3D Printing

What is 3D printing of pharmaceuticals?

Additive manufacturing that creates dosage forms layer-by-layer from digital designs using drug-loaded materials.

What is the goal of pharmaceutical 3D printing?

To enable personalized, precise, and on-demand drug production.

Why is industry–pharmacy partnership critical?

Pharma develops drug “cartridges,” while pharmacists print patient-specific medicines on demand.

What is meant by “super-compounding”?

An advanced form of compounding using digital 3-D printing to make personalized dosage forms.

List the three main 3D printing platforms.

Fused Deposition Modeling (FDM), Powder-Based (PB), and Semisolid Extrusion (EXT).

Describe Fused Deposition Modeling (FDM).

Drug-loaded filament extruded through a heated nozzle, forming layers that solidify on a plate.

Advantages of FDM printing.

Low cost, portable, can produce immediate or sustained-release formulations.

Disadvantages of FDM printing.

Not suitable for thermosensitive drugs due to heat use.

Describe Powder-Based 3D printing.

Uses thin powder layers bound by liquid binder droplets from an inkjet print head.

Example of powder-based 3D printing technology.

ZipDose® technology by Aprecia (first FDA-approved 3D tablet).

Advantages of powder-based 3D printing.

Fast-disintegrating tablets; scalable for mass production.

Disadvantages of powder-based 3D printing.

Long drying time, fragile tablets, poor for personalized dosing.

Describe Semisolid Extrusion (EXT) printing.

Syringe extrudes gel or paste that solidifies layer-by-layer at room temperature.

Advantages of EXT printing.

No high temperature; suitable for chewable or palatable forms.

Disadvantages of EXT printing.

Low resolution; limited to semisolids; possible shrinkage on drying.

List two main benefits of 3D-printed pharmaceuticals.

Product complexity and personalization/precision dosing.

How does 3D printing enhance product complexity?

Allows printing of complex or multilayered dosage forms unachievable by traditional methods.

How does 3D printing enable personalized medicine?

Doses can be tailored to each patient’s weight, BMI, or disease needs.

Give examples of 3-D printed clinic types.

Hypertension, diabetic, statin, and anticoagulation 3-D clinics.

What are polypills?

Single 3-D printed tablets combining multiple drugs for easier adherence.

How does 3D printing improve adherence?

Custom shape, color, and combination therapy increase compliance.

What is the vision for the future of 3D printing in pharmacy?

On-demand precision medicine printed by 3-D pharmacists in clinics and hospitals.

What new role might pharmacists have in 3D printing?

3-D medication specialists who design, print, and counsel on personalized drugs.

List two key regulatory challenges.

Distinction between compounding vs manufacturing and unclear FDA pathways.

What are key legal and safety issues in 3D printing?

Tort liability, intellectual property protection, and product safety verification.

What are technical limitations of 3D printing?

Slow production, heat or solvent sensitivity, weak tablet strength.

What is the future outlook for 3D printed pharmaceuticals?

Bright and rapidly evolving; expected to revolutionize personalized compounding.

What was the first FDA-approved 3D printed drug?

Spritam® (levetiracetam) by Aprecia Pharmaceuticals using ZipDose® technology.

What is a pharmaceutical ink?

A printable formulation containing drug and excipients used as a feedstock for 3-D printers.