Application of 3D printing in early phase development of pharmaceutical solid dosage forms

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Additive Manufacturing

Background:

• Three-dimensional printing (3DP) is an emerging technology with potential for dose-customized solid oral dosage forms (SODFs).
• Traditional drug manufacturing remains the industry standard despite 3DP's capabilities.
• 3DP is anticipated to significantly benefit personalized medicine.

Purpose of the Study:

• To review recent advancements in 3DP technologies for SODFs.
• To highlight applications of 3DP in early clinical development stages for SODFs.
• To discuss current regulatory challenges and quality controls associated with 3DP for SODFs.

Main Methods:

• Literature review of recent advancements in 3D printing for solid oral dosage forms.
• Analysis of 3DP applications in early-phase clinical studies.
• Examination of regulatory considerations and quality control strategies.

Main Results:

• 3DP shows promise for customized SODFs, particularly benefiting personalized medicine.
• 3DP is unlikely to replace conventional mass production but is suitable for small-batch adaptive manufacturing.
• 3DP can facilitate adaptive clinical trial designs in early development stages.

Conclusions:

• 3DP technology is poised to enhance personalized medicine through customized SODFs.
• The application of 3DP in small-batch production for adaptive trials is a key advantage.
• Addressing regulatory hurdles and ensuring quality control are crucial for widespread 3DP adoption in pharmaceutical development.