Download in electronic PDF format for $25

Search the Complete Journal Archives

Physico-chemical Stability of MabThera Drug-product Solution for Subcutaneous Injection under In-use Conditions with Different Administration Materials

Author(s):  Mueller Claudia,Dietel Elde,Heynen Severin R,Nalenz Heiko,Goldbach Pierre,Mahler Hanns-Christian,Schmidt Johannes,Grauschopf Ulla,Schoenhammer Karin

Issue:  May/Jun 2015 - Volume 19, Number 3
View All Articles in Issue

Abstract:  MabThera is an essential component of the standard-of–care regimens in the treatment of non-Hodgkin lymphoma and Chronic Lymphatic Leukemia. MabThera for subcutaneous injection is a novel line extension that has been approved by the European Medicines Agency for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. This study aimed to evaluate in-use stability data of MabThera subcutaneous drug-product solution in single-use syringes for subcutaneous administration according to the European Medicines Agency guideline. The drug-product solution was exposed to material contact surfaces of five different administration setups commonly used in subcutaneous drug delivery. MabThera subcutaneous was transferred under aseptic conditions into polypropylene and polycarbonate syringes and stored for 1, 2, and 4 weeks at 2°C to 8°C followed by 24 hours at 30°C. After storage, subcutaneous administration was simulated and MabThera subcutaneous drug-product solution quality attributes were evaluated by using compendial physico-chemical tests, as well as suitable and validated molecule- and formulation-specific analytical methods. MabThera subcutaneous vials were treated and analyzed in parallel. The physicochemical results of MabThera subcutaneous in the different setups were comparable to the control for all timepoints. No change in drug-product quality after storage and simulated administration was found compared to the control. However, since single-dose products do not contain preservatives, microbial contamination and growth needs to be avoided and product sterility needs to be ensured. The results showed that MabThera subcutaneous remains compatible and stable, from a physico-chemical perspective, for up to 4 weeks at 2°C to 8°C followed by 24 hours at 30°C with the contact materials tested in this study. In order to avoid and minimize microbial growth, MabThera subcutaneous should be used immediately after removal from the original packaging container and strict aseptic handling conditions need to be followed.

Related Keywords: Claudia Mueller, PhD, Elke Dietel, PhD, Severin R. Heynen, PhD, Heiko Nalenz, PhD, Pierre Goldbach, PhD, Hanns-Christian Mahler, PhD, PD, Johannes Schmidt, PhD, Ulla Grauschopf, PhD, Karin Schoenhammer, PhD, MabThera drug product solution, rituximab, CD20, lymphoma, B-cell leukemia, autoimmune disorders, intravenous immunoglobulin, subcutaneous administration, hyaluronidase, stability


Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Physico-chemical Stability of MabThera Drug-product Solution for Subcutaneous Injection under In-use Conditions with Different Administration Materials Mueller Claudia, Dietel Elde, Heynen Severin R, Nalenz Heiko, Goldbach Pierre, Mahler Hanns-Christian, Schmidt Johannes, Grauschopf Ulla, Schoenhammer Karin May/Jun 2015 261-267 Buy
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr Nov/Dec 2003 449-450 Buy
Quality Assurance for Sterile Products Kastango Eric S, Douglass Kate Jul/Aug 2001 246 Buy
Autoclaves for the Sterilization of Compounded Parenteral Products Rahe Hank Mar/Apr 2003 114 Buy
How to Handle a Product Recall Allen Loyd V Jr Jul/Aug 2003 292-293 Buy
Final Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A Blankenship Cynthia E Sep/Oct 2014 379-380 Buy
Basics of Sterile Compounding: Biopharmaceutics of Injectable Dosage Forms Akers Michael J Jan/Feb 2017 47-56 Buy
PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs Allen Loyd V Jr Sep/Oct 2017 356 Buy
Long-term Stability of Vancomycin Hydrochloride in Oral Solution: The Brand Name Versus a Generic Product Huvelle Sophie, Godet Marie, Hecq Jean-Daniel, Gillet Patricia, Jamart Jacques, Galanti Laurence M Jul/Aug 2016 347-350 Buy
Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines Allen Loyd V Jr Jul/Aug 2016 351 View Sample