• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Bye-Bye China?

    Decentralized Trials Fuel AI Revolution in Clinical Research

    Self-Medication: Flexibility for Patients and Drug Manufacturers

    The Single-Use Mixing Landscape: Evaluating Your Options

    DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Bone Therapeutics, Rigenerand Ink Cell Therapy Deal

    NovaQuest Private Equity Acquires CoreRx

    JS Bio and Etta Biotech Advancing Partnership

    Intravacc Completes Project for Provention Bio’s Vax Candidate

    Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules

    Cognate BioServices Announces Major Expansion

    Sanofi Unveils EUROAPI as Name of New European API Company

    Precision Medicine Group Acquires Project Farma

    Cytiva Delivers Modular Biologics Factory to Lonza
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

    Varcode, PL Developments Form Strategic ‘Smart Tag’ Pact

    COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

    Thermo Fisher Expands Clinical Supply Services in Europe

    Schreiner MediPharm Joins DoseID Consortium
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    The Future of Clinical Trials Series: Part I

    JS Bio and Etta Biotech Advancing Partnership

    Intravacc Completes Project for Provention Bio’s Vax Candidate

    Drug Development For Startups

    Metrion, LifeArc Extend Neuroscience Alliance
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management

    CDMO Cognate BioServices Teams Up with L7 Informatics

    The Wasdell Group Earns ISO 13485 Certification
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Syngene

    Reed-Lane

    Emergent BioSolutions

    Flow Sciences

    PCI Pharma Services
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Adare Pharma Solutions

    Reed-Lane

    PCI Pharma Services

    Cytovance Biologics

    Aphena Pharma Solutions
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Advantages of Fixed-Dose Combo Drug Products

    Dr. Anthony Qu of Halo discusses opportunities in this growing market

    Advantages of Fixed-Dose Combo Drug Products
    Related CONTENT
    • Know the Challenges of Biosimilar Manufacturing
    • Flexible Manufacturing Strategies and Data Integrity
    • CMOs/CDMOs: Challenges and Opportunities
    • CEO Spotlight: Catalent
    • Sterile Manufacturing: Future Trends and Challenges
    Kristin Brooks, Contract Pharma11.14.17
    Fixed-dose combination (FDC) drugs, a growing market that combines multiple active pharmaceutical ingredients (APIs) into a single-dose product, aim to improve patient convenience, compliance, and appropriate dosing. Pharma companies can realize substantial savings when developing an FDC comprised of previously approved new chemical entities or their generic counterparts. FDC products have proven to be an attractive strategy for extending the market potential of proprietary drugs.
     
    Halo Pharma has provided technical expertise and formulation technology to support the development and manufacture of FDC drugs that are currently approved, as well as in development, as part of an effort to reduce costs, time to market, and extend market dominance. Dr. Anthony Qu, vice president of scientific affairs at Halo Pharmaceuticals provides insight into the advantages and opportunities of FDC drug products.

    Contract Pharma: What makes FDC so attractive for Pharmaceutical companies?
     
    Anthony Qu: FDCs are a potentially attractive way to repurpose APIs in combinations that solve unmet clinical needs. FDC’s could enable additional protection of intellectual property and extended market exclusivity in some cases. This is because FDCs are composed of previously approved agents. 
     
    Some companies choose the 505(b)(2) pathway for shorter development programs for approval of FDCs. Using this pathway may lead to value creation for the pharma company through marketing of a new product under an NDA instead of an ANDA but without the long lead-time and expense of a full clinical program.
     
    From a patient perspective, FDCs are attractive because the pharma company may be able to offer a lower therapeutic dose of two drugs in one product that may be more effective than a higher dose of a single drug. FDCs may also minimize adverse effects when given in combination and at lower doses that contain two or more APIs. In addition, the simplification of the treatment regimen is a patient benefit where fewer pills taken means better patient adherence to dosing instructions and compliance.
     
    CP: What are some examples of formulation options for FDC?
     
