Bahal Surendra M, Romansky Jamie M
Pharmaceutical Research and Development, DuPont Pharmaceuticals Company, Wilmington, DE 19880-0400, USA.
Pharm Dev Technol. 2002;7(3):317-23. doi: 10.1081/pdt-120005728.
Available tubing for peristaltic pumps tend to shed particulates into the solution due to their poor abrasion characteristics. Most commonly used flexible tubing is silicone rubber or polyvinyl chloride (Tygon) tubing. Two newly available tubing are manufactured from a composite of expanded polytetrafluoroethylene (Teflon PTFE) with platinum-cured silicone rubber (Sta-Pure) and a tubing composite of PTFE with fluoroelastomer (Chem-Sure). These are claimed to resist spalling and deliver constant volume when used in peristaltic pumps. The four tubing were compared for spallation. They were also compared for sorption of methylparaben, propylparaben, and benzyl alcohol over a 72 hr study. Spallation studies indicate that Tygon and silicone tubing are prone to damage and shedding of particulates due to abrasion during use in peristaltic pumps while the Chem-Sure and Sta-Pure tubing are resistant to abrasion and spalling and show negligible shedding of particulates over 72 hr use in the peristaltic pump. Chem-Sure shows no spalling after 48 hr. Decrease in volume delivered is expected using Tygon and silicone tubing only. Chem-Sure tubing did not show any preservative losses. Tygon sorbed all preservatives tested to the greatest extent, followed by Silastic and Sta-Pure tubing, in decreasing order of sorption. Propylparaben was sorbed to the greatest extent. The tubing used appear to approach saturation in 24-48 hr. Chem-Sure and Sta-Pure tubing are ideal for use in peristaltic pumps or for general use for any demanding pharmaceutical applications.
蠕动泵可用的管道由于其耐磨性能差,往往会将颗粒物质脱落到溶液中。最常用的柔性管道是硅橡胶或聚氯乙烯(泰根)管道。两种新推出的管道分别由膨胀聚四氟乙烯(特氟龙PTFE)与铂固化硅橡胶(Sta - Pure)的复合材料以及PTFE与氟橡胶(Chem - Sure)的管道复合材料制成。据称,这些管道在用于蠕动泵时能抵抗剥落并输送恒定体积的液体。对这四种管道进行了剥落比较。在一项为期72小时的研究中,还比较了它们对甲基对羟基苯甲酸酯、丙基对羟基苯甲酸酯和苯甲醇的吸附情况。剥落研究表明,泰根管道和硅橡胶管道在蠕动泵使用过程中容易因磨损而损坏并脱落颗粒物质,而Chem - Sure管道和Sta - Pure管道耐磨且抗剥落,在蠕动泵中使用72小时后颗粒物质脱落可忽略不计。Chem - Sure管道在48小时后未出现剥落现象。仅使用泰根管道和硅橡胶管道时,预计输送体积会减少。Chem - Sure管道未出现任何防腐剂损失。泰根管道对所有测试的防腐剂吸附程度最大,其次是硅橡胶管道和Sta - Pure管道,吸附程度依次递减。丙基对羟基苯甲酸酯的吸附程度最大。所用管道在24 - 48小时内似乎接近饱和。Chem - Sure管道和Sta - Pure管道非常适合用于蠕动泵或任何要求苛刻制药应用的一般用途。