Surface modification of lactose inhalation blends by moisture

International Journal of Pharmaceutics

Volumn 391, Issue 1-2, 2010, Pages 29-37

  Watling, C P ^a   Elliott, J A ^a   Scruton, C ^b   Cameron, R E ^a  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Deliquescence; Dry powder inhalation; Lactose; Ostwald ripening; Relative humidity; Solid bridge

Indexed keywords

ALPHA LACTOSE; LACTOHALE LH200; NITROGEN; RESPITOSE SV003; UNCLASSIFIED DRUG;

ADSORPTION; ARTICLE; CONTROLLED STUDY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG RELEASE; DRUG SOLUBILITY; DRUG STABILITY; DRUG STORAGE; HUMIDITY; LASER DIFFRACTION; MOISTURE; PARTICLE SIZE; POWDER; PRIORITY JOURNAL; ROOM TEMPERATURE; SCANNING ELECTRON MICROSCOPY; SURFACE PROPERTY;

ADMINISTRATION, INHALATION; DRUG CARRIERS; DRUG STABILITY; DRUG STORAGE; HUMIDITY; LACTOSE; PARTICLE SIZE; POROSITY; POWDERS; SURFACE PROPERTIES; TIME FACTORS;

EID: 77952884229     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2010.02.011     Document Type: Article

References (33)

1. Bérard V., Lesniewska E., Andres C., Pertuy D. Dry powder inhaler: influence of humidity on topology and adhesion studied. AFM Int. J. Pharm. 2002, 232:213-224.
2. Cleaver J.A.S., Karatzasa G., Louisa S., Hayati I. Moisture-induced caking of boric acid powder. Powder Technol. 2004, 146:93-101.
3. Cleaver J.A.S., Wong P. Humidity-induced surface modification of boric acid. Surf. Interface Anal. 2004, 36:1592-1599.
4. Dombrowski R.D., Litster J.D., Wagner M.J., He Y. Crystallization of alpha-lactose monohydrate in a drop-based microfluidic crystallizer. Chem. Eng. Sci. 2007, 62:4802-4810.
5. Hodges G.E., Lowe E.K., Paterson A.H.J. A mathematical model for lactose dissolution. Chem. Eng. J. 1993, 53:B25-B33.
6. Huber G., Wirth K.E. Electrostatically supported surface coating of solid particles in liquid nitrogen for use in dry-powder-inhalers. Powder Technol. 2003, 134:181-192.
7. Huynh-Ba K. Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices 2008, Springer.
8. ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), 2003. Stability Testing of New Drug Substances and Products Q1A (R2).
9. Iida K., Hayakawa Y., Okamoto H., Danjo K., Leuenberger H. Evaluation of flow properties of dry powder inhalation of salbutamol sulfate with lactose carrier. Chem. Pharm. Bull. 2001, 49:1326-1330.
10. Iida K., Hayakawa Y., Okamoto H., Danjo K., Leuenberger H. Preparation of dry powder inhalation by surface treatment of lactose carrier particles. Chem. Pharm. Bull. 2003, 51:1-5.
11. Iida K., Inagaki Y., Todo H., Okamoto H., Danjo K., Leuenberger H. Effects of surface processing of lactose carrier particles on dry powder inhalation properties of salbutamol sulfate. Chem. Pharm. Bull. 2004, 52:938-942.
12. Iida K., Hayakawa Y., Okamoto H., Danjo K., Leuenberger H. Effect of surface layering time of lactose carrier particles on dry powder inhalation properties of salbutamol sulfate. Chem. Pharm. Bull. 2004, 52:350-353.
13. Iida K. Preparation of dry powder inhalation with lactose carrier particles surface-coated using a Wurster fluidized bed. Chem. Pharm. Bull. 2005, 53:431-434.
14. Islam N., Gladki E. Dry powder inhalers (DPIs)-a review of device reliability and innovation. Int. J. Pharm. 2008, 360:1-11.
15. Kawashima Y., Serigano T., Hino T., Yamamoto H., Takeuchi H. Effect of surface morphology of carrier lactose on dry powder inhalation property of pranlukast hydrate. Int. J. Pharm. 1998, 172:179-188.
16. Kontny M.J., Grandolfi G.P., Zografi G. Water vapor sorption of water-soluble substances: studies of crystalline solids below their critical relative humidities. Pharm. Res. 1987, 4:104-112.
17. Lowe E.K., Paterson A.H.J. A mathematical model for lactose dissolution, part II Dissolution below the alpha lactose solubility limit. J. Food Eng. 1998, 38:15-25.
18. Martin S. Control of conditioning atmospheres by saturated salt solutions. J. Sci. Instrum. 1962, 39:370-372.
19. Mathlouthi M., Reiser P. Sucrose: Properties and Applications 1994, Springer.
20. Newman S.P., Clarke S.W. Therapeutic aerosols. I. Physical and practical considerations. Thorax 1983, 38:881-886.
21. NIH (National Institutes of Health), 2010. ImageJ, " a public domain Java image processing program" http://rsbweb.nih.gov/ij/.
22. O'Brien F.E.M. Control of humidity by saturated salt solutions. J. Sci. Instrum. 1948, 25:73-76.
23. Ostwald W. Lehrbuch der Allgemeinen Chemie (Textbook of General Chemistry) 1896, Engelmann, Leipzig, pp. 444-465.
24. Podczeck F. Particle-particle Adhesion in Pharmaceutical Powder Handling 1998, Imperial College Press.
25. Podczeck F. Influence of particle size distribution and surface roughness of carrier particles on the in vitro properties of dry powder inhalations. Aerosol Sci. Technol. 1999, 31:301-321.
26. Rowe R.C., Sheskey P.J., Owen S.C. Handbook of Pharmaceutical Excipients 2003, Pharmaceutical Press.
27. Steckel H., Markefka P., TeWierik H., Kammelar R. Functionality testing of inhalation grade lactose. Eur. J. Pharm. Biopharm. 2004, 57:495-505.
28. Washington C. Particle Size Analysis in Pharmaceutics and Other Industries: Theory and Practice 1992, Ellis Horwood Limited.
29. Waterman K.C., Adami R.C. Accelerated aging: prediction of chemical stability of pharmaceuticals. Int. J. Pharm. 2005, 293:101-125.
30. Young P.M., Edge S., Traini D., Jones M.D., Price R., El-Sabawi D., Urry C., Smith C. Influence of dose on the performance of dry powder inhalation systems. Int. J. Pharm. 2005, 296:26-33.
31. Zeng X.M., Martin G.P., Tee S.K., Marriott C. Role of fine particle lactose on the dispersion and deaggregation of salbutamol sulphate in an air stream in vitro. Int. J. Pharm. 1998, 176:99-110.
32. Zeng X.M., Martin G.P., Marriott C., Pritchard J. Influence of carrier morphology on drug delivery by dry powder inhalers. Int. J. Pharm. 2000, 200:93-106.
33. Zeng X.M., Martin G.P., Marriott C., Pritchard J. Lactose as a carrier in dry powder formulations: the influence of surface characteristics on drug delivery. J. Pharm. Sci. 2001, 90:1424-1434.