Analysis of swelling and release mechanism from single core osmotic pump scop of fluvoxamine with emphasis on drug solubility and water transplant

Abstract

quotBackground: Consistent drug release in biological media is always a desirable pattern from any formulation. But due to unfavorable physicochemical properties (mostly solubility), API can t be delivered in such fashion. So, it is always justifiable to develop a drug delivery system that can provide constant drug release for a predetermined time. newlineAim: Fluvoxamine maleate, a poorly water-soluble drug which is required to be formulated into an osmotic pump to achieve consistent drug release. newlineMaterials and Methods: Detailed preformulation study was carried out for Fluvoxamine (FLV) to check its suitability for the proposed dosage form. Analytical method (UV) was developed for FLV. Single Core Osmotic Pump (SCOP) was developed for FLV using two different approaches (solubility modulation-SMFLOP and water transplant-WTFLOP). The solubility modulation of FLV was done by different modulators. The core tablet was prepared by direct compression. Different QbD tools and DoE principles were employed for the fabrication of the product. Central composite design (CCD) was employed for the optimization of SMFLOP, where the amount of osmogen and amount of leachable component in the coating membrane was kept as key independent variables. Box Behnken Design (BBD) was used for the optimization of WTFLOP using the amount of water-swellable polymer (X1), amount of osmogen (X2), and no. of an orifice (X3) as key independent variables. Lag time to initiate drug release (TL) and time required for 25% (T25), 50% (T50), 75% (T75), and 100% (T100) drug release were selected as responses. Physicochemical, performance, and structural characterization was done for the developed system. Short term stability study was conducted for both developed systems. newlineResults and Discussion: Results of preformulation studies indicated the suitability of FLV for SCOP. The citric acid (CA) at 10 % of FLV showed better solubility as a solubility modulator. FLV was found to be compatible with selected excipients. Results of preliminary studies revealed that