How do 3D printed pharmaceuticals make it easier for the consumer to adhere to customized drug regimens?
Over the past twenty years, the drive for personalized medicine has garnered increasing support among healthcare professionals, patients, and government organizations, including the US Food and Drug Administration (FDA).
The term "personalized medicine" was first used in a short article entitled the New Era of Personalized Medicine: Targeting Drugs for Each Unique Genetic Profile published in the Wall Street Journal on April 16, 1999. Personalized medicine involves analyzing an individual's unique genetic profile to guide healthcare diseases to prevent, diagnose, and treat disease.
Genetic variations, particularly single nucleotide polymorphisms (SNPs), in which a person's genetic code or DNA differs from another person's by one single letter (A for adenine, T for thymine, G for guanine, or C for cytosine). These genetic variations predispose certain individuals to specific diseases and also allow certain people to respond better to specific drugs.
How does a person's genetic code cause them to respond to drugs differently?
Pharmacodynamics refers to the relationship between the drug concentration at the site of action (target receptors) and the subsequent effect on the body, such as the duration and intensity of the therapeutic window and any adverse side effects.
Differences in drug responsiveness between individuals who are given the same exact dose of a drug may be due to a variable number of receptors or differences in how the receptors respond to the drug. Slight genetic alterations due to SNPs may contribute to changes in receptor number or drug sensitivity, both of which can alter the way a person's body reacts to a specific drug dose.
Pharmacokinetics refers to the movement of drugs inside the body. Even though people may receive the same drug dose, they can differ in their pharmacokinetics, demonstrating variable drug concentrations in their bodily fluids. This variation in available drug concentration may be caused by individual differences in drug absorption, distribution, metabolism, and excretion.
Slight changes to a person's genetic code can alter the way their body absorbs, distributes, metabolizes, and excretes a drug, thus affecting the overall concentration of the drug in their body and their individualized response to any given drug dose.
These genetic differences that influence an individual's pharmacodynamics and pharmacokinetics mean that the conventional "one-size-fits-all-approach" in drug manufacturing, which uses a single specific dose (determined by clinical trial findings) for each patient is not justifiable, nor is it effective for all patients.
How does the 3D screen printing of pharmaceuticals support personalized medicine?
3D printing can be a game changer in the realm of personalized medicine. 3D-printed tablets can be carefully tailored to each individual's pharmacokinetics and pharmacodynamics. Drug release profiles and individualized dosing can be designed for optimal effects in conjunction with a person's genetic profile.
3D printing can also support the manufacturing of multidrug combinations to reduce polypharmacy and increase patient adherence to their drug regimens, especially the elderly, who are more likely to have multiple comorbid conditions that require treatment with several different pharmaceuticals. It is easier to remember to take one pill on a daily basis compared to more than 5.
The layer-by-layer 3D printing or additive manufacturing technique allows the active pharmaceutical ingredient (API) for multiple drug combinations to be:
pulverized into a powder form
added to a liquid solution
printed using a prespecified geometrical pattern and number of layers
hardened to solid form in a drying process for each individual printed layer
This spatial separation of multiple drugs in the same pill due to layering and geometry, as well as the choice of printing materials with differing physical properties affecting drug solubility, can influence multiple drug release profiles in a single tablet or polypill.
What are the 3D printing techniques available for manufacturing multidrug combinations?
All 3D printing techniques require 2 basic steps:
design of the printed object using computer software
deposition and formation of the 3D printed object using a 3D printer
3D printers primarily use 3 different systems to produce the additive layers that form these personalized polypills:
Inkjet-based 3D printing
The inkjet-based 3D printing system deposits functional materials as inks on edible polymeric substrates. Inkjet printing is classified into 2 main types: continuous inkjet (CIJ) printing and drop-on-demand (DOD) printing.
CIJ printing works by continuous jetting of droplets, while DOD printing works by jetting droplets in response to a trigger signal. These liquid droplets bind the powder particles of the API or can form a solid product after drying with complete evaporation of the residual solvent.
Extrusion-based 3D screen printing
The extrusion-based system is classified into two separate printing techniques: pressure-assisted microsyringe (PAM) printing and fused deposition modeling (FDM) printing.
In the PAM extrusion printing technique, the printing material—a semisolid material or paste—is placed into a metal or plastic syringe mounted on an extruder attached to a pressure-controlled air pump. The air pushes the semisolid material in the syringe through small nozzles of varying shapes and sizes to deposit the first layer, which is dried quickly to prepare for the next layer. The process is repeated layer by layer.
In the FDM extrusion printing technique, the printed material is a filament that is fed to the printer. The filament is melted and extruded through a heated nozzle and returns quickly to a solid state in a layer before the process is repeated layer by layer.
Laser-based 3D printing
Laser-based 3D printing directs a high-energy beam of light, such as ultraviolet light, to create a 3D shape layer-by-layer. Two laser-based 3D printing techniques include stereolithography (SLA) and selective laser sintering (SLS).
The SLA technique focuses the laser beam on the top layer of photosensitive polymeric liquid resins to solidify the layer before the next liquid layer is applied.
In contrast, SLS is a powder solidification technique. The laser beam sinters a powder containing the API without liquefying it while melting the polymeric materials into which the powder is coalesced.
3D screen printing enables personalized medicine via the mass production of polypills on demand
All of these different 3D printing techniques can be applied to mass-produce polypills. The printing parameters and dosing can easily be changed using computer software to design and manufacture tablets that contain multidrug combinations based on each person's unique genetic profile.
Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions which optimize products and benefit patients. Our goal is to establish SPID®-Technology as a manufacturing process that has the individual and the pharmaceutical partner in mind.