Determination of low levels of amorphous content in inhalation grade lactose by moisture sorption isotherms

International Journal of Pharmaceutics

Volumn 395, Issue 1-2, 2010, Pages 62-70

  Vollenbroek, Jasper ^a   Hebbink, Gerald A ^b   Ziffels, Susanne ^c   Steckel, Hartwig ^c  

^a FRIESLANDCAMPINA   (Netherlands)

^b DMV Fonterra Excipients ^*  (Netherlands)

^c UNIVERSITY OF KIEL   (Germany)

Author keywords

Amorphous content; Dry powder inhalation; Dynamic vapour sorption; Lactose; Moisture sorption

Indexed keywords

ALPHA LACTOSE; AMORPHOUS LACTOSE; EXCIPIENT; LACTOCHEM; LACTOHALE; LACTOSE; UNCLASSIFIED DRUG; POWDER; WATER;

ACCURACY; ARTICLE; DRUG DELIVERY SYSTEM; DRY POWDER; DYNAMIC VAPOR SORPTION; FREEZE DRYING; INHALATION; ISOTHERM; MEASUREMENT; METHODOLOGY; MOISTURE SORPTION ISOTHERM; PRIORITY JOURNAL; SPRAY DRYING; CALIBRATION; CHEMICAL MODEL; CHEMISTRY; CRYSTALLIZATION; DRUG FORMULATION; HUMIDITY; INHALATIONAL DRUG ADMINISTRATION; MEDICINAL CHEMISTRY; PHARMACEUTICS; POWDER; PROCEDURES; STANDARDS; STATISTICAL MODEL; VOLATILIZATION;

ADMINISTRATION, INHALATION; CALIBRATION; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DRUG COMPOUNDING; EXCIPIENTS; FREEZE DRYING; HUMIDITY; LACTOSE; LINEAR MODELS; MODELS, CHEMICAL; POWDERS; TECHNOLOGY, PHARMACEUTICAL; VOLATILIZATION; WATER;

EID: 77954312924     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2010.04.035     Document Type: Article

References (38)

