Bioelectronic medicine (electroceuticals)(BEMS), 3d Printing, Yokeshwaran.A, M.Pharm Pharmacology, Annamalai University.

1. Bioelectronic Medicine
& 3D Printing
Presented by,
Yokeshwaran Anandhan
M. Pharm Pharmacology
Annamalai University
Tamil Nadu

2. BIOELECTRONIC MEDICINE : AN INTRODUCTION
• Bioelectronic medicine (BEM) also known as electroceuticals, are medical devices
used to restore patients health.
• Instead of treating patients by intervening with the bloodstream, BEM intervenes with
• regulatory functions of the nervous system &
• technologies that record, stimulate/block neural signaling.(by focusing electrical signaling)
• It brings new insights into the diagnosis & treatment of diseases and conditions:-
• cancer, rheumatoid arthritis, inflammatory bowel disease, obesity, diabetes, asthma, paralysis,
blindness, bleeding, ischemia, organ transplantation, cardiovascular disease, neurodegenerative
diseases, and others.
• BEM can provide novel therapeutic value, 1/3rd of the time and 1/10th of the cost to
develop as traditional pharmaceutical-based treatments.

3. VAGUS & BEM
• The human body is electric.
• Peripheral nerves connect all organs to the central nervous system(CNS), & those
nerves are packaged in various bundles.
For ex: The vagus nerve, carries about 100,000 nerve fibers.
• It’s also the longest nerve in the body, linking the brain to organs from the esophagus
to the intestines while controlling breathing and heart rate.
It is well-known for “gut-brain connection”.
Timir Datta-Chaudhuri (Feinstein Institutes for Medical Research)
• The vagus nerve goes everywhere, so it’s an easy way to get access to a bunch of
different targets”
“It’s like going to the main fuse box.”

4. • He believes the greatest promise for BEM is in manipulating the vagus nerve to
control inflammation & immune response - both of which drive most chronic
disease.
Proven :
• In a groundbreaking study published in Nature in 2000,
Tracey and his colleagues showed that stimulating the vagus nerve could
significantly reduce inflammation in rats .
• Acetylcholine, the principal neurotransmitter that stems from the vagus nerve,
inhibited the production of cytokines such as tumor necrosis factor (TNF), an
inflammatory molecule involved in rheumatoid arthritis.
• His team followed up with studies in humans and found the same .

5. LUDWIG says,
• BEM wouldn’t necessarily replace drugs; in some cases, it could serve as a
complement to traditional therapies.
“We can use devices in harmony with lower levels of drugs so they don't have
side effects and also to prevent habituation”.
• The National Institutes of Health (NIH) and the Defense Advanced Research
Projects Agency (DARPA) have also invested significantly in the field through
programs such as Stimulating Peripheral Activity to Relieve Conditions, or SPARC
, and Electrical Prescriptions, or ElectRx.
• One recent study funded by DARPA’s ElectRx, is to found that “sacral nerve
stimulation decreased inflammation in the colon” .

6. IDEALOGY…
• The idea of electrically stimulating the body to alleviate illness is not new.
• Doctors have implanted patients with
• pacemakers,
• deep-brain stimulators, and
• other electrical devices for decades.
• Vagus nerve stimulation itself is currently US Food and Drug Administration
(FDA)-approved for epilepsy and treatment-resistant depression.

7. Non-invasive Bioelectric Medicine
• Transcutaneous Electrical Nerve
Stimulators
• Transcranial Magnetic Stimulation
(TMS)
• Pulsed Electromagnetic Field
Therapy &
• Other Non-invasive Bioelectric
Medicines
Implantable Bioelectric Medicine
• Cardiac Pacemaker
• Implantable Cardioverter Defibrillators (ICD)
• Spinal Cord Stimulators
• Cochlear Implants
• Deep Brain Stimulators
• Vagus Nerve Stimulators
• Sacral Nerve Stimulators
• Retinal Implants & Others
SOME BEM’S

8. MARKET INTELLIGENCE
• It’s vital you keep your market knowledge up to date segmented by Applications
[Hospitals, Research Institutes & Individual Users] and Product types.
• Global bioelectric medicine market will reach $39.06 billion by 2030, growing by 6.4%
annually over 2020-2030 driven by growing geriatric population and rising acceptance
of bioelectric medicines.
Reference:
• The rise of bioelectric medicine sparks interest among researchers, patients, and industry Lynne Peeples, Science
Writer. PNAS | December 3, 2019 | vol. 116 | no. 49 | 24379–24382,
www.pnas.org/cgi/doi/10.1073/pnas.1919040116 .
• Bioelectric Medicine Market Market Is Booming Globally will Reach $39.06 Billion and Growing by 6.4% Annually
over 2020-2030 12-17-2020 02:41 PM CET | Health & Medicine.

