The FDA’s Center for Drug Evaluation and Research (CDER) announced this week it is continuing to look into the feasibility manufacturing medications with 3D printing technology.
3D printing of pharmaceuticals allows for a unique approach for the manufacture of solid drug products in various shapes, strengths and spatial distributions of the active and inactive ingredients. Designs ranging from a single compartment to designs with multiple drug compartments can allow the release profile of the active ingredients to be tailored to meet the needs of specific patients.
Some of the advantages this manufacturing approach could include producing unique dosage forms such as the instantaneous disintegration of an active ingredient, and other complex drug release profiles. To date, one FDA-approved drug—Spritam®–is manufactured using 3D printing technology. Spritam® tablets, for the treatment of epilepsy, are designed so that a large dose of active ingredient (1000 mg of levetiracetam) disintegrates within seconds after taking a sip of water.
The Office of Testing & Research is examining questions such as
- What are the critical process and component material parameters that affect printability of drugs?
- What are the critical process parameters for each 3D printing technology?
- How can a determination be made regarding when and how a given 3D geometric design is underperforming?
- What are the critical characteristics of the component products for 3D printing including printers, filaments, substrate, and cartridges?
- What are the critical factors in this method of manufacture that affect the drug release rates and MOA?
Of course, with any new pharmaceutical manufacturing process, there are also regulatory hurdles to be managed as well. CEDR is examining to what extent the process can be managed to ensure quality control across the multiple components associated with 3D printing processes, namely printers, substrate, and intermediate products and processes.
Why It’s Hot
In a word where we are expecting increasing levels of personalized service in almost every area of our life, pharmaceuticals as a produce lag due to legacy constraints in manufacturing.
3D printing offers the ability to manufacture drugs on demand for a unique individual’s physiological demands and can have a significant impact on quality of life.