The use of organic vapor sorption to determine low levels of amorphous content in processed pharmaceutical powders

Drug Development and Industrial Pharmacy

Volumn 33, Issue 1, 2007, Pages 91-97

  Young, Paul M ^a   Chiou, Herbert ^a   Tee, Terrance ^a   Traini, Daniela ^a   Chan, Hak Kim ^a   Thielmann, Frank ^b   Burnett, Dan ^b  

^a UNIVERSITY OF SYDNEY   (Australia)

^b USA   (United Kingdom)

Author keywords

Amorphous; Ball milling; Lactose; Organic dynamic vapor sorption; Salbutamol sulfate

Indexed keywords

LACTOSE; OCTANE; SALBUTAMOL;

ARTICLE; DRUG DELIVERY SYSTEM; HUMIDITY; PRESSURE; VAPOR;

ALBUTEROL; CHEMISTRY, PHARMACEUTICAL; LACTOSE; POWDERS; TECHNOLOGY, PHARMACEUTICAL; VOLATILIZATION;

EID: 33845930644     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.1080/03639040600969991     Document Type: Article

References (35)

1. Ahmed, H., Buckton, G., & Rawlins, D. A. (1996). The use of isothermal microcalorimetry in the study of small degrees of amorphous content of a hydrophobic powder. International Journal of Pharmaceutics, 130(2), 195-201.
2. Begat, P., Young, P. M., Edge, S., Kaerger, J. S., & Price, R. (2003). The effect of mechanical processing on surface stability of pharmaceutical powders: Visualization by atomic force microscopy. Journal of Pharmaceutical Sciences, 92(3), 611-620.
3. Briggner, L. E., Buckton, G., Bystrom, K., & Darcy, P. (1994). The use of isothermal microcalorimetry in the study of changes in crystallinity induced during the processing of powders. International Journal of Pharmaceutics, 105(2), 125-135.
4. Buckton, G., Butler, D. A., Thielmann, F., & Williams, D. R. (2001). The use of inverse phase gas chromatography to measure the surface energy of crystalline, amorphous, and recently milled lactose. Pharmaceutical Research, 18(5), 662-666.
5. Buckton, G., & Darcy, P. (1995). The use of gravimetric studies to assess the degree of crystallinity of predominantly crystalline powders. International Journal of Pharmaceutics, 123(2), 265-271.
6. Buckton, G., & Darcy, P. (1999). Assessment of disorder in crystalline powders - a review of analytical techniques and their application. International Journal of Pharmaceutics, 179(2), 141-158.
7. Buckton, G., Darcy, P., & Mackellar, A. J. (1995). The use of isothermal microcalorimetry in the study of small degrees of amorphous content of powders. International Journal of Pharmaceutics, 117(2), 253-256.
8. Burnett, D. J., Thielmann, F., & Booth, J. (2004). Determining the critical relative humidity for moisture-induced phase transitions. International Journal of Pharmaceutics, 287(1-2), 123-133.
9. Columbano, A., Buckton, G., & Wikeley, P. (2002). A study of the crystallisation of amorphous salbutamol sulphate using water vapour sorption and near infrared spectroscopy. International Journal of Pharmaceutics, 237(1-2), 171-178.
10. Craig, D. Q. M., Kett, V. L., Murphy, J. R., & Price, D. M. (2001). The measurement of small quantities of amorphous material - Should we be considering the rigid amorphous fraction? Pharmaceutical Research, 18(8), 1081-1082.
11. Dilworth, S. E., Buckton, G., Gaisford, S., & Ramos, R. (2004). Approaches to determine the enthalpy of crystallisation, and amorphous content, of lactose from isothermal calorimetric data. International Journal of Pharmaceutics, 284(1-2), 83-94.
12. Duncanhewitt, W. C., & Grant, D. J. W. (1986). true density and thermal expansivity of pharmaceutical solids - Comparison of methods and assessment of crystallinity. International Journal of Pharmaceutics, 28(1), 75-84.
13. Gombas, A., Antal, I., Szabo-Revesz, P., Marton, S., & Eros, I. (2003). Quantitative determination of crystallinity of alpha-lactose monohydrate by Near Infrared Spectroscopy (NIRS). International Journal of Pharmaceutics, 256(1-2), 25-32.
14. Gustafsson, C., Lennholm, H., Iversen, T., & Nystrom, C. (1998). Comparison of solid-state NMR and isothermal microcalorimetry in the assessment of the amorphous component of lactose. International Journal of Pharmaceutics, 174(1-2), 243-252.
