What Are The Top Practices For The Method Development Of IVRT?
Reliable drug transportation between test material and receiving medium via a membrane is crucial for successful IVRT. So, while selecting an optimal experimental parameter, the primary focus is given to the properties of active pharmaceutical ingredients or API. The selection of proper membrane, receiving medium, and sampling schedule is the secondary goal of the experimental procedure.
The IVRT is a spectrum of a large number of steps. The first is the solubility screening step. In this step, a receptor medium prevents saturation and maintains sink conditions. Then, a membrane gets selected which should not contain any drug binding minimizers and no rate limiting effects on the release mechanism. Following these steps, a piece of appropriate testing equipment with Franz diffusion cell assembly in an open chamber gets selected. This apparatus is most commonly used to test semisolid topical drug forms.
The selection of the receiving medium has a separate set of guidelines to be followed. Some mediums are an aqueous buffer for water-soluble drugs, hydro-alcoholic medium for sparingly soluble drug forms, and more. Choose a correct medium the solubility of all APIs needs to be considered. Picking up solvents that will provide sink solutions is the aim. The receiving medium must have a relatively higher capacity to carry the drug.
Depending on the time points to evaluate the release profile, formulation dose needs to be determined. Release time is one of the parameters. Sample volume, stirring speed, the temperature of receptor solution, and formulation addition methods are other parameters to consider. Experienced analytic scientists effectively use this method to develop and validate high-performance liquid chromatography or HPLC. Also, the liquid chromatography-mass spectrometry or LC-MS method is used for high throughput sample analysis. To compare formulation prototypes in an aid product development or to compare generic formulation prototypes with a reference listed drug (RLD), IVRT methodology finds extensive application.