Posters

Transmission Raman Microscopy as a Process Analytical Technique for Drug-loaded Hydralese™ (PGSU) Elastomers Show: AAPS 2021 PharmSci 360
Date: 10/19/21 (Presenters: Josh Mealy, PhD, Scientist II; Stephanie Reed, PhD, Director, Translational Product Development)

Long-acting implantables (LAIs) for controlled release are in demand to deliver high-potency APIs, which require controlled content uniformity and drug loading. Developing new analytical technologies that easily fit into manufacturing processes can improve manufacturing capabilities, throughput, and quality. In this study, Secant Group evaluated transmission Raman microscopy as a process analytical technique for manufacturing drug-loaded Hydralese™ rods. Download

Retrievability, IVIVC, and Biocompatibility of a 2’-deoxyadenosine-loaded Hydralese™ (PGSU) Implant Show: AAPS 2021 PharmSci 360
Date: 10/19/21 (Presenters: Dennis Shull, Associate Scientist II; Manasi Chawathe Baker, PhD, Scientist II; Stephanie Reed, PhD, Director, Translational Product Development)

Secant Group examined retrievability of drug-loaded and unloaded Hydralese™ (PGSU) polymer implants in an animal study. Explanted rods were analyzed and an IVIVC was prepared using previous USP IV dissolution data. Unloaded implants were analyzed for inflammatory response, and the complete suite of ISO 10993 biocompatibility testing was performed on unloaded implants. Download

Biodegradable Hydralese™ (PGSU) Microspheres for Controlled Release of Water-soluble Drugs Show: AAPS 2021 PharmSci 360
Date: 10/18/21 (Presenters: Manasi Chawathe Baker, PhD, Scientist II; Stephanie Reed, PhD, Director, Translational Product Development)

Hydralese (PGSU) can achieve steady release of APIs from weeks to months based on crosslinking density, degradation rate, API physical form, and API particle size. Secant Group investigated the results of a study that aimed to manufacture and characterize water-soluble API-loaded Hydralese (PGSU) microspheres using large particle and micronized API and compare in vitro release of the water-soluble API from Hydralese (PGSU) microspheres of different loadings, size distributions, API particle sizes, and crosslinking. Download

Dual Delivery of a Model Contraceptive and Antiretroviral Drug from Hydralese™(PGSU) Implants for Multipurpose Prevention Technology Show: AAPS 2021 PharmSci 360
Date: 10/18/21 (Presenters: Jarrod Cohen, PhD, Scientist II; Dennis Shull, Associate Scientist II; Stephanie Reed, PhD, Director, Translational Product Development)

Multipurpose Prevention Technologies are used to prevent HIV, sexually transmitted infections, and/or unintended pregnancies. Achieving sustained release of a preventative HIV drug and a contraceptive drug concurrently to address patient compliance globally has yet to be achieved in a commercial implant. Secant Group presents data characterizing the co-formulation and simultaneous release of two model compounds in a dual-delivery approach. Download
 

Reaction Injection Molding Scale-up of Hydralese™ (PGSU) Rods for Controlled Drug Delivery Show: AAPS 2021 PharmSci 360
Date: 10/18/21 (Presenters: Dennis Carney, Senior Engineer; Stephanie Reed, PhD, Director, Translational Product Development)

Secant Group is developing long-acting implantable (LAI) and gastroretentive devices manufactured from Hydralese™ (PGSU) for controlled drug release over a multi-month time period. In this study, Secant manufactured drug-loaded Hydralese™ (PGSU) rods using a reaction injection molding process and characterized rod morphology, chemical structure, and crosslinking density. Download
 

Expandable Single-component Gastroretention Devices for Extended Drug Delivery Using Biodegradable Elastomer Hydralese™ (PGSU) Show: AAPS 2021 PharmSci 360
Date: 10/18/21 (Presenters: Alexander Stahl, PhD, Scientist II; Manasi Chawathe Baker, PhD, Scientist II; Stephanie Reed, PhD, Director, Translational Product Development)

Effective gastroretentive drug administration can lead to greater patient convenience, comfort, and compliance. Secant Group investigated the potential for a single-component device made entirely of drug-loaded Hydralese (PGSU) to compress and fit inside an oral delivery capsule, spring back to its original shape, and sustain release of a model drug compound for greater than one month. Download
 

Biodegradable Hydralese™ (PGSU) Microspheres for Controlled Drug Delivery Show: AAPS 2020 PharmSci 360
Date: 10/26/20 (Presenters: Stephanie Reed, PhD, Director, Advanced Biomaterials Development, New Product Development, Secant Group; Manasi Chawathe, PhD, Scientist II, Secant Group)

Secant Group is developing microspheres manufactured from Hydralese™ (PGSU) (poly(glycerol sebacate) urethane), a flexible, synthetic biodegradable elastomer for controlled drug release capable of delivering sustained high drug loadings over a multi-month time period. The unique characteristics of Hydralese (PGSU) make it an ideal candidate for designing microspheres for steady drug release. Download

