Solubility and dissolution enhancement of ketotifen by solid dispersion technique

ABSTRACT

Ketotifen [KT] solid dispersions and physical mixtures were prepared with the objective of solubility and dissolution improvement using Hydroxypropyl-Beta-Cyclodextrin [HP-beta-CD], Pluronic 127 [PF-127], Pluronic 68 [PF-68], Polyethylene glycol 6000 [PEG 6000], and Polyethylene glycol 4000 [PEG 4000]. The saturation solubility and in-vitro dissolution studies showed remarkable improvement in solubility and drug dissolution of these new solid dispersions and physical mixtures over pure ketotifen. The XRD, DSC, IR and SEM studies indicated the transformation of crystalline ketotifen [in pure drug] to amorphous ketotifen [in solid dispersions]. This study concluded that the improved solubility as well as drug dissolution of these new ketotifen solid dispersions may be attributed to improved wettability and reduction in drug crystallinity, which can be modulated by appropriate level of hydrophilic carriers