Nanoemulsion Development with Pharmaceutical Nanotechnology
The use of nanotechnology in pharmaceutical products has become more important as selective drug delivery and the use of compounds with limited solubility becomes more prominent. Nanoscale drug delivery system (NDDSs) can provide unique benefits not easily attained with traditional dosage forms.
Our Nanoemulsion Development Services
PharmSky’s team is highly experienced in complex liquid formulation development, especially biphasic emulsions. Unlike monophasic co-solvent systems, development of a successful nanoemulsion drug product requires balancing of multiple factors to achieve stability and efficacy across all aspects. These include colloidal and interfacial chemistry, material compatibility based on targeted administration routes, API encapsulation, and partition, multi-stage manufacturing process design and scalability, long-term physicochemical stability, and pharmacokinetics.
We also specialise in exploiting value-adding functions to improve product performance and safety, such as targeted and controlled release, bioavailability and adsorption enhancement, and toxicity reduction.
Nano Liquid Emulsion Formulations
Formulation excellence stems from the foundational understanding of the materials, processes, and interactions. Whether it is new formulation development, formulation optimization, or re-formulation, our specialized team will work closely with you to deliver solutions with a focus on quality, efficiency, and innovation.
Nanoemulsion Stability and Testing
PharmSky offers holistic physicochemical testing and stability monitoring of nanoemulsions and other complex liquid products. Our TGA-accredited analytical testing facility and GMP/ICH stability programs ensure quick turnover formulation screening and full traceability for dossier preparation.
See our Analytical and ICH Stability Testing service for more information.
Compared to traditional drug delivery methods such as ointments, tablets, capsules and syrups, NDDSs provide various advantages that include:
Nanoparticles can encapsulate drugs, protecting them from degradation and improving their delivery to target tissues or cells. Encapsulation may improve product stability during storage by minimising available degradation pathways (e.g. oxidation, hydrolysis). It may also protect the product following administration into the patient.
Many drugs have limited solubility, making them difficult to effectively release to the body. Nanotechnology can be used to better formulate these drugs into drug products, increasing their solubility and potential bioavailability while avoiding the use of toxic solvents and surfactants.
Nanodrugs can be designed to target specific cells, tissues or organs. Careful material selection and functionalisation of NDDS can improve the delivery of drugs to the desired location, reducing off-target effects and improving therapeutic outcomes.
Multiple successful nano-pharmaceutical products have demonstrated reduced local and systemic toxicity, allowing for more widespread use, fewer adverse events in patients and offering healthcare providers more treatment options.
NDDS can be used alone or in concert with other depot technologies to modulate the pharmacokinetics of the active pharmaceutical ingredient (API) over an extended period. Therefore potentially reducing toxicity, maximising API efficacy, and reducing the number of doses a patient requires.
Compliance and Regulatory Considerations
While many promising applications that exhibit the above benefits have been published in literature, few have been translated into pharmaceutical products. Common problems include regulatory hurdles, safety concerns regarding nanomaterial toxicity, and scalability issues in manufacturing.
PharmSky scientists have collective decades of experience in formulation and characterisation in a wide range of NDDS including micelles, dendrimers, nanoemulsions, liposomes, nanosuspensions, lipid nanoparticles and many other forms. We have encountered many of the typical problems outlined above and can assist in overcoming them.
Our scientists have been involved in all stages of nanoparticle based pharmaceutical formulation as well as analytical development and manufacture, from the laboratory bench through scale-up to clinical and commercial manufacture.
PharmSky can help bring your nanotechnological product to market with:
If you have a product which would benefit from the advantages highlighted above, PharmSky can rapidly evaluate possible options and provide clear guidance on the feasibility of potential formulations for NDDS including liposomal, lipid nanoparticle, polymeric nanoparticle, emulsion and micelle-based formulations. We provide clear guidance on the advantages and disadvantages of the NDDS options to avoid common pitfalls and develop a product that meets your requirements.
Given their complexity compared to typical pharmaceutical products, nanodrug formulations are difficult to prepare in a robust and repeatable manner. Furthermore, many synthetic methods used in academic laboratories can’t be effectively scaled up to enable large scale manufacture. Following accepted pharmaceutical methodologies, PharmSky can develop a robust formulation using a process designed for scale up.
The methods used to examine a NDDS are critical to support product development at all stages. From concept identification to registration, our analytical team will develop robust methods that can be validated to pharmaceutical standards. NDDSs are complicated by the presence of complex matrices, incomplete product understanding and multiple components that require quantitation. Our team are experienced in dealing with these problems and can help you avoid them, accelerating product development and avoiding regulatory problems.
Whether developed by you or us, we can work with you and your potential manufacturing partners to develop and transfer a robust, manufacturing process following ICH guidelines. PharmSky have the facilities and equipment to manufacture pilot and clinical scale batches in laminar flow environments under GMP processes for use in first in human clinical trials.
Whether your nanoparticle formulation is a drug or drug/device combination, we can help you. PharmSky regulatory specialists have years of experience bringing nanoparticle products to market and can assist in dossier development, avoiding common hurdles.
Why Choose PharmSky To Partner With?
We specialise in bringing complex nanoemulsion products from concept to market-ready success. With deep expertise in formulation development following Quality by Design processes, analytical testing, process optimisation, and regulatory compliance, our team provides comprehensive support at every stage—from initial development and analytical testing to GMP manufacturing, technology transfer, and global regulatory submissions.
Our advanced facilities and specialised equipment allow us to deliver scalable, consistent nanoemulsion product solutions. Partner with us to accelerate your product’s journey to market with confidence and unmatched expertise in nanoemulsion development.
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Frequently Asked Questions
An emulsion is a mixture of two immiscible liquids (e.g. water and oil) that is thermokinectically unstable, eventually leading to phase separation. With fine tuning on the colloidal and surface chemistry and advanced homogenization techniques, emulsion droplet size can be reduced down to the nanometer range. Compared to macroemulsions (i.e., micron-range droplet size), nanoemulsions show an excellent capability to withstand instability mechanisms, which is critical to achieving long-term product stability and homogeneity.
In addition, nanoemulsions can achieve additional functionality, such as drug loading enhancement, bioavaliability improvement, and controlled drug release.
Nanoemulsions enhance drug delivery by improving the solubility and bioavailability of drugs, particularly for poorly water-soluble compounds. Their small particle size allows for better absorption across biological membranes, enabling faster and more efficient drug delivery to target tissues. Nanoemulsions can also offer controlled release capabilities, reduced side effects by lowering the required dose, and can be customized for various routes of administration, including oral, topical, and injectable forms. These advantages make nanoemulsions a valuable approach for maximizing therapeutic effects.
- Excipient selection (e.g., emulsifiers, stabilizers, types of oils) to ensure stability and compatibility.
- Emulsion droplet size control for desired bioavailability and drug release profiles.
- Stability monitoring coupled with systematic screening and rigorous testing for quick formulation iteration.
- Scalability and complexity of the production process.
The presence of water and oil phases offers great design flexibility to incorporate API molecules that could be water-/or oil-soluble. Fine-tuning of colloidal and interfacial properties allows the incorporation of desired functionalities, enabling high value-adding potential.
