Frontage Labs

Product Development of Sterile Nanoemulsions

Nanoemulsions have been of great interest to pharmaceutical companies as the world’s nanotechnology industry could be worth 80 billion dollars and nearing a 17% growth rate by 2024. Nanoemulsions are a special type of emulsion, which is made up of very small droplets of oil and water. These droplets are so small that they can pass through cell membranes, making them ideal for use in product development. Nanoemulsions are particularly interesting when developing liquid formulations of poorly water-soluble drugs for oral or injectable administration.

[PODCAST] Sterile Product Development of Poorly Water-Soluble Drugs

But first, what are Emulsions?

An emulsion is a mixture of two or more immiscible liquids which is stabilized by an emulsifier. Emulsions have an oil phase and an aqueous phase where one of the phases is a continuous phase and the other is the dispersed phase. Depending on the continuous phase, emulsions can be classified as either water in oil (oil as continuous phase) or oil in water (water as continuous phase) emulsions.

Types of Emulsions
Types of Emulsions

Emulsions have various practical applications in agriculture, cosmetics, drugs, and food products. Specifically, in the pharmaceutical space, some emulsions are used to deliver active pharmaceutical ingredients (APIs) in topical, oral, nasal, ophthalmic, or injectable dosage forms.

Nanoemulsions in Drug Delivery

Nanoemulsions are liquid-in-liquid dispersions with droplet sizes of 20-500 nm. Different from microemulsions, which are thermodynamically stable, nanoemulsions are kinetically stable and more resistant to physiological changes such as dilution and pH changes which is more advantageous from a formulation perspective. Producing stable nanoemulsions requires high-energy manufacturing methods such as high-pressure homogenization and ultrasonication.

High-Pressure HomogenizationUltrasonication
High-Pressure HomogenizationUltrasonicationHigh-Pressure Homogenization (Source)Ultrasonication (Source)
High-Pressure Homogenization (Source)
High-Pressure HomogenizationUltrasonicationHigh-Pressure Homogenization (Source)Ultrasonication (Source)Ultrasonication (Source)

Nanoemulsions, being so small, show enhanced functional potentials such as enhanced stability, surface area, optical transparency, rheology, and more. Oil-in-water (O/W) nanoemulsions are specifically used to carry the high load of water-insoluble drugs which can be dissolved in the oil core. Oil-in-water nanoemulsions are also known to stabilize drugs that may experience hydrolytic and oxidative degradation. 

For a complete overview of challenges and future trends in sterile nanoemulsions, check out our webinar on Sterile Nanoemulsion Product Development.

The lower particle size and high effective surface area increase the bioavailability of the drugs nanoemulsions carry. O/W nanoemulsions are also excellent carriers for topical and transdermal drug delivery. Nanoemulsions can dissolve nonpolar active compounds, an important factor in being chosen as drug and bioactive compound delivery systems. Parenteral delivery routes have been used in supplying nutrients, controlled drug release, and vaccine delivery. Nanoemulsions are particularly of interest because they can be developed cost-effectively and on a larger scale, in many dosage forms such as oral, parenteral, topical, and ophthalmic.

Some examples of drugs using nanoemulsions for transdermal drug delivery are caffeine, aspirin, and insulin.

Choosing a Nanoemulsion Product Development Partner

When choosing a partner for product development, it is critical to work with a team that can develop GMP manufacturing processes to help ensure a high-quality final product for clinical trials. Frontage facilities have been designed for flexibility and offer a variety of dosage forms. Frontage’s formulation development team also can handle highly potent compounds and DEA-controlled substances and is a preferred choice for Sponsors looking to develop finished products supporting IND, NDA filings, and generic ANDA filings. Learn more about our vast formulation development capabilities and tell us more about your nanotechnologies.