Pharmaceuticals The Rise of 3D Printed Drugs
3D printed medicines are slowly becoming popular due to its many advantages not only for the end consumer but also for pharmaceutical companies. Numerous firms are also exploring the additive manufacturing technology to reduce costs as well as create on-demand drugs.
The global 3D printed drugs market was valued at 272.17million dollars in 2018 and expected to reach 437.04 million dollars by 2025 with a CAGR of 7.0 % over the forecast period, states a report by research firm Brandessence Market Research. The additive manufacturing technology has revolutionised the pharmaceutical sector like never before and this is evident as more companies are now looking to manufacture 3D printed medicines.
The plus points of this technology are many. Merck, one of the leading science and technology companies has entered into a partnership with Additive Manufacturing Customized Machines (AMCM) to produce 3D-printed medicines. Christoph Huels, Project Leader at Merck explains, “We are simplifying the production process of drug manufacturing by using the 3D printing technology. With this, we can save time for formulation development as well as reduce costs.”
Huels adds, “The simplified production process will also reduce the amount of active pharmaceutical ingredient (API) consumed during formulation development and setting up the production process. The technology holds the promise to enable more flexible and decentralised production in the future.”
The company is making use of powder bed fusion technologies, in particular laser sintering, for this project. This additive manufacturing technology will be effective to produce small molecule drugs. Also, Merck intends to develop it as a GMP compliant technology which will be provided as a service (clinical development and manufacturing organisation, CDMO) to customers in the pharmaceutical industry.
Customise your Medicines with 3D Printing
Additive manufacturing also proves beneficial for developing personalised medicines. “Currently, medicines are produced using mass manufacturing methods which creates dosage forms with identical characteristics (dosage, appearance and drug release),” mentions Alvaro Goyanes, Co-Founder and Director of Development, Fabrx. “Such practices can lead to inappropriate dosing, resulting in undesirable side effects or lack of treatment effect in many patient populations (i.e. children and the elderly).” This is where 3D printing comes in.
Fabrx, a specialist biotech company, has recently developed M3dimakertm, the world’s first 3D printer for the production of personalised medicines. The unique printer is capable of delivering unique customised medicines with appearance and dosages that can be tailored directly to the patient on demand. “The ground-breaking additive manufacturing technology has the capability of producing Printlets (3D printed tablets) with a precise dose, tailored drug release and can even combine multiple medications into a single ‘polypill’ for patients with complicated medication regimens,” adds Goyanes. The 3D printer can be used for the formulation of a wide variety of drugs, ranging from small molecule compounds to large molecules and biologics.
World’s First 3D Printed Tablet
Another prominent organisation is Aprecia Pharmaceuticals. It is the first company to develop a 3D printed tablet (Spritam) and also obtain approval from the US FDA (Food and Drug Administration) for the drug. Spritam is used for the treatment of seizures in patients with epilepsy. The company uses its proprietary powder bed and inkjet 3D-printing technology known as Zip Dose for producing highly prescribed oral medications that disintegrate rapidly.
It is the first drug-formulation platform that makes use of 3D printing to make medications. With the Zip Dose technology, medicines can be disintegrated within seconds; significantly higher dosage loads up to 1,000 mg are possible and more taste-masking options are available. It also proves advantageous for patients that find it difficult to swallow medicines.
Another well-known example is the British pharmaceutical major Glaxosmithkline (GSK). GSK partnered with scientists at the University of Nottingham in the UK and completed a study in which inkjet printing and UV curing was used to produce 3D tablets in order to treat Parkinson’s disease.
Developing a unique and innovative additive manufacturing system especially for the pharmaceutical industry can be challenging. Goyanes opines, “Regulatory requirements have been a key consideration in the development of the M3dimakertm. The main considerations involve ensuring the quality of the medicines produced.”
Fabrx has integrated a number of novel non-destructive quality control methods that can be integrated into its 3D printers to enable a real-time check of product quality for on-demand dispensing. It has also integrated a fingerprint scanner and data matrix reader to ensure access and data security, as well as a track-and-trace mechanism.
In order to meet regulatory requirements, the firm is seeking the advise of experts including UK’s Medicines Healthcare and Products Regulatory Agency (MHRA), the Spanish Medicines Agency (AEMPS), EMA and the FDA.
Poised for Growth
In today’s ever-evolving world, there is a need to explore new technologies in order to significantly benefit from it. As the pharmaceutical industry is steadily gaining ground to develop 3D printed drugs which are more customised, more tastier and easily dissolvable, we are convinced that the pharma industry is heading in the right direction and is poised for growth!