Scientific Evidences

CLINICAL TRIAL

Clinical trial conducted by independent investigators has established that pain relief with Dynapar QPS is so powerful that patients did not need to take any oral painkillers. In contrast, 22.85% of patients using Diclofenac gel had to take oral painkillers.

Scintigraphy Study

Dynapar QPS Penetration 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 were tagged with radioactive material (Technetium) and then the formulations were applied on the knees and backs of our volunteers. The radioactivity levels were thereafter, measured at regular intervals.

Images taken by gamma camera

QPS Gel

  • Reference Documents:SCINTIGRAPHY STUDY
  • Scintigraphy Study PDF

Dynapar QPS application resulted in significantly higher radio activity as compared to diclofenac gel application, indicating better penetration of the diclofenac from Dynapar QPS.
-Published in Int J Pharm Sci Res.2015;6(5):1936-1942

Microdialysis Study

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 a higher concentration of drug in tissues as compared to the systemic circulation, producing superior clinical effects and reducing the dependence on oral NSAIDs.

Sample Fraction Collector

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.

Published in Inter J Pharm Sci & Drug Res.2013;5(4):175-178

  • Reference Documents:Microdialysis Study
  • Microdialysis Study PDF

Franz Diffusion Study

% of applied dose that penetrates Strat-M membrane

Franz Diffusion Study

  • * Data on File

 

Confirms that DYNAPAR QPS has the highest Transdermal Penetration *

A globally patented drug delivery platform that is best-in-class by a wide margin

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.