Download in electronic PDF format for $25

Kalchem International - Chemicals and Compounding Supplies

Search the Complete Journal Archives

Compatibility and Stability of Rolapitant Injectable Emulsion Admixed with Intravenous Palonosetron Hydrochloride

Author(s):  Wu George, Yeung Stanley, Chen Frank

Issue:  Jan/Feb 2017 - Volume 21, Number 1
View All Articles in Issue

Abstract:  Neurokinin-1 receptor antagonist, 5-hydroxytryptamine-3 RA, and dexamethasone combination therapy is standard of care for the prevention of chemotherapy-induced nausea and vomiting. Herein we describe the physical and chemical stability of rolapitant injectable emulsion 166.5 mg in 92.5 mL (185 mg hydrochloride salt) admixed with palonosetron injection 0.25 mg in 5 mL (0.28 mg hydrochloride salt). Admixtures were prepared and stored in two types of container closures (110-mL Crystal Zenith plastic and glass bottles) and four types of intravenous administration sets (or intravenous tubing sets). Assessment of the physical and chemical stability was conducted on the admixtures in the ready-to-use container closure systems as supplied by the manufacturer, stored at room temperature (20°C to 25°C under fluorescent light), and evaluated at 0, 1, and 6 hours; 1 and 2 days; and under refrigeration (2°C to 8°C protected from light) after 1, 3, and 7 days. For admixtures in intravenous tubing sets, the assessment of physicochemical stability was performed after 0 and 7 hours of storage at 20°C to 25°C initially, and then after 20 hours (total 27 hours) at 2°C to 8°C protected from light. Physical stability was assessed by visual examination of the container contents under normal room light, and measuring turbidity and particulate matter. Chemical stability was assessed by measuring the pH of the admixture and determining drug concentrations and impurity levels with high-performance liquid chromatographic analysis. The results indicated that all samples were physically compatible throughout the duration of the study. The pH, turbidity, and particulate matter of the admixture stayed within narrow and acceptable ranges. Rolapitant admixed with palonosetron was chemically stable when admixed in glass and Crystal Zenith bottles for at least 48 hours at room temperature and for 7 days under refrigeration, as well as in the four selected intravenous tubing sets for 7 hours at 20°C to 25°C and then for 20 hours at 2°C to 8°C. No loss of potency of any admixed components occurred in the samples stored at the two temperature ranges and time period studied.

Related Keywords: George Wu, PhD, Stanley Yeung, PharmD, Frank Chen, PhD, rolipatant, neurokinin-1 receptor antagonist, NK-1 inhibitor, 5-hydroxytryptamine-3 receptor antagonist, 5-HT3 inhibitor, palonosetron hydrochloride, drug combination, drug admixtures, chemotherapy-induced nausea and vomiting, serotonin pathway, substance P/NK-1 pathway, emesis, antiemetic agents, storage containers, intravenous tubing sets, stability, compatibility, injectable emulsion compound

Related Categories: CANCER AND AIDS, GASTROENTEROLOGY, PARENTERALS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STORAGE

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Compatibility and Stability of Rolapitant Injectable Emulsion Admixed with Intravenous Palonosetron Hydrochloride Wu George, Yeung Stanley, Chen Frank Jan/Feb 2017 76-82 Buy
Compatibility and Stability of Rolapitant Injectable Emulsion Admixed with Dexamethasone Sodium Phosphate Wu George, Yeung Stanley, Chen Frank Jan/Feb 2017 66-75 Buy
Compatibility and Stability of VARUBI (Rolapitant) Injectable Emulsion Admixed with Intravenous Palonosetron Hydrochloride Injection and Dexamethasone Sodium Phosphate Injection Wu George, Powers Dan, Yeung Stanley, Chen Frank Jan/Feb 2018 76-85 Buy
Compatibility and Stability of VARUBI (Rolapitant) Injectable Emulsion Admixed with Intravenous Granisetron Hydrochloride Wu George, Powers Dan, Yeung Stanley, Chen Frank, Neelon Kelly Jan/Feb 2018 86-94 Buy
Compatibility and Stability of Palonosetron Hydrochloride with Gentamicin, Metronidazole, or Vancomycin During Simulated Y-Site Administration Kupiec Thomas C, Ben Michel, Trusley Craig, Trissel Lawrence A Mar/Apr 2008 170-173 Buy
Compatibility and Stability of Palonosetron Hydrochloride with Four Neuromuscular Blocking Agents During Simulated Y-Site Administration Trusley Craig, Ben Michel, Kupiec Thomas C, Trissel Lawrence A Mar/Apr 2008 156-160 Buy
Compatibility and Stability of Palonosetron Hydrochloride with Lactated Ringer's, Hetastarch in Lactated Electrolyte, and Mannitol Injections During Simulated Y-Site Administration Ben Michel, Kupiec Thomas C, Trusley Craig, Trissel Lawrence A Sep/Oct 2008 460-462 Buy
Compounded Pain Formulations: What is the Evidence? Asbill Scott, Sweitzer Sarah M, Spigener Shuler, Romero-Sandoval Alfonso Jul/Aug 2014 278-286 Buy
Basics of Compounding for the Treatment of Warts Allen Loyd V Jr Mar/Apr 2004 126 Buy
Compatibility and Stability of Palonosetron Hydrochloride and Propofol During Simulated Y-Site Administration Trissel Lawrence A, Trusley Craig, Kupiec Thomas C, Ben Michel Jan/Feb 2009 78-80 Buy