title: Effects of ethanol to water ratio in feed solution on the crystallinity of spray-dried lactose.
abstract: In the present study, the effects of ethanol to water ratio in feed solution on the physical properties of spray-dried alpha-lactose monohydrate were evaluated. Crystallinity of the spray-dried lactose was determined by isothermal microcalorimetry (IMC) and by differential scanning calorimetry (DSC). Water content of the spray-dried lactose was determined by thermogravimetric analysis and the surface area was evaluated by Brunauer, Emmett, and Teller (BET) method. The crystallinity of spray-dried lactose varied from 0% to 100%, depending on the ratio of ethanol to water in the feed solution. Lactose spray dried from pure ethanol was 100% crystalline and contained hydrate water. Lactose spray dried from pure water was 100% amorphous. The feed solution substantially affected the ratio of surface water to hydrate water, as the content of surface water increased and hydrate water decreased, while the crystallinity of spray-dried lactose decreased. Surface area of the spray-dried lactose increased as a function of amorphous content.
authors.affiliation: Department of Pharmaceutics, University of Kuopio, P.O. Box 1627, FIN-70211 Kuopio, Finland. paivi.harjunen@uku.fi
authors.forename: Päivi
authors.initials: P
authors.lastname: Harjunen
authors.forename: Vesa-Pekka
authors.initials: VP
authors.lastname: Lehto
authors.forename: Jouni
authors.initials: J
authors.lastname: Välisaari
authors.forename: Tapio
authors.initials: T
authors.lastname: Lankinen
authors.forename: Petteri
authors.initials: P
authors.lastname: Paronen
authors.forename: Kristiina
authors.initials: K
authors.lastname: Järvinen
mesh_terms: D002151:Calorimetry / Q000379:methods; D002626:Chemistry, Pharmaceutical; D003460:Crystallization; D000431:Ethanol; D007785:Lactose / Q000737:chemistry*; D008855:Microscopy, Electron, Scanning; D019999:Pharmaceutical Solutions; D013818:Thermogravimetry; D014867:Water
chemical_list: D019999:Pharmaceutical Solutions; D014867:Water; D000431:Ethanol; D007785:Lactose