Drug Delivery
Biomaterial Solutions
Secant Group has developed Hydralese®, a novel polymer platform for controlled delivery of active pharmaceutical and biopharmaceutical ingredients (API/ABI). Hydralese demonstrates unparalleled benefits over traditional polymers that are currently used for drug delivery, enabling innovative custom-developed solutions for complex long-acting drug delivery challenges.
Hydralese provides an unmet need for long-acting drug delivery systems since it is suitable for a variety of routes of administration and therapeutic modalities.
A solutions-focused approach
Hydralese can be custom developed into a multitude of form factors, making it an ideal excipient for implantables, injectables, and coatings. Derived from our patent-protected polymer innovations, the Hydralese platform provides a library of flexible elastomers comprised of poly(glycerol ester urethanes (PGEUs)) that provide the versatility needed to deliver APIs via controlled-release mechanisms for multi-month periods.
API Compatibility
- Hydralese can be tuned to deliver small- and large-molecule APIs
Biocompatible
- Minimal pH change observed in vitro during Hydralese degradation
- Minimal chronic inflammation and fibrous encapsulation observed in rats after subcutaneous implantation
- All tissues return to normal upon degradation of Hydralese after subcutaneous implantation in rats
Biodegradable
- Degradation timeframe of 3 to 12+ months
- Degrades back into monomers that can be metabolized by the body
Linear Release Kinetics
- Zero-order release kinetics
High Drug Loading
- Ideal for high drug loading up to 60% w/w in a solvent-free formulation
- Formulation processed at ambient conditions
Highly Flexible
- Flexible at high drug loadings
- Suitable for loading into applicators
Shelf Stable
- Room temp/humidity shelf storage
- Compatible with terminal gamma sterilization
- Stable post-sterilization for up to 6 months
Customizable
- Customizable polymers can be synthesized based on API characteristics, therapeutic dose, and degradation kinetics required
- Different form factors of Hydralese can be manufactured such as cylindrical implants, microspheres, coatings, and closed geometries
- Co-delivery of two APIs loaded in the same implant is possible for applications such as Multipurpose Prevention Therapy (MPT)
Explore Drug Delivery Solutions
Secant’s development team partners with innovators to custom develop the optimal Hydralese dosage form based on customers’ target product profiles.
Implants
Hydralese cylindrical implants can be manufactured in various sizes ranging from 300 µm to 3 mm in diameter. They are flexible and easy to load into an applicator. They can be manufactured at ambient conditions. Up to 60% drug loading is achievable under solvent-free conditions depending on API characteristics.
Microspheres
Secant has developed Hydralese-based microspheres for controlled drug delivery. Microspheres or microparticles are a multi-particulate drug delivery system that can be administered parenterally or orally. Hydralese microspheres can range from 10-100 µm based on the desired route of delivery.
Closed Geometries
Hydralese can be molded into closed geometries such as torus rings, flat rings, and star-shaped structures. Up to 35% drug loading is achievable without losing its flexibility to fold into a capsule for oral administration. Hydralese closed geometries can be used for ultra-long-acting gastroretentive and vaginal administration.
Coatings
Hydralese is ideal for coating materials commonly used in medical devices due to its elastomeric and biocompatible properties. Hydralese can uniformly coat multiple polymeric materials and has shown utility in improving the biological and physical properties of finished devices.
Formulation/Manufacturing Technologies
• Extrusion
• Molding
• Castings
• Coatings
• Emulsion
Partnering with Secant
Our team is seeking, establishing, and fostering industry partnerships to bring improved long-acting solutions to life with Hydralese.
Benefits of Custom-development
Leverage our expertise in polymer development and synthesis to innovate the optimal custom formulation based on the desired target product profile. We can develop, test, and characterize prototypes in house. Our team supports your needs in multiple ways:
- In-house analytical testing and method validation
- Small-scale formulation development
- ISO 7 and 8 cleanrooms
- In vitro release and polymer degradation set-up
- Process scale-up and optimization
We can support your innovation from development to GLP to GMP phases:
- Scale-up
- Technical transfer
- Phase I/II Clinical trials
- Production GLP toxicity batches
- cGMP
Start your Hydralese-based drug delivery project today.
Contact us to learn more or explore resources on drug delivery.