Innovation In Pharmaceutical Tablet Manufacturing

Use of 3D printer in pharmaceutical industry

1. Pharmaceutical Management Assignment on : Innovation In Pharmaceutical Tablet Manufacturing Submitted to : Mr. Md. Saiful Islam Pathan Associate Professor, Department of Pharmacy State university of Bangladesh 1 Submitted by : Tasmia Tabassum ( UG08-21-12-003) Hurain Jinnat Tanni ( UG08-21-12-009) Md. Reyaz Ahamed ( UG08-21-12-007) Ishrat Jahan (UG08-20-12-034) State University of Bangladesh. (Department of Pharmacy ).Batch: 21 A

2. Introduction Tablet is defined as a compressed solid dosage form containing medicaments with or without excipients .

3. Unit Operation Wet granulation Dry granulation Direct compression 1. Dispensing/Weighing Dispensing/Weighing Dispensing/Weighing 2. Sieving/Milling Sieving/Milling Sieving/Milling 3. Dry powder mixing Dry powder mixing/Lubrication Dry powder mixing/Lubrication 4. Wet massing with addition of granulating fluid Roller compaction/Slugging Compression 5. Wet screening Milling/Crushing 6. Drying Compression 7. Dry screening after checking LOD 8. Lubrication 9. Compression 3

4. Innovation To be called an innovation, an idea must be replicable at an economical cost and must satisfy a specific need. Innovation involves deliberate application of information, imagination and initiative in deriving greater or different values from resources, and includes all processes by which new ideas are generated and converted into useful products.

5. Innovation (cont..) Innovations are divided into two broad categories: Evolutionary innovations(continuous or dynamic evolutionary innovation) that are brought about by many incremental advances in technology or processes and Revolutionary innovations (also called discontinuous innovations) which are often disruptive and new.

6. Innovation (cont..) Innovation is synonymous with risk-taking and organizations that create revolutionary products or technologies take on the greatest risk because they create new markets. Imitators take less risk because they will start with an innovator's product and take a more effective approach. Examples are IBM with its PC against Apple Computer, Compaq with its cheaper PC's against IBM, and Dell with its still-cheaper clones against Compaq.

7. Innovation in the pharmaceutical industry Continuous innovation is one of the pharmaceutical industry’s most defining characteristics. New medications can be crucial for maintaining the quality of human life, and may even affect its duration. The sales potential is staggering: the global pharmaceutical market is expected to reach $1.1 trillion by 2015. The pressure to succeed is tremendous. Yet, pharmaceutical innovation is hardly an orderly, predictable process. It follows a technology-push model dependent on a meandering path of scientific breakthroughs with uneven timing and hard to foresee outcomes.

8. Innovation in the pharmaceutical industry ( contd …) Technological competency, decades of rigorous research, and profound understanding of unmet customer needs, while necessary, may prove insufficient for market success as the critical decision for commercialization remains outside the firm. Drug innovation as a business process requires savvy strategic, organizational, and managerial decisions. It is already enjoying intensive research coverage, giving rise to abundant but relatively dispersed knowledge of the mechanisms driving drug discovery and development

9. 3D Printer 3D printing  (also called additive manufacturing) is any of various processes used to make a three-dimensional object. In 3D printing, additive processes are used, in which successive layers of material are laid down under computer control. These objects can be of almost any shape or geometry, and are produced from a 3D model or other electronic data source. A 3D printer is a type of industrial robot.

10. 3D Printing in tablet manufacturing 3D printing is revolutionizing pharma by allowing new substance to be tested directly on human tissues, and by changing the economics of scale, whereby any drug can be cost effective.

11. 3D Printing in tablet manufacturing 3D printing,a technology is just found in the world of medicine. The US Food and Drug Administration approved an epilepsy medicin called Spritam , made by 3D printers, approved by the FDA for use inside the human body. Aprecia , is the pharmaceutical company introduced this new form of tablet manufacturing.

12. Development of Drug Using 3D printer The drug was developed using Pennsylvania-based Aprecia Pharmaceutical’s proprietary ZipDose technology, which builds on existing 3D printer research carried out by MIT into creating fast-melting materials.

13. Development of Drug Using 3D printer ( Contd …..) ZipDose is a 3D printer that creates pills by printing out thin layers of medicine in powder form, with layers of a water based binder spread between each of the powder layers. The result is a tablet that can dissolve with a sip of water in less than 5 seconds.

14. Development of Drug Using 3D printer ( Contd …..) Apart from Aprecia’s 3D printed drug, the only other similar example in the market is Hewlett Packard’s D300 Digital Dispenser device, which dispenses liquids directly into assay plates to speed up the experiments of drug discovery biologists.

15. Development of Drug Using 3D printer ( Contd …..) Aprecia refers to these new 3D printed pills as “fast melt” to differentiate them from tablets and capsules. With 3D printing, each dosage can be individually measured and then printed.

16. 3D printer can produce a tablet with a precise quantity of medicine Britain’s University of Central Lancashire ( UCLan ) is developing a 3D printer that can produce a tablet containing a precise quantity of medicine, with the potential of creating customized drugs for individuals. The device uses a new drug-polymer filament system to replicate complex tablet design. Researchers predict that hospitals and drug makers will use the technique within the next five years and hope that eventually patients who require daily dosage changes could use the printer in their homes.

17. 3D printer can produce a tablet with a precise quantity of medicine (contd..) The UCLan team says that the machine, which is awaiting a patent application, can “print” a tablet with a precise quantity of medicine that can be taken by a patient. Although the printer can reproduce existing drugs available in drugstores and hospitals, the UCLan team says that the main advantage of the printer is that it could potentially tailor drugs to a patient’s needs.

18. How does it works…… A 3D printer works by adding materials layer by layer until a 3D shape emerges.

19. How does it works…… The new technology was made possible by a drug-polymer filament system that can replace the original filaments in a 3D printer. This new system allows the printer to replicate a complex tablet design, matching dose and weight with a high level of accuracy. The system can provide medical institutions with a new option and maintain dosage form properties while accurately adjusting the dose with simple software order—something that was previously considered costly and required experienced staff and dedicated facilities.

20. How does it works ( contd ….) A 3D printing process also allows layers of medications to be packaged more tightly in precise dosages. 3D-printed pills could be custom-ordered, based on specific patient needs, rathe than on a one-drug-fits-all approach. The possibility to 3D print drugs on affordable devices could eventually lead to cheaper medication. UCLan hopes for this method to be used by pharmaceutical companies and hospitals within five years. Eventually, the project could allow for patients to 3D print their personalised medication at home.

21. A video from UCLan  shows the MakerBot Replicator 3D printer printing a Theophylline tablet is there.

22. Advantages of 3d printer If drugs can be produced with 3D printing, companies like Aprecia pharmaceuticals would be able to licence its medication to hospitals to produce onsite, lowering the company’s manufacturing costs significantly. Moreover, it is easier to manufacture high dose medication by this method .