Developers of long-acting implantables (LAI) now have another option for achieving zero-order release kinetics of hydrophilic and hydrophobic drugs, other than bulk-degrading and non-degradable commercial polymers currently on the market.
Secant Group's Hydralese™ technology for controlled release consists of biocompatible and shelf-stable polymers that can be manufactured into a variety of forms such as implants, microspheres, and coatings. Hydralese polymers are based on poly(glycerol sebacate) (PGS) polymer resin crosslinked with various chemistries to provide tailored release profiles and other customizable properties.
Long-acting implants composed of surface eroding polymers can offer long-lasting, zero-order release kinetics for a more controlled drug delivery over bulk eroding polymers. With surface eroding polymers, the implant will gradually get smaller over time while remaining intact, making extraction of the implant easier if necessary.
High Drug Loading
Hydralese polymers can be loaded with both hydrophilic and hydrophobic drugs up to 80% w/w. Even at high drug loading, they demonstrate minimal burst release in vitro
and in vivo
and can sustain release for greater than six months’ duration.
In stark contrast to rigid thermoplastic polymers such as lactides and glycolides, which can become brittle and fracture, especially at high drug loads, Hydralese polymers are highly flexible elastomers. They exhibit stretchable, compressible, and bendable mechanical properties that can be tuned by changing the crosslinking density of the polymer. Implants can be tailored to mimic the elastic properties of tissue to achieve enhanced safety and comfort for the patient, resulting in improved compliance.
Formulation and Development Support
Secant Group can provide an end-to-end solutions for the development of long-acting implants, including CRO services, scale-up, and manufacturing support. We have deep formulating knowledge for both drug delivery and medical devices, along with decades of expertise in polymer chemistry.
Contract Extrusion, Molding, and Finishing
Secant Group works closely with our sister company SanaVita Medical,
an FDA registered contract manufacturer for medical device processing services. SanaVita’s services are perfectly aligned to support your implant manufacturing, finishing and assembly, packaging and labeling, sterilization management, and regulatory registration and compliance needs.