    AQ: Because Halo possesses a wide range of formulation capabilities, our clients can choose from multilayer tablets, or even mini-tablets that can be compressed together or combined into capsules, sachets, or stick-packs. Halo offers a variety of polymer-coating options to enable controlled release of differing drug substances in one tablet, as well as taste-masking methods that rely on ion exchange technology. This range of options is enabled by the flexibility and variety of manufacturing platforms at Halo. Customers can choose the FDC solid dose form that is most suitable for their clinical needs. Our process capabilities include not only hot melt extrusion, wet or dry granulation, roller compaction, extrusion-spheronization in addition to multiparticulate capsule filling and bilayer press capabilities suitable for FDCs.
     
    We have seen a marked interest in FDC products from current and new customers. The capabilities Halo offers, all under one roof, provide many options for customers in the development of their products. Halo is one of only a select group of CDMOs that have both development and commercial manufacturing experience in FDCs. We have made, and will continue to make, significant investments in equipment and technical expertise to support this capability.
     
    CP: Please provide an example of using the 505(b)(2) pathway
     
    AQ: Based on published data from the U.S. FDA, there were 63 FDCs among 655 NDA approvals[i] (2010-2015), and the majority of those FDC approvals followed the 505(b)(2) pathway, rather than completion of all phases of clinical trials required under NCE programs.
     
    The following are two examples of approved FDCs that benefitted from 505(b)(2). For the treatment of diabetes, Actoplus MET XR is a combination of pioglitazone and metformin.
    For the treatment of hypertension, Azor is a combination of amlodipine and olmesartan.
     
    Drugs are often combined due to their respective pharmacokinetics (PK) and metabolic profiles. A pharma company might be able to pursue the 505(b)(2) pathway for single combination product approval of two statins that lower LDL and HDL cholesterol if both statins are individually approved at the same dose.


    [i] Kwon KC Lee C. Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration, 2010-2015. Implications for Designing a Regulatory Shortcut to New Drug Application. Ther Innov & Reg Sci 2017;51:111-117
     


     Dr. Anthony Qu
    Dr. Anthony Qu is vice president of scientific affairs at Halo Pharmaceuticals. In this role, Anthony leverages more than two decades of research and development experience in brand, generic and contract pharma companies to help clients develop and transfer their molecules from earlier phase to commercialize drug products. He works with his product development team and has successfully developed and transferred multiple fixed dose combination products.
     
    Related Searches
    • marketing
    • tablets
    • Manufacturing
    • apis
    Suggested For You
    Know the Challenges of Biosimilar Manufacturing Know the Challenges of Biosimilar Manufacturing
    Flexible Manufacturing Strategies and Data Integrity Flexible Manufacturing Strategies and Data Integrity
    CMOs/CDMOs: Challenges and Opportunities CMOs/CDMOs: Challenges and Opportunities
    CEO Spotlight: Catalent CEO Spotlight: Catalent
    Sterile Manufacturing: Future Trends and Challenges Sterile Manufacturing: Future Trends and Challenges
    Contracting & Outsourcing Session Highlights and Key Takeaways Contracting & Outsourcing Session Highlights and Key Takeaways
    2017 Contracting & Outsourcing Conference Wrap up 2017 Contracting & Outsourcing Conference Wrap up
    Know the Challenges of  Biosimilar Manufacturing Know the Challenges of Biosimilar Manufacturing
    Outsourcing Partnerships:  Trends in the CDMO Sector Outsourcing Partnerships: Trends in the CDMO Sector
    Marketing Code Round The Corner Marketing Code Round The Corner
    Cancer Trials in the New Age of Drug Development Cancer Trials in the New Age of Drug Development
    Senate Passes FDA Reauthorization Act Senate Passes FDA Reauthorization Act
    CPhI Worldwide Opens Entries for Pharma Awards CPhI Worldwide Opens Entries for Pharma Awards
    Patheon to Invest $45M to Expand Capabilities  Patheon to Invest $45M to Expand Capabilities
    Warning Letters & Close-out Letters Warning Letters & Close-out Letters

