ARTICLE; CALCULATION; CARBON NUCLEAR MAGNETIC RESONANCE; CHEMICAL ANALYSIS; CHEMICAL COMPOSITION; DRUG DETERMINATION; DRUG DOSAGE FORM; POWDER; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SOLID STATE;

CALORIMETRY, DIFFERENTIAL SCANNING; DOSAGE FORMS; MAGNETIC RESONANCE SPECTROSCOPY; TREHALOSE;

EID: 3242695947     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2004.05.012     Document Type: Article

References (34)

1. Alamo R.G., Vanderhart D.L., et al. Morphological partitioning of ethylene defects in random propylene ethylene copolymers. Macromolecules. 33:2000;6094-6105
2. Apperley D.C., Fletton R.A., et al. Sulfathiazole polymorphism studied by magic-angle spinning NMR. J. Pharm. Sci. 88:1999;1275-1280
3. Apperley, D.C., Harris, R.K., et al. 2003. Quantitative nuclear magnetic resonance analysis of solid formoterol fumarate and its dihydrate. J. Pharm. Sci. 92, 2496-2503.
4. 13C NMR spectroscopy in studies of the nature of native celluloses Solid State Nucl. Magn. Reson. 15:1999;1-19
5. Carpenter J.F., Crowe J.H. An infrared spectroscopic study of the interactions of carbohydrates with dried proteins. Biochemical. 28:1989;3916
6. Corrigan O.I., Holohan E.M., et al. Amorphous forms of thiazide diuretics prepared by spray-drying. Int. J. Pharm. 18:1984;195-200
7. Crowe L.M., Reid D.S., et al. Is trehalose special for preserving dry biomaterials? Biophys. J. 71:1996;2087
8. Ding S., Fan J., et al. Vitrification of trehalose by water loss from its crystalline dihydrate. J. Ther. Anal. Calorim. 47:1996;1391
9. Ek R., Alderborn G., et al. Particle analysis of microcrystalline cellulose: differentiation between individual particles and their agglomerates. Int. J. Pharm. 111:1994;43-50
10. Ek R., Wormald P., et al. Crystallinity index of microcrystalline cellulose particles compressed into tablets. Int. J. Pharm. 125:1995;257-264
11. Fukuoka E., Makita M., et al. Glassy state of pharmaceuticals. II. Bioinequivalence of glassy and crystalline indomethacin. Chem. Pharm. Bull. 35:1987;2943-2948
12. Gombas A., Antal I., et al. Quantitative determination of crystallinity of alpha-lactose monohydrate by near infrared spectroscopy. Int. J. Pharm. 256:2003;25-32
13. Green J.L., Angell C.A. Phase relations and vitrification in saccharide-water solutions and the trehalose anomaly. J. Phys. Chem. 93:1989;2880
14. Gustafsson C., Lennholm H., et al. Comparison of solid-state NMR and isothermal microcalorimetry in the assessment of the amorphous component of lactose. Int. J. Pharm. 174:1998;243-252
15. Hancock B.C., Parks M. What is the true solubility advantage for amorphous pharmaceuticals? Pharm. Res. 17:2000;397-404
16. Harris R.K. Quantitative aspects of high resolution solid-state nuclear magnetic resonance spectroscopy. Analyst. 110:1985;649-655
17. Hu W.G., Schmidt Rohr K. Characterization of ultradrawn polyethylene fibers by NMR: crystallinity, domain sizes and a highly mobile second amorphous phase. Polymer. 41:2000;2979-2987
18. Kaji H., Schmidt Rohr K. Selective observation and quantification of amorphous trans conformers in doubly C-13-labeled poly(ethylene terephthalate), PET, by zero-quantum magic-angle-spinning solid-state NMR. Macromolecules. 35:2002;7993-8004
19. Levine H., Slade L. Another view of trehalose for drying and stabilizing biological materials. BioPharm. 5:1992;36
20. Maunu S.L. NMR studies of wood and wood products. Progress in nuclear magnetic resonance spectroscopy. 40:2002;151-174
21. 13C NMR and DSC Int. J. Radiat. Appl. Instrum. Part C Radiat. Phys. Chem. 39:1992;209-214
22. 13C CP MAS NMR spectroscopy. 1: Spectral decomposition Carbohydr. Polym. 39:1999;327-339
23. Roos Y. Melting and glass transitions of low molecular weight carbohydrates. Carbohydr. Res. 238:1993;39-48
24. Shakhtshneider, T.P., Boldyrev, V.V., 1999. Mechanochemical synthesis and mechanical activation of drugs. In: Boldyreva E., Boldyrev V. (Eds.), Reactivity of Molecular Solids, vol. 3, Wiley, New York.
25. Sussich F., Cesaro A. Transitions and phenomenology of a, a-trehalose polymorphs inter conversion. J. Therm. Anal. Calorim. 62:2000;757-768
26. Sussich F., Princivalle F., et al. The interplay of the rate of water removal in the dehydration of α,α-trehalose. Carbohydr. Res. 322:1999;113-119
27. Sussich F., Urbani R., et al. Polymorphic, amorphous and crystalline forms of trehalose. J. Am. Chem. Soc. 120:1998;7893-7899
28. Tishmack P.A., Bugay D.E., et al. Solid-state nuclear magnetic resonance spectroscopy - pharmaceutical applications. J. Pharm. Sci. 92:2003;441
29. Vanderhart D.L., Alamo R.G., et al. Observation of resonances associated with stereo and regio defects in the crystalline regions of isotactic polypropylene: toward a determination of morphological partitioning. Macromolecules. 33:2000;6078-6093
30. Vromans H., Bolhuis G.K., et al. Studies on tableting properties of lactose. VII. The effect of variations in primary particle size and percentage of amorphous lactose in spray dried lactose products. Int. J. Pharm. 35:1987;29-37
31. Weisberg, S., 1985. Applied linear regression. In: John Wiley & Sons. (Eds.), Series in Probability and Mathematical Statistics, Wiley, New York.
32. Willart J.F., De Gusseme A., et al. Direct crystal to glass transformation of trehalose induced by ball milling. Solid State Commun. 119:2001;501-505
33. 13C NMR investigations of the glycosidic linkage in α-α′ trehalose Solid State Nucl. Magn. Reson. 12:1998;221-225
34. 15N n.m.r. studies of curing with hexamethylenetetramine Polymer. 38:1997;5835-5848