Bot Detector
Download FREE Sample Issue or Article
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.

Stability of Morphine Sulfate in Polypropylene Infusion Bags for Use in Patient-Controlled Analgesia Pumps for Postoperative Pain Management

Author(s):  Nguyen-Xuan Tho, Griffiths William, Kern Christian, Van Gessel Elisabeth, Bonnabry Pascal

Issue:  Jan/Feb 2006 - Sports Medicine
View All Articles in Issue

Page(s):  69-73

Download in electronic PDF format for $65

Abstract:  The objective of this study was to develop a stable intravenous solution of 1-mg/mL morphine sulfate in polypropylene bags for use in patient-controlled analgesia pumps for postoperative pain management. Three large-scale batches of 1-mg/mL morphine sulfate solution filled into polypropylene bags and terminally sterilized at 120°C for 20 minutes were used in this study. The stability of the drug was monitored at 3, 6, 12, 18, 24, and 36 months after preparation in a longterm study (25°C) and after 3 and 6 months in accelerated studies (30° and 40°C) using a stability-indicating high-performance liquid chromatography assay. The levels of degradation products (morphine-N-oxide and pseudomorphine) were determined. Measures of physical stability included pH values, presence of subvisible particles, and weight loss. Microbiological stability was tested by performing sterility tests. There was practically no loss of morphine, and impurity contents were very low. Subvisible particles were below pharmacopeial specifications. No significant change in pH was observed and water losses were minimal. The sterility of the bags was demonstrated throughout the study. In conclusion, terminally sterilized 1-mg/mL morphine sulfate solution packed in polypropylene bags is stable for at least 3 years when stored at 25°C.

Related Keywords: Tho Nguyen-Xuan, MSc, PhD, William Griffiths, MRPharmS, Christian Kern, MD, Elisabeth Van Gessel, MD, Pascal Bonnabry, PhD, morphine sulfate, stability, polypropylene bags, infusion, postoperative pain control, postsurgical pain relief, PCA, analgesic, patient-controlled analgesia


Printer-Friendly Version

Related Articles from IJPC
(Click for Abstract / Details / Purchase)
Stability of Morphine Sulfate in Polypropylene Infusion Bags for Use in Patient-Controlled Analgesia Pumps for Postoperative Pain Management
Nguyen-Xuan Tho
, Griffiths William, Kern Christian, Van Gessel Elisabeth, Bonnabry Pascal
Jan/Feb 2006
Pg. 69-73

Compounded Analgesic Therapy for Disorders of Movement: Arthritis, Neuropathic Pain, and Postpolio Syndrome
Brown Scott
, Erickson Brian, Muller George, Bryant-Snure Susan J, Mestayer Richard F III
May/Jun 2010
Pg. 182-192

Topical Ketamine 10% for Neuropathic Pain in Spinal Cord Injury Patients: An Open-Label Trial
Rabi Joseph
, Minori Joshua, Abad Hasan, Lee Ray, Gittler Michelle
Nov/Dec 2016
Pg. 517-520

Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump
Tomasello Cristina
, Leggieri Anna, Rabbia Franco, Veglio Franco, Baietto Lorena, Fulcheri Chiara, De Nicolò Amedeo, De Perri Giovanni, D'Avolio Antonio
Jul/Aug 2016
Pg. 343-346

Long-term Stability of Morphine Hydrochloride in 0.9% NaCl Infusion Polyolefin Bags After Freeze-thaw Treatment and in Polypropylene Syringes at 5°C ± 3°C
Hecq J-D
, Godet M, Gillet P, Jamart J, Galanti L
Jan/Feb 2014
Pg. 78-82

Compounded Pain Formulations: What is the Evidence?
Asbill Scott
, Sweitzer Sarah M, Spigener Shuler, Romero-Sandoval Alfonso
Jul/Aug 2014
Pg. 278-286

Stability of Gentamicin Sulfate and Tobramycin Sulfate in AutoDose Infusion System Bags
Xu Quanyun A
, Trissel Lawrence A, Saenz Christopher A, Ingram Delshalonda S
Mar/Apr 2002
Pg. 152-154

Chemical Stability of Fentanyl in Polypropylene Syringes and Polyvinylchloride Bags
Donnelly Ronald F
Nov/Dec 2005
Pg. 482-483

Long-term Physiochemical Stability of Concentrated Solutions of Salbutamol (Albuterol) in Polypropylene Syringes for Use in the Intensive Care Unit and in Obstetrics
Lardinois Benjamin
, Baltzis Alexandre, Delcave Charlotte, Soumoy Laura, Jamart Jacques, Bihin Benoît, Hecq Jean-Daniel, Galanti Laurence
Sep/Oct 2019
Pg. 434-437

Pain Management in the Elderly
Peralta Alexander Jr
May/Jun 2004
Pg. 187-191

Particle Measuring Systems - USP <797> Environmental Monitoring Solutions