    Related Online Exclusives

    • Analytical Services | Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | Fill/Finish
      A New Era of Vaccine and Biologic Drug Development

      A New Era of Vaccine and Biologic Drug Development

      As a result of COVID-19, unprecedented investments in vaccines, diagnostics, and treatments have had a tremendous impact on the Biotechnology industry.
      Kristin Brooks, Managing Editor 01.12.21

    • Clinical Trials | Drug Development | Information Technology
      Advancing Digital Endpoints in Clinical Trials

      Advancing Digital Endpoints in Clinical Trials

      An end-to-end approach to managing wearable devices through clinical development.
      Kristin Brooks, Contract Pharma 12.14.20

    • Drug Delivery | Drug Development
      Inhaled Drug Delivery Technology Trends

      Inhaled Drug Delivery Technology Trends

      The success of new inhaled medicines relies on the correct combination of formulation and device technology.
      Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 11.24.20


    • Bioanalytical Services | cGMP Manufacture | Drug Development | Scale-up/Technology Transfer
      CDMOs: Keeping up with Science & Technology

      CDMOs: Keeping up with Science & Technology

      Enhancing the development of increasingly advanced and complex drug candidates is needed to drive growth in the industry.
      Kristin Brooks, Contract Pharma 11.12.20

    • Clinical Trials | Drug Development | Preclinical Outsourcing
      Accelerating R&D Trends

      Accelerating R&D Trends

      The pandemic has propelled lingering trends into the forefront and increasingly complex molecules and biologics have drug developers outsourcing more.
      Kristin Brooks, Contract Pharma 10.20.20

    • Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
      Expediting a COVID-19 Vaccine: FDA Approval Process

      Expediting a COVID-19 Vaccine: FDA Approval Process

      The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.
      Kristin Brooks, Contract Pharma 08.25.20


    • Drug Development | Information Technology
      Trade Secret Litigation: Vulnerabilities Within Pharma Amid Hacking Efforts

      Trade Secret Litigation: Vulnerabilities Within Pharma Amid Hacking Efforts

      Theft of IP belonging to companies developing biologics and other drugs, including COVID-19 treatments and vaccines, poses a threat to innovation.
      Kristin Brooks, Contract Pharma 08.19.20

    • Drug Development | Industry News
      Top Companies Report: Biogen

      Top Companies Report: Biogen

      Expands pipeline of disease-modifying therapies for Alzheimer’s and Parkinson’s, adds gene therapies focused on AAV treatments, bolsters biosimilars portfolio.
      Kristin Brooks, Contract Pharma 07.10.20

    • Analytical Services | Biologics, Proteins, Vaccines | Drug Development | Drug Discovery | Laboratory Testing
      A Shifting Drug Development Landscape Amid COVID-19 Crisis

      A Shifting Drug Development Landscape Amid COVID-19 Crisis

      Responding to demand for challenging assays and custom solutions required for complex molecules, biologics, vaccines and other innovative therapies.
      Kristin Brooks, Contract Pharma 06.22.20


    • Drug Development | Information Technology
      Advancing AI Initiatives in R&D

      Advancing AI Initiatives in R&D

      Richard Lee of ACD/Labs discusses the possibilities of using AI in R&D, and what this outlook means for IT leaders at pharmaceutical organizations.
      Kristin Brooks, Contract Pharma 06.11.20

    • Clinical Trials | CRO News | Drug Development | Information Technology | R&D
      CRO Industry Update

      CRO Industry Update

      Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.
      Kristin Brooks, Contract Pharma 04.27.20

    • Drug Development | R&D
      COVID-19 and the Importance of Combating Antimicrobial Resistance

      COVID-19 and the Importance of Combating Antimicrobial Resistance

      Dr. Frank of Working to Fight AMR discusses the global COVID-19 pandemic and the critical need to address the public health crisis of Antimicrobial Resistance
      Kristin Brooks, Contract Pharma 04.13.20


    • Biologics, Proteins, Vaccines | cGMP Manufacture | Clinical Trials | Drug Development | Scale-up/Technology Transfer
      Rapid Delivery of Medical Countermeasures Amid Pandemic

