Recently the USFDA approved Aprecia Pharma’s SPRITAM® levetiracetam – a drug for epilepsy treatment manufactured by 3D
printing. This approval should encourage other players to pursue drug
development with renewed vigor.
Last week saw a revolutionary approval from
the US Food and Drug Administration (USFDA). For the first time, the USFDA
approved a drug manufactured by three dimensional printing
(3DP) – Aprecia Pharmaceuticals received the USFDA approval of epilepsy treatment SPRITAM® levetiracetam. Leveitracetam
was first approved in 1999.
Revolutionary
formulation & rapid delivery system
Aprecia gained the exclusive licence to 3DP technology
from MIT in the late 1980s, and by 2007 it began developing its proprietary ZipDose technology. But SPRITAM is revolutionary, not just because it is 3D printed, but for other reasons as well. SPRITAM® is a porous formulation that rapidly disintegrates with a sip of liquid. The dispersion is significantly superior to a conventional over the counter fast-melt tablet (watch the video: https://www.aprecia.com/zipdose-platform/zipdose-technology.php).
In fact, the drug is designed to dissolve
in the tongue (rather than swallowed as a whole). The patient experience is
enhanced since SPRITAM delivers an extremely high drug load, up to 1,000 mg in
a single dose. No measuring is needed as each dose is individually packaged,
making it easy to carry this treatment on the go.
3D
printers are not even expensive
For those not familiar with 3DP (or
additive manufacturing), it is a process used to make a three-dimensional
object without the use of dies, molds or machining. Instead, additive processes
are used, in which successive layers of material are laid down under computer
control (watch the video: https://www.youtube.com/watch?v=G0EJmBoLq-g).
These objects can often be of virtually any shape or geometry, and are produced
from a 3D model or another electronic data source. A 3D printer is a type of
industrial robot, and can range from small scale consumer models to large
factory units.
Now for the moot question – why are pharmaceutical companies not developing drugs with 3D printing? In fact, 3D printers are inexpensive, and the ingredients used to produce the drugs are the same that are currently being used and there are multiple candidates, other than those Aprecia is working on which would benefit from this technological revolution.
Making 3D printed drugs is really not that complicated or expensive. A recently published paper by researchers at the University College of London (UCL), “Effect
of geometry on drug release from 3D printed tablets” produced different shaped tablets using 3D printing which would be otherwise difficult to produce using traditional methods.
Simple
guide to make 3D printed drugs
The researchers simply purchased water-soluble PVA filament from MakerBot (not currently
available but other
PVA filaments are available on Amazon for under US $ 50), along with widely
used pain reducer and fever reliever, Paracetamol (also known as Acetaminophen)
and salts. They cut the filament into small pieces (approximately 2mm in
length), basically turning the spool of filament into pellets. This was
followed by mixing in the Paracetamol, and extruding the mixture from a Filabot filament extruder (it
costs US $ 949) at 180 degrees C. What came out of the printer was a 3D printed
drug.
PharmaCompass’ potential candidates for 3DP
Staying focused on opportunities where an extremely high drug load – up to 1,000 mg – has to be delivered in a single dose we ran a search on the PharmaCompass
database to find a few potential candidates for 3D printing.
Drug Name
Therapeutic Indication
Aminocaproic
Acid
Bleeding disorder treatment
Sucralfate
Ulcer medication
Cefadroxil
Antibiotic
Colestipol
Hydrochloride
Lipid lowering
Metformin
Hydrochloride
Diabetes
Methenamine
Hippurate
Urinary Tract Antiseptic
Ranolazine
Chronic Angina
Valacyclovir
Hydrochloride
Viral Diseases
Icosapent
Cholesterol reduction
In addition to these products, there are
multiple other possibilities which can get created by producing combination
drugs using 3D printing.
Overcoming
the challenges of slow 3D printing
With nearly three million people in the United States diagnosed with active epilepsy, Aprecia Pharmaceuticals’ revolutionary form of Levetiracetam clearly has a very large market need to address. However, the problem with 3D printing is that it is exceptionally slow when compared with conventional production methods for tablets.
Anticipating the problems, Aprecia
Pharmaceuticals announced on Feb. 23, 2015, that the company will open
a new manufacturing facility in Ohio that will use its powder–liquid three-dimensional printing (3DP) technology.
With plans to invest $25 million in a
190,000-ft2 facility, the new facility will be in addition to the
company's existing manufacturing and R&D facility in New Jersey.
Disrupting
healthcare in 3D
In the healthcare industry, 3D printers are
used by dentists to create
replicas of jaws and teeth as well as some finished dental implants and
orthopedic surgeons have tested them to make customized hip replacements.
In 2012, a two-year-old girl in Illinois,
born without a trachea, received
a windpipe built with her own stem cells.
British scientists have also used 3D
printing to create personalized replica models of cancerous parts of the body
to allow doctors to target tumors more precisely.
Our
View
The current way of consuming tablets can
definitely undergo a serious overhaul. With 3D printing technology rapidly
evolving and already inexpensive, there is little reason for the industry not
to pursue this area of drug development with greater vigor.
In addition, if we can measure our blood sugar levels using diagnostic kits at home, is it unrealistic to imagine a day when we’ll start printing our own medicines in 3D?
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