Siden Rivka, Wolf Matthew
University of Michigan Hospitals and Health Centers, Ann Arbor, MI 48109-5008, USA.
J Oncol Pharm Pract. 2013 Jun;19(2):145-50. doi: 10.1177/1078155212455446. Epub 2012 Aug 20.
The administration of oral chemotherapeutic drugs can be problematic in patients with swallowing difficulties. Inability to swallow solid dosage forms can compromise compliance and may lead to poor clinical outcome. The current technique of tablet crushing to aid in administration is considered an unsafe practice. By developing a technique to disintegrate tablets in an oral syringe, the risk associated with tablet crushing can be avoided. The purpose of this study was to determine the feasibility of using disintegration in an oral syringe for the administration of oral chemotherapeutic tablets. Eight commonly used oral chemotherapeutic drugs were tested.
Tablets were placed in an oral syringe and allowed to disintegrate in tap water. Various volumes and temperatures were tested to identify which combination allows for complete disintegration of the tablet in the shortest amount of time. The oral syringe disintegration method was considered feasible if disintegration occurred in ≤15 min and in ≤20 mL of water and the dispersion passed through an oral syringe tip.
The following tablets were shown to disintegrate within 15 min and in <20 mL of water: busulfan, cyclophosphamide 50 mg, dasatinib, imatinib, methotrexate, and thioguanine. For these drugs, drug-specific information pamphlets can be prepared for patient or caregiver use. Mercaptopurine, cyclophosphamide 25 mg, and mitotane tablets did not pass the disintegration test.
Disintegrating oral chemotherapeutic tablets in a syringe provides a closed system to administer hazardous drugs and allows for the safe administration of oral chemotherapeutic drugs in a tablet form to patients with swallowing difficulties.
对于吞咽困难的患者，口服化疗药物的给药可能存在问题。无法吞咽固体剂型会影响依从性，并可能导致临床预后不佳。目前将片剂碾碎以辅助给药的技术被认为是不安全的做法。通过开发一种在口腔注射器中使片剂崩解的技术，可以避免与片剂碾碎相关的风险。本研究的目的是确定在口腔注射器中进行崩解以给药口服化疗片剂的可行性。对八种常用的口服化疗药物进行了测试。
将片剂放入口腔注射器中，使其在自来水中崩解。测试了不同的体积和温度，以确定哪种组合能在最短时间内使片剂完全崩解。如果在≤15分钟内且在≤20毫升水中发生崩解，并且分散液能通过口腔注射器尖端，则口腔注射器崩解方法被认为是可行的。
以下片剂在15分钟内且在<20毫升水中崩解：白消安、50毫克环磷酰胺、达沙替尼、伊马替尼、甲氨蝶呤和硫鸟嘌呤。对于这些药物，可以编写特定药物的信息手册供患者或护理人员使用。巯嘌呤、25毫克环磷酰胺和米托坦片剂未通过崩解测试。
在注射器中使口服化疗片剂崩解提供了一个用于给药危险药物的封闭系统，并允许以片剂形式安全地给吞咽困难的患者服用口服化疗药物。
