The Silbione® Difference...A Brand You Can Trust
for high quality healthcare silicone solutions

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silbione@elkem.com

The Silbione® Difference

Drug Delivery Systems

Drug Delivery

Silicones for Drug Delivery Systems

Silicone can function as a perfect matrix or membrane to control the release of specific drugs into the body. Localizing the delivery of the active ingredient and bypassing the blood flow can help to improve the bioavailability of the drug. The localized drug delivery may also allow for decreased active ingredient loading and can potentially reduce systemic side effects. This difficult task can be mastered by the tailor-made Elkem series of silicones for drug delivery. The innovation potential is practically limitless because the silicone can be molded into virtually any shape. Specialty drug delivery silicones can be customized and adapted to various requirements to guarantee the most effective and targeted release right on the spot.

Due to the variety of potential active pharmaceutical ingredients that could be utilized and their unique chemical structures, we do not take a “one size fits all” product approach to this market. We have a range of silicone technologies including, liquid silicones rubber, high consistency rubber, and skin adhesives that we can provide for implantable or transdermal drug delivery systems. Click here to contact us to learn how we can help deliver your pharmaceutical ingredients.

 

Product Range

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.