Soluble itraconazole in tablet form using disordered drug delivery approach: critical scale-up considerations and bio-equivalence studies.

ABSTRACT: The present research work explores formulation design, critical scale-up considerations and bio-equivalence studies of soluble itraconazole (ITZ) in a tablet form using disordered drug delivery approach. Disordered system of ITZ with a lower viscosity grade of hydroxypropyl methyl cellulose (Pharmacoat 603) was developed for the first time and extensively characterised at three different stages, namely development of glass system, pellet coating and tablet compression using advanced analytical techniques. Complete molecular embedment of ITZ resulting in amorphisation was observed and found to be sustained until end of the real-time and accelerated stability studies. Developed formulation exhibited comparative in vitro dissolution profile (similarity factor>70) with reference product (Spora

SUBMITTER: Swaminathan S 

PROVIDER: S-EPMC3581659 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature