3D PRINTING FOR DRUG
MANUFACTURING:

A PERSPECTIVE ON THE FUTURE OF
PHARMACEUTICALS

Presented by:

ZUFIKA QAMAR

M.PHARMA (PHARMACEUTICS)

CONTENT
1.Introduction to 3d printing technology

2.History of 3d printing technology

3.Different types of Technology

4.Material used in 3d printing technology

5.Process parameter

6.Application

7.Advantages and disadvantages

8.Company producing 3d printing dosage form

9.Examples of pharmaceutical formulations that were developed by 3dp technology

10.Patents

11.References

INTRODUCTION TO 3D PRINTING
TECHNOLOGY

• It is called as ADDITIVE MANUFACTURING PROCESS.

• An object is created by laying down successive layers of material until the entire
object is created.

• Each layers is seen as a THINLY SLICED HORIZONTAL CROSSSECTION of the eventual
object.

• FDA‘s approved a 3D-printed drug product in August 2015 in pharmaceutical field.

• The U.S. Food and Drug Administration agency (FDA) granted the approval of
Spritam (levetiracetam)

• SPRITAM : The first 3D printed tablet for the treatment of epileptic seizures.

HISTORY OF 3D PRINTING TECHNOLOGY

• Charles W. Hull – The father of 3D printing, created and patented its earliest
incarnation in 1984.

• His invention, STEREO LITHOGRAPHY,‘‘Slicing a computer-aided design
(‘CAD’) file into two-dimensional crosssections and used an ultraviolet laser to
‘print’ the crosssections layer by layer in a photosensitive resin.”

• In 2004, Adrian Bowyer started the RepRap project, an ongoing online
community initiative relying on open source design to create affordable 3D
printers.

• The FIRST DIY-TYPE 3D PRINTER to use injection molded plastic parts,” could print
nearly all the parts required to self-replicate.

• MakerBot is one of the most recognized names in the commercial 3D printer
industry.

APPLICABLE 3D PRINTING METHODS

• Selective laser sintering (SLS)

• Powder-based Method

• Stereolithography

• Inkjet printing

• Extrusion printing (of viscous material)

• Fused deposition modeling (for solid materials)

POWDER-BASED PRINTING –
SELECTIVE LASER SINTERING

•SLS is a rapid prototyping (RP) process.
•Builds models using an ADDITIVE
FABRICATION METHOD.
•The build media for SLS comes in
powder form
•which is fused together by a powerful
carbon dioxide laser to form the final
product.

STEREOLITHOGRAPHY

• Called as photo-polymerization, the drug is dissolved
into a liquid pool of hydrogel or resin material

• It utilizes a laser or projector to solidify material while in a
bulk setting.

• Material of choice must be photosensitive.
• Laser light shines onto the surface of the pool/bed of

photosensitive drug-loaded material, the material cures
and solidifies.

• The nature of the pool of drug-loaded material has an
inherent risk of cross-contamination between the
fabrications of different drug products.

INKJET PRINTING

• A thermal inkjet nozzle uses a heating element to create a bubble in the
continuous flow of ink, which generates a droplet.

• Inkjet-based printing follows the same principles as a commercial inkjet printer for
paper: ink is deposited onto a substrate by either a thermal-driven or
piezoelectric-driven nozzle, offering high resolution printing capa-bilities.

• With the introduction of z-axis motion, 3D patterns may be fabricated by this
method.

• For the thermal inkjet printing approach, a thermal element within the print head
generates droplets of ink.

• The increase in thermal energy causes the formation of a small bubble, which
provides a pulse of pressure to force ink out of the nozzle, thereby producing a
droplet.

• An alternative to thermal inkjet printing is the piezo-electric approach, which
implements a piezoelectric actuator to form droplets.

• A piezoelectric crystal within the print head is stimulated when voltage is applied,
which induces a rapid, reversible deformation

• The inkjet printing method can further be applied to microvalve-based 3D
printing.

• Microvalve printing utilizes a motorized stage comprised of an array of mi-
cro valves which are capable of depositing droplets of material.

• Each microvalve is connected to its own pressure regulator, allowing for
individual con trol of each one. By controlling the stage and the pres sure
regulators in unison, various materials can be simultaneously deposited.

• This scheme has been previously applied to cell-laden bioprinting,
whereby support material, growth media, and cell-laden material were
printed together[37].

• Microvalve-based 3D printing can be applied to drug fabrication by
depositing various drug-loaded materials along with binders, scaffolds,
and other biodegradable materials

EXTRUSION-BASED PRINTING

Extrusion-based printing (of viscous materials). On the left, a piston is used to
apply mechanical pressure to the ink to extrude a continuous stream. On
the right, pneumatic pressure is applied from above to extrude the ink.

• Extrusion-based printing entails the extrusion of a
continuous stream of ink, as compared to the
droplets which are formed via inkjet printing.

• This method, the substrate material is mixed with the
drug of interest, and deposited by a nozzle or
needle.

• The substrate may be a viscous liquid or a solid
filament.

