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.

Prolonged In-use Stability of Reconstituted Herceptin in Commercial Intravenous Bags

Author(s):  Nalenz Heiko, Köpf Ellen, Dietel Elke

Issue:  Sep/Oct 2018 - Volume 22, Number 5
View All Articles in Issue

Abstract:  Herceptin is a humanized monoclonal antibody that selectively binds to the extracellular domain of human epidermal growth factor receptor 2 (HER2). Herceptin has an important role in the treatment of HER2-positive breast cancer when used in the neoadjuvant, adjuvant, and metastatic settings, and in the treatment of HER2-positive metastatic gastric cancer, and gastroesophageal junction adenocarcinoma. Prior to intravenous infusion, Herceptin must be reconstituted with sterile water for injection and then diluted in intravenous bags with normal saline. The objective of this study was to test the in-use physicochemical stability of the Herceptin drug product after dilution in 0.9% sodium chloride in commercial polyvinylchloride, and polyolefin/ polyethylene/polypropylene infusion bags over the course of a 7-day storage at 2°C to 8°C followed by 24 hours of storage at 30°C with ambient light exposure. Three batches of Herceptin were reconstituted to yield a 21-mg/mL solution that was stored for 48 hours at 2°C to 8°C prior to dilution with 0.9% sodium chloride to create low (0.24-mg/mL) and high (3.84-mg/mL) concentration solutions that were then tested in simulated infusions with a polyvinylchloride or polyolefin/polyethylene/polypropylene infusion bag. Samples for analysis were obtained immediately after dilution of the reconstituted solution (T0), after 7 days of storage at 5°C (T7), after 1 further day of storage at 30°C (T7+1), and after administration through intravenous tubing (Tend). Control samples were obtained from bags containing only 0.9% sodium chloride at each time point. For experiments with both infusion bags, all samples were practically free from particles, were colorless, and had low numbers of subvisible particles with no differences between control and experimental samples. No change in turbidity was detected between T0 and Tend for low and high-concentration samples for each batch. The pH values remained consistent between T0 and T7+1, and osmolality values were consistent across low-concentration and high-concentration samples. Protein content, size, and potency remained consistent throughout storage and simulated infusion. In conclusion, Herceptin remains physicochemically stable for 7 days when stored at 2°C to 8°C, followed by an additional 24 hours at 30°C when diluted in 0.9% sodium chloride and stored in commercially available polyvinylchloride or polyolefin/polyethylene/polypropylene infusion bags.

Related Keywords: Heiko Nalenz, PhD, Ellen Köpf, PhD, Elke Dietel, PhD, herceptin, human epidermal growth factor receptor 2, HER2 antibody, HER2-positive breast cancer, HER2-positive gastric cancer, gastroesophageal junction adenocarcinoma, polyvinylchloride infusion bags, polyolefin/polyethylene/polypropylene infusion bags, compatability, physical stability, chemical stability

Related Categories: CANCER AND AIDS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, ENDOCRINOLOGY/HORMONES/ MENOPAUSE/ANDROPAUSE, STORAGE

Printer-Friendly Version




Download in electronic PDF format for $35

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Prolonged In-use Stability of Reconstituted Herceptin in Commercial Intravenous Bags Nalenz Heiko, Köpf Ellen, Dietel Elke Sep/Oct 2018 417-423 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
Providing Positive Outcomes through Compounding for Animal Cancer Patients Davidson Gigi S Jul/Aug 2000 264-272 Buy
The Hormonal Link to Breast Cancer: The Estrogen Matrix Zava David T Jul/Aug 2002 250-254 Buy
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr Nov/Dec 2003 449-450 Buy
The Effects of Compounded Bioidentical Transdermal Hormone Therapy on Hemostatic, Inflammatory, and Immune Factors; Cardiovascular Biomarkers; Quality of Life Measures; and Health Outcomes in Perimenopausal and Postmenopausal Women Stephenson Kenna, Neuenschwander Pierre F, Kurdowska Anna K Jan/Feb 2013 74-85 View Sample
Surviving Cancer - How the Compounding Pharmacist Can Help Maddox Suzan Jul/Aug 2000 257-260 Buy
Estrogen and Breast Cancer: Is There a Link? Gever Marcy Portnoff Jan/Feb 1998 21-23 Buy
Physiochemical Stability of Diluted Trastuzumab Infusion Solutions in Polypropylene Infusion Bags Kaiser Jeanette, Kramer Irene Nov/Dec 2011 515-520 Buy
In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers Bhattacharya Sisir, Parekh Satish, Dedhiya Mahendra Sep/Oct 2015 432-436 Buy