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POLYMERS » Biodegradable Polymers
 
BIODEGRADABLE POLYMERS
APPLICATION

In the first half of the 20th century, scientists working to synthesize polymers from glycolic acid and other alpha-hydroxy acids abandoned their research, because the resulting polymers were too unstable for long-term uses. This instability, however, has proven immensely important for medical uses in the past 30 years.

Biodegradable polymers are manufactured from glycolide, lactide and e-caprolactone monomers for use in medical applications. These three cyclic monomers can be assembled into a wide variety of polymers and copolymers. We can tailor polymer properties from soft elastomerics to rigid engineering plastics. In addition to physical properties, we can customize other properties of the polymers, including degradation rate, hydrophilicity and solubility for individual applications.

A great deal of research is currently underway with polyanhydrides, polyorthoesters, polyphosphazenes and other materials. But to date, products prepared from glycolide, lactide and e-caprolactone have consistently been approved for use in humans.

Controlled Delivery

The most active area of current research using biodegradable polymers is in controlled delivery of pharmaceuticals. The most notable products treat cancer, where a single, once-a-month injection or up to once every four months using biodegradable polymers for sustained delivery has replaced the old system of daily injections. There are two primary systems for delivering active agents using biodegradable polymers: microspheres and devices. The devices can be rods, films or other shapes based on the specific product needs.

Researchers are investigating other promising treatments for cancer, viral and bacterial infections and AIDS, as well as innovative new birth control techniques. Recent work has also shown promise for improving vaccines and for local delivery of dopamine into the brains of Parkinson's patients. Because of their proven record of success, glycolide, lactide and e-caprolactone polymers and copolymers are expected to be the major excipients used in most formulations.

We tailor polymers to specific applications. For example, increased polymer solubility aids in preparing many microspheres. An independent evaluation of 50/50 poly (DL-lactide-co-glycolide) from three commercial suppliers confirmed ours as the most soluble. We have similar expertise in tailoring other polymer properties that can be useful in your programs.

Medical Devices

There are currently more than 40 medical devices using biodegradable polymers to produce a variety of sutures, staples, fixation rods, screws and clips. In addition to biocompatibility, other properties make these polymers uniquely suited for medical devices:

  • thermoplasticity
  • high strength
  • controlled crystallinity
  • controlled degradation rates
  • controlled hydrophilicity
  • proven non-toxicity

The FDA has approved numerous uses for these materials and continues to review and approve new uses. Other potential medical applications include:

  • bone plates and other orthopedic applications
  • ear vent tubes
  • nerve growth tubes
  • wound dressings

Injection molding and extrusion are the most common methods for manufacturing devices. The particular polymer and its molecular weight usually determine the processing method. Melt and glass transition temperatures are given in the table of chemical properties. Because these polymers react with water, they should be thoroughly dried before melt processing.

A number of characteristics, including physical properties, degradation rate and ease of processing, determine which material is required for a specific application. A standard material may meet your requirements, and we can aid in that material selection. Often, however, an application requires additional material optimization. We can participate in this optimization process through experimental input and custom synthesis.

 

 


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