Review Article
3D PRINTING FOR THE FUTURE OF PHARMACEUTICALS DOSAGES FORMS
MONISHA BANSAL, VARUN SHARMA, GURFATEH SINGH
*
, S. L. HARIKUMAR
University School of Pharmaceutical Sciences, Rayat Bahra University, Saharuan, Kharar, Mohali, Punjab, 140104 India
Email: dr_sugga@yahoo.co.in
Received: 29 Jan 2018, Revised and Accepted: 26 Mar 2018
ABSTRACT
With the rapid pace of development in industrial sector, the pharma sector and researchers involved are equally contributing in developing the
latest technology for the growth and development. The computer-aided designs and manufacturing that provides 3 Dimensional printed dosage
forms is the new step being taken into consideration. With the FDA approval to first 3D printed tablet in August 2015, Spritam, 3 Dimensional
printing (3DP) has become the all new method for preparation of drug delivery system. 3D printing has the capability of dispensing the drug more
accurately, precisely, and the layer by layer assembly helps in forming complex composition and geometries. 3D printing enables the preparation of
personalised dosage form and tailored release profiles. 3D printing can be seen as future of solid dosage forms produced on demand, with
customised dose and possibly lower in cost. It can help in reducing side effects caused by excessive doses. This review highlights the 3D printing
technology and its applications in growth of pharmaceutical sector. An overview of reviews was conducted to locate published literature between
2000 and 2017.
Keywords: 3D, Computer aided design, FDM, Spritam, FDA
© 2018 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
DOI: http://dx.doi.org/10.22159/ijap.2018v10i3.25024
INTRODUCTION
In the past decade, the use of 3D printers has grown dramatically for
both industries and public. There has been increase in global sales of
consumer based printers by more than 33% over last 3 y, worth $4.1
billion in 2014 [1]. The most renowned, distinct and novel solid
dosage forms have been found to be fabricated by variety of three-
dimensional printing (3DP) technologies [2-4]. 3DP or additive
manufacturing (AM) is a process of making three dimensional solid
objects from a digital file [5]. 3DP is unique and powerful technology
that was first described by Charles Hull in 1986 and called it as
“stereolithography” [6]. It uses “.stl file format” to interpret the data
in Computer Aided Design file. These data instructions are then
electronically communicated to the 3D printer [7]. These
instructions include the shape, size, texture, thickness of the object
to be printed [8]. Hull later founded his own company as “3D
system” where he designed a stereo lithography based 3D printer
and was commercially available in market in 1988 [5]. Since then
many companies developed 3D printers for commercial application.
In 1987, Carl Deckard filed a patent for the selective laser sintering
(SLS) rapid prototyping process in US and was issued in 1989. In the
same year, Scott Crump, a co-founder of Stratasys Inc. filed a patent
for a technology that is still used by the company i. e, fused
deposition modelling (FDM) and was issued in 1992 [9]. Hans
Langer founded the EOS GmbH in Germany and further focused on
the laser sintering (LS) process and now it is well known around the
world for their quality outputs and applications in 3D printing and
still is continuing to strengthen the production applications.
Throughout the 1990’s and early 2000’s a host of new technologies
continued to be introduced. The Solidscape and ZCorporation,
Arcam, Object Geometries, MCP Technologies, EnvisionTec and
ExOne were set up in 1996, 1997, 198, 2000, 2002 and 2005. These
companies speeded the development of 3D printing across a global
market. The terminology for all the applications was accepted to be
additive manufacturing. These technologies were large, very
expensive for small enterprises or individuals. However, in the last
decade many new companies entered the market with small,
cheaper and high quality machines. The first small kit form 3D
printer was made available in 2009, for the commercial application
based on RepRap concept. Furthermore, in June 2012, alternate
process of 3D printing utilising DLP technology “B9Creator” was
introduced. In same year, Form 1 was introduced utilising
stereolithography [10]. From then, much more growth was observed
in this field and the fact was demonstrated that the 3DP is having
commercial applications in various industrial sectors. 3DP expanded
rapidly and revolutionized health care as well [12]. The medical use
of 3DP includes: creation of custom prosthetics, body tissue, organ
fabrication, anatomical models, dental implants, pharmaceutical
research regarding drug dosage forms, drug delivery and discovery
[11]. In December 2015, the FDA had approved more than 85 3D-
printed medical devices [12]. Moreover, FDA also granted approval
to first 3D printed tablet, Spritam (levetiracetam), manufactured by
Aprecia Pharmaceuticals in 2015 [13]. Aprecia’s product ‘Spritam’ is
used to treat epilepsy, which showed a significant advancement for
patients suffering from seizures. With this landmark milestone in 3D
Pharming in market, the future of drug manufacturing could change
drastically [9].
3DP is a layer-by-layer process capable of producing 3D drug
products from digital design [14]. 3DP technology based on
computer aided design is used to achieve unparalleled flexibility,
save time, and exceptional manufacturing capability of
pharmaceutical drug products, to formulate drug materials into the
desired dosage form [15]. The process involves 3D proto-typing of
layer-by-layer fabrication (via computer-aided design models) to
formulate drug materials into the desired dosage form.
The Principle behind a 3D printer can be assumed to be similar to a
regular printer. 3D printer consists of an extruder that moves
horizontally on an axis which is held on top of two axes that allow it
to move back and forward in x-y plane to create the base of the
object [6]. These two axes are attached to the sides of the printer.
The only difference is the 3D printer has a base that moves vertically
along the z axis to create the layers over the object. While printing
the first layer the extruder remains at the top and moves only in 2D.
The base that holds the substrate will decrease in height so that next
layer could be built upon it. The process is repeated following the
computer-aided drafting instructions until the object is built layer by
layer. This process is referred to as additive manufacturing, rapid
prototyping (RP), or solid freeform technology (SFF) [16]. 3D
printers are used to print various porous scaffolds with controlled
chemistry, interconnected porosity and special shapes. These prints
are biodegradable and proved to be ideal for drug delivery abilities
[17-21]. Some of the highly complex structures incorporating living
cells can be created by this technique and has gained popularity and
applicability in cancer treatment [22-25].
Different types of drug delivery systems such as oral controlled
release systems, micro pills, microchip, drug implants, fast
International Journal of Applied Pharmaceutics
ISSN- 0975-7058 Vol 10, Issue 3, 2018