The purpose of this research was to evaluate different parameters that can influence in vitro drug release from topical dermatological drug products such as creams, gels, and ointments. In vitro release from topical dermatological drug products was carried out by using a static diffusion cell, a synthetic membrane, and an appropriate receptor medium. The receptor medium was mixed by means of a magnetic bar rotated at 400 rpm. Experiments were designed to evaluate the influence of (i) receptor media, (ii) different lots of synthetic membranes, and (iii) agitation on drug release. Release experiments were also carried out to study inter- and intralot variability. The in vitro release test was used to evaluate the marketed glucocorticoid products. Among the parameters studied, the receptor medium was found to be the most important and critical variable that influenced drug release. The release rate ranged between 0.61 and 2.68 micrograms/cm2/min0.5 for betamethasone dipropionate, depending on the percentage of ethanol in the receptor medium. The drug release was not influenced by agitation or by different lots of synthetic membranes. Very small inter- and intralot variability was observed. These experiments establish the ruggedness of the in vitro diffusion cell test system used for the drug release measurements.
The in vitro drug release profile of hydrocortisone (HC) from creams, ointments, and lotions has been determined using an automated procedure. A diffusion cell system and commercially available synthetic membranes were utilized for the studies. The use of a synthetic membrane obviates the problems associated with using skin membranes. Uniform creams and ointment samples for determining release rate profile were prepared by using the teflon mask. Automated sampling avoids operator artifacts. The automated technique developed for determining the in vitro release rate profile of the drug from creams, ointments, and lotions using a diffusion-cell system appears to be a reasonable and practical procedure for assuring batch-to-batch uniformity of topical drug products.
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