Refractory small molecules are often a barrier to translation due to their low solubility, low bioavailability, and formulation challenges. Nanocrystallization is a versatile approach to salvage refractory drugs with the added advantage of carrier-free delivery systems.

Protheragen-ING specializes in providing cutting-edge nanocrystal development services to help clients rescue hydrophobic drugs through nanocrystal formulation approaches. Depending on the disease, customized formulations can be administered via different routes, including oral, transdermal, and parenteral. This highlights the versatility of the nanocrystal drug platform. Our team of experienced scientists and engineers can assist you at every stage of the development process.

Pharmaceutical Nanocrystal Platform

Drug nanocrystals can be defined as pure solid particles with an average diameter <1 μm and crystalline characteristics. This platform provides an excellent opportunity to deliver hydrophobic drugs. It is unique in that the nanocrystals consist entirely of 100% drug or payload, thus eliminating the role of carrier assistance.

Fig. 1 Nanocrystallization of poorly soluble drugs improves physicochemical stability and drug bioavailability. (Jarvis M, et al. 2019)

Nanocrystal drug technology improves the solubility of hydrophobic drugs due to an increase in the surface area to volume ratio as well as an increase in the dissolution rate associated with the nano-size. The drug crystals are particularly suitable for the repair of Biopharmaceutics Classification System (BCS) Class II and IV drugs (low solubility drugs).

Nanocrystalline drug formulations have also been shown to be stable in suspensions, often referred to as nanocrystalline colloidal dispersions (NCDs), allowing for easy scale-up and manufacture of highly stable and marketable products.

Our Comprehensive Development Services

• Customized Nanocrystal Development - We understand your project goals and design nanocrystals to meet your specifications, ensuring optimal performance and functionality in your intended application.
• Nanocrystal Synthesis - We provide expert synthesis of high-quality nanocrystals with precise control over size, shape, composition, and surface properties.
• Characterization and Analysis - We employ advanced tools such as electron microscopy, spectroscopy, X-ray diffraction, and surface analysis to ensure accurate characterization and detailed understanding of the synthesized nanocrystals.
• Surface Functionalization - Our experts can functionalize nanocrystals with a variety of ligands, polymers, biomolecules, or other desired coatings to enhance stability, dispersion, and compatibility with different matrices.
• Scale-up and Fabrication - We assist in scaling up nanocrystal synthesis processes from laboratory scale to larger production volumes.
• Consulting and Technical Support - We guide material selection, process optimization, quality control, and troubleshooting to help you overcome challenges and achieve project goals.

Our Nanocrystal Types

We can help develop a variety of nanocrystalline materials with different surface charges for drug delivery purposes.

Production Methods of Nanocrystal Drugs

Top-down approaches: High‐pressure homogenization (HPH), and Media milling (MM)

• Works for drugs that are insoluble in both aqueous and non-aqueous solvent.
• No organic solvents are used.
• Ease of scale-up.
• Minimal batch to batch variation.
• Narrow size distribution of particles.
• High drug loading efficiency.

Bottom-up approach: Precipitation

• Simple and less expensive.
• Minimal energy requirements.
• Ease of scale‐up.
• Possible non‐stop production.

Combined approach

New microfluidic technique

Fig. 2 Main nanocrystal production techniques. (Zingale E, et al. 2022)

Contact us today to discuss your nanocrystal development needs and discover how our services can accelerate your research, development, and innovation efforts. Let Protheragen-ING be your trusted partner in unlocking the potential of nanotechnology.