Boston Medical Center, Boston, MA, USA.
Curr Med Res Opin. 2011 Dec;27(12):2241-3. doi: 10.1185/03007995.2011.628304. Epub 2011 Oct 12.
Sodium ferric gluconate in complex (SFG) is used to treat iron deficiency anemia in patients aged ≥6 years undergoing chronic hemodialysis and receiving supplemental epoetin therapy. Both the branded product (Ferrlecit, branded SFG) and a new generic version of sodium ferric gluconate in complex (Nulecit; generic SFG) are provided in 5 mL vials. SFG may be administered by slow intravenous (IV) injection of the undiluted product or by 1 h IV infusion after dilution in 100 mL 0.9% sodium chloride. This study evaluated the short-term stability of undiluted and diluted generic SFG at room temperature and under refrigeration.
Samples of generic SFG undiluted in 10 mL syringes or diluted in IV infusion bags containing 0.9% sodium chloride solution were stored at room temperature or under refrigerated conditions (2-8°C). Samples at room temperature were stored for ≤48 h if undiluted and for ≤24 h if diluted. All refrigerated samples were stored for ≤7 days. Parameters evaluated were elemental iron (Fe) concentration and SFG apparent molecular weight. All tests were performed on two lots of the generic product.
Fe concentrations were identical in both lots and did not vary substantially over time under different conditions of storage or dilution. SFG apparent molecular weight varied across all samples from 306,000 to 354,000 Daltons, well within the range of 289,000 to 440,000 Daltons specified as the molecular weight in the FDA-approved prescribing information.
Iron content and SFG apparent molecular weight were stable under all experimental conditions. Undiluted generic SFG was stable for ≥2 days at room temperature and ≥7 days under refrigerated conditions, and generic SFG diluted in IV infusion bags containing 0.9% sodium chloride solution was stable for ≥1 day at room temperature and ≥7 days under refrigerated conditions.
在接受补充促红细胞生成素治疗的、年龄≥6 岁的慢性血液透析患者中，葡萄糖酸铁钠复合物（SFG）用于治疗缺铁性贫血。品牌产品（Ferrlecit，品牌 SFG）和一种新的葡萄糖酸铁钠复合物的通用版本（Nulecit；通用 SFG）均以 5mL 小瓶提供。SFG 可以通过不稀释产品的缓慢静脉内（IV）注射或在 100mL 0.9%氯化钠中稀释后进行 1 小时 IV 输注来给药。本研究评估了未稀释和稀释的通用 SFG 在室温下和冷藏条件下的短期稳定性。
在 10mL 注射器中未稀释的或在含有 0.9%氯化钠溶液的 IV 输注袋中稀释的通用 SFG 样品分别在室温或冷藏条件（2-8°C）下储存。未稀释的样品在室温下储存时间≤48 小时，稀释的样品储存时间≤24 小时。所有冷藏样品均储存≤7 天。评估的参数为元素铁（Fe）浓度和 SFG 表观分子量。对两个批次的通用产品均进行了所有测试。
两个批次的铁浓度相同，在不同的储存或稀释条件下，随着时间的推移，浓度变化不大。SFG 表观分子量在所有样品中均在 306000 至 354000 道尔顿之间变化，远远在 FDA 批准的说明书中规定的 289000 至 440000 道尔顿的分子量范围内。
在所有实验条件下，铁含量和 SFG 表观分子量均稳定。未稀释的通用 SFG 在室温下至少稳定 2 天，冷藏条件下至少稳定 7 天，而在含有 0.9%氯化钠溶液的 IV 输注袋中稀释的通用 SFG 在室温下至少稳定 1 天，冷藏条件下至少稳定 7 天。
