Newsletter | July 7, 2025

07.07.25 -- Managing Supplier Quality For Combination Products

FEATURED EDITORIAL

Managing Supplier Quality For Combination Products

This Combination Products Handbook: Series videocast covers key considerations for using third-party suppliers of raw materials, constituent parts, and services in combination product development.

Risk Assessment And Control Strategy In Solid Oral Dosage Forms

Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

INDUSTRY INSIGHTS

Boosting Bioavailability In Complex Oral Formulations

In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.

Understanding Essential Drug Delivery Outputs For Devices

Review how submissions are expected to align with the FDA's draft guidance and clarify the expectations for establishing and controlling Essential Drug Delivery Output (EDDO) requirements.

Enhancing Patient Adherence Through Autoinjector Administration

Examine how autoinjectors have evolved to accommodate a diverse array of chronic diseases, consider the impact of partnering with experienced device manufacturers and fill/finish providers.

3D Screen Printing For Enabling Complex Tablet Formulations

Learn how innovative drug technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.

Formulation And Evaluation Of Enteric Coated Aspirin Capsules

Discover how polymer coatings play a crucial role in oral drug formulations, protecting the API from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location.

SOLUTIONS

Fill-Finish Capacity Expansion Update

Glass Prefillable Syringe Solution Delivering Complex Biologics