Background: Skin as route of administration avoids many side effects of oral
administration of NSAIDS like irritation of the gastrointestinal tract, systemic toxicity and
improves the patient compliance and therapeutic efficacy.
Objective: To study the influence of Piper betle on the permeation of Naproxen sodium gel
when applied on skin.
Method: The leaves of P. betle were subjected to maceration using successive solvent
extraction with solvents like n-hexane, chloroform, methanol and water. All four extracts
were screened for preliminary phytochemical tests. The carbopol gel formulations containing
Naproxen sodium (1% w/w) and selected concentrations (1% / 2% w/w) of synthetic
penetrations enhancers or four herbal extracts were prepared as various batches. These
formulations were subjected to characterization tests of colour, pH, viscosity, spreadability. Formulations
were subjected to ex-vivo permeation of the drug across rat skin using Franz diffusion cell. The permeation
using herbal extracts was compared with synthetic penetration enhancer, Transcutol P.
Results: The formulation containing 2% w/w of N- hexane extract showed better % cumulative release
(47.97%) and flux (157.072 μg/cm2h), as compared to synthetic enhancer transcutol P (43.11% CR and flux as
141.15 μg/cm2.h) and other extracts. Histopathology shows focal stripping of stratum corneum and normal
adnexal structure in both formulations containing synthetic and n-hexane extract. But mild degeneration of
epidermis and dermis was seen along with hemorrhage in skin treated with formulation containing Transcutol P.
Conclusion: Piper betle may be safer and better option for increasing the skin permeability of Naproxen
sodium as compared to synthetic penetration enhancers.