Stability and Compatibility of Morphine-Clonidine Admixtures in an Implantable Infusion System

Nonopioid analgesics are often coadministered with intrathecal morphine to increase efficacy. The purpose of this study was to evaluate stability and compatibility of morphine-clonidine admixtures with an implantable infusion system that is commonly used to treat pain patients. Infusion systems were...

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Bibliographic Details
Published in:Journal of pain and symptom management 2003-05, Vol.25 (5), p.464-471
Main Authors: Hildebrand, Keith R, Elsberry, Dennis D, Hassenbusch, Samuel J
Format: Article
Language:English
Subjects:
Analgesics
Analgesics - administration & dosage
Analgesics - chemistry
Analgesics - therapeutic use
Analgesics, Opioid - administration & dosage
Analgesics, Opioid - chemistry
Analgesics, Opioid - therapeutic use
Biological and medical sciences
clonidine
Clonidine - administration & dosage
Clonidine - chemistry
Clonidine - therapeutic use
compatibility
Drug Incompatibility
Drug Stability
Drug Therapy, Combination
Humans
implantable pump
Infusion Pumps, Implantable
intrathecal
Medical sciences
Morphine
Morphine - administration & dosage
Morphine - chemistry
Morphine - therapeutic use
Neuropharmacology
pain
Pain - drug therapy
Pharmacology. Drug treatments
stability
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Summary:Nonopioid analgesics are often coadministered with intrathecal morphine to increase efficacy. The purpose of this study was to evaluate stability and compatibility of morphine-clonidine admixtures with an implantable infusion system that is commonly used to treat pain patients. Infusion systems were filled with admixture and maintained at 37°C for 90 days. Samples were collected monthly. Drug concentrations were determined using stability-indicating, high-performance liquid chromatography. For compatibility testing, individual materials comprising the fluid pathway of the device were immersed in clonidine solution and stored at 37°C for various periods through 64 weeks and mechanical performance evaluated. After 3 months of containment in the infusion system, morphine and clonidine concentrations remained at ≥ 94% of the theoretical starting concentrations. All device materials retained acceptable mechanical performance following clonidine exposure. These results demonstrate that morphine and clonidine are stable when combined in aqueous solution maintained at body temperature in an implantable infusion system for at least 3 months.
ISSN:0885-3924
1873-6513
DOI:10.1016/S0885-3924(03)00041-1