ORAL DRUG DELIVERY ARTICLES
7 Management Strategies For Combination Product Regulatory Success
In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success.
ORAL DRUG DELIVERY VIDEOS
‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 11 on analytical testing with the book’s editor, Susan Neadle, and chapter coauthor Jennifer Riter. Susan and Jennifer discuss various analytical methods for testing compatibility, performance, stability, and safety when combining drugs or biologics with delivery devices and device constituent parts.
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 segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, traces the evolution of delivery technologies for the opioid overdose drug Naloxone to illustrate enablers of emergency use not requiring trained professionals to administer.
ORAL DRUG DELIVERY RESOURCES
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![GettyImages-839214700-topical_medicine_cream_ssd]( "Semi-Solid And Semi-Liquid Dosage Forms: What To Know")
Interest in semi-solid dose (SSD) forms has been on the rise. Learn more about the advantages of formulating medications into SSD forms as well as the challenges to consider.
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![Improved Bioavailability Of Trio Medicines In 12 Weeks]( "Improved Bioavailability In 12 Weeks")
A lead compound showed clinical promise but had limited bioavailability owing to low solubility. Learn about the challenges, including the molecular characterization and limited budget, and the structured 3-step approach.
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![iStock-843765314-scientist-lab]( "Solutions For Accelerated Pharmaceutical Development")
Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.
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![iStock-1205850790-oral-solid-dose-OSD-tablet-capsule-pill]( "Understanding Of Amorphous Solid Dispersions & Their Downstream Development")
Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.
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![GettyImages-1201263001-lab-team]( "Strategies To Mitigate Common Pitfalls In Early Drug Development")
Two experts discuss the ways companies can address issues with low bioavailability and the benefits of enlisting an experienced drug development partner.
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![GettyImages-1339305459-3d-printing]( "3D Printing Of Pharmaceutical Dosage Forms – Has The Time Come?")
Additive manufacturing, or 3D printing, is arguably balancing on the cusp of translation from academic research into industry practice for pharmaceuticals. What will the future impact of 3D printing be?
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![Evonik]( "Benefits Of Microparticle Technology For Oral Drug Solubility Enhancement")
Spray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.
ORAL DRUG DELIVERY SOLUTIONS
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![GettyImages-669121480-pill-tablet-capsule-OSD-oral-solid]( "Manufacturing For Oral Solid Dose Success")
Adare Pharma Solutions provides end-to-end CDMO services for oral solid dose drugs, enabling efficient development, manufacturing, and packaging with advanced technologies and global scale.
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![GettyImages-2156834696-light-bulb-innovation-idea-creativity]( "Battelle: 90 Years Of Innovation")
Battelle, a leading nonprofit in applied science and technology, drives innovation in national security, healthcare, environment, and education while managing research labs and advancing critical discoveries.
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![GettyImages-2176475661 tabet press, pharma manufacturing]( "Streamlining The Generic Combination Device Design Assessment Process")
A new six-phase assessment process simplifies regulatory approval for generic drug-device combination products, reducing costs and timelines while maintaining safety, effectiveness, and substitutability with reference-listed drugs.
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![GettyImages-637368252 Scientist Monitoring Equipment Readings, CQV Concept]( "<em>Nano</em>Improve Your Small And Large Molecule Formulations")
Can your product be NanoImproved? Find out at at-a-glance with a 4-page informational spread covering new molecules and reformulations, small molecules and biologics, technology details, and proof points.
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![GettyImages-675683632-lab]( "Formulation And Manufacturing Equipment")
AustinPx offers integrated GMP manufacturing services for oral dosage forms with a full complement of analytical development and testing capabilities.
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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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![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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![Nanoform]( "Controlled Expansion Of Supercritical Solutions (CESS®) Technology")
Nanoform’s award-winning Controlled Expansion of Supercritical Solutions (CESS®) technology is a bottom-up nanoparticle engineering approach that enables the creation of API nanoparticles and can unlock the full therapeutic potential of small molecule drugs.
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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-1354171846-lab-research-development]( "End-To-End Drug Development, Analytical Testing, & Fill/Finish")
August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.
