Comparing Luliconazole Cream with Reference Drug


Bilim Pharmaceuticals in Kocaeli, Turkey, recently performed a diffusion study that was published in Lab Asia Buyers Guide 2021/22 called, “Comparative In Vitro Release Test Using Franz Diffusion Cell for Luliconazole 1% Cream With Reference Drug Product.” They used Teledyne Hanson’s Phoenix DB-6 manual diffusion testing system to gather the needed data. In vitro release testing (IVRT) was used to compare the Bilim product Bilconazol 1% cream with Luzu Cream 1% as the reference drug. Several semi-solid formulations with different concentrations were placed on the cellulose ester membranes. The receptor medium was a phosphate buffer containing 50% ethanol. The DB-6 dry heat diffusion system was heated to 32 °C, with a stirring speed of 600 rpm. Samples were taken at 1 hour intervals for 6 hours. Two products were compared with each run. The six-cell system was run in an ABABAB pattern with three cells used for each of the two products being compared.

HPLC was used to analyze the samples. Results showed no statistically significant difference between the Bilim product and the reference product. It was also determined that the temperature of the receptor environment was a critical parameter for the study, and suggests the temperature of the lab should be monitored.

About Teledyne Hanson Diffusion systems.

The Teledyne Hanson Phoenix dry heat diffusion systems make diffusion-cell testing faster, easier, and more economical. The Phoenix DB-6 manual sampling system offers six-cell manual sampling in a compact footprint with an advanced touch screen display. The Phoenix RDS Robotic Diffusion Station fully automates sampling, collection, and media replace with the ability to run up to 24 cells at once. Both systems rely on the new Phoenix™ dry heat diffusion cell, made from precision borosilicate glass, with mixer inserts engineered to produce instant homogenization of receptor media.