Basic procedure of 3D Printing in Pharmaceutical manufacturing is discussed.

1. A New Chapter in Pharmaceutical
Manufacturing: 3D-Printed Drug
Products
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Presented By:
V Anitha
M Pharmacy Year I Semester I (Pharmaceutics)
Under the guidance of:
Dr. S Ramakanth,
Professor, Department of Pharmaceutics,
Annamacharya College of Pharmacy, RAJAMPET-516216

2. CONTENTS
INTRODUCTION
3D PRINTING TECHNOLOGY
3D – PRINTED DRUG PRODUCTS
CONCLUSION
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3. 3

4. INTRODUCTION
3D printing is layer-by-layer production of 3D objects from digital designs
This technology developed at the confluence of chemistry, optics, and robotics research
more than 30 years ago to facilitate the creation of prototypes from UV-cured resins
It quickly became a standard tool in the automotive, aerospace, and consumer goods
industries.
More recently, 3D printing has gained traction in pharmaceutical manufacturing,
by FDA’s approval of a 3D-printed drug product in August 2015.
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5. 3D PRINTING TECHNOLOGY
Drug Product
• A drug product means a finished dosage form, for example, tablet,
capsule, solution, etc., that contains an active drug ingredient
generally, but not necessarily, in association with inactive
3D printing of
drug products
• Printing finished products from active pharmaceutical ingredients
excipients rather than synthesizing drug substances in a step-wise,
computer-controlled manner.
3D Printing
• According to the United States Government Accountability Office
(GAO), 3D printing produces 3D objects from digital models using
layer-by-layer process.
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6. BASIC PROCEDURE
Design The intended product design is digitally rendered
Designs can be rendered in 3D with computer-aided design (CAD) software
Conversion of the
design to a
machine-readable
format
3D designs are typically converted to the STL file format, which describes the
external surface of a 3D model
Raw material
processing
Raw materials may be processed into granules, filaments, or binder solutions to
facilitate the printing process.
Printing Raw materials are added and solidified in an automatic, layer-by-layer manner to
produce the desired product
Removal and post-
processing
After printing, products may require drying, sintering, polishing or other post-
processing steps
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7. 3D PRINTING METHODS
Binder
Deposition
Material
Jetting
Extrusion
Powder Bed
Fusion
Pen-Based
3D Printing
Use of 3D-
Printed
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8. Binder Deposition
• In this schematic, inkjet printers spray
formulations of drugs or binders in small
droplets at precise speeds, motions, and
sizes onto a powder bed.
• Unbound powder serves as the support
material for free-standing or porous
structures.
• The liquid formulation inside the printer may
contain a binder only, and the powder bed
may contain the active ingredient (API) with
additional excipients.
• The solidification mechanisms for binder
deposition are identical to the mechanisms
for wet granulation
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9. Material Jetting
• A powder bed is not necessary for 3D
printing with inkjets..
• Inkjets can also print free form structures
that solidify drop-by-drop, similar to
stalagmites..
• Material jetting, shown in Figure , differs
substantially from binder deposition, and it
can be more challenging to implement.
• The entire formulation needs to be
formulated for jetting and rapid
solidification, and product geometry
becomes highly dependent on droplet flight
path, droplet impact, and surface wetting.
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10. Extrusion
• Extrusion is the most widely used 3D printing
technology.
• In an extrusion process, material is extruded
from robotically-actuated nozzles.
• Unlike binder deposition, which requires a
powder bed, extrusion methods can print on
any substrate.
• A variety of materials can be extruded for 3D
printing, including molten polymers, pastes
and colloidal suspensions, silicones, and
other semisolids.
• A particularly common type of extrusion
printing is fused filament fabrication (FFF).
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11. OTHER METHODS
Powder Bed
Fusion
• Powder bed fusion involves sintering (partial surface melting and congealing) or
of high-melting-point particles with a low-melting-point binder.
• Both cases require heat, which is typically supplied by a laser.
Pen-Based
3D Printing
• Pen-based 3D printing is an extension of the extrusion 3D printing process where the
layer-by layer assembly is manually-controlled with a hand held device.
Use of 3D-
Printed
• Every 3D printing method has restrictions on what can and cannot be printed in a
reasonable amount of time.
• Creating molds from a 3D printed object may enable drug product manufacturers to
fabricate complex objects with non-printable materials.
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12. MOTIVATION FOR DEVELOPING 3D-PRINTED
DRUG PRODUCTS
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Increased product complexity
Personalization
On-Demand Manufacturing

13. 13 EXAMPLES OF 3D PRINTED
DRUGS

14. CONCLUSION
 3D printing is a layer-by-layer, automated process capable of producing
complex, personalized products on demand
 In recent years, researchers proposed dozens of 3D printing innovations to
improve the safety, efficacy, and tolerability of medicines
 The commercial feasibility of this technology has been shown through the
FDA approval of a 3D printed drug product in August 2015.
 Overall, FDA encourages development of complex dosage forms and
manufacturing processes, such as 3D tablet printing, using science- and
risk-based approaches.
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15. REFERENCES
 1. B.C. Gross, et al. Evaluation of 3D printing and its potential impact on biotechnology and the chemical sciences, Anal. Chem. 86 (2014)
3240-53.
 2. United States Food and Drug Administration. Highlights of Prescribing Information - Spritam. 2015; Available from
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207958s000lbl.pdf.
 3. R. Kolakovic, et al. Printing technologies in fabrication of drug delivery systems. Expert Opin. Drug. Deliv. 10 (2013) 1711-23.
 4. S. E. Moulton and G.G. Wallace. 3-dimensional (3D) fabricated polymer based drug delivery systems, J. Control. Release. 193 (2014) 27-34.
 5. I. D. Ursan, L. Chiu, and A. Pierce. Three-dimensional drug printing: a structured review, J. Am. Pharm. Assoc. 53 (2013) 136-44.
 6. C. L. Ventola. Medical Applications for 3D Printing: Current and Projected Uses. P&T. 39 (2014) 704-11.
 7. D. G. Yu, L.M. Zhu, C.J. Branford-White, X.L. Yang, et al. Three-dimensional printing in pharmaceutics: promises and problems, J. Pharm. Sci.
97 (2008) 3666-90.
 8. L. K. Prasad and H. Smyth. 3D Printing technologies for drug delivery: a review. Drug Dev. Ind. Pharm. 13 (2015) 1-13.
 9. P. Katakam, B. Dey, F. H. Assaleh, et al. Top-Down and Bottom-Up Approaches in 3D Printing Technologies for Drug Delivery Challenges.
Crit. Rev. Ther. Drug Carrier Syst. 32 (2015) 61-87.
 10. G. Jonathan and A. Karim. 3D printing in pharmaceutics: A new tool for designing customized drug delivery systems, Int. J. Pharm. 499
(2016) 376-394.
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16. THANK YOU
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