3D Printing technology in Pharmaceuticals
3D Printing technology in Pharmaceuticals: Additive manufacturing, commonly known as 3D printing, is making significant strides in the pharmaceutical sector. This innovative technology allows for the creation of complex drug formulations and customized medications tailored to individual patient needs. By using layers of material to construct products, 3D printing improves the efficiency of drug delivery systems and facilitates the production of specialized dosage forms. This approach not only enhances the precision of dosages but also opens the door to novel pharmaceutical designs and accelerated development processes. As the industry continues to explore the potential of 3D printing, it holds the promise of transforming how medications are developed, manufactured, and administered in the future.
Personalized medications are becoming more commonplace as traditional mass production gives way to three-dimensional (3D) printing;
A variety of healthcare and resource-constrained environments could incorporate 3D printing;
Medications that are customized to a patient’s therapeutic needs (such as dosage, medication combination, and release patterns) and individual preferences (such as form, size, texture, and flavor) can be made using this technology;
The pharmaceutical sector and clinical practice can both profit greatly from 3D printing, since it can save costs and accelerate development times. However, the use of 3D printing in clinical settings requires the support of healthcare professionals, including pharmacists.
Pharmacies’ various 3D printing systems:3D Printing technology
Charles Hull invented and commercialized 3D printing technology in 1986; since then, a number of distinct 3D printing techniques have been presented [47–49]. A variety of printing processes are now referred to by the umbrella term “3D printing.” All of these 3D printing technologies, in general, adhere to a similar printlet creation process known as the “3 Ds of 3D printing,” which paves the way for future application and integration of this technology into clinical practice:
Over the last thirty years, 3D printing has advanced significantly across various fields, including automotive, robotics, and chemical sciences. This technological innovation is now set to transform the pharmaceutical industry. Unlike conventional pharmaceutical production methods that follow established procedures, 3D printing, also known as additive manufacturing, builds products layer by layer based on a digital design. This method enables the creation of customized formulations tailored to individual patient needs, moving away from the mass production model.
Personalized medicine, which aims to treat individuals with precision, stands to gain immensely from 3D printing. By considering factors such as age, weight, and specific health conditions, personalized medicine ensures optimal dosing and effectiveness. This approach not only enhances patient outcomes but also reduces the risk of adverse effects associated with standard dosages. Additionally, 3D printing’s applications extend beyond traditional pharmaceuticals to areas like cosmetics and nutraceuticals, where customized formulations meet specific skin and nutritional requirements.
Beyond its uses in the pharmaceutical industry, 3D printing has potential uses in the dental, orthopedic, and ophthalmological professions. In the field of dentistry, for instance, 3D printing makes it easier to create dental prosthesis that are tailored to each patient’s requirements, enhancing both appearance and functionality. In the medical field, on the other hand, 3D-printed implants provide customized treatments for ocular and orthopedic ailments, improving patient results and quality of life.
Additionally, 3D printing has the ability to help with difficult medical problems including cancer treatment tailored medicine administration. 3D printing is a viable way to maximize therapeutic efficacy while reducing side effects by precisely targeting tumor locations with specially made medication delivery devices. The potential of 3D printing is highlighted by recent developments, including as the successful printing of a 5-fluorouracil patch for the treatment of pancreatic cancer.
However, resolving regulatory issues and guaranteeing safety and efficacy are necessary before 3D printing is widely used in clinical practice. Although oversight bodies such as the US Food and Drug Administration (FDA) have expressed interest in developing guidelines for 3D printing in the medical field, more standardization and validation are required to guarantee patient safety and compliance. Cost-effectiveness is still a crucial factor to take into account, as 3D printing has the potential to eventually lower overall healthcare costs by streamlining production processes.
To sum up, 3D printing is a revolutionary technology that has the power to completely change the pharmaceutical industry. 3D printing has the potential to improve patient outcomes and improve healthcare delivery by enabling individualized medication, advancing targeted drug administration, and encouraging innovation across healthcare industries. With the continuous improvement of technology and the evolution of regulatory frameworks, 3D printing in medicines appears to have a bright future.
Advantages of 3D Printing in Clinical Pharmacy Practice:
Due to their portable, compact, and user-friendly design, 3D printers can be seamlessly integrated into both community and hospital pharmacy environments. Technologies like FDM, SSE, and DPE are particularly well-suited for this purpose. The primary reason for incorporating 3D printing into clinical pharmacy is to provide pharmacists with a highly adaptable automatic compounding system. This system can create customized dosage forms on demand, tailored to the evolving needs of patients. It allows for the production of printlets in various shapes and sizes, individualized dosages, and the ability to adjust the number of drugs in a formulation.
Advantages of 3D Printing in the Pharmaceutical Industry
3D printing technology offers numerous advantages to the pharmaceutical industry, particularly in the early stages of drug development. The traditional process from drug discovery to market can take 10-15 years and cost around £1.3 billion. There is a pressing need to reduce both the time and cost involved in bringing new drugs to market, as highlighted by the rapid development and repurposing of drugs during the COVID-19 pandemic.