      Rapid Delivery of Medical Countermeasures Amid Pandemic

      Robert Erwin of iBio discusses the company’s COVID-19 vaccine development efforts and FastPharming manufacturing platform for the rapid delivery of vaccines
      Kristin Brooks, Contract Pharma 04.03.20

    • Biologics, Proteins, Vaccines | Clinical Trials | Drug Development
      COVID-19 Vaccine Response

      COVID-19 Vaccine Response

      ICON execs discuss developments in vaccine research efforts and key challenges of delivering a coronavirus vaccine
      Kristin Brooks, Contract Pharma 04.01.20

    • cGMP Manufacture | Drug Development | Logistics | Supply Chain
      COVID-19: Business Update

      COVID-19: Business Update

      Thermo Fisher Scientific provides perspective on the COVID-19 pandemic and how the company is working to help minimize disruptions
      Kristin Brooks, Contract Pharma 03.30.20

    Trending
    • Lonza To Exit Pharma Softgels And Liquid-Filled Hard Capsules
    • Roche Canada To Invest $500M To Create 500 Jobs In Ontario
    • Grifols Begins COVID-19 Plasma Treatment Trial
    • Fujifilm To Invest $2B In US Manufacturing Site
    • Virtual Clinical Trials: The Future Of Dermatology Studies
    Breaking News
    • Bone Therapeutics, Rigenerand Ink Cell Therapy Deal
    • NovaQuest Private Equity Acquires CoreRx
    • JS Bio and Etta Biotech Advancing Partnership
    • Intravacc Completes Project for Provention Bio’s Vax Candidate
    • Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Modeling Process Safety Workflows in Pharmaceutical Manufacturing Scale-Up
    • Ensuring Quality During the Transfer and Scale Up of Rx Drugs
    • Inspecting the Unexpected
    • Cold Chain Trends
    • Catering for the Complex
    • Biopharma Contract Manufacturing: Robust Growth Ahead
    • DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    • The Single-Use Mixing Landscape: Evaluating Your Options
    • Self-Medication: Flexibility for Patients and Drug Manufacturers
    • Decentralized Trials Fuel AI Revolution in Clinical Research
    • 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

    BGG Obtains U.S. Patent on AstaZine Natural Astaxanthin for Heart Function During Exercise
    Qualitas Health/iwi Raises $10 Million in Investment Round
    Aker BioMarine Expands Krill Portfolio with Novel Protein Hydrolysate
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    Miller Paint Declares Simple Serenity its 2021 Color of the Year
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    CHF Solutions Appoints CEO
    Freehand Partners with Imperial Medial Solutions
    Intersect ENT Announces CMS Approval of Coding Application for Sinus Implant
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bone Therapeutics, Rigenerand Ink Cell Therapy Deal
    NovaQuest Private Equity Acquires CoreRx
    JS Bio and Etta Biotech Advancing Partnership
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Marino Belotti Presents New Website
    Essence Cosmetics Expands in the U.S.
    Sigma Beauty Launches 'Brush Care' Sets at Sephora
    Happi

    Latest Breaking News From Happi

    Mix:Bar Launches at Target
    Crystal Deodorant Unveils Magnesium-Enriched Sticks
    Euromonitor Reveals Top 10 Global Consumer Trends for 2021
    Ink World

    Latest Breaking News From Ink World

    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Packaging Printing Market Worth $433.4 Billion by 2025: MarketsandMarkets
    O-I Foundation Gifts $50k to Facilitate COVID-19 Vaccine Access
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Domino grows installation and service teams
    ABG keeps pace with demand with recruitment drive
    Acucote expands FSC-certified portfolio
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Honeywell Delivered 225 Million Masks in December
    Techtextil, Texprocess Postponed to 2022
    Super Strong Inks Survive Tough Environments
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Bioventus Appoints SVP of Operations
    DePuy Synthes Receives 510(k) FDA Clearance for VELYS Robotic-Assisted Solution
    OrthoPediatrics Expands Agent Network in Three European Countries
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    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