Newsletter | October 23, 2023

10.23.23 -- Your Best Chance At Regulatory Compliance For Combination Products

Welcome to the new Drug Delivery Leader newsletter, delivering weekly updates on the latest developments in drug formulation and delivery. Based on your professional interests, we believe you’ll find it useful for staying up to date on regulations, discovering new technologies, learning best practices, and identifying supplier partners. If not, you can unsubscribe at any time.


Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development

The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.


Developmental Testing Of IV Solutions

As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

Inspection Of Injectable Products For Visible Particulates

Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.

The Right Choice For Multiparticulate Modified Release Dosage Forms

Wurster processing is a versatile technique used for manufacturing multiparticulates in modified release dosage forms. Determine if it is suitable for your modified-release project.

Keys To Developing Complex Injectables For Early-Phase Studies

Complex injectables offer unique drug delivery advantages, but their development is challenging due to formulation intricacies, strict FDA regulations, and rigorous testing.

Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying

A recent R&D project has found that spray drying Itraconazole with selective hydrophilic polymers can help maintain an amorphous state, improving its solubility and dissolution characteristics.

Strategies For Accelerating The Development Of Modified Release Oral Forms

Careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.

Accelerating Drug Product Development With Precision Microdosing

Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.

How Drug Delivery Is Enabling A Clinical Trial For Glioblastoma

Discover highly promising in-vivo data, enabled by a nanoformed drug product for the treatment of glioblastoma multiforme (GBM).


Better Solutions For Your Drug Product

Highly Flexible And Customizable On-Body Delivery System Platform

Drug Product Manufacturing: Aseptic Fill/Finish

Glass Prefillable Syringe Solution Delivering Complex Biologics