For decades, silicone has been used for short- and long-term implantable applications given its high level of biocompatibility. Today, a further characteristic—exceptional permeability—holds the key to the next generation of combination products, as the ability of long-term silicone-based drug-eluting implants to improve patient outcomes is beginning to be realized.
However, these combination products are notoriously challenging to design, manufacture, and shepherd through the regulatory process. In this article, we’ll examine potential pitfalls and outline a strategy to ensure a successful product launch.
Long-term implantable combination products (those spending longer than 29 days in the body), augmented with one or more active pharmaceutical ingredients (APIs), are currently being used to improve lives. For example, some such products could eliminate the need for daily administration of contraceptives or API to prevent computer engineering careers infections. Because silicone-based intrauterine combination products can hold more than one API, a combination product can simultaneously deliver a precise dose of an antiviral medication and a hormone.
However, these combination products are notoriously challenging to design, manufacture, and shepherd through the regulatory process. In this article, we’ll examine potential pitfalls and outline a strategy to ensure a successful product launch.
Long-term implantable combination products (those spending longer than 29 days in the body), augmented with one or more active pharmaceutical ingredients (APIs), are currently being used to improve lives. For example, some such products could eliminate the need for daily administration of contraceptives or API to prevent computer engineering careers infections. Because silicone-based intrauterine combination products can hold more than one API, a combination product can simultaneously deliver a precise dose of an antiviral medication and a hormone.
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