Phytosomes in Drug Delivery: Preparation, Characterization, Applications, and Clinical Evidence

Phytosomes are advanced vesicular systems that improve the solubility, stability, and bioavailability of plant-derived bioactives. By forming stable complexes between phytoconstituents and phospholipids, phytosomes address major limitations of conventional herbal formulations, such as poor systemic absorption and variable therapeutic  response. This review critically examines recent developments in phytosome technology. Preparation methods including solvent evaporation, anti-solvent precipitation, and freeze-drying are discussed. Characterization techniques such as scanning and transmission electron microscopy, differential scanning calorimetry, and dynamic light scattering are evaluated for their ability to ensure optimized morphology, stability, and particle size. Insights from recent patents and marketed formulations highlight the translational relevance of phytosomes in nutraceutical and pharmaceutical sectors. Preclinical and clinical data confirm therapeutic potential across diverse applications, including oncology, wound healing, neuroprotection, and dermatology. Commercial formulations have demonstrated enhanced pharmacokinetics and improved patient outcomes compared to conventional herbal products. Despite advancements, significant challenges remain. These include difficulties in large-scale manufacturing, variability in extract standardization, regulatory complexities, and the scarcity of randomized controlled trials establishing long-term safety and efficacy. Addressing these limitations is essential to achieve wider clinical adoption and regulatory approval. Phytosomes represent next-generation delivery systems for botanical bioactives, offering both scientific and commercial promise. Future directions should emphasize interdisciplinary integration of nanotechnology, artificial intelligence, and advanced analytical approaches to refine formulation design, ensure reproducibility,and accelerate clinical translation.