DIFFUSIONAL AND RHEOLOGICAL
EVALUATIONS AS VALUABLE QUALITY
CONTROL AND IN VIVO PERFORMANCE
PROGNOSTIC TOOLS FOR TOPICAL DRUG
PRODUCTS.
DALIA SIMONA MIRON1, FLAVIAN STEFAN RADULESCU1,
VICTOR A.VOICU2, DUMITRU LUPULEASA1, IUSTINA SACUIU1
1University of Medicine and Pharmacy „Carol Davila” Bucharest,
Faculty of Pharmacy, 6 Traian Vuia street, 020956, Bucharest, Romania
2Romanian Army Center for Medical Research, 37 C.A.Rosetti street,
020012, Bucharest, Romania.
*corresponding author: dalia_simona_m@yahoo.com
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Abstract:

The current paper describes a combined rheological and diffusion approach to the in vitro evaluation of four commercially available topical semisolid dosage forms containing 0.5% piroxicam. The experimental conditions represent an adaption of the USP Topical/Transdermal Ad Hoc Advisory Panel stimuli for revision process, for the considered low solubility, high permeability drug, enclosed in hydrophilic gel matrix. The cumulative mass release profiles in hydro-alcoholic receptor media, using two hydrophilic membranes as a procedure applicable for scale-up post-approval changes are correlated with the study of rheological behavior. The static character of vertical diffusion cell and the flow indexes of the topical drug product are analyzed as key factors for the in vivo performance.

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