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Dilution and Compounding of Ziconotide for Intrathecal Administration

Author(s):  Buchta Tony, Fakata Keri, Stuart William

Issue:  May/Jun 2008 - Pain Management
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Abstract:  Intrathecal therapy is an established treatment option for patients with severe chronic pain who do not receive adequate relief from less invasive methods. Ziconotide is the only nonopioid analgesic approved by the U.S. Food and Drug Administration for intrathecal administration. Ziconotide is approved for monotherapy only, but combination intrathecal therapy is considered an acceptable treatment option by experts in the field. When ziconotide is administered as monotherapy, the stability exceeds the refill intervals recommended in the ziconotide prescribing information. Compounding ziconotide with other intrathecal drugs speeds ziconotide degradation, but the stability loss does not increase patient risk for withdrawal symptoms, because ziconotide dose reductions are not associated with adverse effects and the drugs compounded with ziconotide remained stable in a series of studies. Results from in vitro studies suggest that the stability of ziconotide can be maximized by diluting commercial ziconotide formul

Related Keywords: Tony Buchta, RPh, Keri Fakata, PharmD, William Stuart, RPh, ziconotide, chronic pain, pain control, pain management, intrathecal administration, intraspinal administration, analgesia, analgesics, infusion pumps, stability, degradation, nitrogen sparging, sterile preparations, methionine

Related Categories: PAIN MANAGEMENT, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS, DOSAGE FORMS/DRUG CARRIERS

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