In vitro release: comparative evaluation of vertical diffusion cell system and automated procedure.
In vitro release for topical drug products is carried out using a vertical diffusion cell system and a synthetic support membrane. The improvements in vertical diffusion cell design and automated procedures have been carefully studied and evaluated to establish their reproducibility and ruggedness of the experimental procedure. The data were analyzed using 90% confidence interval procedure developed and published by the US Food and Drug Administration in SUPAC-SS (Start Up and Post Approval Changes-Semi Solid) guidance.
Shah
Vinod P
VP
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA.
Elkins
Jerome
J
Shaw
Steve
S
Hanson
Royal
R
D015194:Diffusion Chambers, Culture / Q000295:instrumentation / Q000379:methods; D008567:Membranes, Artificial; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000378:metabolism*; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods*
D008567:Membranes, Artificial; D004364:Pharmaceutical Preparations