FAQ: Everything to Know About Excipients in the Digital Era

1. What is the current primary driver behind excipient innovation?

Innovation in excipients is explicitly needed to meet current drug development demands. They are crucial for addressing challenges in formulation and drug delivery, particularly in optimizing oral solid dosage bioavailability, a main challenge for developers.

2. How do excipients facilitate shifts in formulation?

The industry is shifting toward rational design using mechanistic models and hypothesis-driven strategies to generate efficient solutions. Excipients are the physical components manipulated in this process to optimize drug delivery.

3. How are excipients utilized in advanced dosage forms?

Excipients are integral to specialty dosage drugs. For instance, 3D-printed tablets are being developed to achieve precise, delayed delivery for specific treatments, which requires highly specialized excipient properties.

4. What are the primary regulatory challenges facing excipient suppliers and pharmaceutical developers?

Regulatory decisions regarding specific ingredients can have profound impacts. A ban on ingredients, such as the potential titanium dioxide ban, could have significantly crippled pharma products.

5. How do excipients impact quality assurance and risk in drug manufacturing?

Excipient quality affects overall quality assurance/quality control. Strategies for accelerating development and reducing risk require maintaining a flexible CMC process that ensures quality.

6. How are pressures and regionalization affecting excipient sourcing?

Supply chain pressures, including the strategy of achieving a regionalized supply chain, are crucial strategies for optimizing efficiency and affect small molecule development and excipient use in pharma.

7. How is digitalization impacting the excipient side of manufacturing?

The emerging prevalence of digitalization is a key topic for manufacturers handling excipients. Digital transformation and data integrity protocols are crucial strategies for optimizing drug development and manufacturing efficiency.

8. How are AI and Machine Learning (ML) being used to improve excipient selection?

The industry is focused on mastering AI capabilities and data integration to optimize bio/pharmaceutical manufacturing. Specifically, AI/ML in-silico modeling can accelerate poorly soluble drug development, which often requires specialized excipient strategies (like amorphous solid dispersion development).

9. What is the link between excipient selection and pharmaceutical sustainability goals?
Sustainability efforts are being integrated into pharmaceutical science to meet client expectations and climate pressures. Sustainability is a specific factor reshaping small molecule development and excipient use.