Formulation Development

Mechanical Engineering Design Process For Combination Products

Mechanical engineering for combination drug-delivery devices demands more than good design — it requires data-driven risk management from specs through simulation. Learn how a structured phase approach ensures global manufacturing readiness.

Considerations In Design And Development Of Novel Combination Drug-Delivery Devices

Poor scoping kills drug delivery device programs before they start. Learn how to define the right problem, assess risk early, and set boundaries that protect your timeline and budget.

Beyond PMI: Solvents As A Key To Sustainable Process Design

Discover how data-driven solvent selection helps uncover sustainability opportunities, boost efficiency, and enable smarter process optimization decisions.

How Data-Driven Development Is Transforming Phosphoramidites

High-quality phosphoramidites are key to oligonucleotide therapies. Learn how data-driven optimization boosts purity, streamlines manufacturing, speeds scale-up, and supports commercialization.

Three Keys To E&L Success: Study Design, Partner Selection, And Timing

Successful E&L planning starts before testing begins. Aligning study design, partner expertise, and timing helps teams focus on the right risks, avoid surprises, and support stronger development.

Predicting Food Effects In Oral Drug Delivery Using PBPK Modeling

Learn how integrated PBPK and molecular dynamics modeling predicted an ~11% fed-state Cmax increase for fenofibrate, giving formulation teams earlier, mechanistic insight into food-dependent absorption.

Compaction Simulation For Tablet Technology Transfer And Scale-Up

Compaction simulation de-risked tech transfer for a 40 mg fexuprazan tablet by defining optimal roller compaction and lubrication parameters before scale-up. Access the full case study to see the data.

Predicting Softgel Stability And Shelf Life Using Accelerated Modeling

Predict ibuprofen softgel shelf life in 21 days instead of years. ASAPprime modeling identified PEG-ester degradants as the limiting factor, estimating 5.5-year and 3.8-year shelf lives before long-term studies concluded.

Predicting Drug-Loading Limits In Tablet Formulations

Learn how predictive percolation modeling identified critical drug-loading limits of ~20% for crystalline API and ~15% for SDD forms, cutting tablet formulation trial-and-error significantly.

Improving Bioavailability Through Predictive Modeling Of Solubility Enhancement Strategies

In silico modeling cut through formulation guesswork for a compound with 0.015 mg/mL solubility, delivering an 8× Cmax and 5× AUC improvement and Phase I progression.