title: The influence of PVP incorporation on moisture-induced surface crystallization of amorphous spray-dried lactose particles.
abstract: We have recently shown that atomic force microscopy (AFM) may be an appropriate method for characterisation of the re-crystallization of amorphous particles. In this study, spray-dried composite particles consisting of lactose and polyvinyl pyrrolidon (PVP) were characterised by AFM and electron spectroscopy for chemical analysis (ESCA), and their response on increasing the relative humidity (RH) was investigated. The PVP content in the particles used was 0, 5 or 25 wt.% of either PVP K17 or PVP K90. All composite particles were found to be enriched with PVP at the surface. The incorporation of PVP in the particles influenced the way the particles responded to an increase in RH. The specific RH interval in which the surface of the particles smoothened and the RH where crystallization could be detected, increased with an increase in the amount and molecular weight of the PVP in the particles. The crystallization kinetics of single particles was analysed with AFM and by utilising the JMAK equation. The rate constant for this transformation increased in an exponential manner with increasing RH. Furthermore, above the RH needed for the crystallization to occur, the exponential increase in the crystallization rate was larger for particles with higher polymer content which indicates that the stabilising effect decreases as the water content in the particles becomes higher. In this study we report a method for determination of crystallization kinetics on single composite particles, which is valuable when evaluating the effect of stabilisers in amorphous powders.
authors.affiliation: Department of Pharmacy, Uppsala University, Box 580, SE-751 23 Uppsala, Sweden.
authors.forename: Denny
authors.initials: D
authors.lastname: Mahlin
authors.forename: Jonas
authors.initials: J
authors.lastname: Berggren
authors.forename: Ulrik
authors.initials: U
authors.lastname: Gelius
authors.forename: Sven
authors.initials: S
authors.lastname: Engström
authors.forename: Göran
authors.initials: G
authors.lastname: Alderborn
mesh_terms: D003460:Crystallization; D006813:Humidity; D007785:Lactose / Q000737:chemistry*; D018625:Microscopy, Atomic Force; D011145:Polyvinyls / Q000008:administration & dosage*; D011759:Pyrrolidines / Q000008:administration & dosage*; D013678:Technology, Pharmaceutical
chemical_list: D011145:Polyvinyls; D011759:Pyrrolidines; C505150:poly(N-vinylpyrrolidine); D007785:Lactose