General information of 3D Printing in Pharmaceutical field.

1. 3D PRINTING
CHANDIGARH COLLEGE OF PHARMACY
PHARMACEUTICS
DEPARTMENT
Presented by:
MAJID FAROOQ
1911788
M.Pharm
(Pharmaceutics)
1st Year (Sem. 1st)

2. CONTENTS
 Introduction
 Process
 3D Printing in Pharmaceutical Industry
 Aprecia Zip Dose
 Regulations
 Advantages
 Disadvantages

3. INTRODUCTION
• 3D printing or additive manufacturing is a process of
making three dimensional solid objects from a digital
file.
• The creation of a 3D printed object is achieved using
additive processes.
• In an additive process an object is created by laying
down successive layers of material until the object is
created.
• Each of these layers can be seen as a thinly sliced

4. PROCESS
• It all starts with making a virtual design of the object
you want to create.
• This virtual design is for instance a CAD (Computer
Aided Design) file.
• This CAD file is created using a 3D modeling
application or with a 3D scanner.
• A 3D scanner can make a 3D digital copy of an object.
• 3D printing is unique technology that was first
described by Charles Hull in 1986.

5. 3D PRINTING IN
PHARMACEUTICAL INDUSTRY
• In 2015, Aprecia Pharmaceuticals produced the first tablet
manufactured through 3D printing to be approved by the FDA.
• Two years later, GlaxoSmithKline (GSK) completed a study
where inkjet 3D printing and ultraviolet (UV) were used to
create tablets that treat Parkinson’s disease.
• With applications in controlled release, short-run medicines,
and even the potential for on-site printing at pharmacies, 3D-
printing technology has the ability to transform the
pharmaceutical industry.

6. • In the example of Aprecia Pharmaceuticals, 3D
printing was used to reformulate the anti-epileptic
medication levetiracetam.
• The new product, Spritam, has a highly porous
structure that could not be achieved with traditional
manufacturing.
• This structure causes the pill to dissolve in seconds
upon contact with saliva, helping both elderly and
young patients suffering from trouble swallowing pills.
• This innovative development was achieved through a
proprietary powder bed and inkjet 3D-printing

7. APRECIA ZIP DOSE
• Powder-liquid 3D printing technology was developed at the
Massachusetts Institute of Technology (MIT) in the late 1980s
as a rapid prototyping technique.
• This technology uses an aqueous fluid to bind together
multiple layers of powder using a unique, patent-protected
process to create a wide range of products.
• Aprecia developed the ZipDose® platform, which is designed to
enable delivery of high dose medications in a rapidly
disintegrating form.
• ZipDose® Technology produces a product layer-by-layer
without using compression forces, punches, or dies.

8. REGULATIONS
• To date, Spritam is the only FDA-approved 3D-printed
pharmaceutical on the market.
• However, the FDA sees 3D printing as a tool to improve
drug quality and consistency.
• Although no GMP guidelines have been administered
for 3D-printed pharmaceuticals, the FDA established
guidelines for 3D printing of medical device products in
2017.

9. REGULATIONS
• 3D-printing technology is already being applied to
medical device and surgical manufacturing, particularly
in research and development.
• Using 3D printing, hearing aid company Sonova is able
to mass-produce hundreds and thousands of custom-
made products per year.

10. ADVANTAGES
• Ability to customize products.
• Rapid production of prototypes.
• Low cost of production.
• Improves the safety, efficacy, and accessibility of
medicines.
• Decrease storage cost.

11. DISADVANTAGES
• Intellectual property issues.
• Unchecked production of dangerous items.
• Limitations of size.
• Limitations of raw material.
• Cost of printers is high.

12. THANK YOU