The R&D Aspects of 3D Printing Pharmaceuticals

With the release of the first 3D printed and FDA approved drug last year, pharmaceutical companies from all around are investing in 3D printing technologies. It has proven to be an efficient way of prototyping new products, with its cost efficient and effortless manner, but it is now moving into a new realm of printing the finished drugs themselves. In addition to efficient prototyping, 3D printed drugs can be tailored to patients in terms of its dose, size, appearance, and delivery, all of which can make the drug safer and more effective.

The Research & Development Tax Credit

Enacted in 1981, the federal Research and Development (R&D) Tax Credit allows a credit of up to 13 percent of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

• New or improved products, processes, or software
• Technological in nature
• Elimination of uncertainty
• Process of experimentation

Eligible costs include employee wages, cost of supplies, cost of testing, contract research expenses, and costs associated with developing a patent. On December 18, 2015 President Obama signed the bill making the R&D Tax Credit permanent. Beginning in 2016, the R&D credit can be used to offset Alternative Minimum Tax and startup businesses can utilize the credit against $250,000 per year in payroll taxes.

Spritam

The first 3D printed drug to be FDA approved was Spritam by Aprecia Pharmaceuticals. It is a prescription drug that treats seizures and primarily prescribed to epileptic patients. Spritam became available in the United States market in 2016. It was developed by Aprecia with their ZipDose technology; a drug-formulation method that is designed to produce medication in rapidly disintegrating forms. The seizure treatment drug is printed layer by layer in a combination of powdered medication and liquid droplets. The powder and liquid bond together at a microscopic level, creating the solid tablets. Spritam is the first and to date only 3D printed drug on the market.

GlaxoSmithKline

The British pharmaceutical company GlaxoSmithKline (GSK) has been investing in 3D printing technology for a few years now. Their R&D department dedicated to 3D printing, headquartered in Pennsylvania, uses the technology in a variety of ways including prototyping, packaging, and tissue sampling. 3D printing has proven to be a progressive technology for the company. By using 3D printed tissue to test new drugs, the need for animal testing is eliminated and it leads to a clearer understanding of drug performance since the testing is being done on tissue that is closer to humans than animals. Rapid prototyping by 3D printing has also accelerated the rate of learning at a lower cost. Scientists at GSK are currently exploring the possibility of patient-specific dosage forms. GSK’s director of technology, Martin Wallace, claims that printing tailored medicine can significantly simplify their chain supply. Though they are a long way off from pharmacies and homes being able to print their own medication, 3D printing personalized medicine means more specific solutions for each patient.

UCL School of Pharmacy

At University College London School of Pharmacy, researchers have been applying an old method to the concept of 3D printing drugs.  The hot melt extrusion method is the process of applying heat and pressure to melt a polymer and force it through an orifice in a continuous process. By doing this, the researchers at UCL were able to 3D print drugs into different geometrical shapes. Certain shapes, such as pyramid shaped pills, help to quicken the releasing of the active ingredient by having less surface area. They also created animal shaped tablets to make the experience of taking medication more child-friendly. In 2014, the researchers at UCL started their own pharma company, FabRx, which focuses on developing 3D printing technology for pharmaceutical production and medical devices. They started the company in hopes of making 3D printing more widely used in the pharma industry and are now a rapidly growing business that creates 3D printed medicines.

The Chemputer

At the University of Glasgow, researchers came up with the chemputer; a 3D printed chemistry set that focuses on developing new drugs at a molecular level. The chemputer is revolutionizing drug discovery. It allows test tubes and other systems to be 3D printed in different shapes, giving way to different molecular discoveries due to the changed geometry of a substance as it passes through the altered test tube. The researchers at Glasgow have tested and printed ibuprofen, the main ingredient in mainstream painkillers.

Conclusion

The pharmaceutical industry is being transformed by the benefits and technology that 3D printing has to offer. By investing in a 3D printer, a pharma company can save thousands of dollars and many hours on research and development, while also making groundbreaking discoveries on new methods and drug formulations.

 

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Charles Goulding and Rafaella July of R&D Tax Savers discuss 3D printing in the pharmaceutical industry.