Dissolution testing of a poorly soluble compound using the flow-through cell dissolution apparatus

Using USP I and USP IV for Discriminating Dissolution Rates of Nano- and Microparticle-Loaded Pharmaceutical Strip-Films

“…1 and have been previously described by Bhattachar et al (30). The cell may be represented as the lower cone, a cylindrical portion, and the filter head (30). Dissolution medium enters at the bottom of the cone and exits through the filter head.…”

“…The lower cone holds a glass bead 6 mm in diameter, which serves as a check valve, preventing material to descend into the inlet tubing. Strip-films were loaded into the cell using six different patterns following the work presented by Bhattachar et al for powders (30). For powders, when the glass beads are used, their approach involved mixing of the powder with the beads.…”

“…This dissolution technique has been proven to be reproducible and robust, which is an important characteristic for dissolution testing (27)(28)(29). The increased sensitivity of the flow-through cell dissolution method related to particle size of a poorly soluble drug powder has also been reported recently (30,31). In the work by Heng et al (31), the paddle, rotating basket, and flow-through cell from the USP, and a dialysis method, were used to measure the dissolution rates of cefuroxime axetil as a model for drug nanoparticles.…”

Investigation of the Effect of Different Flow-Through Cell Designs on the Release of Diclofenac Sodium SR Tablets

“…In a study by Morihara et al (20), the release of salicylic acid from USP calibrator tablets was the highest when the tablet was buried in the glass beads, followed by placement on top of the glass beads bed. In another study (18), different designs of powder loading within the glass beads and their impact on dissolution of a poorly soluble compound (PD 198306) were investigated. The results showed that the lowest release rate was obtained when the drug powder was embedded in a glass-bead bed, while homogeneous mixing of the drug with glass beads was the best method of drug loading into the cell.…”

“…FTC systems offer other distinct advantages including (1) a built-in filtration system, (2) use as either an open or closed system, (3) a high degree of automation, and (4) ideal hydrodynamic conditions for mild agitation, homogeneity, and definable flow (3). Few studies (12,(15)(16)(17)(18)(19)(20) have discussed the optimization of the different FTC parameters that affect the release of drugs, such as flow rate, the type of flow (laminar or turbulent), cell size, gradient change of pH of the dissolution medium, closed and open system of the FTC, and the position of the dosage form in the dissolution cell. The objective of this study was to investigate different variables and hydrodynamic conditions in the FTC that might affect the release rate of a partially soluble DS (solubility > 9 mg/mL in deionized water at pH 5.2 and 25 °C) from sustained-release tablets (21).…”