Combination Products / Drug-Eluting Medical Devices
Combination products offer several advantages when compared with drug delivery via oral, injection, and infusion methods:
- Controlled release of the Active Pharmaceutical Ingredients (API): The controlled release as opposed to the bolus-type delivery facilitates consistent API concentrations within an optimal therapeutic range.
- Targeted delivery of the API: this strength of drug-eluting devices, particularly implanted devices, permits higher therapeutic dosages to be delivered while minimizing adverse side effects.
- Improved Patient Compliance: combination products improve patient compliance and most healthcare practitioners agree that within an aging population, compliance becomes less certain and therefore more important.
Trelleborg Sealing Solutions contract manufacturing services provide complete support for innovators in both the pharmaceutical and medical device industries for the development of drug-eluting medical devices. We possess a wealth of engineering experience and pharmaceutical licensing to offer complete start to finish drug eluting product development and manufacturing.
Partnering with Trelleborg Sealing Solutions
Trelleborg Sealing Solutions Tustin is licensed by the State of California as a Drug Manufacturing Facility. Our business model, quality system, and facility layout are all designed for maximum flexibility in meeting the myriad requirements of our various clients. Our engineering and quality experts assist our drug-device clients in areas including design, feasibility, prototyping, clinical builds, and commercial release.
Trelleborg Sealing Solutions offers deep expertise in material science, biochemistry, mechanical engineering, process design, and quality systems to match each customer’s specific needs. We work with many bioresorbable materials as well as silicone and can manufacture drug-eluting components as well as complete drug-eluting combination products.
We can work with a provided API or compound an API specified by our client. Typical work flow involves procuring an API, compounding the drug into silicone, fabricating a drug component, and assembling this component into a complete combination product.
Combination Products: Start-to-finish drug eluting product development and manufacturing in an FDA compliant facility