Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia

Author(s):  Robert Julien, Sorrieul Jérémy, Rossignol Elsa, Beaussart Hélène, Kieffer Hélène, Folliard Caroline, Dupoiron Denis, Devys Catherine

Issue:  Jul/Aug 2017 - Volume 21, Number 4
View All Articles in Issue

Page(s):  347-351

Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia Page 1
Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia Page 2
Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia Page 3
Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia Page 4
Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia Page 5

Download in electronic PDF format for $75

Abstract:  Pain is the most feared symptom amongst individuals living with cancer. In 15% to 20% of patients, conventional analgesic therapy either fails to relieve pain or induces adverse effects. Intrathecal drug delivery systems may present an effective alternative for pain management. The Cancerology Center Paul Papin protocol includes an admixture of morphine, ropivacaine, and ziconotide in intrathecal preparations. These drugs are administered by a fully implantable or an external pump. Syringes or polyolefin infusion bags are prepared for refill just before use. Few centers in France use the method of intrathecal analgesia. Therefore, for those patients receiving intrathecal preparations, each filling requires that the patients be transported from their local hospital (or their home) to a referral center where the patients are monitored. They sometimes must travel up to a hundred kilometers to have a pump filled. The preparation and the analytical control of the mixture are carried out only by those centers meeting the proper criteria, which includes the proper equipment. To spare the patient this travel, a peripheral center may be subcontracted to manage the patient’s pump refill. No data are available concerning the chemical stability of admixtures in syringes or polyolefin infusion bags. The aim of this study was to evaluate, with a new analytical method using ultra high-performance liquid chromatography, the chemical stability of these admixtures in syringes or in polyolefin infusion bags. Ziconotide 1 µg/mL was combined with ropivacaine (7.5 mg/mL) and morphine (3.5 mg/mL) in syringes at 5°C, 21°C, and 31°C, and in polyolefin infusion bags at 21°C. Assays were performed using ultra high-pressure liquid chromatography. In syringes stored at 21°C and 31°C, concentrations after 6 hours were not in the acceptable criterion of 10% variability. When syringes were stored at 5°C, the residual concentration of ziconotide after 3 days was 100.5% +/- 2.6% [92.7% to 108.4%]. In polyolefin infusion bags, the residual concentration of ziconotide after 14 days was 96.9% +/- 2.2% [90.1% to 103.6%]. This study demonstrates the chemical stability of this admixture in syringes stored at 5°C for 3 days and in polyolefin plastibags stored at 21°C for 14 days.

Related Keywords: Julien Robert, Pharmacy Resident, Jérémy Sorrieul, PharmD, Elsa Rossignol, Engineer, Biochemistry, Hélène Beaussart, PharmD, Hélène Kieffer, PharmD, Caroline Folliard, PharmD, Denis Dupoiron, MD, Catherine Devys, PharmD, morphine, ropivacaine, ziconotide, drug admixtures, intrathecal analgesia, pain relief, pain control, compounded sterile preparations, chemical stability, storage

Related Categories: CANCER AND AIDS, PAIN MANAGEMENT, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS, STORAGE

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia
Robert Julien
, Sorrieul Jérémy, Rossignol Elsa, Beaussart Hélène, Kieffer Hélène, Folliard Caroline, Dupoiron Denis, Devys Catherine
Jul/Aug 2017
Pg. 347-351

Physicochemical Stability of Ternary Mixtures of Sufentanil, Baclofen, and Ropivacaine in Polypropylene Syringes for Intrathecal Analgesia
Sorrieul Jérémy
, Robert Julien, Chapel Fanny, Gossye Thomas, Devys Catherine
Mar/Apr 2020
Pg. 156-162

Chemical Stability of Admixtures Combining Ziconotide with Fentanyl or Sufentanil During Simulated Intrathecal Administration
Shields David E
, Aclan Jennifer, Szatkowski Aaron
Sep/Oct 2008
Pg. 463-466

Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula
Hossain Mohammad Faisal
, Levesque Dan, Frye John, Rashid Mamoon
Jul/Aug 2020
Pg. 322-326

Chemical Stability of Admixtures Containing Ziconotide 25 mcg/mL and Morphine Sulfate 10 mg/mL or 20 mg/mL During Simulated Intrathecal Administration
Shields David E
, Aclan Jennifer, Szatkowski Aaron
Nov/Dec 2008
Pg. 553-557

