Benefits of NanoCrystal® Technology Parenteral (IV/SC or IM) Products include:

• Avoidance of Harsh Vehicles
• pH extremes eliminated
• Organic Solvents eliminated
• Ability to Modulate Distribution and PK
• Platform for Targeting
• Enhancing Efficacy/Decreasing Toxicity
• Large Dose/Small Volume
• Capability for sterile filtering             

Nanocrystal Colloidal Dispersions™ of poorly water-soluble drugs can also provide improved performance characteristics for intravenous, subcutaneous or intramuscular dosage forms. Aqueous Nanocrystal Colloidal Dispersions ™ are formulated with concentrations between 50 mg/mL and 400 mg/mL. For injectables, NanoCrystal® particle sizes may be typically less than 100nm, and allow for safe and effective passage through capillaries. Injectable NanoCrystal® formulations have proven successful in Phase I and II clinical trials.

The data compares the plasma levels after a single infusion of two formulations of a poorly water-soluble drug over two hours. Nanoformulations™ achieve significantly greater drug concentration than the cyclodextrin formulation, without the use of any harsh excipients. Clearance is notably similar. For more detail on work undertaken with Itraconazole, see the following paper “Pharmacokinetics of Itraconazole and Hydroxyitraconazole in Healthy Subjects after Single and Multiple Doses of a Novel Formulation” J.W. Mouton et al., Antimicrobial Agents and Chemotherapy, Dec 2006, pp4096-4102".

NanoCrystal® Technology has permitted the creation of insoluble parenteral products devoid of undesirable co-solvents.

Efficacy studies in Murine Tumor Models following Paclitaxel IV Injection (MTD) 3X

Sterile filtration
NanoCrystal® size range suitable for sterile filtration

NanoCrystal® Technology can deliver average crystal sizes of 100 nm or less. For some poorly soluble compounds, NanoCrystal® Technology is a valuable way to achieve sterile filtration of a crystalline dispersion. As illustrated in this example, 99.7% of the crystals were smaller than 200 nm. 

The particle size of this Nanocrystal Colloidal Dispersion™ of a proprietary client compound shows the narrow particle size distribution attainable with NanoCrystal® Technology. Greater than 99.7% of the drug crystals were smaller than 200 nm.