INHALATION DRUG DELIVERY ARTICLES
Delivery Device Functional Scrutiny: Can You Pass (Without) The Test?
In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).
INHALATION DRUG DELIVERY VIDEOS
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage.
In this unique episode of In Combination, series host Tom von Gunden, Chief Editor at Drug Delivery Leader, puts himself in combination with DDL Executive Editor Fran DeGrazio as the two share perspectives on drug delivery trends.
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 6 on risk management from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Edwin Bills.
In this segment of the Drug Delivery Leader Live online event, Just Breathe: Increasing Efficacy And Expanding Targets With Inhalation Delivery, Chief Editor Tom von Gunden asks panelist Stephen Stein to comment on sustainability considerations for inhalation delivery. Stein notes propellants and plastics as two key focus areas for climate-attentive innovations in inhaler design.
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-1426603202-scientist-research-lab]( "Application Of A Novel Temperature Shift Process For Particle Engineering")
Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.
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![GettyImages-995087800-lab]( "Drug Formulation Development: Quick Reference Guide")
This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
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![GettyImages-1279969622-self-injector-injection]( "Streamlining The Path To Market For Generic Drug-Device Combinations")
Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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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-1346675635-lab-tablet-research-team]( "Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations")
Dr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.
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![GettyImages-1219894348-lab-cleanroom-PPE]( "Driving Sustainability In Spray Drying Through Enabling Technologies")
By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.
INHALATION DRUG DELIVERY SOLUTIONS
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![GettyImages-1268574717-food-inspect-ship-package]( "A/L/P Assembly, Label And Packaging")
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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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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![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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![analytical-timelines-GettyImages-2247278213]( "A Comprehensive Approach That's Exceptional By Design")
An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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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.
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![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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![OFM]( "Pharmaceutical Filling System For Non-Injectable Products: Ophthalmic, Nasal Sprays, Syrups: OFM")
OFM automatic filling and closing machines are designed for pharmaceutical formulations, such as syrups, ophthalmic products, and nasal sprays either in glass or plastic containers.
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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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![GettyImages-1392016982 business meeting]( "Medical Device Technical Due Diligence")
By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
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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.
