03 - 04 December, 2019
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Could 3D Printing Solve the Challenges of Personalised Medicines?
While personalised medicine presents clear manufacturing challenges to the pharmaceutical industry, 3D printing could present an elegant solution.
The goal of personalised medicine is to ensure that each patient is treated as an individual and match them up to the specific solutions for their ailments. This holistic attitude to medicine prescription can go as far as designing drugs which are coded to the individual patient’s genotype – helping to make sure the remedies will be accepted by the body, and significantly reducing the chances of unwanted side-effects.
The obvious challenge associated with personalised medicine lies in the manufacturing process. With increased automation and a move towards continuous manufacturing, the act of making smaller batches of medicine – especially ones designed for a single patient – can be inconvenient, costly, and time-consuming.
However, all that may be set to change with the recent FDA approval of the world’s first prescription drug manufactured using 3D printing technology.
The drug in question is a brand of the epilepsy drug levetiracetam, named Spritam, The medicine, produced by Aprecia Pharmaceuticals, joins existing medical 3D printing advances, such as the creation of replacement joints.
The 3D printed drug is made possible thanks to a proprietary bioprinting technology created by Aprecia themselves. Dubbed ZipDose, the technology produces rapidly disintegrating medical formulations using a special 3D printer. An inkjet process prints aqueous fluid onto layer upon layer of powdered medication to produce a water-soluble drug without compression or any other traditional moulding techniques.
“It’s exciting to see the ways 3D printing is being used in the medical environment,” said Editorial Director for Future Medicine, publishers of Journal of 3D Printing in Medicine, Laura Dormer. “To date, this has predominantly involved printing of plastics and metals, such as surgical planning, prosthetics, or reconstructive surgery. Surgeons are now able to 3D print accurate models of their patients’ organs, allowing them to plan complex procedures with a higher degree of confidence than with imaging alone. 3D printing of pharmaceuticals is less advanced but offers an exciting opportunity for the future.”
3D Printing for Pharmaceuticals
While Spritam is a mass-produced medication, its manufacture and subsequent FDA approval paves the way for more medicines to be produced using 3D printing technology.
Of course, one field in which this technology could be applied to great effect is in the manufacture of personalised medicines. Imagine a future where a doctor or pharmacist could take a prescription, complete with specific biological data about that particular patient, feed it into a computer, and have a single machine automatically produce the tablets.
Other aspects of personalisation include dose strength. This is the main requirement for personalised medicines, as different patients with various conditions can benefit from higher or lower strengths of medicine than would be provided as standard. Dosage strength can also become relevant when it comes to those drugs designed to help patients give up harmful habits, such as nicotine or illegal drugs. For example, 3D printing could create a course of methadone medication which gradually reduces in strength as the addict weans, but with the option of bringing the dosage back up in the event of a relapse.
3D printing can also allow medicines to be personalised in other ways. Size, shape, colour, texture, and flavour can all make a drug more, or less, appealing, especially when it comes to children. By experimenting with different combinations of these qualities, pharmaceutical manufactures can help to facilitate and improve medicine taking adherence – one of the biggest obstacles to effective healthcare.
Of course, all these things can be achieved with traditional manufacturing, but the speed, low cost, efficiency, and the ability to make individual tablets, as opposed to batches, makes 3D printing far more suitable for experimentation.
“I believe over the next five years we will continue to see a few select technologies with lower risk profiles achieve regulatory clearance, whereas some of the more advanced applications will move from proof-of-concept and academic research on a path toward commercialisation,” said Transformational Health Partner and Senior Vice President at Frost & Sullivan, Reenita Das. “The approval of Spritam was a significant first step that opens the way from which other, more complex concepts can build. Other developers can now move forward with greater confidence that there is a pathway for their concepts to achieve regulatory clearance.”
Personalised medicine is set to be a hot topic at Manupharma 2018, in December, at the Steigenberger Frankfurter Hof, Frankfurt.
Please download the agenda today for more information and insights.