Technological advancements in drug eluting products offer medical device manufacturers and pharmaceutical companies the opportunity to develop smaller, less invasive, and more effective products. Silicone materials provide many advantages and are commonly used in drug delivery applications, but alternative polymer excipients can also provide distinct advantages.

 

Applications

  • Female Healthcare
  • Implantable Drug Delivery Forms
  • Ophthalmic Devices
  • Wound Care
  • Steroidal Collars
  • Pacemaker Leads
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Reviewing the methods for introducing an API to raw silicone and exploring a new means of controlling long-term elution rates, with test results proving the effectiveness of each.

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A deep-dive into the manufacturing methods to formulate combination products and implantable drug delivery systems, including detail on patient impact, use cases, market outlook and case studies.

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Introducing APIs to Silicone

Adding an API to Raw Silicone

Introducing an API into silicone usually involves the combination of Liquid Silicone Rubber (LSR) with an API before fabrication into a silicone part. The API combines with both parts of the raw silicone just before manufacturing it into its final form via extrusion, molding, or sheeting processes.

 

Impregnating Vulcanized Silicone with an API

Another method of introducing an API to silicone is to immerse a finished silicone part in a drug-loaded solvent, which causes swelling and allows the pharmaceutical ingredient to impregnate the silicone matrix.

 

Membrane-Controlled Elution Rates

Using a silicone membrane also enables manufacturers to control the elution rate. A commonly used method is to apply a membrane, such as an extruded silicone tube, to a drug-loaded core to modulate its release profile.

 

Advantages of API Elution

 

  • Controlled release of an API enables a consistent concentration of the drug, in contrast to bolus-style delivery which fluctuates within the therapeutic range. 
  • Implanted devices can provide a targeted release of pharmaceutical ingredients to a specific site within the body.
  • As opposed to systemic administration, drug elution allows for the delivery of longer-term dosages while minimizing adverse side effects. 
  • Drug eluting products can offer significant advantages when patient compliance is a high-risk element of other existing therapies on the market.
  • Patient’s quality of life can be improved by minimizing the effort they have to put in to manage a condition that is particularly high-maintenance. 
  • Lowered dosage requirements may be possible through targeted delivery of an implantable API system.
  • Simplified treatment regimens lead to fewer visits to the practitioner, relieving the strain on health services.