Key material considerations for drug delivery include biocompatibility, stability and durability, and the ability of the material to control the release of the active pharmaceutical ingredient (API). Silicones have long been the material of choice for drug delivery because of their extreme chemical inertness, stable set of mechanical properties, and ability to complex various APIs in matrices. CD Formulation provides customers with professional silicone drug delivery services to help customers efficiently develop the drug delivery industry.
Drug delivery systems are one of the fastest growing products in healthcare today, with the implantable systems market growing at double-digit rates. Novel drug delivery methods are now part of product strategy as pharmaceutical companies seek additional patent protection and seek to improve patient compliance. Silicones are widely used materials in the medical device industry. These materials have a long history in medical devices and offer versatility and biocompatibility to drug delivery product engineers. Silicone systems can also be customized to suit specific applications. Manufacturers of drug delivery devices have incorporated silicones into products that require a matrix to allow the device to elute or ionically release the active additive or ingredient.
Medical-grade silicones can be an important part of many healthcare and medical devices due to their unique properties of being gentle on the body, such as in flexible wearable medical devices and health monitoring devices. Silicones are used in skin medications to aid absorption and function. Moreover, the silicone material is very easy to sterilize, helping to reduce the risk of bacterial infection.
At CD Formulation, work has historically focused on forming silicone drug delivery devices using injection and compression molding techniques. Several factors must be considered when optimizing material formulations and developing a robust molding or extrusion process. Material systems, mixing or compounding techniques, API particle size cure temperature and pressure can all affect drug release consistency and drug content uniformity from manufacturing batch to batch.
In some biomedical applications, silicone rubber must be surface and bulk modified by appropriate methods to make silicone rubber hydrophilic. In controlled drug delivery systems, enzymatic modification is preferred for drug delivery throughout the polymer. The bulk modification method mainly adopts the process of blending, copolymerization, formation of interpenetrating polymer network and functionalization.
CD Formulation's toxicology group performed descriptive toxicology studies as well as more specialized investigations including pharmacokinetics, metabolism, biochemical and in vitro/in vivo skin absorption assessments. Our toxicology team can also provide health summaries, research reports and/or health opinions based on the safety and toxicology information that has been generated.
CD Formulation's regulatory team has expertise in supporting silicone in drug delivery. We will work with you through clinical stage and marketing authorization review to support the use of silicone products in your application.
As a leading provider of drug delivery services, we provide a variety of related delivery technologies to help your project development, thereby accelerating the commercialization of your drug.