Research Journal of Pharmacy and Technology

The aim of this investigation was to develop Rizatriptan (RIZ) mouth dissolving films (MDFs)and evaluate the effect of formulation variables like film thickness, plasticizers, film formers and solubilizing agents on physicomechanical, chemical and drug release properties of MDFs. MDFs were prepared (using wet film applicator, a commercially scalable technique) using Hydroxy propyl methyl cellulose (HPMC) of different viscosity grades (E3, E5 and E15) as film former, PEG 400 and glycerol as plasticizers. FTIR studies showed no RIZ-excipient interactions in the MDF formulations. Photomicrographs together with DSC and X-RD studies confirmed the absence of RIZ recrystallization within the MDFs. MDFs of higher film thickness were brittle with low tensile strength values indicating an inverse relationship between film thickness and tensile strength. Whereas, increase in polymer viscosity increased the tensile strength of MDFs and about a 2.6fold increase in tensile strength was obtained with HPMC E15 MDFs compared to E3. In vitro drug release studies revealed that higher film thickness and polymer viscosities delayed the RIZ release from MDFs and the release was in the order of E3>E5>E15. Addition of solubilizing agents (PVP K30 and SLS) to the E3 formulations resulted in 2 and 1.43 fold faster RIZ release compared to formulations without them. Overall, F11 formulation (1% w/w RIZ+7.5% w/w HPMC E3+0.04% w/w PVP K30+0.5% w/w PEG 400) showed faster disintegration (within 8sec) and RIZ release rates (complete release was obtained in 60sec) compared to other formulations. The MDFs showed 98102% RIZ content even after 6months time period indicating that the RIZ was stable in MDF formulations.