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  • Title: Effect of polymer content and molecular weight on the morphology and heat- and moisture-induced transformations of spray-dried composite particles of amorphous lactose and poly(vinylpyrrolidone).
    Author: Berggren J, Alderborn G.
    Journal: Pharm Res; 2003 Jul; 20(7):1039-46. PubMed ID: 12880290.
    Abstract:
    PURPOSE: The aim was to investigate the influence of polymer content and molecular weight on the morphology and heat- and moisture-induced transformations, as indicators of stability, of spray-dried composite particles of amorphous lactose and poly(vinylpyrrolidone) (PVP). METHODS: Amorphous lactose and composite particles of amorphous lactose with different contents and molecular weights of PVP were prepared by spray drying. The nanostructure of the particles was analyzed by x-ray powder diffractometry, the morphology by light microscopy and SEM, the glass transition temperatures (Tg), crystallization temperatures (Tc), heats of crystallization and melting temperatures by differential scanning calorimetry, and moisture-induced crystallizations gravimetrically and by microcalorimetry. RESULTS: All the types of particles prepared were amorphous. The Tg was unchanged or only marginally increased as a result of the inclusion of PVP. However, crystallization temperature, time to moisture-induced crystallization, and particle morphology were affected by both content and molecular weight of PVP. CONCLUSIONS: Increased content and molecular weight of PVP may have the potential to increase the physical stability of amorphous lactose. However, Tg seems not to be a relevant indicator for the stability of this type of amorphous composite materials.
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