Pharmaceutical Manufacturing and Drug Delivery
Pharmaceutical Manufacturing & Drug Delivery
Whether the application requires the transfer of critical pharmaceutical fluids or for a material to act as an excipient for a drug, medical grade silicones are chosen for use in Pharmaceutical Manufacturing and Drug Delivery applications due to their biocompatibility, chemical inertness, thermal stability, flexible physical properties and environmental stability.
Flexibility in Product Range
Silbione™ medical and drug delivery silicones are available in many forms to support the best manufacturing method for a given component design: from High Consistency Rubbers (HCR) for extrusion to Liquid Silicone Rubbers (LSR) suitable for molded components. Each product line has an array of physical properties to choose from.
Applications utilizing silicones related to pharmaceutical and drug delivery include :
Silicones have been used for handling critical fluids in the pharmaceutical manufacturing arena across a wide range of applications: peristaltic pump tubing, transfer tubing, high pressure reinforced hoses, gaskets and seals. This flexibility in use coupled with the ability to be sterilized by a wide variety of methods (steam, heat, radiation) without undergoing major changes make them a good choice to prevent imparting leachables or extractibles into a critical fluid.
Transdermal Drug Delivery
A Transdermal Drug Delivery System (TDDS) is an adhesive patch that contains a drug or medication which is placed on the skin to deliver specific doses over time transdermally into the body, at a defined release rate. Silicone adhesives are widely used to manufacture TDDS because they provide many advantages compared to other traditional adhesive technologies, including a reduced skin irritation and a good compatibility with the main drugs used in this field.
The key advantages for using drug eluting devices include targeting drug delivery to specific locations (lowering systemic toxicity and minimizing drug dosage) and eliminating reliance on patient compliance (through sustained release over a given time). Silicone is selected as an excipient for active pharmaceutical ingredients (API) because it represents the highest standard for biomaterials and forms a permeable matrix structure when cured, creating space for API to reside and pass through over time.
Silbione™ medical grade silicones meet the highest quality and manufacturing standards, complying with the Elkem Silicones Quality Management System. This includes:
- Inhouse clean operation standards, applying the principles of Good Manufacturing Practices
- Certified ISO 9001
- Application of the Responsible Care Management System®
At Elkem Silicones, we believe in the safety and efficacy of our silicone products for healthcare and biomedical applications. Our medical Silbione™ products have been tested to meet USP Class VI and ISO 10993 requirements. Our drug delivery silicones have the additional testing required for long term implantation plus the submission of a Drug Master File (DMF) with the US FDA. Our regulatory support team is available to support customers with biocompatibility needs, either directly by providing the relevant documentation, or by supplying information to regulatory agencies in support of their medical device submissions.
At Elkem silicones, we are dedicated people located around the globe, committed to your success. Whether you are looking for a product recommendation, for customized silicone solutions, or for regulatory support, we have the people in place when and where you want them. If you have a medical device project, contact us and our experts will be there to help.