3D printed dosage forms, where are we headed?

ABSTRACT

Introduction

3D Printing (3DP) is an innovative fabrication technology that has gained enormous popularity through its paradigm shifts in manufacturing in several disciplines, including healthcare. In this past decade, we have witnessed the impact of 3DP in drug product development. Almost eight years after the first USFDA approval of the 3D printed tablet Levetiracetam (Spritam), the interest in 3DP for drug products is high. However, regulatory agencies have often questioned its large-scale industrial practicability, and 3DP drug approval/guidelines are yet to be streamlined.

Areas covered

In this review, major technologies involved with the fabrication of drug products are introduced along with the prospects of upcoming technologies, including AI (Artificial Intelligence). We have touched upon regulatory updates and discussed the burning limitations, which require immediate focus, illuminating status, and future perspectives on the near future of 3DP in the pharmaceutical field.

Expert opinion

3DP offers significant advantages in rapid prototyping for drug products, which could be beneficial for personalizing patient-based pharmaceutical dispensing. It seems inevitable that the coming decades will be marked by exponential growth in personalization, and 3DP could be a paradigm-shifting asset for pharmaceutical professionals.

Article highlights

This review encompasses 3DP techniques that could challenge the conventional adage of “one size fits all” in pharmaceutical manufacturing and possibly facilitate personalized manufacturing of patient-specific medicines and drug products.
The promises of first-generation 3DP technologies are evident in pharmaceutical premises for pharmaceutical dosage forms. The evolution of disruptive principles has resulted in a set of second-generation technologies with improvement in fabrication efficiency.
Second-generation 3DP technologies are technically superior to first-generation technologies in production throughput. However, adequate research attempts have not been made to translate these techniques into real-world applications and regulatory approval. However, the surge in the technical growth related to smart polymers, AI (Artificial Intelligence), and ML (Machine Learning) has given this range of technologies an efficient head start.
With new technologies emerging rapidly, regulatory approval strategies for drug products need a lot of effort and homework to materialize and implement in actual practice amidst looming uncertainty. The responsibility lies heavily on regulatory agencies and all pharmaceutical industry/academia researchers to streamline this technology sooner for its practical implementation for faster public outreach.
Current approvals and frequency of clinical trial attempts have shown an increasing trend over the past five years. They are expected to grow in the upcoming decades as pharmaceutical industries and regulatory bodies consider relevant products and look into streamlining 3DP into mainline manufacturing.