Dep. de Eng. Mecânica e Gestão Industrial, Escola Superior de Tecnologia e Gestão de Viseu, Campus Politécnico de Repeses, 3504-510, Viseu, Portugal.
AAPS PharmSciTech. 2010 Jun;11(2):852-8. doi: 10.1208/s12249-010-9447-3. Epub 2010 May 19.
A polymeric solution and a reinforcement phase can work as an injectable material to fill up bone defects. However, the properties of the solution should be suitable to enable the transport of that extra phase. Additionally, the use of biocompatible materials is a requirement for tissue regeneration. Thus, we intended to optimize a biocompatible polymeric solution able to carry hydroxyapatite microspheres into bone defects using an orthopedic injectable device. To achieve that goal, polymers usually regarded as biocompatible were selected, namely sodium carboxymethylcellulose, hydroxypropylmethylcellulose, and Na-alginate (ALG). The rheological properties of the polymeric solutions at different concentrations were assessed by viscosimetry before and after moist heat sterilization. In order to correlate rheological properties with injectability, solutions were tested using an orthopedic device applied for minimal invasive surgeries. Among the three polymers, ALG solutions presented the most suitable properties for our goal and a non-sterile ALG 6% solution was successfully used to perform preliminary injection tests of hydroxyapatite microspheres. Sterile ALG 7.25% solution was found to closely match non-sterile ALG 6% properties and it was selected as the optimal vehicle. Finally, sterile ALG 7.25% physical stability was studied at different temperatures over a 3-month period. It was observed that its rheological properties presented minor changes when stored at 25 degrees C or at 4 degrees C.
一种聚合物溶液和增强相可以作为可注射材料来填充骨缺损。然而,该溶液的性能应该适合于能够输送额外的相。此外,使用生物相容性材料是组织再生的要求。因此,我们旨在优化一种可生物相容的聚合物溶液,使其能够使用骨科可注射装置将羟基磷灰石微球输送到骨缺损中。为了实现这一目标,选择了通常被认为是生物相容的聚合物,即羧甲基纤维素钠、羟丙基甲基纤维素和海藻酸钠(ALG)。在湿热灭菌前后通过粘度计评估了不同浓度的聚合物溶液的流变性。为了将流变性能与可注射性相关联,使用骨科设备对溶液进行了测试,该设备适用于微创外科手术。在这三种聚合物中,ALG 溶液具有最适合我们目标的特性,并且成功地使用非无菌 ALG 6%溶液进行了羟基磷灰石微球的初步注射测试。发现无菌 ALG 7.25%溶液与非无菌 ALG 6%溶液的特性非常接近,并将其选为最佳载体。最后,在 3 个月的时间内,在不同温度下研究了无菌 ALG 7.25%的物理稳定性。观察到当在 25°C 或 4°C 下储存时,其流变性能仅发生微小变化。