Silicones have been used for a long time as implants and combination products. ProMed Pharma has been molding silicone parts for 25 years and has significant experience in silicone drug delivery devices. Given their extreme chemical inertness, their range of stable mechanical properties and the ability to compound various active pharmaceutical ingredients makes silicones the material of choice for drug eluting implants
Advantages of Implantable Drug Delivery Devices
Implantable drug delivery devices offer several advantages over conventional oral or parenteral dosage forms. For example, implants allow site specific administration where the drug is most needed and lower doses of the drug may be needed. Additionally, implants allow for sustained release of a therapeutic agent. Last but not least, implants are less burdensome than pills or injections for patients, hence the patient compliance is increased.
Active Pharmaceutical Applications
Applications include the use of a variety of active pharmaceuticals including steroids, sex hormones, microbicides, antibiotics, analgesics, and other small molecule compounds. Subcutaneous solid implants provide long-term, "passive" release without the need for replenishment. Typically found as thin flexible rods or "matchsticks" these delivery systems are particularly effective for the delivery of highly potent drugs such as hormones. Additional applications include treatment of schizophrenia, breast cancer, photosensitivity, Parkinson's disease, and glaucoma as well as age-related macular degeneration. Other novel drug delivery forms such as intrauterine devices and intravaginal rings are increasing.
For over 20 years, ProMed has been a leading supplier for medical silicone molded parts as well as drug eluting silicone devices. ProMed Pharma is ISO13485 certified and the quality system was designed using the 21 CFR 820 Quality System Model supplemented with applicable section of 21 CFR 210 & 211 GMPs.