Elan Drug Technologies

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Injectable Route of Administration

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
• potential for long acting formulations (1 week, 1 month, 3-6 months)

NanoCrystal Colloidal Dispersion^® formulations of poorly water-soluble drugs can also provide improved performance characteristics for intravenous, subcutaneous or intramuscular dosage forms. Injectable aqueous NanoCrystal Colloidal Dispersion^® compositions are formulated with drug concentrations between 50 mg/mL and 400 mg/mL. For injectables, the size of the NanoCrystal^® particles are critical. Injectable NanoCrystal^® formulations have proven successful in Phase I, II and III clinical trials.

 

Janssen’s (J&J’s) one month paliperidone palmitate (Invega® Sustenna™) depot injection which was approved by US FDA in July 2009 uses EDT’s NanoCrystal® technology.

The data compares the plasma levels after a single infusion of two itraconazole formulations over two hours. The NanoCrystal^® formulation achieves a significantly greater drug concentration than the formulation using cyclodextrin, a harsh excipient. 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".

Through the application of NanoCrystal^® technology insoluble parenteral products can be developed, devoid of undesirable co-solvents and excipients.

Sterile filtration
NanoCrystal® technology can deliver average particle sizes of 100 nm or less. As illustrated by the example below, 99.7% of drug particles were smaller than 200 nm.  By identifying a unique combination of drug and surface stabilisers, a NanoCrystal Colloidal Dispersion® formulation was successfully sterilised by filtration.