• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Previon, Spectrum Solutions Partner to Deliver At-Home COVID-19 Test

    NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

    Global Peripheral Intravenous Catheter Market to Reach $7.5 Billion by 2027

    SpinTech Inc. Acquires MR Innovations

    Millstone Medical Outsourcing Reaches 600-Employee Milestone
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    FUTEK Advanced Sensor Technology Inc.

    Creganna Medical, part of TE Connectivity

    Spectrum Plastics Group

    Forefront Medical Technology

    Concise Engineering
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services

    The 8 Major Types of PPE Supply Chain Fraud

    Evolving Trends in the Medical and Orthopedic Devices Industry
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    PTI Engineered Plastics Inc.

    maxon

    Qosina Corp.

    FUTEK Advanced Sensor Technology Inc.

    Concise Engineering
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Novel Polymers for Sustained Release: Trends Impacting the Drug Delivery Market

    An interview with ProMed Pharma's director of pharma services James Arps analyzes the diverse drug delivery/combination products market.

    Novel Polymers for Sustained Release: Trends Impacting the Drug Delivery Market
    Related CONTENT
    • New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
    • Pharmaceutical Focus: A Look at Combination Products
    • Engineering and Manufacturing Partnerships: The Key to Successful Combination Products
    • Mike on Medtech: Combination Products Update
    • The Medtech Supply Chain and COVID-19
    Sam Brusco, Associate Editor11.15.19
    The drug delivery and combination products market is made up of a number of markets, all based on the means by which the drug is delivered. Some are administered through injection, some through infusion, some orally, some transdermally, and the list continues. Nanomedicine and nano delivery systems are emerging as a method of targeted drug delivery, in which particles attracted to diseases cells directly treat those cells. Implant technology can also deliver targeted medication, providing longer-lasting, localized therapy.
     
    In order to gain more insights about the trends and challenges affecting the diverse drug delivery and combination products markets, I spoke to James Arps, Ph.D., director of pharma services at ProMed Pharma LLC, a Minneapolis, Minn.-based contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components. A portion of his input was included in the November/December issue feature article “Delivering the Goods: The Evolving World of Combination Products.” The entirety of our interview is featured here.

    Sam Brusco: What were the trends that drove the biopharma and drug delivery/combination product markets in 2019?
     
    James Arps, Ph.D.: We focus on sustained release complex dosage forms and drug/device combination products, essentially, we’re looking at ways to keep from forcing patients to take a daily pill or visit the clinic for a weekly or monthly injection. Patients simply don’t want to do these things, which impacts how well the therapy works.
     
    The industry has been focusing more on sustained release applications due to the rise of some innovative technologies. For example, a company has developed a novel once-a-month pill that utilizes an interesting polymer drug release technology for a number of applications.
     
    We also notice significant interest in pain management alternatives due to the opioid crisis. We’ve seen neurostimulation devices that mask the pain by stimulating the spinal cord, as well as sustained release, non-opioid drug-eluting implants that deliver locally to the region of the pain. These technologies have been used for applications like treating post-knee-surgery pain and sciatic nerve-based lower back pain.
     
    Brusco: Which latest developments and/or innovations in drug delivery technology/combination products have captured your attention?
     
    Dr. Arps: A particular class of drug delivery technologies involves sustained release, long-acting implants implanted underneath the skin. These have a long history, particularly in the area of contraception. Most of these are composed of durable polymers like silicones or ethylene vinyl acetate.
     
    The preferred approach to using these devices is a low-effort one: implant it, have it release the drug, then it will slowly dissolve away so you never have to worry about taking it out. And if you want a new one implanted after a year or two, that can be done. Unfortunately, the number of resorbable polymers on the market has been limited, and these polymers don’t always have the best properties for the application.
     
    We’re working with a couple of companies with new polymer technologies that are much more effective for sustained release. These polymers maintain mechanical integrity over a longer period of time and slowly dissolve away like a bar of soap while the drug is released. For example, we have a public strategic partnership with DSM Biomedical, who has developed a polymer called polyester amide (PEA) that has some novel resorption properties.
     
    Brusco: What effect is the convergence of pharma and medtech having on the medical device industry?
     
    Dr. Arps: From a regulatory standpoint, the medtech-pharma convergence is evident simply because it’s a combination product. In the U.S., the FDA’s Office of Combination Products regulates these technologies. This office pulls in people from both the pharma and medical device regulatory groups. Because of that convergence, pharma has recruited quality personnel associated with the medical device industry. It is important to have this perspective because the pharma industry hasn’t previously had to deal with medical device regulatory constraints like design master files.
     
    The medical device side has to engage higher levels of pharma requirements like data integrity. When testing combination products, how data is managed, maintained, and protected for both development and the commercial manufacture is crucial. FDA is also paying more attention to how we manage and approve suppliers to ensure components going into drug-device combination products are high-quality and appropriately controlled.
     
    Brusco: How does the approach to designing, manufacturing, and/or testing a drug delivery device/combination product (or components that go into these devices) differ from other medtech products?
     
    Dr. Arps: Quality by design is a huge buzzword in the pharma world, and that is starting to migrate more into the medical device world. It’s important to lay out the target product profile andthe critical quality attributes of the product we’re developing with our partners. Trying to draft process FMEAs early on, and anticipate where the potential bottlenecks and challenges will be.
     
    The other piece with a combination product is a lot of analytical testing to characterize how the drug comes out of it, and if any of the processing of the drug into the device can degrade the drug at all. We have an in-house analytical lab with a lot of experience specific to some of these long-acting implants and combination products, so we can very quickly develop and test new formulations. We have a good efficiency backloop on that.
     
    Brusco: What are the challenges and opportunities for drug delivery and combination products in the next few years?
     
    Dr. Arps: Everyone has their own particular “mousetrap” and a way of doing things. We want to be able to tailor our solutions to the particular customer’s needs and to come up with an efficient development and manufacturing timeline for them. Speed to market is still a huge consideration, and part of that is speed to clinical trial. Once a decision is made that you’re happy with this formulation, you must move as quickly as possible to get into clinical studies with the appropriate safety profile, and have all the details worked out at the appropriate time.
     
    Brusco: Is there anything else you’d like to say regarding the manufacturing of drug delivery/combination products or components?
     
    Dr. Arps: When trying to establish a partnership with a company in this field, look at their background and experience. We have a history of manufacturing these products—to our knowledge we were the first contract manufacturer to make drug-device combination component like steroid-eluting leadss for cardiac pacing. We were the first one in the U.S. to really establish that—before, it was all the final device manufacturer. Being the first contract manufacturer with the quality systems and manufacturing processes in place to handle these was key.
     
    We’ve also embraced having experience with a wide range of polymers and active pharmaceutical ingredients for drug delivery because the various drugs interact differently with each polymer. That background experience has been helpful to moving development forward as quickly as possible.
    Related Searches
    • therapy
    • clinical trial
    • market
    • fda
    Related Knowledge Center
    • Materials
    Suggested For You
    New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
    Pharmaceutical Focus: A Look at Combination Products Pharmaceutical Focus: A Look at Combination Products
    Engineering and Manufacturing Partnerships: The Key to Successful Combination Products Engineering and Manufacturing Partnerships: The Key to Successful Combination Products
    Mike on Medtech: Combination Products Update Mike on Medtech: Combination Products Update
    The Medtech Supply Chain and COVID-19 The Medtech Supply Chain and COVID-19
    Smart Devices and Drug Formulations: Trends Affecting the Combination Products Market Smart Devices and Drug Formulations: Trends Affecting the Combination Products Market
    Connectivity and Biologics: Trends Impacting the Drug-Device Combo Product Market Connectivity and Biologics: Trends Impacting the Drug-Device Combo Product Market
    5 Questions for DSM at Medica/CompaMed 2019 5 Questions for DSM at Medica/CompaMed 2019
    Mike on Medtech: The Special 510(k) Program Mike on Medtech: The Special 510(k) Program
    Anaconda Biomed Completes First-in-Human Study of Thrombectomy System Anaconda Biomed Completes First-in-Human Study of Thrombectomy System
    Delivering the Goods: The Evolving World of Combination Products Delivering the Goods: The Evolving World of Combination Products
    Fiasp Approved for Use with the Omnipod System in the U.S. Fiasp Approved for Use with the Omnipod System in the U.S.
    Top Surgeons Write Letter to the FDA Top Surgeons Write Letter to the FDA
    Corvia Medical Corvia Medical's Shunt Device Receives Breakthrough Device Designation
    Medtronic Stent Graft System Receives FDA Breakthrough Device Designation Medtronic Stent Graft System Receives FDA Breakthrough Device Designation

    Related Online Exclusives

    • Materials
      Setting the Standard: Protective Nanocoatings for Today

      Setting the Standard: Protective Nanocoatings for Today's Medtech

      Ensuring medical products are safe from the outside environment is a significant challenge that nanocoatings can help resolve.
      Zsolt Pulai, EVP, Technology & Development, HZO Inc. 12.02.20

    • Materials
      Stock vs. Custom Springs for Medtech

      Stock vs. Custom Springs for Medtech

      A review of the pros and cons for medical equipment designers.
      Edward Jones, Marketing Manager, John Evans’ Sons 10.08.20

    • Materials
      New Materials Impact the Medical Technology Outsourcing Market

      New Materials Impact the Medical Technology Outsourcing Market

      How UHMWPE fiber is driving innovation in a quickly expanding sector.
      Abey Paul, Global Business Leader for Honeywell 06.02.20


    • Materials
      Addressing the COVID-19 Crisis: Best Practices in PPE Development and FDA Review

      Addressing the COVID-19 Crisis: Best Practices in PPE Development and FDA Review

      How a supply partner can help a non-traditional medtech manufacturer navigate the regulatory process successfully.
      Lise H. Moloney, Director of Business Development—Healthcare, Sciessent 05.18.20

    • Materials
      Plastics and Medtech: Annual Industry Survey Results

      Plastics and Medtech: Annual Industry Survey Results

      Medical device manufacturers prefer domestic plastics manufacturing and many use thermoforming on a project.
      Jason Middleton, Vice President of Sales & Development, Ray Products 04.24.20

    • Electronics | Materials
      Ultra-Thin Base Materials Take PCB Miniaturization to the Next Level

      Ultra-Thin Base Materials Take PCB Miniaturization to the Next Level

      Flexible and rigid ultra-thin base materials enable highly reliable, thinner PCBs.
      Daniel Schulze, Engineering Manager at Dyconex 02.07.20


    • Materials
      Advancing Infection Prevention Tools

      Advancing Infection Prevention Tools

      The applications and benefits of porous polymer materials and components.
      Jack Chan, Global Marketing Director, Porex 01.17.20

    • Materials
      Avoiding Problems While Collaborating in the Medical Textile Industry

      Avoiding Problems While Collaborating in the Medical Textile Industry

      When to include or exclude an inventor from a patent application.
      Mareesa Frederick and Courtney Bolin, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 12.19.19

    • Materials
      Understanding Key Processes for Mixing APIs with Silicone

      Understanding Key Processes for Mixing APIs with Silicone

      The pros and cons of drug delivery and device enhancement.
      Andrew Gaillard, Healthcare & Medical Segment Manager, Trelleborg Sealing Solutions 12.05.19


    • Materials
      5 Questions for Scapa Healthcare at Medica/CompaMed 2019

      5 Questions for Scapa Healthcare at Medica/CompaMed 2019

      Formulation development, adhesive coating, filling, converting, printing, and packaging for skin-contact adhesive and skin care topical solutions.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Materials
      5 Questions for NuSil Technology at Medica/CompaMed 2019

