Fabrication and characterization of single layer osmotic pump (scop) by solubility modulation approach for fluvoxamine maleate

Fluvoxamine maleate (FLV) is a sparingly water-soluble drug which is prescribed for compulsive disorder (OCD) and social anxiety disorder. Pharmacokinetics parameters of FLV urge it to be formulated into controlled release design which provides constant release. So, in the present study an attempt has been made to develop single core osmotic pump (SCOP) along with solubility modulation of FLV. Different tools of QbD were employed for risk free formulation of SCOP. Central composite design (CCD) was used defining, amount of osmogene (X1) and amount of leachable component in coating (X2) as independent variables (IVs). The quantification of FLV was done by UV method with a linearity range of 5-25μg/mL. Citric acid was found as best solubility modulator which had shown 43.12% increment in solubility of FLV. The stand error of applied CCD was less than 1. The ANOVA results of CCD proved significant effect of selected IVs on critical quality attributes of FLV osmotic pump (FLVOP). Initial drug release from SCOP was greatly affected by the amount of leachable component in coating. %Error was found to be less than 5% in check point batches confirming suitability of developed multiple linear regression (MLR) equations. Risk free control space was outlined from overlay region. The optimized batch was composed of 13.04% osmogen (Xylitab) and 12.79% leachable component in coating (HPMC E5). The SEM study helped to understand the mechanism of drug release from SCOP. The drug release data were best suited to zero order with RSQ is 0.998. The drug release profile of optimized batch was unaffected by change in pH, agitation and ionic strength. Short term stability data proved stable characteristics of developed SCOP of FLV.