Intrathecal Duros Opioid Delivery Using a Precision Miniature Catheter

To deliver drug to a specific target site, DURECT company developed a proprietary miniaturized catheter technology that can be attached to the DUROS® system to direct the flow of drug directly to the target organ within the spinal cord. Undergoing preclinical evaluation, this site-specific delivery enables a therapeutic concentration of a drug to be present at the desired target opioid receptor sites without exposing the entire body of the patient to a similar dose. The precision, miniature size, and performance characteristics of the DUROS® system allows continuous site-specific delivery, using DUROS® with a miniature catheter are presented (Fig. IV-43).

The precision DUROS® Intrathecal Opioid Delivery System is indicated for a number of chronic pain conditions, which include chronic back and leg pain, chronic cancer pain, complex regional pain syndromes (usually in the foot or

Figure IV-43. The DUROS® opioid intrathecal delivery system hand), and painful neuropathy. By directly delivering opioids, such as morphine or hydromorphone, into the intrathecal space surrounding the spinal cord using the DUROS® system, significantly smaller doses of the drug are required to elicit pain relief. A DUROS® Intrathecal (opioid) delivery system presently is at the preclinical stage.

The figure illustrates the DUROS® intrathecal (opioid) delivery system with a catheter, which is surgically implanted subcutaneously near the target-site of drug administration. The proprietary miniature catheter is attached to the DUROS® system and tunneled under the skin to the site where opioid is to be delivered. The DUROS® system is designed to deliver the drug at a constant, preset rate through the catheter to the targeted intrathecal site for a prescribed duration of approximately 3 months. The proprietary catheter has a hold-up volume of about 20 ju,l.

DUROS® Intrathecal Opioid Delivery System has a nominal volume-pumping rate of 10 ^l/day (0.42 ^l/h). The following figure demonstrates a constant volume-pumping rate from a DUROS® system over 100 days. The in vitro pumping rate was determined by placing the systems in an aqueous buffer solution at 37 °C, and by measuring the effluent from the systems at preset time intervals. Both the initial start-up time and completion of systems pumping action are predictable and reproducible between different systems (Fig. IV-44). By varying the drug concentration in the reservoir, the opioid can be intrathecally administered at the rate from 10 to 100 ^g/h.

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Figure IV-44. In vitro release rate from the DUROS® opioid intrathecal delivery system

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