Delivery Systems

ITI can offer a range of delivery device options. These include:

• Unit dose delivery
• Bi dose delivery
• Multi-dose delivery

Unit dose delivery technology

By supplying the dose in discrete single use, unit dose devices, these products have advantages over multidose spray pumps in terms of:

• Sterility
• Preservative free formulations
• Bioburden reduction

Unit dose technology is appropriate for products requiring discrete treatment events e.g. migraine pain relief, seizure treatment or vaccination. It is easily administered by either a patient performing self administration or by a third party e.g. parent or nurse. Typically the dose volume is very small (~100 microliters) which aids in patient acceptance of nasal delivery. Dose accuracy is very high which is particularly important in products with a narrow therapeutic index.

For drug products subject to abuse, unit dose delivery technology keeps to a minimum the product available in a prescribing event and have a low residual dose following actuation.

ITI is utilizing proven device technology for unit dose delivery.

Bi dose delivery technology

Some products may demand or require that the dose is available in two discrete sprays. Typically this is administered as one spray per nostril. Two different populations may be served (e.g. pediatric and adult) with one SKU by offering the option of one or two sprays.

The advantages of unit dose delivery technology (sterility, preservative free and Bioburden reduction) are retained in bi-dose technology since the product is used once by a patient.