Phytosomes as a Plausible Nano-Delivery System for Enhanced Oral Bioavailability and Improved Hepatoprotective Activity of Silymarin.

Silymarin, a phyto-constituent derived from the plant Silybum marianum, has been widely acknowledged for its hepatoprotective activities. Nevertheless, its clinical utility is adversely hampered by its poor water-solubility and its limited oral bioavailability. The aim of this study was to investigate the efficacy of phospholipid-based phytosomes for enhancing the oral bioavailability of silymarin. The phytosomes were prepared using the solvent evaporation technique and were optimized using a full factorial design. The optimized silymarin phytosomal formulation was then characterized for particle size, surface morphology, aqueous solubility, and in vitro drug release. Furthermore, in vivo antioxidant activity, hepatoprotective activity and oral bioavailability of the optimized formula were investigated in a rat model. The prepared silymarin phytosomes were discrete particles with a porous, nearly smooth surface and were 218.4 ± 2.54 nm in diameter. In addition, the optimized silymarin phytosomal formulation showed a significant improvement in aqueous solubility (~360 µg/mL) compared to pure silymarin and manifested a higher rate and extent of silymarin release from the optimized formula in dissolution studies. The in vivo assessment studies revealed that the optimized silymarin phytosomal formulation efficiently exerted a hepatoprotective effect in a CCl4-induced hepatotoxicity rat model via restoring the normal levels of antioxidant enzymes and ameliorating cellular abnormalities caused by CCl4-intoxication. Most notably, as compared to pure silymarin, the optimized silymarin phytosomal formulation significantly improved silymarin oral bioavailability, as indicated by a 6-fold increase in the systemic bioavailability. Collectively, phytosomes might represent a plausible phospholipid-based nanocarrier for improving the oral bioavailability of phyto-constituents with poor aqueous solubility.

Vaccines in the United States: a systematic review on history of evolution, regulations, licensing, and future challenges.

Vaccines are credited with reducing or effectively eradicating a number of infectious diseases such as smallpox, measles, and diphtheria. Particularly in nations like the United States, where a large number of infectious diseases were prevalent, vaccines proved to be timely interventions. The approval procedure for vaccines in the United States is regulated by the Center for Biologics Evaluation and Research. Vaccine development is often found to be demanding and requires astute knowledge and understanding of recent developments by physicians and researchers to ensure that effective vaccines are made available to the masses with minimum risk. This article aims to illustrate the regulatory scenario with regards to vaccine development and licensure in the United States with a brief look at the origin of vaccines and their regulations in the nation. Also, it details the challenges faced by the United States vaccine industry to remain relevant in today's constantly evolving world.

Microemulsion Based Gel of Sulconazole Nitrate for Topical Application.

OBJECTIVES: Sulconazole is a broad spectrum antifungal agent of the imidazole class used against dermatophytes and other fungi to treat skin infections. The aim of the present work was to formulate and evaluate a microemulsion-based topical sulconazole gel. MATERIALS AND METHODS: Microemulsion formulation of sulconazole nitrate was prepared by using oil, surfactant, cosurfactant and water at different ratios. This was then subjected to clarity and particle size analysis, a centrifugation test, a dilution test, and freeze thawing. RESULTS: The zeta potential of formulation F1 was -41.3 and stable. The pH of the microemulsion formulation was within the range of pH of skin. F1 showed a higher percentage amount of drug as compared with the other formulations. The viscosity showed that F1 was optimum. The freezing and thawing results showed there was no phase separation and the formulation was stable. In vitro drug release showed that the drug release from the microemulsion of F1 was higher when compared to the other formulations. It revealed F1 had the highest drug content of 95.88±0.3% and % cumulative drug release was 88.75% release in 8 h. The in vivo skin irritation study on rats confirmed that formulation was nontoxic and nonirritant. CONCLUSION: The present study confirmed the safety of the formulated sulconazole loaded microemulsion gel for topical application.