The U.S. is experiencing a shift in the regulatory environment for animal testing, driven by the evolving use of AI. This impacts the formulation development approach for new drugs in the non-clinical phase.
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Spray Drying To Enable New Inhaled Drug Products
The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.
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Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development
The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.
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Making A Case For A Fixed Dose Combination Drug Strategy
As patient-centricity spurs innovation in drug delivery systems, examine the potential of FDCs to provide convenient dosing and how increased patient compliance is alleviating the cost of health care.
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Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization
Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes.
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Applying Automation To The Manufacture Of Drug Delivery Devices
Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.
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Key Considerations For Selecting Flexible Fillers
Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.
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3D Screen Printing: Enabling A New Generation Of Complex Formulations
Screen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.
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Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages
Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.
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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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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.
Tom hosts multiple videocast series providing expert takes and insider perspectives on drug delivery:
FRANKLY FRAN
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In this article, Fran DeGrazio explains why innovation in drug delivery technologies may not need to be revolutionary, but will no doubt need patient adoption, payor support, and regulatory follow-on to become sticky in the marketplace.