Dilution and Compounding of Ziconotide for Intrathecal Administration
Buchta Tony
, Fakata Keri, Stuart William
May/Jun 2008
Pg. 200-207

Compounding for Diabetic Patients:An Interview with Paul Lofholm, PharmD
Allen Loyd V Jr
Nov/Dec 1997
Pg. 381-385

Chemical Stability of Progesterone in Compounded Oral Rapid-dissolving Tablets
Sayre Casey L
, Cox Christopher, Velazquez Gabriel, Le Minh Thi, Nguyen Amy Hong, Ramos Marjorie, Burrows Anna, Yellepeddi Venkata Kashyap
Jan/Feb 2019
Pg. 62-64

Stability Studies of Fludrocortisone Acetate Capsules and Fludrocortisone Acetate Titrated Powders (Powder Triturates)
Brandin Thibaut
, Wasilewski Maya, Panuccio Camille, Bouguergour Cyrielle, Primas Nicolas, Lamy Edouard, Jean Christophe, Bertault-Peres Pierre, Rathelot Pascal, Curti Christophe, Vanelle Patrice
Mar/Apr 2022
Pg. 150-154

Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Clonidine Hydrochloride Packaged in Plastic Syringes
Xu Quanyun A
, Trissel Lawrence A, Pham Lien
Jan/Feb 2002
Pg. 66-69

Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Bupivacaine Hydrochloride Packaged in Plastic Syringes
Trissel Lawrence A
, Xu Quanyun A, Pham Lien
Jan/Feb 2002
Pg. 70-73

Finding the Right Balance: A Nationwide Study of Student Pharmacist Exposure to and Perceptions of Nonsterile Compounding
Fredrickson Mary E
, Belcher Faith G, Del Vecchio Kamryn N, Galleher Miranda N, Jugo Leila S, Gothard M David, Pallotta Raneem H, Pallotta Victor A Jr
May/Jun 2022
Pg. 242-247

Chemical Stability of Hydromorphone Hydrochloride in Patient-Controlled Analgesia Injector
Khondkar Dristi
, Chopra Poonam, McArter John P, Rosen Joseph A, Li S Kevin
Mar/Apr 2010
Pg. 160-164

Stability of Extemporaneously Prepared Hydroxycarbamide Oral Suspensions
Kabiche Djamila
, Balde Issa-Bella, Majoul Elyes, Kabiche Sofiane, Bourguignon Elodie, Fontan Jean-Eudes, Cisternino Salvatore, Schlatter Joel
Mar/Apr 2017
Pg. 160-163

Development and Validation of a Stability-indicating High-performance Liquid Chromatographic Method for Quantification of Progesterone in Compounded Glycerinated Gelatin Troches
Burrows Anna C
, Yellepeddi Venkata Kashyap, Snyder Spencer, Wakefield Meagan, Jackson David, Huynh Johnny, Nguyen Khoa, Sayre Casey L
Jul/Aug 2019
Pg. 340-350

Stability of Furosemide 5 mg/mL in Polypropylene Syringes
van der Schaar JAJ
, Grouls R, Franssen EJF, Crul M
Sep/Oct 2019
Pg. 414-417

Physical and Chemical Stability of Pharmaceutical Preparation of Bumetanide and Scopolamine
Catry Emilie
, Colsoul Marie-Louise, Closset Melanie, Hubert Justine, Soumoy Laura, Bihin Benoit, Thiry Emmanuell, Jamart Jacques, Hecq Jean-Daniel, Galanti Laurence
May/Jun 2022
Pg. 248-254

Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design
Patel Gopesh
, Davis Countaney, Liu Yi, Ip Kendice, Debideen Krystal E, Anderson Stephanie, Byrne Robert, Herr Dylan, Rhoads Melissa Merrell, Caputo Ross, Banov Daniel, Bassani August S
Jan/Feb 2021
Pg. 73-81

Evaluation of Containment Ventilated Enclosure Performance in Absence of Negative Pressure Containment Secondary Engineering Control
Hutson Chad
, Day A J
Nov/Dec 2019
Pg. 511-518

Stability of Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions in SyrSpend SF pH4
Espana B
, Joseph-Tornabène F, Jaquet Cécile, Perrot S, Prouillac C
Jul/Aug 2020
Pg. 327-336

Return to Top