      5 Questions for NuSil Technology at Medica/CompaMed 2019

      Celebrating 40 years of high purity materials for medical devices.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Materials
      5 Questions for Elkem Silicones at Medica/CompaMed 2019

      5 Questions for Elkem Silicones at Medica/CompaMed 2019

      Range of implant-grade silicones, comprised of injectable and extrudable silicone rubbers, as well as adhesives.
      Sean Fenske, Editor-in-Chief 11.15.19


    • Materials
      5 Questions for DSM at Medica/CompaMed 2019

      5 Questions for DSM at Medica/CompaMed 2019

      Material solutions for cardiology, soft tissue repair, wound care, diabetes, cellular therapies, and orthopedics applications.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Materials
      5 Questions for Saint-Gobain Life Sciences at Medica/CompaMed 2019

      5 Questions for Saint-Gobain Life Sciences at Medica/CompaMed 2019

      Filtration technologies and custom-developed, purpose-built, filtration-based solutions.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Materials | Molding | Packaging & Sterilization
      5 Questions for Colorite at Medica/CompaMed 2019

      5 Questions for Colorite at Medica/CompaMed 2019

      Thermoplastic elastomer compound line for a wide variety of uses in medical devices and packaging.
      Sean Fenske, Editor-in-Chief 11.15.19


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Top 10 Trends In The Medical Device And Equipment Industry
    • 7 Considerations For Designing Medical Device Mechanisms
    • FDA Approves Daytime Treatment For Sleep Apnea And Snoring
    Breaking News
    • Previon, Spectrum Solutions Partner to Deliver At-Home COVID-19 Test
    • NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions
    • Global Peripheral Intravenous Catheter Market to Reach $7.5 Billion by 2027
    • SpinTech Inc. Acquires MR Innovations
    • Millstone Medical Outsourcing Reaches 600-Employee Milestone
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Clinical Trial Finds Metabolic Benefits for Polyphenols Formula
    JRF Technology Debuts Elderberry Oral Film Strip
    Danone Adds to Plant-Based Portfolio with Acquisition of Follow Your Heart Brand
    Coatings World

    Latest Breaking News From Coatings World

    Hempel Launches Sustainability Framework: Futureproof
    ChemQuest Hires Rich Gibson
    New Increase in Kynar Fluoropolymer Capacities at Arkema's Chinese Site
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Previon, Spectrum Solutions Partner to Deliver At-Home COVID-19 Test
    NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions
    Global Peripheral Intravenous Catheter Market to Reach $7.5 Billion by 2027
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement
    Pfizer Selects Seven Bridges to Support RNA Sequencing Data
    ACG Launches ACG Laboratories
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Afro Sheen Launches New Brand Initiatives
    Neopac Introduces Lightweight Plastic Tube
    Estée Lauder Companies Increases Investment in Deciem Beauty Group Inc.
    Happi

    Latest Breaking News From Happi

    PBA Opposes House Bill 2325 in West Virginia
    J.R. Watkins Tackles Pain with New Lines
    RB Launches Vanish Miracle
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Lowe-Martin Adds 2 KODAK NEXFINITY Digital Presses
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eaglewood Technologies debuts new anilox cleaning system
    INX International and VerifyMe sign supply agreement
    Soma partners with DTM Flexo Services
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Fiber Bond VE3 Technology Inactivates SARS-CoV-2 in HVAC Filtration Systems
    Citizens Provides $325 Million Senior Credit Facility to Nice-Pak
    Ontex Reports Lower Revenues
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OrthoGrid Releases New Hip Replacement Software
    Nexus Spine Announces Availability of Spine Surgery Implants
    FDA OKs Brainlab's Loop-X Mobile Imaging Robot, Cirq Robotic Alignment Module
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    RFID Locks Market to Reach $9.93 Billion by 2027: Allied Market Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login