ORAL DRUG DELIVERY ARTICLES
Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation
The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.
ORAL DRUG DELIVERY VIDEOS
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, panelists Carolyn Dorgan and Courtney Evans from delivery device consultancy Suttons Creek talk with host Fran DeGrazio about factors creating challenges and opportunities in moving patients to on-body injectors (OBIs) and other wearable drug delivery systems.
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.
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, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for an on-body injector (OBI) to demonstrate a template for identifying EDDOs.
In this episode of In Combination, the technical leadership team from device consultancy Suttons Creek joins host Tom von Gunden to discuss trends in the patient landscape driving innovation in drug delivery, including combination products and therapies. The conversation covers patient self-administration, emerging modalities, and key considerations in product development, regulatory pathways, and the supply chain.
ORAL DRUG DELIVERY RESOURCES
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![Syringes GettyImages-171324030]( "Engineering Advances In Needle Geometry To Accommodate Viscous Biologics")
Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.
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![GettyImages-1288978528 Scientist Using Microscope In Lab]( "A New Framework For Identifying Nitrosamine Risks And Derisking Products")
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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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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![GettyImages-1354172420-lab-development]( "Integrating Early-Phase Clinical Supply Manufacturing & Distribution")
A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.
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![Signing contract-GettyImages-1405364155]( "Contract Design And Development Vs. In-House: How To Find The Best Fit")
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Crystallization Process Development: Peptide Crystallization")
Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.
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![GettyImages-1320388413-crystallization-crystal]( "Crystallization Process Dev: Ramping Up Bench-Scale Control")
Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.
ORAL DRUG DELIVERY SOLUTIONS
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![adare manu]( "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.
