Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures
In-vitro-Untersuchung zur Langzeit-Stabilität von CT-P6 in verschiedenen Konzentrationen: 21 mg/ml (Stammlösung), Verdünnung auf Endkonzentration 2,4 mg/ml bzw. 0,8 mg/ml Die unterschiedlichen Konzentrationen wurden jeweils bei 4 °C und 22 °C gelag...
Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures
Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures
Vieillard V et al.
GaBI Journal 2018; 7(3): 101-10
Abstract
Objectives: This study assessed the long-term stability of the trastuzumab biosimilar CT-P6
(Herzuma®, Biogaran) in vials under various storage conditions; after reconstitution of the
lyophilized powder (21 mg/mL) and after dilution for final concentrations of 0.8 mg/mL and 2.4
mg/mL in polyolefin bags, stored at 4 °C and 22 °C.
Methods: The physical and chemical stability of the drug was evaluated by several
complementary methods.
Results: After 90 days of storage at both 4° C and 22 °C, no signs of physical instability, such as
the formation of aggregates or oligomers, were observed, regardless of the antibody
concentration. After 90 days at 4 °C, there was no change in the distribution of the seven ionic
variants of the compound. The tertiary structure of the compound was unaltered after storage for
28 days at 4 °C.
Discussion: When stored at 22 °C for 28 days, tertiary structure was slightly altered and there
were signs of hydrolysis, but no observable aggregate formation or significant signs of
thermodynamic destabilization. The same conclusions can be made for reconstituted vials at 21
mg/mL.
Conclusion: The trastuzumab biosimilar CT-P6 remained physically and chemically stable for at
least 90 days, when stored at 4 °C and away from light. These results strongly support the safe use
of this biosimilar in several contexts such as preparation in advance, dose banding, supply of
prepared but un-administered drug or cold chain rupture. Such usage could improve patient
management, lessen nurse and pharmacy workload, and avoid non-justified losses of this
expensive drug.
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Extended stability of the rituximab biosimilar CT-P10 in its opened vials and after dilution and storage in polyolefin bags
In-vitro-Untersuchung der Langzeit-Stabilität von CT-P10 in verschiedenen Konzentrationen: 10 mg/ml (Stammlösung), Verdünnung auf Endkonzentration 4 mg/ml bzw. 1 mg/ml Die unterschiedlichen Konzentrationen wurden jeweils bei 4 °C und 25 °C gelagert. Auch bei Abreißen der Kühlk...
Extended stability of the rituximab biosimilar CT-P10 in its opened vials and after dilution and storage in polyolefin bags
Extended stability of the rituximab biosimilar CT-P10 in its opened vials and after dilution and storage in polyolefin bags
Viellard V et al.
Ann Pharm Fr. 2017; 75: 420-435
Summary
The stability of the rituximab biosimilar CT-P10, in 50 mL vials at a concentration of
10 mg/mL, and after dilution to final concentrations of 1 and 4 mg/mL and storage in polyolefin
bags at 4 °C and 25 °C was studied by several orthogonal and complementary methods. No
significant change (as defined by a magnitude greater than the inter-batch variability) was
observed, for each of the parameters characterizing physical and chemical stability studied,
for the two concentrations and temperatures tested, or for any of the three batches tested.
This implies that cold-chain rupture and exposure to room temperature up to 15 days both for
vials and diluted bags have no deleterious consequence on the quality of the product. Moreover,
this extended stability permits safe in-advance preparation, dose-banding or flat-dose, that to
avoid unnecessary delays in the management of the patient, improvement of the pharmacy and
nurse workload and money saving by avoiding non justified losses of this expensive drug.
© 2017 Academie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.
Report Physicochemical stability of Vegzelma 25 mg/mL concentrate for solution for infusion in original vials after first opening
In-vitro-Untersuchung der Langzeit-Stabilität von CT-P16 Die offenen Vials der Konzentration zur Herstellung einer Infusionslösung wurden jeweils lichtgeschützt bei 25 °C oder 2-8 °C 28 Tage lang gelagert. Auch bei Abreißen der Kühlkette und Lagerung bei Raumtemperatur f...
Report Physicochemical stability of Vegzelma 25 mg/mL concentrate for solution for infusion in original vials after first opening
Report Physicochemical stability of Vegzelma 25 mg/mL concentrate for solution for infusion in original vials after first opening
Linxweiler H et al.
Hospital Pharmacy, Universitätsmedizin Mainz
Study of the stability of Bevacizumab after opening, after dilution or during a temperature excursion
In-vitro-Untersuchung zur Langzeit-Stabilität von CT-P16 in verschiedenen Konzentrationen: 100 mg/4 ml und Verdünnung auf Endkonzentration 1,4 mg/ml bzw. 16,5 mg/ml Die unterschiedlichen Konzentrationen wurden für 72 h bei 25 °C und anschließend für 24 h bei 2-8 °C gelagert. CT-P16 zeigt sowoh...
Study of the stability of Bevacizumab after opening, after dilution or during a temperature excursion