Institute of Drug Research, School of Pharmacy-Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem 91120, Israel.
Ortho-Space Ltd, Caesarea, Israel.
Int J Pharm. 2020 Jan 25;574:118870. doi: 10.1016/j.ijpharm.2019.118870. Epub 2019 Nov 22.
Biodegradable poly(l-lactide-co-ε-caprolactone) (PLCL) are used to prepare inflatable balloon implants in treating rotator-cuff injuries and tissue separation. These balloon implants act as a temporary spacer for tissues, while reducing pain and allowing rehabilitation after surgery. It is essential to ensure that each balloon fulfill two requirements after implantation: (1) display a well-defined degradation profile, and (2) remain unaffected by premature rapture or leakage. Storage also affects the stability of a polymer-based implant. Since the balloons are implanted into humans, it is essential to understand their in vitro and in vivo degradation along with their physicochemical properties. It is unpredictable if balloon storage on their performance. Therefore, the in vitro and in vivo degradation behavior of PLCL balloons was examined during one year, and the information obtained was used to correlate reliability under prolonged storage conditions. We investigated changes in weight, melting temperature (T), molecular weight distribution (M, M and PDI), crystallinity (Χ), optical activity [α], and inherent viscosity (η) of the balloons during the entire degradation time. We also examined the molecular properties of the balloons under annealing and extreme temperature conditions, such as the combined effect of temperature and humidity that simulate various storage conditions. We have concluded that degradation of the PLCL balloons is slow, and they remain stable during the test period. Results reveal that the balloons retain their molecular properties under long-term storage, annealing, and extreme temperature conditions. The balloons did not show any variation from reference samples, and they exhibited a constant stability profile even after shelf-storage of more than 3 years. These findings can serve as a case study for evaluating various other biodegradable materials.
可生物降解的聚（L-丙交酯-共-ε-己内酯）（PLCL）用于制备治疗肩袖损伤和组织分离的可充气球囊植入物。这些球囊植入物作为组织的临时间隔物，同时减轻疼痛并允许手术后康复。至关重要的是要确保每个球囊在植入后满足两个要求：（1）显示明确的降解曲线，（2）不受过早破裂或泄漏的影响。储存也会影响基于聚合物的植入物的稳定性。由于球囊被植入人体，因此了解其体外和体内降解以及理化性质非常重要。如果球囊储存会影响其性能，这是不可预测的。因此，在一年内检查了 PLCL 球囊的体外和体内降解行为，并利用获得的信息来关联在延长储存条件下的可靠性。我们研究了球囊在整个降解时间内的重量、熔点（T）、分子量分布（M、M 和 PDI）、结晶度（Χ）、光学活性[α]和固有粘度（η）的变化。我们还研究了球囊在退火和极端温度条件下的分子性质，例如模拟各种储存条件的温度和湿度的综合影响。我们得出的结论是，PLCL 球囊的降解速度较慢，并且在测试期间保持稳定。结果表明，球囊在长期储存、退火和极端温度条件下保留其分子特性。球囊与参比样品没有任何差异，即使在货架储存超过 3 年后，它们仍保持稳定的稳定性曲线。这些发现可以作为评估各种其他可生物降解材料的案例研究。