9. THREE - DIMENSIONAL
PRINTING

10. THREE-DIMENSIONAL PRINTING - INTRO
• 3 D Printing is a revolutionary technique that uses computer aided design software &
programming
- to create three dimensional objects by placing material on a substrate.
• It is an additive layer manufacturing techniques, where consecutive layers of material
are deposited or solidified to form a 3D structure.
• The 3D printing process desires to be espoused by pharmaceutical sector and capable
of exploring the marvels fetched by the approach.
• 3D printing can include a very new possibilities to optimized medicine.

11. TECHNIQUES IN 3D PRINTING
• There are different 3D printing techniques has been developing and developed to
fabricate novel solid dosage forms, which are among the most well-known and discrete
products today. (as follow)
•Hot Melt Extrusion •Ink Jet Printing
•Fused Deposition Modeling •Thermal Ink Jet Printing
•Zip Dose •Extrusion 3D Printing,
•Laser-based Writing System, •Powder Based 3D
•Stereolithography •3D Printer
•Continuous Layer Interface Production •Printing Selective Laser Sintering

12. 3D Printer
• The 3D printer was an exclusive tool is used to create optimized medications
with tailored release profiles and for patients’ comfort
Hot melt extrusion (HME)
• Hot melt extrusion (HME) is the method of melting polymer and drug at elevated
temperature and the pressure is employed in the instrument sequentially for
blending.
• It is a continuous manufacturing technique that involves feeding, heating, mixing
and shaping.
• In recent years, it has proved that HME capable to optimize the solubility and
bioavailability of moderately soluble drugs.

13. Laser-Based Writing System
• On grounded to the photo polymerization principle, the free radicals which can
contribute to the numerous diseases are released then to the interactions in among
the photo originator and Ultra Violet light.
Selective laser sintering
• SLS act as a way in the powder bed to bind.
• The laser is designed to draw a specific pattern on the surface of the powdered bed
during the printing process, thus creating a 3D structure.
• For example, Paracetamol Orodispersible tablet.
• It is currently used for industrial manufacturing of plastic, metallic and ceramic
objects.

14. Inkjet Printing
• Inkjet printing known as ‘mask-less’ or ‘tool-less’ approach for its desired structure
formation mainly depends upon the inkjet nozzle movement / substrate movement for
an accurate and reproducible formation.
• In this methodology, the Ink is deposited onto a substrate either in the form of
Continuous Inkjet printing / Drop on demand printing.
• Hence it provides a capability of high-resolution printing @ low cost, low rate of
wastes in printing and generation process.
• It gives CAD information in a ‘direct write’ manner and process material over large
areas with minimal contamination.

15. Advantages of 3D Printed Drug Delivery
• 3D printers capture minimal space and are affordable.
• A Reduced production cost due to less wastage of materials.
• High drug loading capability compared to conventional dosage forms.
• Manufacture of small batch is feasible and the process can be completed in a single run.
• Accurate & Precise dosing of potent drugs which are administered at small doses for
activity.
• Suitable, immediate & controlled release layer drug delivery for difficult to formulate
active ingredients like poor water solubility and narrow therapeutic windows drugs.
• Tailored Patient Medication in particular based on age, gender, genetic variations, ethnic
differences and environment.

16. Disadvantages
• Problems related to nozzle are a major challenge as stopping of the print head which
affects the final products structure.
• Powder printing clogging is another hurdle.
• Possibility of modifying the final structure on to mechanical stress, storage condition
adaptions and ink formulations effects.
• Printer related parameters and these effects on printing quality and printer cost.
Reference:
1. 3D Printing in Pharmaceutical Technology – A Review, Ravikumar Tamil Ponni*, Mahalingam Swamivelmanickam,
Sivagnanam Sivakrishnan Dept of Pharmacy, Annamalai University, International Journal of Pharmaceutical Investigation,
Vol 10, Issue 1, Jan-Mar, 2020.