In August 2015, the US FDA approved the first 3D printing technology to produce drugs. Currently, Pennsylvania-based Aprecia Pharmaceuticals is the only pharmaceutical company in the world to develop 3D printing drugs. Compared to 3D printing, existing production lines cannot produce special dosage forms and require other technologies, and this technology is 3D printing. The prototype of 3D printing dates back to the late 1990s, but until recently computing power and micro-components made it a reality. The 3D printer is a step-by-step system that uses technology from document printing (inkjet and laser) to control the size and chemical composition of the droplets.
The following four figures show how the first layer of powder, the liquid layer, the second layer of powder... are superimposed on a conveyor belt to form the final dosage form. But as to whether the process is legal, there is no official agency to approve such a preparation method.
As shown in Figure 1, the powder mist (excipient or bulk drug or a mixture of the two) is sprayed onto the moving belt.
As shown in Figure 2, the liquid is dripped onto the powder by a controlled method.
As shown in Figure 3, the liquid selectively combines with the particles in the porous layer.
As shown in Figure 4, the process is repeated for a predetermined number of times to ultimately produce a dosage form with specific efficacy.
The FDA has developed a draft guide that provides FDA's initial vision of technical issues, particularly with regard to the application of additive manufacturing techniques. Overlay Manufacturing (AM) is a broader manufacturing concept that includes 3D printing, which refers to the manufacture of articles by repeatedly constructing two-dimensional (2D) layers and combining each layer. The manufacturer only needs one machine, and the design can be changed quickly without changing the machine used in the factory or the equipment used by the company during the manufacturing process. Due to the rapid development of technology and the increasing number of AM manufacturing machines, the investment attracted by this technology has gradually increased, and this technology has become more and more used in the medical field.
So, what can 3D printing use to print?
1. Personalized pharmaceutical dosage form
3D printing adds a new dimension to personalized medicine, which is simply the production of personalized 3D printed oral tablets. Personalized 3D printed drugs can help patients cope with the same drugs in different ways. The doctor or pharmacist can select the best drug dose from the patient's personal information (age, race, and gender) instead of the original bulk, same dose of the drug. 3D printing can also print multi-level tablets, combine different tablets to treat a variety of diseases, and allow patients to get all the drugs they need in a single dose. This is very important for infants and toddlers, people who have difficulty swallowing pills, and older people who take multiple pills daily and are prone to confusion.
2. Unique pharmaceutical dosage form
3D printing technology can be used to create unique dosage forms that create unlimited dosage forms with 3D inkjet printing technology. This idea will challenge the traditional pharmaceutical manufacturing industry. The process of creating new dosage forms has now been tested on many drugs, such as osmotic pumps and multi-layer formulations, each of which is dispensed at a different rate.
3. More complicated drug release behavior
Drug release behavior shows how the drug breaks down in the patient. 3D printing technology creates personalized drugs by printing an adhesive on a multi-layered rectangular powder layer to aid in the controlled release of the drug. The barrier between the apis helps researchers delve into different release behaviors and make more effective drugs.
4. Printing active tissue
Although the current 3D printing active organization is small, it is predicted that this technology will be able to print a fully functional 3D printed heart within 20 years. The current difficulty of this technology lies in the intricate vascular network of organs. According to the director of the Wake Forest Institute of Regenerative Medicine, each organ of the human body exhibits varying degrees of complexity. Therefore, although some tissues are easy to print (such as a flat structure like human skin), the most difficult and important area is to print the heart, liver and kidneys.
3D printing has been used in medical fields such as dentistry, medical, implants, etc., and the printing materials used in these fields are different. Dental implants mostly use metal and ceramic to print crowns, while the medical industry uses a range of biomaterials. It is estimated that the revenue of 3D printing in the medical market in 2014 was 285 million US dollars, and it is expected to achieve a compound annual growth rate of 19.1% in the next 6 years.
3D printing adds a new dimension to personalized medicine, which is simply the production of personalized 3D printed oral tablets.
Review
The price of medical 3D printers should decrease as demand increases and government subsidies (research funding). Medical 3D printed materials are plastics, metals, ceramics, donor cells, bone binders, biomaterials, and the like. Metal powders and biomaterials are expensive, and many of the biomaterials currently under study will play an important role in the medical 3D printing industry. The increased demand for orthopaedic and maxillofacial surgery products tailored to patients will expand the overall market size. Advances in tissue engineering related to 3D printing are becoming more and more important, and the organization of 3D bioprinting will soon be available.
North America is currently the largest consumer in the global 3D printing medical industry, followed by Europe. It can be predicted that future high cost and regulatory barriers will hinder market development. Other influencing factors include technological innovation, printer efficiency and flexibility, and access to high quality materials.
3D printing new trends
The application we mentioned above may be interesting. In fact, for some specific short-term and long-term products, 3D printing will become its preferred technology.
Orphan Drugs: These rare early-stage, low-yield drugs are due to A. The drug has passed the patent period; B. These drugs are small and the production profit is less than their production costs. 3D printing will make on-demand production of rare diseases a reality. In the best case, the line only needs to clean two nozzles (one powder and the other liquid) and a conveyor belt. This not only minimizes the cost of goods sold (COGS), but also the retail cost is within reach of most patients. Will this be a win-win situation?
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