Untitled

Abstract

The crystallization behavior of mannitol in frozen solutions was influenced by the cooling rate and the presence of phosphate buffers and PVP.

Subambient Behavior of Mannitol in Ethanol–Water Co-solvent System

“…The exotherm at −22°C arises from the crystallization of mannitol. It is well known that mannitol readily crystallizes in aqueous solution as reported in previous publications (4,5,15). The glass transition was observed with onset at −32°C in this study.…”

“…Kett et al concluded, based on modulated DSC experiments, that this thermal event could be an endothermic relaxation accompanied by a glass transition (5). Cavatur et al also examined with oscillatory DSC and concluded that it is a second glass transition but not enthalpic recovery (15). A DSC thermogram was also obtained at a slower cooling rate of 0.5°C/min.…”

State diagrams for improving processing and storage of foods, biological materials, and pharmaceuticals (IUPAC Technical Report)

“…Molecular-level mixing with other components may limit the spatial rearrangement of mannitol molecules required for crystallization. In fact, various solutes that can remain amorphous in frozen solutions and during freeze-drying (e.g., NaCl, K 2 HPO 4 , L-glycine 30 ) were reported to inhibit mannitol crystallization [23,[159][160][161][162][163][164][165][166][167][168]. Altering molecular mobility in an amorphous phase by complex formation and/or molecular interaction is another approach to prevent mannitol crystallization.…”

Influence of mannitol concentration on the physicochemical, mechanical and pharmaceutical properties of lyophilised mannitol

“…Although amorphous mannitol can serve as a stabiliser for the active pharmaceutical ingredient (API) (Izutsu et al, 1994), the difficultly to maintain mannitol in the amorphous state during lyophilisation makes mannitol a poor choice as stabiliser (Pikal, 2002). However, the crystallisation of mannitol in frozen solutions during lyophilisation was inhibited by using phosphate buffer salts (Izutsu et al, 1994), polyvinylpyrrolidone (Cavatur et al, 2002) and NaCl (Telang et al, 2003). During lyophilisation, mannitol was shown to crystallise as three common stable anhydrous polymorphic forms (i.e.…”

“…During lyophilisation, mannitol was shown to crystallise as three common stable anhydrous polymorphic forms (i.e. α, β and δ) (Bauer et al, 2000;Berman et al, 1968;Botez et al, 2003;Burger et al, 2000;Kim et al, 1968) or as mannitol hemihydrate (Cavatur and Suryanarayanan, 1998;Cavatur et al, 2002;De Beer et al, 2007;Nunes et al, 2004;RomeroTorres et al, 2007;Yu et al, 1999). The polymorphic form of lyophilised mannitol was shown to have an effect in the stability of the lyophilised product during its storage (Cao et al, 2006;De Beer et al, 2009Pisano et al, 2013).…”