Nanotechnology Platform

Nanotechnology platform

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, such as ointments, tablets, capsules and syrups. These 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 deliver 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, potentially reducing toxicity, maximising API efficacy, and reducing the number of doses a patient requires

While many promising applications exhibiting the above benefits have been published in literature, few have 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 of 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 help you overcome them. Our scientists have been involved in all stages of nanoparticle based pharmaceutical formulation and 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, our services include:

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.

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