The release rate of MCP from trial formulations (F1-F20) was determined using USP apparatus II (Erweka, DT 600 Heusentamn, Germany). The dissolution test was conducted in 900 mL of acidic buffer (pH 1.2) for the first 2 hours at a paddle speed of 50 rpm, followed by the testing in phosphate buffer (pH 6.8).24 (link) During the test, the temperature of the medium was maintained at 37°C ± 0.5°C. A sample of 10 mL was drawn at fixed time intervals and filtered through 0.45μm membrane filter paper. An equal volume of fresh medium replaced the volume of each sample drawn. Cumulative drug release was determined by a validated HPLC method23 (link) has already been described in Content Assay.
As a dependent variable cumulative drug release at 1hr., 6hrs and 12hrs were observed. The results were grouped into four based on low, medium, and high levels of Sodium Chloride concentrations and center point formulations, with different orifice sizes, and % weight gain of tablet after coating. Low-level group (−1) bears F-5, F-7, F-9, F-13, and F-18, the medium-level group (0) contains F-1, F-4 and F-11whereas, F-2, F-8, F-14, F-15and F-20 were grouped into high-level concentration of NaCl (+1). The remaining formulation F-3, F-6, F-10, F-12, F-16, and F-17 were center point batches with the same composition. F-19 is the axial formulation with no orifice.
As a dependent variable cumulative drug release at 1hr., 6hrs and 12hrs were observed. The results were grouped into four based on low, medium, and high levels of Sodium Chloride concentrations and center point formulations, with different orifice sizes, and % weight gain of tablet after coating. Low-level group (−1) bears F-5, F-7, F-9, F-13, and F-18, the medium-level group (0) contains F-1, F-4 and F-11whereas, F-2, F-8, F-14, F-15and F-20 were grouped into high-level concentration of NaCl (+1). The remaining formulation F-3, F-6, F-10, F-12, F-16, and F-17 were center point batches with the same composition. F-19 is the axial formulation with no orifice.