Design, development, and validation of a novel static horizontally aligned drug diffusion cell (Shan DDC) for in vitro drug assessment

Abstract

Anesthetic drug permeation across biological membranes is commonly analyzed by customized side-by-side diffusion cells, and their availability in the commercial market is limited. Hence, the present study has designed and validated a novel static horizontally aligned drug diffusion cell (Shan DDC) for in vitro permeation studies. The diffusion chambers in Shan DDC are rectangular, measuring 28 × 12 × 15 mm in length, width, and thickness, respectively, to hold a volume of 5 mL separately in each chamber and a 3.36 cm2 opening for drug diffusion, offering a surface area to volume ratio of 0.67. The performance of the device was validated. The temperature inside the chamber was maintained within a narrow range of 37 ± 1.2 °C. The leak fraction was 1.6% (162 ± 45 µL) of the total chamber volume (10 ml). The optimal stirring efficiency inside the individual chamber was achieved within 36 ± 14 s at 200 rpm. The coefficient variation of lignocaine drug flux through the model membrane (nitrocellulose) was 4.2%. Thus, Shan-DDC has been demonstrated to provide reproducible permeation data in vitro.