In vitro release of hydrocortisone from topical preparations and automated procedure.
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.
Shah
V P
VP
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857.
Elkins
J
J
Hanus
J
J
Noorizadeh
C
C
Skelly
J P
JP
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000032:analysis / Q000493:pharmacokinetics; D002482:Cellulose / Q000031:analogs & derivatives; D002851:Chromatography, High Pressure Liquid; D004058:Diffusion; D006854:Hydrocortisone; D007202:Indicators and Reagents; D008567:Membranes, Artificial
D000893:Anti-Inflammatory Agents; D007202:Indicators and Reagents; D008567:Membranes, Artificial; C005062:acetylcellulose; D002482:Cellulose; D006854:Hydrocortisone