15. Hill, V. L., Craig, D. Q. M., & Feely, L. C. (1998). Characterisation of spray-dried lactose using modulated differential scanning calorimetry. International Journal of Pharmaceutics, 161(1), 95-107.
16. Hogan, S. E., & Buckton, G. (2000). The quantification of small degrees of disorder in lactose using solution calorimetry. International Journal of Pharmaceutics, 207(1-2), 57-64.
17. Hogan, S. E., & Buckton, G. (2001). The application of near infrared spectroscopy and dynamic vapor sorption to quantify low amorphous contents of crystalline lactose. Pharmaceutical Research, 18(1), 112-116.
18. Kawakami, K., Numa, T., & Ida, Y. (2002). Assessment of amorphous content by microcalorimetry. Journal of Pharmaceutical Sciences, 91(2), 417-423.
19. Krycer, I., & Hersey, J. A. (1991). Detection of mechanical activation during the milling of lactose monohydrate. Int J Pharm Tech Prod Mfr, 2, 55-56.
20. Mackin, L., Zanon, R., Park, J. M., Foster, K., Opalenik, H., & Demonte, M. (2002). Quantification of low levels (< 10%) of amorphous content in micronised active batches using dynamic vapour sorption and isothermal microcalorimetry. International Journal of Pharmaceutics, 231(2), 227-236.
21. Murphy, B. M., Prescott, S. W., & Larson, I. (2005). Measurement of lactose crystallinity using Raman spectroscopy. Journal of Pharmaceutical and Biomedical Analysis, 38(1), 186-190.
22. Newell, H. E., Buckton, G., Butler, D. A., Thielmann, F., & Williams, D. R. (2001). The use of inverse phase gas chromatography to study the change of surface energy of amorphous lactose as a function of relative humidity and the processes of collapse and crystallisation. International Journal of Pharmaceutics, 217(1-2), 45-56.
23. Price, R., & Young, P. M. (2004). Visualization of the crystallization of lactose from the amorphous state. Journal of Pharmaceutical Sciences, 93(1), 155-164.
24. Price, R., & Young, P. M. (2005). On the physical transformations of processed pharmaceutical solids. Micron, 36(6), 519-524.
25. Richardson, G. M., & Malthus, R. S. (1955). Salts for the static control of humidity at relatively low levels. Journal of Applied Chemistry, 557-567.
26. Saleki-Gerhardt, A., Ahlneck, C., & Zografi, G. (1994). Assessment of Disorder in Crystalline Solids. International Journal of Pharmaceutics, 101(3), 237-247.
27. Saunders, M., Podluii, K., Shergill, S., Buckton, G., & Royall, P. (2004). The potential of high speed DSC (Hyper-DSC) for the detection and quantification of small amounts of amorphous content in predominantly crystalline samples. International Journal of Pharmaceutics, 274(1-2), 35-40.
28. Schellinger, A. K. (1950). Calorimetric method for the determination of the surface energy of a brittle crystalline solid. Science, 111(2895), 693-694.
29. Schultz, R. K. (1995). Process-induced crystallinity changes in albuterol sulfate and its effect on powder physical stability. Pharmaceutical Research, 12(5), 773-779.
30. Shalaev, E. Y., & Franks, F. (1995). Structural glass transitions and thermophysical processes in amorphous carbohydrates and their supersaturated solutions. Journal of the Chemical Society-Faraday Transactions, 91(10), 1511-1517.
31. Stubberud, l., Arwidsson, H. G., Hjortsberg, V., & Graffner, C. (1996). Water-solid interactions. III. Effect of glass transition temperature, Tg, and processing on tensile strength of compacts of lactose and lactose/polyvinyl pyrrolidone. Pharmaceutical Development and Technology, 1(2), 195-204.
32. Suryanarayanan, R., & Mitchell, A. G. (1985). Evaluation of two concepts of crystallinity using calcium gluceptate as a model compound. International Journal of Pharmaceutics, 24(1), 1-17.
33. Ward, G. H., & Schultz, R. K. (1995). Process-induced crystallinity changes in albuterol sulfate and its effect on powder physical stability. Pharmaceutical Research, 12(5), 773-779.
34. Wargo, D. J., & Drennen, J. K. (1996). Near-infrared spectroscopic characterization of pharmaceutical powder blends. Journal of Pharmaceutical and Biomedical Analysis, 14(11), 1415-1423.
35. Young, P. M., & Price, R. (2004). The influence of humidity on the aerosolisation of micronised and SEDS produced salbutamol sulphate. European Journal of Pharmaceutical Sciences, 22(4), 235-240.