I will first briefly consider the basics of what 3dprinting is and the application of its use in medicine. However, the main focusof this essay is to explore what challenges we face when using 3d printing andthe limitations around them. I will explain in detail of certain challengeswith a very exhaustive view on regulation and the impact it has on the practiceof 3d printing in producing medicine. The first part of the essay will look atthe practical challenges associated with 3d printing and the latter part willbe regulation and how important it is.

 3d printing is a way of producing a three-dimensional productby multiple processes which involve placing layers upon one another; this isall inputted by a digital file. There has been a growing interest in researchof using 3d printing for pharmaceutical drugs. There has already been one drugwhich has been approved by the FDA in 2015 which makes it an interesting fieldto do more research on.

This drug is called Spritam which is an anti-epilepticdrug produced by Aprecia pharmaceuticals. However, this is only ONE drug which has been approved andthere are several reasons for this and this essay will delve into some of thesereasons why it is a challenge to get more 3d printed drugs into the market. One of the mainbarriers is that will the printed drug product have the same efficacy, samepharmacological effect or perhaps even safety profile compared to the standardformulations we already have like tablets and capsules. In order for it to besuitable, it needs to at least pass these parameters.

An example on how certaintechniques can affect the drug product is from a study done by a research teamwhen they analyzed the content of a 3d printed drug. They found from that the analysisof the content of the 3D printed tablets where the active ingredient was4-Aminosalicylic acid (4-ASA); it showed a reduction in drug content of over50%. There may have been a specific reason for this and it stems from theuncertainty around the quality of the printed products. Certain 3d printingtechniques may produce a fragile structure so it is hard to achieve the perfectproperties you want your medicine to be like being able to disperse well in thebody; how it dissolves; how it disintegrates and also the overall stability ofthe product. Regarding the 4-ASA product, they found that considerable thermaldegradation (50%) had occurred during printing.

It would be too naïve to justblame the printing process but what this means is that you have to be carefulwith what printing technique you use as it depends whether it would be suitablefor the drug you are printing. In the case of 4-ASA, the temperature of theprinter was far higher than the thermal degradation temperature of 4-ASA. Therehave also been cases where 3 printing causes more porosity and could thenaffect the release profiles of these drugs in the body so it is important tomonitor this when formulating and printing these drugs. Figure 1 (Comparison between control and 3d printed drug Vorndran et al Advanced functional materials) Another example is shown in Figure 1 which is acomparison between three 3d printed products and their respective controlswhich were not printed. You can see that the biological activity is lower forall the drugs which were printed; the purged solution and Eluate are twodifferent components in printing the drugs. This perhaps means that we are notat the stage where we are seeing a viable enough improvement and so moreresearch needs to take place thus more wastage of resources and perhaps money. Another challenge is willit be possible to do an assay on a 3d product when you want to check if thecorrect dose in the product. An assay is a way of finding out drug contentwithin a formulation.

Assay techniques on tablets and capsules may not besuitable for a 3d printed formulation. Perhaps formulators may need to come upwith new techniques for different types of 3d printed formulation. As there arevarious techniques within 3d printing; thus, the type of 3d printed product youproduce will be very heterogeneous with different techniques. This may providean additional challenge although personally I would say this is not a hugelimitation and should be easy to overcome. As there has also beentalk of 3d printing being used in point of care rather than in industry, youwould need to take measures on who will be running the printer by training themadequately. Point of care means in a hospital, care home or even a pharmacy.Whether it will be the pharmacists, technicians, dispensers, nurses or anyrelevant health care professional; this will take time and money to train thestaff and so these places of care should evaluate whether it is worth the cost.

As 3d printing involvesthe use of use of computer software; this means that it could be prone to computererrors. This potentially could cause harm to a patient if for some reason theerror does not get picked up on. An example of an error could be that anincorrect file was used or the printer is not working at the rate it should be orthe ratio of excipients inputted had been incorrect. A technical error likethese could cause one batch to be more different to another, consequentlycreating homogeneity issues.What could then be afurther issue is that if a problem does occur, who would be responsible forthese accidents or printer failure. There are numerous parties involved such asthe file designer, 3D printer manufacturer, person who is printing it, or thecompany itself.

In order to find out who is responsible for the mistake, theremay have to be an investigation which would take up more time, resources andmoney. A huge loss in opportunity cost may then occur for the company or anyplace of care which is producing the medicine The table on the left showsin more detail how there are various parties involved in the productionprocess. The table also includes other aspects such as shelf life, quality andsafety.     Figure 2      Manufacturers or anyoneinterested in using 3d printing must consider whether it would be costeffective compared to the other standard formulations. This is a question manufacturerswill have to ask themselves but now it is cheaper for some small-scale productioncompanies to invest in as it eliminates using unnecessary resources. Findingout whether it is cost effective could provide a challenge for themanufacturers At the moment, I wouldsay there still is not enough research for pharmacies or big Pharma companiesto willingly use 3d printing.

Although the reasons mentioned above are hugefactors in this, I would say in my opinion the biggest challenge is regulationinvolved in this sector.Regulation:  Regulation is a huge challenge or hurdle that 3d printinghas; simply because it is a relatively new form of technology involved inmaking medicine. As already mentioned, there is only 1 3d printed drug on themarket thus highlighting the fact how tough it is for companies in this sector.3d Printing must be closelyregulated both within the company using it whilst also being regulated byofficial bodies like the FDA in America or the MHRA in the UK. Regulation willalways cost money for the manufacturers which in turn could act as adisincentive for them.

There have also been cases where 3D printers or 3Dprinting software being tampered with in order to make certain illegalequipment like guns and knives. If this was to happen with medicine, there is apossibility of producing counterfeit medicine. As one of the ultimate goals ofthis 3d printing project in the future is to place it in places like homes, itmay give easy access to criminals who could use these 3D printers tomanufacture and make illegal drugs on a mass-scale. This not only has anegative impact on people using these illegal drugs, it may cause an increasedamount of regulation from the official bodies and make it much harder to pursuethe project of having these printers in peoples’ home and could againdisincentives companies in investing in 3d printing because of the addedregulation. 3d printing involves the uses of files which means that anotherproblem is illegal file sharing or illegal downloading which may have thepotential to happen.  To emphasise on the point on how difficult it is in regard toregulation, The FDA actually provide guidance on the specific printers whichshould be used in the manufacturing of products involved with 3D printing.

Theguidance draft document also includes points manufacturers have to considerwhen printing. This includes the final product’s dosage form, the materialsinvolved and many other factors listed in the table below. The reason I haveincluded this table is because I would like to highlight the complexity ofproducing a product which will comply with the high requirements standards theFDA ask for. All these factors are given because it helps the manufacturer orthe company maintain consistency of producing a high-quality product. Presently,there is no single regulatory pathway for 3d printed formulations which meansthat if any company wanted to submit a 3d printed drug into the market, itwould have to be submitted through existing regulatory pathways for example ifa drug had similar action to oral dispersible tablets(ODT); in checking for itsquality, the FDA would use similar or same standard tests as they would withthe ODT.

In my opinion, this regulation is important to maintain the quality ofproduct and that the FDA should then subsidise or find ways to incentivisecompanies and manufacturers to produce printed drugs

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