Nanoemulsion
A nanoemulsion is an oil-in-water dispersion system composed of nanoscale droplets (approximately 20–200 nm). It is stabilized using specialized emulsification processes and surfactants, effectively enhancing the solubility, bioavailability, and delivery efficiency of hydrophobic drugs.
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Enhanced Absorption: High surface area accelerates dissolution and permeation, reducing dose variability and food effects.
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Multi-Route Applications: Suitable for oral, ophthalmic, topical, and injectable formulations; supports 505(b)(2) submissions and differentiated generic drug development.
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Formulation Flexibility: Can be designed as transparent or translucent emulsions; adjustable oil phase composition, viscosity, and release profiles; compatible with controlled release and mucoadhesive enhancements.
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High-Energy Preparation: Ensures droplet size stability and batch-to-batch consistency.
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Strict Control: Droplet size distribution and physical stability are tightly regulated, with processes aligned to international pharmacopeial and regulatory standards.
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Droplet Size & Distribution: Target size range of 20–200 nm; monitored using DLS/PSD for PdI and batch consistency.
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Stability Mechanisms: Formulated to inhibit Ostwald ripening, aggregation, and coalescence.
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Compatibility & Safety: Uses pharmaceutically acceptable lipids and surfactants; compatibility and extractables/leachables evaluations completed.
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Regulatory Alignment: Aligned with FDA guidance on Nanomaterials in Drug Products and relevant pharmacopeias; injectable products adhere to stricter standards such as USP <729> (MDD, PFAT5).
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Oral Delivery of Poorly Soluble Small Molecules: Enhances Cmax, reduces Tlag; supports 505(b)(2) formulation upgrades or differentiated generics.
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Ophthalmic Delivery: Improves corneal retention and permeability, increasing local bioavailability.
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Topical/Mucosal & Injectable Use: Enhances local and systemic exposure; injectables comply with sterility, particulate, and endotoxin requirements.