• Furthermore, advances in micro-extrusion allow for
highly precise deposition of drug-loaded material for
small-scale products

FUSED DEPOSITION MODELING

For solid materials.
Solid lament is fed through the nozzle by rollers, then melted by
heating elements within the nozzle, and extruded on the print
bed

ADVANTAGES AND
DISADVANTAGES

MATERIAL REQUIREMENT IN 3D
PRINTING IN PHARMACY

• In discussing 3D printed pharmaceuticals, it is also important to consider the
type of material – whether it be

• a powder, solid bulk, or lique ed substance – that is used to print the drug
product.

• SLS and binder deposition both require a powder substance.

• Compatible with extrusion-based printing, fused deposition modeling (FDM)
relies on the extrusion of solid laments loaded with the desired drug.

• Due to the reliance on solid polymer-based filaments, this method poses
more challenges in making it appropriate for oral dosage medicines.

• Conversely, natural and synthetic hydrogels have a more viscous
consistency that makes them more appropriate for oral drug products.

•Materials for Powder-Based Printing
•Fused Deposition of Solid Materials
•Natural and Synthetic Hydrogels
•Smart Materials for Drug Delivery

MATERIALS FOR POWDER-BASED PRINTING

• Factors that impact the printability include particle size, binder
viscosity, droplet size of the binder solution, the concentration of the
binder solutions, and the thickness of each powder layer.

• The powder size must not be too small as to cause low flowability, nor
may it be too large such that high density printed parts are not
feasible.

• The binder solution must be of low enough viscosity and high surface
tension to precisely form small droplets, while also being able to
penetrate the layer of powder

• The binder-powder mixture may either dry to form the solid part, or the
materials may react to cause localized polymerization, curing or
bonding.

• Powders may include soluble polymers, plastics and starches, while
binders include chloroform and water, among other solvents

FUSED DEPOSITION OF SOLID MATERIALS
• Fused deposition modeling (FDM) 3D printers are a specific category of extrusion-

based printers which use a solid, polymer lament.

• The filament is fed through an electronically controlled nozzle which melts the
lament and deposits it onto the print bed where the melted filament solidifies into
the final 3D printed form.

• Such printers are simple and versatile, and are compatible with laments such as
poly(lactic acid) (PLA), poly(vinyl alcohol) (PVA), and ethylene vinyl acetate (EVA).

• Due to the polymer nature of the laments, they exhibit considerable structural
stability after printing and solidifying.

• These filaments are also largely water-soluble, and are capable of being loaded
with a drug in solution.

• Filament can be loaded with varying con-centrations of drugs for specified doses by
dissolving the drug in an ethanolic solution and submerging the unprinted, solid
filament in the solution

•

NATURAL AND SYNTHETIC
HYDROGELS

• As opposed to the solid nature of polymer-based filaments used in
FDM printing, hydrogels are viscous and capable of being extruded or
deposited as droplets via extrusion-based printing and inkjet-based
printing, respectively.

• Implementing a controllable gelling hydro-gel system, many layers of
drug-loaded hydrogels can be printed into 3D structures,
characterized by pores and channels which can be printed into the
materials.

• Following printing, curing and soaking, the hydrogel patterns develop
into water-swollen networks formed by the deposited hydrogel
materia

•

ADVANTAGES OF 3D FOR DRUG
MANUFACTURING

• 3D printing enables increased geometric and architectural complexity,
facile fabrication of multi-layer delivery systems, and the application of
various controlled release mechanisms.

Theoretical scheme of 3D printing for drug manufacturing. Based on a patient’s speci c
prescription from his doctor, a custom medication is designed via computer-aided
design. The dosage form may be composed of complex geometries, multiple doses, or
even multiple drugs. Drug-loaded bioink (biocompatible material) is then 3D printed on-
demand

• Printing as an approach for drug manufacturing also introduces
precise and unique dosing, and the ability to create multi-dose or
multi-drug pharmaceutical products.

• Dosing may also be tailored specifically for individual patients

• The printing of drugs makes point-of-care, pharmacy-based drug
production possible, without the risks and extensive fabrication time
associated with com-pounding pharmacies.

• Release Characteristics of Drugs.
• Precise and Unique Dosing

• On-Demand Capabilities

COMPANY PRODUCING 3D PRINTING
DOSAGE FORM

• FIRST FDA-APPROVED MEDICINE MANUFACTURED USING 3D PRINTING
TECHNOLOGY NOW AVAILABLE.

• SPRITAM® is Designed to Transform Experience of Taking Epilepsy Medication

FORMULATIONS THAT WERE DEVELOPED BY
3DTECHNOLOGY

PATENTS

REFERENCE
• 1. Chua CK, Leong KF, An J: 1 – Introduction to rapid prototyping of

biomaterials. In: Rapid Prototyping of Biomaterials, Narayan R (Eds).
Woodhead Publishing, 2014; 1- 15.

• 2. United States Food and Drug Administration. Highlights of Prescribing
InformationSpritam.2015;http://www.accessdata.fda.gov/drugsatfda
_docs/label/2015/207958s000lbl.pdf. .

• 3. Skowyra J, Pietrzak K, Alhnan M (2015) Fabrication of extendedrelease
patient-tailored prednisolone tablets via fused deposition modelling (FDM)
3D printing. Eur J Pharm Sci 68: 11- 17.

• Tasoglu S, Lepowsky E (2018):Printing for Drug Manufacturing: A Perspective
on the Future of Pharmaceuticals

•