INHALATION DRUG DELIVERY ARTICLES
Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
In this article, consultant Doug Mead reports on precedent research he conducted into FDA databases on 21 CFR Subpart cGMPs for combination products. His observations and conclusions offer sound advice on how to approach summaries submitted for BLA and NDA purposes.
INHALATION DRUG DELIVERY VIDEOS
How are EDDOs (Essential Drug Delivery Outputs) determined during the design of a drug-led or biologic-led combination product? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC lays out the foundational considerations.
In this segment of the Drug Delivery Leader Live online event, Just Breathe: Increasing Efficacy And Expanding Targets With Inhalation Delivery, panelists David Morton, Geraldine Venthoye, Stephen Stein, and Nani Kadrichu comment on the current state of innovation, platform technologies, supplier consolidation, and the role of CDMOs in the inhalation drug delivery industry.
In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC uses a hypothetical case study for a meter dose inhaler (MDI) to demonstrate a template for identifying EDDOs.
In this videocast episode, host Tom von Gunden discusses Chapter 14 of The Combination Products Handbook (CRC Press) with the book’s editor Susan Neadle, along with chapter coauthors Stephanie Goebel, Cherry Malonzo Marty, and Viky Verna. The group provides overviews of the commonalities and variances in regulatory definitions and guidances for combination products across global jurisdictions and agencies.
INHALATION DRUG DELIVERY RESOURCES
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![GettyImages-1206035004-spectroscopy-lab]( "Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway")
Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.
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![GettyImages-1213498599-lab-research-microscope]( "Complex Molecules, Complex Problems")
The support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.
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![science drug development data iStock-1209661917]( "Is Your Combination Product Drug-Led Or Device-Led?")
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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![GettyImages-1645853102-injectable-injection-self]( "Data-Driven Innovation Is Drug Delivery's Next Evolution")
To mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.
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![GettyImages-946264472-test-tube-lab]( "Improving Toxicology Testing For Inhalation Products")
By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.
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![GettyImages-1413332879 diabetes]( "10 Ways To Align Your Medical Device With Human Factors Industry Best Practices")
Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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![drug-delivery-GettyImages-1156884561]( "The Gateway Delivery To The Brain")
Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.
INHALATION DRUG DELIVERY SOLUTIONS
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![GettyImages-1600719545 lab]( "Innovative Formulations And Higher Drug Loads Across The Life-Cycle")
Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.
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![Working on testing machine]( "Organ On A Chip: Advancing New Approach Methodologies")
Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.
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![Blow Fill Seal Packaging]( "Blow-Fill-Seal Packaging Systems For Large Volume Nebulizers And Humidifiers")
Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.
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![scientist in lab microscope-GettyImages-1867575565]( "NanoImprove The Performance Of Your Biologic Formulation")
Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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![pulmonary-GettyImages-2148494976]( "Pulmonary")
See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.
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![Syringes-injectables=tablets-GettyImages-1353657651]( "Combination Products")
Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).
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![GettyImages-1585548490-modular-facility-laboratory-drug-development]( "From Discovery To Impact: New Approach Methodologies")
Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.
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![Nasal spray, allerfies, common cold-GettyImages-2147519597]( "Nasal Drug Delivery")
How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Global Experts In Nanotechnology And Drug Particle Engineering")
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
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![GettyImages-884796056-solubility-test-pill]( "Pharmaceutical Development")
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