1. Al-Muhtaseb A.H., McMinn W.A.M., Magee T.R.A. Moisture sorption isotherm characteristics of food products: a review. Trans. IchemE 2002, 80:118-128.
2. Barbosa-Cánovas G.V., Fontana Jr.A.J., Schmidt S.J., Barbosa-Cánovas G.V. Water Activity in Foods: Fundamentals and Applications 2007, 1-435. Blackwell Publishing Professional, Ames, Iowa (US), ISBN-13: 978-0-8138r-r2408-6. first ed.
3. Bronlund J., Paterson T. Moisture sorption isotherms for crystalline, amorphous and predominantly crystalline lactose powders. Int. Dairy J. 2004, 14:247-254.
4. Buckton G., Darcy P. The use of gravimetric studies to assess the degree of crystallinity of predominantly crystalline powders. Int. J. Pharm. 1995, 123:265-271.
5. Buckton G., Darcy P. Water mobility in amorphous lactose below and close to the glass transition temperature. Int. J. Pharm. 1996, 136:141-146.
6. Buckton G., Darcy P. Assessment of disorder in crystalline powders-a review of analytical techniques and their application. Int. J. Pharm. 1999, 179:141-158.
7. Burnett D., Malde N., Williams D. Characterizing amorphous materials with gravimetric vapour sorption techniques. Pharm. Tech. Eur. 2009, 21:41-45.
8. Burnett D.J., Thielmann F., Booth J. Determining the critical relative humidity for moisture-induced phase transitions. Int. J. Pharm. 2004, 287:123-133.
9. Chen X., Bates S., Morris K.R. Quantifying amorphous content of lactose using parallel beam X-ray powder diffraction and whole pattern fitting. J. Pharm. Biomed. Anal. 2001, 26:63-72.
10. Craig D.Q.M., Kett V.L., Murphy J.R., Price D.M. The measurement of small quantities of amorphous material-should we be considering the rigid amorphous fraction?. Pharm. Res. 2001, 18:1081-1082.
11. Das S., Larson I., Young P., Stewart P. Influence of storage relative humidity on the dispersion of salmeterol xinafoate powders for inhalation. J. Pharm. Sci. 2009, 98:1015-1027.
12. Dilworth S.E., Buckton G., Gaisford S., Ramos R. Approaches to determine the enthalpy of crystallisation, and amorphous content, of lactose from isothermal calorimetric data. Int. J. Pharm. 2004, 284:83-94.
13. Dwivedi S.K., Mitchell A.G. Gas chromatographic analysis of anomeric composition of lactose. J. Pharm. Sci. 1989, 78:1055-1056.
14. Geppi M., Mollic G., Borsacchi S., Veracini C.A. A solid-state NMR studies of pharmaceutical systems. Appl. Spectrosc. Rev. 2008, 43:202-302.
15. Hancock B.C., Zografi G. Characteristics and significance of the amorphous state in pharmaceutical systems. J. Pharm. Sci. 1997, 86:1-12.
16. Hogan S.E., Buckton G. The application of near infrared spectroscopy and dynamic vapor sorption to quantify low amorphous contents of crystalline lactose. Pharm. Res. 2001, 18:112-116.
17. Jouppila K., Roos Y.H. Water sorption and time-dependent phenomena of milk powders. J. Dairy Sci. 1994, 77:1798-1808.
18. Jouppila K., Roos Y.H. Water sorption isotherms of freeze-dried milk products: applicability of linear and non-linear regression analysis in modeling. Int. J. Food Sci. Technol. 1997, 32:459-471.
19. Karel M., Lund D.B. Water activity and food preservation. Physical Principles of Food Preservation 2005, 117-169. Marcel Dekker, Inc., New York. M. Karel, D.B. Lund (Eds.).
20. Katainen E., Niemelä P., Harjunen P., Suhonen J., Järvinen K. Evaluation of the amorphous content of lactose by solution calorimetry and Raman spectroscopy. Talanta 2005, 68:1-5.
21. Kirk J.H., Dann S.E., Blatchford C.G. Lactose: a definitive guide to polymorph determination. Int. J. Pharm. 2007, 334:103-114.
22. Lehto V.-P., Tenho M., Väkä-Heikkilä K., Harjunen P., Päällysaho M., Välisaari J., Niemelä P., Järvinen K. The comparison of seven different methods to quantify the amorphous content of spray dried lactose. Powder Technol. 2006, 167:85-93.
23. Listiohadi Y., Hourigan J.A., Sleigh R.W., Steele R.J. Thermal analysis of amorphous lactose and a-lactose monohydrate. Dairy Sci. Technol. 2009, 89:43-67.
24. Listiohadi Y.D., Hourigan J.A., Sleigh R.W., Steele R.J. Properties of lactose and its caking behaviour. Aust. J. Dairy Technol. 2005, 60:33-52.
25. Omar A.M.E., Roos Y.H. Water sorption and time dependent crystallization behaviour of freeze-dried lactose-salt mixtures. LWT 2007, 40:520-528.
26. Price R., Young P.M. Visualization of the crystallization of lactose from the amorphous state. J. Pharm. Sci. 2004, 93:155-164.
27. Roetman K., Buma T.J. Temperature dependence of the equilibrium a/b ratio of lactose in aqueous solution. Neth. Milk Dairy J. 1974, 28:155-165.
28. Shah B., Kakumanu V.K., Bansal A.B. Analytical techniques for quantification of amorphous/crystalline phases in pharmaceutical solids. J. Pharm. Sci. 2006, 95:1641-1665.
29. Son Y.-L., McConville J.T. Advancement in dry powder delivery to the lung. Drug Dev. Ind. Pharm. 2008, 34:948-959.
30. Steckel H., Markefka P., teWierik H., Kammelar R. Functionality testing of inhalation grade lactose. Eur. J. Pharm. Biopharm. 2004, 57:495-505.
31. Timmermann E.O., Chirife J., Iglesias H.A. Water sorption isotherms of foods and foodstuffs: BET or GAB parameters?. J. Food Eng. 2001, 48:19-31.
32. Timmermann I.-L., Steckel H., Trunk M. Assessing the re-crystallisation behaviour of amorphous lactose using the RH-perfusion cell. Eur. J. Pharm. Biopharm. 2006, 64:107-114.
33. Vrentas J.S., Vrentas C.M. Sorpt. Glassy Polym. Macromol. 1991, 24:2404-2412.
34. Vuataz G. The phase diagram of milk: a new tool for optimising the drying process. Lait 2002, 82:485-500.
35. Whiteside P.T., Luk S.Y., Madden-Smith C.E., Turner P., Patel N., George M.W. Detection of low levels of amorphous lactose using H/D exchange and FT-Raman spectroscopy. Pharm. Res. 2008, 25:2650-2656.
36. Willart J.F., Descamps N., Caron V., Capet F., Danede F., Descamps M. A thermal character of the solid state amorphization of lactose induced by ball milling. Solid State Commun. 2004, 132:693-696.
37. Young P.M., Chlou H., Tee T., Traini D., Chan H.-K., Thielmann F., Burnett D. The use of organic vapor sorption to determine low levels of amorphous content in processed pharmaceutical powders. Drug Dev. Ind. Pharm. 2007, 33:91-97.
38. Zeng X.-M., MacRitchie H.B., Marriott C., Martin G.P. Humidity-induced changes of the aerodynamic properties of dry powder aerosol formulations containing different carriers. Int. J. Pharm. 2007, 333:45-55.