Vieillard V, Paul M, Ibrahim T, Astier A
UPREC, service de pharmacie, groupe hospitalo-universitaire Henri-Mondor, 51, avenue du Maréchal-de-Lattre-de-Tassigny, 94010 Créteil, France.
UPREC, service de pharmacie, groupe hospitalo-universitaire Henri-Mondor, 51, avenue du Maréchal-de-Lattre-de-Tassigny, 94010 Créteil, France.
Ann Pharm Fr. 2017 Nov;75(6):420-435. doi: 10.1016/j.pharma.2017.06.003. Epub 2017 Aug 4.
The stability of the rituximab biosimilar CT-P10, in 50mL vials at a concentration of 10mg/mL, and after dilution to final concentrations of 1 and 4mg/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.
通过多种正交和互补方法研究了利妥昔单抗生物类似药CT-P10在50mL小瓶中浓度为10mg/mL时，以及稀释至最终浓度1mg/mL和4mg/mL并在聚烯烃袋中于4°C和25°C储存后的稳定性。对于所测试的两种浓度和温度，或所测试的三批中的任何一批，在所研究的表征物理和化学稳定性的每个参数方面，均未观察到显著变化（定义为变化幅度大于批次间变异性）。这意味着小瓶和稀释袋的冷链中断以及暴露于室温长达15天对产品质量均无有害影响。此外，这种延长的稳定性允许提前安全制备、剂量分组或固定剂量，从而避免患者管理中的不必要延误，改善药房和护士的工作量，并通过避免这种昂贵药物的不合理损失节省资金。
