A new breed of devices, called combination products has emerged over the last decade. These products incorporate drugs or biological agents in a cured matrix. Silicone elastomers and gels exhibit properties which make them ideal candidates for the drug eluting matrix. Combination products blur the classic distinction between medical devices and bioactive pharmaceuticals. The FDA defines these products as "a product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity".
Combination products offer advantages when compared with the more standard drug delivery devices. First, these products target drug delivery to specific localized tissue, allowing higher therapeutic doses to be delivered while minimizing systemic toxicity. Second, combination products can include biologics such as bone growth factors as well as genetically modified material and can localize these materials at the point of implant.
The drugs found in combination products vary widely in terms of molecular weight and chemical structure. Also, all combination products are designed to release drugs at very specific rates. For example, in one therapy an initial drug "burst" may be desirable while for another therapy it is avoided. It's not surprising then that the silicone component of combination products must be chosen with attention given to both the chemical structure of the drug and desired drug release rates. A one-size-fits-all approach will not work.
Considered as a group, silicones offer the flexibility to tailor polymers and elastomer systems to meet the varied requirements of combination products. First, polymers can be modified by choice of pendant groups which in turn will affect the steric characteristics of the system. Second, fillers can be added or removed or changed to further adjust drug release rates. Third, silicones offer a number of cure systems such that a drug incompatible with one system may be compatible in another.
With the completion of our new clean room facility, dedicated to the manufacturing of combination products, Specialty Silicone Fabricators, Inc. is optimally equipped to assist our customers with the development of these types of products. We also have received the necessary certification to purchase and mix active pharmaceutical ingredients (API's) into various silicones for the development and manufacturing of these innovative devices.
The development and commercialization of combination products is predicted to increase rapidly. Silicones will be integral in the growth of this field. Specialty Silicone Fabricators, Inc. is poised and keenly interested in working with you to develop your combination products.