Enhanced Transdermal Delivery of Piroxicam via Nanocarriers

Jul 16, 2026

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An optimized nano-niosomal piroxicam emulgel was formulated and characterized for particle size, polydispersity, zeta potential, drug entrapment and in vitro release, and transdermal permeation. Animal studies assessed pain, prostaglandin E2 in synovium, knee swelling and histopathology. A randomized double-blind trial compared analgesic effects of nano-niosomal piroxicam emulgel versus piroxicam gel. Results showed sustained release, markedly higher transdermal permeation and significant reductions in knee swelling and prostaglandin E2, with superior clinical pain relief.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages20

Reading Time50 min

AAPS PharmSciTech (2025) 26:79 [https://doi.org/10.1208/s12249-025-03075-x](https://doi.org/10.1208/s12249-025-03075-x) Enhanced Transdermal Delivery of Piroxicam via Nanocarriers, Formulation, Optimization, Characterization, Animal Studies and Randomized Double‑Blind Clinical Trial Moein Masjedi1,2 · Mohammad Ali Helforoush1,3 · Katayoun Rohani Rad1,2 · Soliman Mohammadi‑Samani2 · Talieh Montahaei4 · Zarindokht Helforoush5 · Afshin Amini6 Received: 5 December 2024 / Accepted: 18 February 2025 / Published online: 6 March 2025 © The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists 2025 Abstract Piroxicam is a non-steroidal anti-inflammatory drug which is used topically as an adjunctive treatment of knee osteoarthritis and as an option to control joint pain in patients suffering rheumatoid arthritis. In this study, an emulgel containing optimized nano-niosomal piroxicam was formulated and characterized in terms of mean size, polydispersity index, zeta potential, drug entrapment efficiency and capacity, release and transdermal permeation. Also, animal studies including pain level assessment, synovial prostaglandin E2 levels, knee joint swelling degree and histopathologic investigations were conducted. A randomized double-blind clinical trial was also performed to compare the analgesic effect of nano-niosomal piroxicamemulgel with piroxicam gel. The results showed optimized niosome formulation with 142 ± 7nm mean size and 0.23 ± 0.08 PDI, entrapped 99.48 ± 0.79% of added piroxicam with a sustained release pattern. Permeation studies indicated a 3.31-fold transdermal permeation of niosomal piroxicam emulgel compared with the piroxicam gel. The niosomal formulation significantly reduced knee joint swelling and prostaglandin E2 levels. The clinical trial indicated that the painkilling efficiency of the niosomal piroxicam emulgel was 37.30-fold and 3.16-fold greater compared to the placebo and the positive control groups, respectively. In conclusion, the niosomal piroxicam emulgel which may enable the drug to permeate through the skin and accumulate in synovial tissue more efficiently, showed a promising performance in lowering pain and inflammation based on the animal studies and the human clinical trial. Keywords clinical trial · niosome · NSAIDs · osteoarthritis · pain · piroxicam · rheumatoid arthritis * Moein Masjedi [Masjedi_m@sums.ac.ir](Masjedi_m@sums.ac.ir); [Masjedimoein@gmail.com](Masjedimoein@gmail.com) 1 Department of Research and Development, Daroosazan Sorena Exir Pharmaceutical Company, Shiraz, Iran 2 Department of Pharmaceutics, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran 3 Department of Traditional Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran 4 School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran 5 Department of Mathematics and Systems Engineering, Florida Institute of Technology

Jul 16, 2026

106

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