Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
Vol. 16, No. 2, 2017, pp. 477-482
Bioline Code: pr17062
Full paper language: English
Document type: Research Article
Document available free of charge
Tropical Journal of Pharmaceutical Research, Vol. 16, No. 2, 2017, pp. 477-482
© Copyright 2017 - Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria.
Diclofenac transdermal patch versus the sustained release tablet: A randomized clinical trial in rheumatoid arthritic patients|
Xu, Peng-Gang; Lei, Xi-Feng; Ren, Bao-Di; Lv, Shui-Ying & Zhang, Jun-Li
Purpose: To prepare and characterize transdermal films of diclofenac diethanolamine as a safer and
more effective alternative than the sustained release (SR) tablet equivalent for prolonged relief from
pain and inflammation in arthritis.
Methods: Transdermal films of diclofenac were prepared using sodium carboxymethyl cellulose and
polyvinyl pyrrolidone K30, with turpentine oil and sesame oil as penetration enhancers. The films were
characterized for physicochemical properties and for ex vivo permeation in a randomized clinical trial
(RCT) for analgesic activities in arthritic patients.
Results: The transdermal films were uniform in weight and thickness, flat, with high drug content (94.40
± 1.04 to 98.62 ± 1.08 %) and with high folding endurance (149 ± 9.09 to 192 ± 10.12). Drug permeation
through excised rat abdominal skin was prolonged. Films containing penetration enhancers showed
higher ex vivo drug permeation than those without the enhancer; furthermore, drug permeation
increased with increase in the concentration of enhancer. The films were non-irritating to the skin. In
RCT, F3 (containing turpentine oil, 1 %v/w) decreased the pain score from 9.87 ± 1.14 to 4.94 ± 0.78
units, compared with the SR tablet (once daily) which decreased pain from 9.59 ± 0.42 to 6.49 ± 1.20
units, 48 h post-administration. Turpentine oil showed better permeation enhancement than sesame oil
in the transdermal films.
Conclusion: Transdermal films of diclofenac, formulated with permeation enhancers, may have greater
therapeutic advantages over conventional oral tablets in terms of prolonged release and improvement of
patient compliance in rheumatoid arthritis.
Analgesic activity; Diclofenac; Permeation enhancer; Rheumatoid arthritis; Transdermal films
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