Zero-order Release of Hydrophilic Drugs at High Loadings Using Novel Biodegradable Elastomer Hydralese™ (PGSU) Show: AAPS 2020 PharmSci 360
Date: 10/26/20 (Presenters: Stephanie Reed, PhD, Director, Advanced Biomaterials Development, New Product Development, Secant Group; Dennis Shull, BS, Associate Scientist II, Secant Group; Carissa Smoot, BS, Scientist II, Secant Group)

Secant Group’s Hydralese™ (PGSU) (poly(glycerol sebacate) urethane) provides an attractive drug delivery system due to its surface-erosion release mechanism, which allows for near zero-order release kinetics, even at high hydrophilic drug loadings. Hydralese (PGSU) is also highly flexible, water impermeable, shelf-stable, and biocompatible. Download

Ultra-long-acting Oral Drug Delivery Using a Single-component Hydralese™ (PGSU) Gastroretentive Device Show: AAPS 2020 PharmSci 360
Date: 10/26/20 (Presenters: Stephanie Reed, PhD, Director, Advanced Biomaterials Development, New Product Development, Secant Group; Carissa Smoot, BS, Scientist II, Secant Group)

The elastic resilience, surface erosion degradation, and high API-loading capacity, combined with steady release over long durations, make Secant Group’s Hydralese™ (PGSU) (poly(glycerol sebacate) urethane) an attractive option for ultra-long-acting oral delivery via a gastroretentive device. Download

Long-acting Implantables Using Surface-eroding Elastomers Sustain Zero-order, Multi-month Release Show: 3rd Long-acting Injectables and Implantables Conference
Date: 02/06/20 (Presenters: Stephanie Reed, PhD, Director, Advanced Biomaterials Development, New Product Development, Secant Group; Carissa Smoot, Scientist II, Secant Group)

Secant Group's Hydralese™ (PGSU) (poly(glycerol sebacate) urethane) is a synthetic biodegradable elastomer for controlled drug release. Hydralese (PGSU) offers many advantages over other polymers for long-acting implantables, particularly for high-loading, long-duration implants that are gaining interest in the pharmaceutical industry. Download

Surface-eroding Elastomer Exhibits Zero-order Release in Highly Loaded LAIs Show: AAPS 2019 PharmSci 360
Date: 11/04/2019 (Presenter: Carissa Smoot, Scientist II, Secant Group)

Commonly used non-biodegradable polymers used for long-acting implantables (LAI) lack the ability to achieve controlled release kinetics for multi-month therapies that require high drug loadings. Surface-eroding biodegradables such as Secant Group's Hydralese™ (PGSU) (poly(glycerol sebacate) urethane), a synthetic biodegradable elastomer for controlled drug release, offer a superior polymeric delivery system able to provide zero-order release at high drug loadings over many months. Download

Methods for Dissolution Testing of Surface-eroding Long-acting Implantables Show: AAPS 2019 PharmSci 360
Date: 11/05/2019 (Presenter: Dennis Shull, Associate Scientist, Secant Group)

Surface-eroding polymers are ideal for long-acting implantables due to their ability to provide long-term sustained release based on degradation. This work investigates in vitro dissolution testing of caffeine-loaded implanted rods made of poly(glycerol sebacate) urethane, also known as Hydralese™ (PGSU) (Secant Group), using a USP IV flow-through cell apparatus. Hydralese (PGSU) is a synthetic biodegradable elastomer for controlled drug release capable of delivering sustained high drug loadings over a multi-month time period. Download

Next-generation Long-acting Implantables using Surface-eroding Elastomers Show: 2019 Controlled Release Society Annual Meeting & Exposition
Date: 07/23/2019 (Presenter: Stephanie Reed, PhD, Director, Advanced Biomaterials Development, New Product Development, Secant Group)

Secant Group's Hydralese™ (PGSU) (poly(glycerol sebacate) urethane) is a synthetic biodegradable elastomer for controlled drug release. PGSU is elastomeric, water impermeable, shelf-life stable, biocompatible, and biodegradable via surface erosion. Hydralese (PGSU) ultimately offers many advantages over other polymers for long-acting implantables (LAIs), particularly for high-loading, long-duration implants that are gaining interest in the pharmaceutical industry. Download

Histological and Biomechanical Evaluation of Braided Tissue Engineered Arterial Grafts in a Mouse Model Show: International Symposium for Applied Cardiovascular Biology and Vascular Tissue Engineering
Date: 06/19/2019 (Presenter: Nationwide Children's Hospital)

Tissue-engineered arterial grafts (TEAGs) are designed from biodegradable materials capable of forming a neoartery of autologous tissue that can grow and remodel within the body. Textile braiding techniques have the potential to aid in the creation of compliant TEAGs with tunable mechanical properties. In this work, TEAGs were fabricated from braided polyglycolic acid fibers with or without poly(glycerol sebacate) coating. Download