Manufacturing technology
at a patient’s profile to determine their optimal dose before 3D printing and dispensing it using an automated system.
3D printing might also help manufacturers improve a drug’s solubility, control the speed of absorption or incorporate it into a range of drug- eluting implants.
“It opens up the possibility of designing and fabricating customised and complex geometries to achieve different drug release kinetics,” says Fouladian. “It also gives you the ability to control the spatial distribution of the therapeutic agent within the body, and allows for the deposition of very small amounts of therapeutic agents.”
Dose on demand To give a quick primer on how 3D printing works: 3D objects are fabricated from a digital file, which can be easily changed or adapted according to need. Unlike traditional manufacturing processes, in which a raw material is shaped into its final form via carving or injection moulding, 3D printing builds up different materials, layer upon layer. This intricate process allows for the creation of complex, customised objects. Within drug delivery specifically, the most popular technique is called fused deposition modelling (FDM), in which filaments are loaded with medicine. Other common techniques include direct powder extrusion (suitable for delayed or sustained release dosing), stereolithography, inkjet printing and selective laser sintering. In most cases, these methods are based around polymers. “Polymers, as the most versatile class of materials, play a crucial role in drug delivery systems,” explains Fouladian. “To identify possible polymers for the desired application, several criteria need to be considered, including chemical inertness, biocompatibility, ease of fabrication, sterilisation and compatibility with drugs.” The world’s first 3D-printed drug, Spritam, was approved for the treatment of epilepsy by the FDA in 2015. Normally, a large dose of medication means a large pill, which can stick in the throat, causing problems for elderly patients. By 3D printing the tablets, the manufacturer, Aprecia, was able to improve their porosity and make them easier to swallow.
Since then, a UK start-up called FabRx has used 3D printing to create personalised medicine for children with a rare metabolic disorder that causes a harmful buildup of amino acids in the blood and urine. The pharma giant Merck has also announced plans to produce 3D-printed tablets for clinical trials, in partnership with additive manufacturing company AMCM.
Medical Device Developments /
www.nsmedicaldevices.com Implants used to regenerate damaged bone
Each year, around four million people worldwide develop bone infections following an open fracture or surgery. The gold standard treatment consists of a lengthy antibiotic therapy, usually delivered orally or intravenously, and the removal of infected bone tissue, which often leaves behind a hole too large for the body to fi ll via normal bone regeneration. In a study published in April 2021, in the journal Bioactive Materials, a group of researchers from the Netherlands, Italy and Spain, outlined a new treatment approach they have developed – novel antibiotic-releasing and biodegradable 3D printed scaffolds, capable of supporting bone regeneration and delivering antibiotics at the same time. The study’s multidisciplinary team of scientists found that covering the antibiotics with lamellar inorganic protectors, prior to mixing them with the polymer and placing them in the 3D scaffolds, not only protected the antibacterial agents, it also enabled a more controlled release. This extended the period the antimicrobial was active and helped to keep local antibiotic concentrations under potentially toxic levels. At the same time, the cells in contact with these scaffolds maintained their viability and could perform normal cell functions, including bone formation –the ultimate goal of
the implant. Source: KeAi Communications
More recently, Chinese company Triastek has received investigational new drug (IND) approval from the FDA for its own 3D printed drug product, T19. The drug in question – which is likely to become the second 3D-printed pharmaceutical on the market – is designed to treat rheumatoid arthritis. According to the manufacturer, its internal geometry allows the mode of drug delivery to be closely controlled and adjusted.
Another line of research lies with ‘polypills’ – multiple drugs combined into a single pill. These would be suitable for patients suffering multiple conditions who want to simplify their treatment regimen. Because 3D printing enables manufacturers to build up different layers with different geometries, the drugs would be physically separated from each other and could be given different release profiles, meaning they didn’t interact. In 2019, a research team successfully 3D-printed polypills containing six different drugs (paracetamol, naproxen, caffeine, prednisolone, aspirin and chloramphenicol) in spatially separated compartments.
“Over the last decade, 3D printing has gained considerable attention in pharmaceutical formulations and drug delivery systems as an effective strategy to overcome the challenges of conventional manufacturing approaches.”
Drugs in devices
Other researchers are incorporating drugs into 3D-printed implants, like stents, as well as antitumoural and bone treatment devices. The idea is to administer drugs into the tissue surrounding the implant to avoid the side effects of systemic administration.
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