pgsu eva tpu pdms plga pcl · 2021. 1. 22. · secant group’s controlled active release platform...

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INTRODUCING HYDRALESE A Breakthrough in Safe and Effective Drug Delivery Hydralese Advanced Technology Outperforms Other Polymers Therapeutic duration >6months High drug load >50% w/w Loading independent release rate Zero-order release kinetics Retrievable initially if adverse reaction No need for implant retrieval after therapy Rapidly degradable after payload released Reduced burst effect once implanted Reduced tail effect once sub-therapeutic Minimal pH change during degradation Minimal fibrous encapsulation All tissues return to normal upon degradation Polymer stable under sterilization Room temp/humidity shelf storage Flexible even at high loading Discrete Regenerative Boost your implant with (PGSU) (poly(glycerol sebacate) urethane), a biomaterial with pro-healing, anti-microbial, and anti-inflammatory properties. Surface-eroding Provide more targeted drug delivery with long-lasting, zero-order release kinetics that outperform bulk-degrading and non-degradable polymers. Biocompatible Avoid toxicity, irritation, inflammation, fibrous encapsulation, or acidic pH common in other drug delivery systems. Flexible Increase patient comfort with a soft polymer implant that exhibits unchanged bend radius across a variety of drug types and drug loadings. Secant Group’s controlled active release platform Hydralese™ consists of implantable biocompatible and shelf- stable polymers that provide sustained drug delivery lasting 3-18 months via surface erosion. As a highly tunable, elastomeric, and retrievable soft polymer technology, Hydralese enhances patient comfort and compliance by reducing side effects commonly associated with current drug delivery systems. PGSU EVA TPU PDMS PLGA PCL

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Page 1: PGSU EVA TPU PDMS PLGA PCL · 2021. 1. 22. · Secant Group’s controlled active release platform Hydralese™ consists of implantable biocompatible and shelf-stable polymers that

INTRODUCING HYDRALESE™

A Breakthrough in Safe and Effective Drug Delivery

Hydralese Advanced Technology Outperforms Other Polymers

Therapeutic duration >6monthsHigh drug load >50% w/wLoading independent release rateZero-order release kineticsRetrievable initially if adverse reactionNo need for implant retrieval after therapyRapidly degradable after payload releasedReduced burst effect once implantedReduced tail effect once sub-therapeuticMinimal pH change during degradationMinimal fibrous encapsulationAll tissues return to normal upon degradationPolymer stable under sterilizationRoom temp/humidity shelf storageFlexible even at high loadingDiscrete

Regenerative Boost your implant with (PGSU) (poly(glycerol sebacate) urethane), a biomaterial with pro-healing, anti-microbial, and anti-inflammatory properties.

Surface-erodingProvide more targeted drug delivery with long-lasting, zero-order release kinetics that outperform bulk-degrading and non-degradable polymers.

Biocompatible Avoid toxicity, irritation, inflammation, fibrous encapsulation, or acidic pH common in other drug delivery systems.

FlexibleIncrease patient comfort with a soft polymer implant that exhibits unchanged bend radius across a variety of drug types and drug loadings.

Secant Group’s controlled active release platform Hydralese™ consists of implantable biocompatible and shelf-stable polymers that provide sustained drug delivery lasting 3-18 months via surface erosion. As a highly tunable, elastomeric, and retrievable soft polymer technology, Hydralese enhances patient comfort and compliance by reducing side effects commonly associated with current drug delivery systems.

