Company insight
The potential of UV-cured silicone elastomers
With the compatibility between APIs and implant materials becoming increasingly significant in the medical device sector, a study conducted by Momentive Performance Materials demonstrates the possibilities of UV-cured technology.
s the medical device industry continues to advance toward more sophisticated drug-eluting implants and insertable drug-delivery systems, developers face a critical challenge: ensuring compatibility between active pharmaceutical ingredients (APIs) and implant materials. Recognising this need, Momentive Performance Materials conducted a theoretical study of API compatibility with its innovative ReliaSil UV-curable silicone elastomer platform, providing valuable insights for medical device manufacturers seeking to accelerate development while minimising formulation risk. Silicone elastomers have long been trusted for implantable applications due to their exceptional biocompatibility, flexibility, and long-term durability. However, incorporating APIs into silicone formulations introduces complex considerations that can affect both drug stability and material performance. Traditional implant-grade silicone systems often require thermal curing at elevated temperatures, which can compromise heat- sensitive pharmaceuticals and limit formulation options. Momentive’s ReliaSil UV technology offers a compelling alternative. Utilising a photoactivated platinum-cure system, ReliaSil UV cures on demand with 365nm UV light, eliminating the need for high- temperature processing while delivering the performance expected of long-term implantable silicone elastomers. For device developers working with temperature-sensitive APIs, this lower temperature curing capability can provide a significant advantage. To better understand compatibility challenges, Momentive theoretically screened more than 30 APIs commonly used in implantable and sustained- release applications. The research established a practical, risk-based framework that examines four key areas
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early compatibility screening when selecting APIs for silicone-based drug- delivery platforms. A higher catalyst percentage or other formulation modification may be needed to overcome this interaction.
The research established a risk-based framework that examines four key areas of compatibility.
of compatibility: thermal sensitivity, platinum inhibition risk, crosslinking reactivity, and UV sensitivity. Among these factors, thermal stability emerged as one of the most significant considerations. Many pharmaceutical compounds demonstrated potential degradation risks under the temperatures typically associated with conventional heat-cured silicone processing (120°C-180°C). By eliminating thermal exposure during cure, ReliaSil UV expands opportunities for incorporating sensitive drug compounds into implantable devices.
The study also examined the potential for APIs to interfere with platinum- catalysed silicone chemistry. For example, rifampicin, a widely used antibiotic, was identified as having a high potential platinum inhibition risk due to the presence of multiple functional groups associated with catalyst interaction. This example illustrates the importance of
The research also evaluated whether certain APIs could potentially react with the silicone cross-linking system or undergo photodegradation during UV curing. These considerations are particularly important for achieving consistent cure performance, maintaining drug potency, and ensuring long-term device reliability. Importantly, the study found that the presence of a compatibility risk does not necessarily indicate incompatibility. Rather, the framework serves as an efficient first-pass screening tool to help developers identify compounds that may require additional formulation modifications or experimental testing. This approach can significantly streamline development efforts by focusing resources where they are most needed. For medical device manufacturers developing next-generation drug-eluting technologies, Momentive’s research demonstrates how a science-based compatibility assessment can accelerate innovation. By combining the proven benefits of implantable silicone with the flexibility of UV-curable processing, ReliaSil UV silicone elastomers provide a powerful platform for enabling controlled drug delivery while helping developers overcome the challenges associated with API incorporation.
Through continued investment in materials science and application research, Momentive Performance Materials is helping device manufacturers bring safer, more effective, and innovative implantable drug-delivery solutions to patients worldwide. ●
www.momentive.com
www.medicaldevice-developments.com
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