Rofecoxib is one of the most potent nonsteroidal anti-inflammatory agents for the treatment of pain and inflammation associated with musculoskeletal disorder, primary dysmenorrhea, rheumatoid arthritis and osteoarthritis. However, the oral administration of rofecoxib is inconvenient due to its gastric ulcerogenic activity and systemic cardiac toxicities. The topical administration may help in the localized delivery with improved availability of the drug at the site of action and in turn, reduce the dose and dose-dependent side effects. The purpose of the present investigation is to encapsulate rofecoxib in niosomes and incorporate the prepared niosomes into the dermal gel base for sustained therapeutic action. The entrapment efficiency of rofecoxib in niosomes was optimized by altering the proportion of nonionic surfactant (Span 20, Span 40 and Span 60) and cholesterol. The mean niosomes sizes were in the range of 10.16�±1.17 to 11.94�±1.24 ?m. The drug-leakage study carried out at different temperature of 4�±20 C and 25�±20 C for a period of two months affirms that the drug leakage increased at a higher temperature. The ex vivo permeation study using pig ear skin shows slower permeation with niosomal gel (20.93 ?g/cm2/h) as compared with the plain drug gel (55.26 ?g/cm2/h), ointment base (29.70 ?g/cm2/h) and cream base (46.09 ?g/cm2/h). The lower ex vivo flux value with niosomal gel indicates the prolong drug release behavior with sustained therapeutic action.
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