Call: 866-474-6342
silbione@elkem.com

The Silbione® Difference

Drug Delivery Systems

Drug Delivery

Silicone Elastomers for Controlled Drug Delivery Systems

The engineering of drug delivery systems has allowed for specific targeting and controlled release of drugs that are introduced into the body resulting in more desired therapeutic effects. Silicones can be used in the manufacturing of drug delivery device applications due to their ability to store and release drugs within the body.

     

  • A wide range of applications and development of drug delivery systems can include diabetes management, contraception, HIV/AIDS prevention, chronic pain management, cardiology, oncology, and central nervous system health, etc.
  •  

  • Elkem Silicones is committed to participating in advanced medical innovations like drug delivery and implantable devices. In addition to a comprehensive series of Silbione™ Biomedical M series Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR), which support the long-term implantable device applications, Elkem offers the Silbione™ Biomedical LSR D series that supports the drug delivery applications.
  •  

  • These silicone materials are manufactured in an ISO 9001 registered facility, in controlled environments under GMP principles. Type IV Drug Master Files (DMF) have been filed at FDA.
  •  

  • Elkem routinely works with customers to provide custom formulation development projects as many of the specific drug molecules may require customization of silicone elastomer for robust controlled release.
  •  

Quality and Manufacturing Standards

  • Dedicated Elkem Silicones Quality Management System
  • Elkem clean operation standard following GMP principles and ISO 14949 guidelines
  • Certified ISO 9001 Manufacturing Facility
  • Certified ISO Class 8 Manufacturing Environment
  • Certified ISO Class 7 Packaging Environment
  • Responsible Care Management System®

Biocompatibility

Tested according to ISO 10993/USP Class VI:

  • 12-week implant
  • Hemolysis
  • USP Intracutaneous Reactivity
  • USP Acute Systemic Toxicity
  • Cytotoxicity
  • Mutagenicity Pyrogenicity
  • Skin Sensitization
  • Tissue Irritation

Masterfile Support

  • Drug Master File, Type IV (DMF) with FDA CDER

Application Solutions

  • Vaginal Rings
  • Intrauterine Devices (IUD)
  • Transdermal Patches
  • Implantable Rods
  • Coatings

Click here to contact us to learn how we can help you achieve more than you thought possible with our Silbione® silicone solutions.