Topical corticosteroids: quality control considerations.
A simple procedure is developed, which can be used as a quality control test. The method utilizes commercially available diffusion cell assembly, synthetic membrane, and an appropriate receptor phase. The amount of drug released over time is determined using an HPLC method. From this, the drug release rate, flux, microgram/cm2/min0.5 is calculated. This drug release rate can serve as a good quality control test to assure batch-to-batch uniformity.
Shah
V P
VP
Office of Generic Drugs, Food and Drug Administration, Rockville, Maryland 20855.
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000737:chemistry* / Q000493:pharmacokinetics*; D001623:Betamethasone / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D015194:Diffusion Chambers, Culture; D004353:Drug Evaluation, Preclinical; D006854:Hydrocortisone / Q000737:chemistry; D008567:Membranes, Artificial; D011786:Quality Control; D012995:Solubility; D013810:Therapeutic Equivalency; D014867:Water
D000893:Anti-Inflammatory Agents; D008567:Membranes, Artificial; D014867:Water; D001623:Betamethasone; D006854:Hydrocortisone