Division of Pharmaceutical Analysis, Food and Drug Administration, Saint Louis, MO, USA.
Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA.
Pharm Dev Technol. 2021 Oct;26(8):846-851. doi: 10.1080/10837450.2021.1948567. Epub 2021 Jul 26.
Lansoprazole orally disintegrating tablets (ODTs) can be administered orally or through a nasogastric (NG) tube for patients who are unable to swallow. In addition, off-label administration through gastrostomy (G) or jejunal (J) tubes has been reported. The purpose of this study was to develop methods to assess the risk of clogging during administration of two lansoprazole ODTs through enteral feeding tubes. Feeding tubes of various compositions and geometries were selected for testing. Disintegration, sedimentation, percent recovery, acid phase dissolution testing, and particle size distribution measurements were performed. The results indicated that G tubes had the greatest risk of clogging compared to NG and J tubes. In addition, larger particles and an increased amount of insoluble excipients observed in Product B resulted in more irreversible enteral tube clogging than compared to Product A. The geometry and design of the tube also had an impact on the amount of lansoprazole recovered after enteral tube administration. Lansoprazole ODTs demonstrated acid resistance stability regardless of the water used for suspension. The methods discussed in this work could be used to evaluate in vitro equivalence and to assess the risk of delivering a drug product through an enteral feeding tube.
兰索拉唑口崩片（ODT）可经口或经鼻胃（NG）管给药，适用于无法吞咽的患者。此外，已有通过胃造口（G）或空肠（J）管超说明书使用的报道。本研究旨在开发评估两种兰索拉唑 ODT 通过肠内喂养管给药时堵塞风险的方法。选择了各种组成和几何形状的喂养管进行测试。进行了崩解、沉淀、回收率、酸相溶解测试和粒度分布测量。结果表明，与 NG 和 J 管相比，G 管的堵塞风险最大。此外，与产品 A 相比，产品 B 中观察到的较大颗粒和增加的不溶性赋形剂含量导致更严重的不可逆肠内管堵塞。管的几何形状和设计也会影响肠内管给药后兰索拉唑的回收率。兰索拉唑 ODT 表现出对酸的稳定性，无论混悬液中使用何种水。本研究中讨论的方法可用于评估体外等效性，并评估通过肠内喂养管输送药物产品的风险。
