Application of Predictive Modeling in the Development of Amorphous Solid Dispersions

Effective modeling and simulation can reduce physical experimental requirements, ASD development risks, and time to market.

Formulators challenged by promising investigational drug candidates with high bioactivity but limited solubility increasingly find amorphous solid dispersions (ASDs) an attractive solution for enhancing bioavailability. The FDA approved nearly 50 drug products formulated as ASDs between 2012 and 2023.¹ However, identifying the optimum method of ASD preparation (eg, spray drying [SD] or hot-melt extrusion [HME]) and choosing the polymeric carrier, surfactant, and drug loading level can be challenging.

Related to this article

November 6th, 2026

Supply Chain Excellence: Managing Temperature and Time Requirements for Ultra-Rare Therapies

Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains how her team managed the study’s strict −80 °C handling requirement, quality release, and site readiness, and how the Almac Adapt approach can apply beyond this program.

Subcutaneous amivantamab wins head and neck cancer approval as IV-to-subcutaneous biologics expand.

November 6th, 2026

Why Amivantamab's Approval Matters to Formulators

The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.

From ADCs to molecular glues, four licensing deals raise tech transfer stakes for manufacturers.

November 5th, 2026

ADCs, Degraders, Agonists: 4 Deals CMC Teams Should Track

Boehringer, AbbVie, ASKA, and Evommune license ADC, IBD, thyroid eye disease, and degrader assets, raising tech transfer demands for manufacturers.

November 5th, 2026

Supply Chain Excellence Through Just-in-Time Manufacturing

Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains the benefits and challenges of the company’s just-in-time manufacturing solution.

November 5th, 2026

PharmSci 360: Build the Device Into Dosage Form Development From Day One

Vivek Gupta of Duquesne University explains at AAPS PharmSci 360 why device decisions can't wait and why excipient makers must test beyond drug molecules.

Speaker, wellness conference and speech of man on stage with host on mic and tablet at event. Workshop, talking and seminar presentation on health, pharma and medical innovation of drugs with guest | Image Credit: ©WesSide/peopleimages.com -stock.adobe.com

November 4th, 2026

Expert Commentary on Formulation, Scale-Up, and Patient-Centered Design Found at CPHI Milan

Industry subject matter experts spoke about the challenges of turning complex molecules into medicines patients can reliably use.

Hopeful clinical setup features medical peptide vial and syringe for wellness therapy in modern clinic environment promoting healthy lifestyle | Image Credit: ©Nim9ty Pics -stock.adobe.com

November 2nd, 2026

Improving Oral Peptide Delivery Through Structural Modifications

Structural modifications can improve peptide stability, solubility, and absorption to enable effective oral delivery.

October 30th, 2026

PharmTech Weekly Roundup—October 30, 2026: Formulation, AI, and NAMs at AAPS PharmSci 360

The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.