In pre-clinical and clinical formulation development, 3D printing can serve as a rapid prototyping tool. This allows for the evaluation of small batches of different drug formulations quickly. By doing so, it speeds up the assessment of how various formulation compositions affect critical quality attributes, such as drug performance in both in vitro and in vivo models. To date, 3D printed formulations have been tested in a wide range of pre-clinical animal models. Compared to traditional manufacturing methods, 3D printing can provide an earlier understanding of process and formulation variables, facilitating quicker entry into first-in-human (FIH) clinical trials and reducing development time and costs.
Additionally, 3D printing can be used throughout pre-clinical and early phase clinical trials to produce small batches of dose-flexible drug products on demand. This capability is crucial for evaluating the safety and efficacy of new drugs.
3D printing also offers an alternative manufacturing method for producing mass-customized or personalized medicines. While conventional manufacturing methods for high-volume, low-added-value pharmaceuticals (such as tableting or encapsulation) will likely remain cost-efficient in centralized facilities, 3D printing is valuable for formulations that require personalization to enhance therapeutic outcomes. This technology enables the mass customization of formulations to meet individual patient needs, improving overall treatment effectiveness.
The Future of Pharmacy: Integrating 3D Printing
3D printing holds significant promise for the pharmaceutical industry, particularly in the manufacturing of medicines and patient care. Numerous research papers have highlighted its potential and role in this sector. A timeline of 3D printing in pharmaceuticals showcases the major milestones achieved so far.
We are at a pivotal moment, requiring collaboration from key stakeholders such as researchers, regulators, clinicians, pharmacists, and patients. This collective effort is essential to advance 3D printing technology for practical benefits in pharmacy and patient care. However, several challenges must be addressed before widespread integration can occur. These include meeting regulatory requirements, building a robust evidence base to demonstrate safety and efficacy, and developing 3D printers and dosage forms that are widely accepted by healthcare professionals and patients.
Significant progress has been made in overcoming these challenges. Initially, commercially available 3D printers were not standardized or suitable for producing pharmaceutical products according to good manufacturing practice (GMP). Recently, biotech companies have collaborated with regulatory agencies to develop pharmaceutical 3D printers that produce safe and effective printlets. For example, FabRx developed a multi-nozzle GMP printer in close communication with regulatory bodies like the MHRA and hospital end-users, creating a system tailored for pharmaceutical use.
Other notable advancements include Aprecia Pharmaceutical’s ZipDose technology. This scaled-up binder jet printing process enables the mass production of highly porous, rapidly orally-disintegrating drug products, such as levetiracetam for epilepsy treatment.
Although there is a substantial body of evidence supporting the use of 3D printing in pharmaceuticals, further efforts are needed to build confidence in the technology among all stakeholders. Several regulatory and technical hurdles remain, particularly in ensuring the quality and safety of the medicines produced. Traditional pharmaceutical manufacturing adheres to Good Manufacturing Practices (GMP) and involves extensive testing, such as assessing cross-contamination risks, weight uniformity, and stringent cleaning protocols. However, these testing methods are often costly, time-consuming, and destructive, making them unsuitable for evaluating 3D printed medicines.
To address these challenges, ongoing research is exploring innovative and real-time quality assurance methods for 3D printed pharmaceuticals. For instance, researchers are investigating the use of real-time analytical technologies like near-infrared and Raman spectroscopy to ensure the quality and safety of formulations produced by 3D printers. Additionally, some have proposed ‘track and trace’ measures, incorporating QR codes and data matrices on formulations that can be scanned with smartphones or barcode readers to verify drug quality and safety. Others have suggested using blockchain technology to track printed formulations and enhance safety. Moreover, several companies are developing GMP-compliant 3D printers that can be effectively cleaned and validated to ensure the safety and quality of printed drug products. These innovative strategies aim to provide real-time assurance of 3D printed tablet quality and facilitate the integration of 3D printing technologies into clinical settings.
Despite these advancements, certain technical challenges persist before the technology can be widely adopted. Currently, there is a shortage of suitable materials and excipients specifically designed for the production of 3D printed medicines.
The role of pharmacy in printing medicines
Pharmacists and pharmacy technicians play a crucial role in the adoption of 3D printing in pharmaceuticals, working across various sectors including frontline healthcare, academia, industry, regulatory bodies, and government. As experts in medicines, they can provide guidance on the optimal strategies and pathways for integrating 3D printers into pharmaceutical practice.
Globally, pharmacists have been pioneers in recognizing the potential of 3D printing for medicine production. The initial studies on using FDM, SLA, and SLS 3D printing technologies for creating medicines, conducted in 2014, 2016, and 2017 respectively, were led by academic pharmacists at the UCL School of Pharmacy, with other pharmacy schools worldwide pursuing similar research.
The future of 3D printing in clinical practice envisions pharmacists and pharmacy technicians returning to their foundational role as formulators. They will design and customize formulations to meet specific patient needs and become experts in using 3D printers for the automatic preparation of these formulations. One proposed model is akin to a ‘Nespresso’ system, where drug-loaded cartridges are pre-manufactured and quality-checked at a central facility, then distributed to local pharmacies for on-demand dispensing. Biotech companies aim to make these systems user-friendly and safe, incorporating end-to-end tracking and ensuring only trained and approved personnel can operate them.
This innovative approach to pharmaceutical production addresses common challenges in medicine manufacturing and necessitates a shift in mindset.