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KMID : 1040020230140020059
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International Journal of Pain
2023 Volume.14 No. 2 p.59 ~ p.67
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Superior Skin Penetration of Diclofenac from Dynapar QPS Plus as Compared to Diclofenac Aerosol Spray
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Aamirraza Mansuri
Vivek Kumar Agarwal
Sanjay B Patel
Sohin K Zalavadiya
Ketan R Patel
Kanaiyalal D Prajapati
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Abstract
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Background: The currently available topical diclofenac products do not provide effective penetration of diclofenac across the layers of skin. Troikaa Pharmaceuticals Ltd, has developed Dynapar QPS Plusⓡ, a novel, topical formulation of diclofenac and compared its skin penetration with Diclofenac Aerosol Spray.
Methods: In this randomized, two way crossover study, healthy human subjects (n = 8) received single dose of either 2 ml of Dynapar QPS Plus or approximately 4 gm of marketed Diclofenac Aerosol Spray. The blood samples were drawn at pre dose and up to 24 hours post dose. The plasma concentrations of Diclofenac was measured using validated LC-MS/MS bioanalytical method.
Results: The mean Cmax after administration of Dynapar QPS Plus and Diclofenac Aerosol Spray were 102.945 ± 66.0109 and 15.885 ± 14.7750 ng/ml, respectively. Median Tmax for Dynapar QPS Plus was earlier compared to Diclofenac Aerosol Spray (7 hrs vs. 19 hrs). The mean AUC0-t after administration of Dynapar QPS Plus was significantly higher as compared to Diclofenac Aerosol Spray (AUC0-t: 855.289 ± 494.0262 vs. 149.707 ± 116.6317). Both the products were well tolerated and no adverse event occurred during the study.
Conclusions: The results of this study showed that Dynapar QPS Plus is safe and provides faster and more than six times higher skin penetration of diclofenac in comparison to marketed Diclofenac Aerosol Spray. Due to faster and higher penetration of diclofenac, from Dynapar QPS Plus it is best suitable option to treat pain and inflammation related to acute as well chronic musculoskeletal disorders.
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KEYWORD
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diclofenac, penetration, pharmacokinetics, skin, topical
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