This study was conducted by the Department of Nuclear Medicine, Institute of Nuclear Medicine and Allied Sciences (lNMAS), Delhi. In this study, Diclofenac in the reference gel and Dynapar QPS was tagged with radioactive material (Technetium) and then the Formulations were applied on volunteers' knees and backs. The radioactivity levels were thereafter, measured at regular time intervals.
Dynapar QPS application resulted in significantly higher radio activity as compared to diclofenac gel application, indicating higher penetration of Diclofenac from Dynapar QPS.
Based on the success of the scintigraphy study, the microdialysis study was performed to estimate the amount of Diclofenac penetrating the skin (stratum corneum) after application of Dynapar QPS as compared to a conventional diclofenac gel. In this study, a semi-permeable capillary system (Microdialysis catheter) was placed below the skin. Conventional diclofenac gel and Dynapar QPS were alternately applied on the marked patch over the skin. A micropump circulated a dialysate in the capillary and whatever amount of the drug that crossed the skin (stratum corneum), entered the capillary and came in the dialysate. Samples of the dialysate were drawn at regular intervals & were estimated for the amount of diclofenac that actually crossed the skin. More amounts of Diclofenac were found in the dialysate when Dynapar QPS was applied in comparison to the conventional diclofenac gel application. This confirms that Diclofenac penetration through the skin is significantly higher as compared to conventional gel.
Hence, making Dynapar QPS a targeted drug delivery, which provides higher concentration of drug in tissues as compared to systemic circulation, producing superior clinical effects and reducing the dependence on oral NSAIDs.
From the above two proof of concept studies, it is clear that Dynapar QPS provides significantly better penetration of Diclofenac through the stratum corneum and skin. The superior efficacy resulting from the better penetration can be seen in the Clinical Trial below.
Franz diffusion study was conducted to evaluate and compare in-vitro permeability of diclofenac from Dynapar QPS against internationally available topical diclofenac products. Franz diffusion cell uses a synthetic Strat-M Membrane, which is a non animal based model for testing diffusion of topical drugs. The membrane contains multiple layers that create morphology similar to human skin. Franz diffusion study demonstrated a 3 fold higher penetration of diclofenac from Dynapar QPS as compared to other internationally available topical products.