PGSU EVA TPU PDMS PLGA PCL

Page 2: PGSU EVA TPU PDMS PLGA PCL · 2021. 1. 22. · Secant Group’s controlled active release platform Hydralese™ consists of implantable biocompatible and shelf-stable polymers that

Hydralese Enables Targeted Drug Delivery and Enhances Patient Comfort and Compliance

Hydrophilic and Hydrophobic API Release

Hydrophobic Release• Outperforms PLGA• Linear release more predictable• Multi-month duration product• No lag to reach therapeutic release

Hydralese can handle high drug loadings (up to 80% w/w) of hydrophilic and hydrophobic active pharmaceutical ingredients (API) while maintaining a predictable, linear release. Compared to bulk-degrading polymers, the surface erosion mechanism of Hydralese (PGSU) demonstrates no burst release, diffusion, or swelling, and remains solid and retrievable until fully resorbed by the body.

Hydrophilic Release• Outperforms PLGA and PCL• No burst release at start of therapy• Surface erosion protects interior API• Resorbable means fewer clinic visits

A Better Drug Delivery by Surface ErosionPLGA COATING ON KNIT

BULK DEGRADATION

Day 35

Day 49

• Burst release/lag release• Diffusion• Swelling• Erratic degradation• Heterogeneous topography• Softening• Not retrievable

PGSU COATING ON KNIT SURFACE EROSION

Day 35

Day 49

• No burst release/lag release• No diffusion• No swelling• Predictable degradation• Smooth topography• Remains solid• Retrievable

60% in PLGA

60% in PGSU (nominal crosslinking)

60% in PGSU (nominal crosslinking)

60% in PGSU (high crosslinking)

60% in PGSU (high crosslinking)

60% in PCL60% in PCL40% in PCL40% in PCL

60% in PLGA60% in PLGA40% in PLGA40% in PLGA

60% in PGSU60% in PGSU40% in PGSU40% in PGSU20% in PGSU20% in PGSU10% in PGSU 10% in PGSU

Cum

ulat

ive

Rele

ase

(%)

Cum

ulat

ive

Rele

ase

(%)

Time (weeks)

Time (weeks)

Page 3: PGSU EVA TPU PDMS PLGA PCL · 2021. 1. 22. · Secant Group’s controlled active release platform Hydralese™ consists of implantable biocompatible and shelf-stable polymers that

Learn how Hydralese can improve patient compliance and global health:

551 E. Church Avenue, Telford, PA 18969 • 215.257.8680 • www.secant.com

The information contained in this document is proprietary to Secant Group and may not be used or disseminated inappropriately. ©Secant Group, LLC 2021

Next-generation Long-acting Implantables Using Surface-eroding ElastomersDrug Development and Delivery (November/December 2020)By Stephanie Reed, PhD; Dennis Shull, BS; Secant Group

Read Articles

Biodegradable Urethane’s Potential for Drug-delivery ImplantsMD+DI (August 2020)Interview with Stephanie Reed, PhD, Secant Group

LET’S TALK. To learn more, contact us at

www.secant.com/hydralese or email [email protected]

Serving Human and Animal Health• Cardiovascular diseases• Contraception• Diabetes• Gastroenterology

Zero-order Release at High Loadings Using Hydralese™Carissa Smoot, BS; Dennis Shull, BS; Stephanie Reed, PhD;Secant Group, 2020 AAPS PharmSci 360

Download Posters

Ultra-long-acting Oral Drug Delivery Using a Single-component Hydralese (PGSU) Gastroretentive Device Carissa Smoot, BS; Stephanie Reed, PhD; Secant Group,2020 AAPS PharmSci 360

Long-acting Implantables Using Surface-eroding Elastomers Sustain Zero-order, Multi-month Release Stephanie Reed, PhD; Carissa Smoot, BS; Dennis Shull, BS; Secant Group, 2020 LAII Conference

Customizable Implantable Forms Our formulation experts will collaborate with you to create the right Hydralese form for your project:

Implants Microspheres Metal Stent Coatings Metal Braid Coatings

Core-sheath Impants Gastric Retention Woven Coatings Knit Coatings

Fibers

Thin Films

• HIV treatment and prevention• Immunosuppression• Infection• Inflammation

• Neurodegenerative disorders• Oncology• Ophthalmology• Pain management