The document discusses several topics in customized drug delivery including personalized drug delivery systems, 3D printing of pharmaceuticals, bioelectronic systems, and telepharmacy. Personalized drug delivery aims to tailor treatment to each patient's characteristics and involves risk assessment, prevention, detection, diagnosis, treatment and management. 3D printing allows customized dosage forms by precisely depositing drug and excipient inks or melts in a layer-by-layer process. Bioelectronic devices attach to nerves to modulate signaling patterns and potentially treat conditions like arthritis and asthma. Telepharmacy enables remote dispensing and counseling using telecommunications.

1. Customized Drug Delivery, 3D printing,
Bioelectronic system, Tele pharmacy
PRESENTED BY:
Bhavana Sawadi
M. Pharm 1st YEAR
KLE COLLEGE OF PHARMACY, BELAGAVI
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2. Contents
 Customized drug delivery
 Bioelectronic system
 3D printing of
pharmaceuticals
 Tele pharmacy
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3. Customized drug delivery
It is also termed Personalized drug delivery systems (PDDS).
Personalized medicine is the tailoring of medical treatment to the individual
characteristics of each patient.
The approach relies on scientific breakthroughs in our understanding of how a
person’s unique molecular and genetic profile makes them susceptible to certain
diseases.
This same research is increasing our ability to predict which medical treatments
will be safe and effective for each patient.
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4. Customized drug delivery
Personalized medicine may be considered an extension of traditional approaches
to understanding and treating disease.
Personalized medicine has the potential to change the way we identify and
manage health problems.
It is already having an exciting impact on both clinical research and patient care
and further helps to enhance the technology.
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5. Customized drug delivery
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6. Personalized Medicine Is…
Personalized medicine is a multi-faceted approach to
patient care that not only improves our ability to
diagnose and treat disease but offers the potential to
detect disease at an earlier stage when it is easier to
treat effectively.
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7. Personalized Medicine Is…
The full implementation
of personalized
medicine encompasses:
• Risk assessment
• Prevention
• Detection
• Diagnosis
• Treatment
• Management
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8. Personalized Medicine Is Impacting Patient
Care in Many Diseases. For Example...
1. In Breast Cancer:
 One of the earliest and most common examples of personalized medicine came
in trastuzumab.
 About 30% of patients with breast cancer have a form that over-expresses a
protein called HER2, which is not responsive to standard therapy.
 Trastuzumab was approved for patients with HER2-positive tumors in 1998 and
further research in 2005 showed that it reduced recurrence by 52% in
combination with chemotherapy.
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9. Personalized Medicine Is Impacting Patient
Care in Many Diseases. For Example...
2. In Melanoma:
 BRAF is the human gene responsible for the production of a protein called B-
Raf, which is involved in sending signals inside cells to direct cell growth and
shown to be mutated in cancers.
 In 2011, a drug called vemurafenib, a B-Raf protein inhibitor, and the
companion BRAF V600E Mutation Test were approved for the treatment of
late-stage melanoma.
 Vemurafenib only works in the treatment of patients whose cancer tests positive
for the V600E BRAF mutation.
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10. CUSTOMIZED DRUG DELIVERY SYSTEM
1. 3D PRINTING
2. TELEPHARMACY
3. BIOELECTRIC DEVICES
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3D PRINTING OF PHARMACEUTICALS

12. 3D PRINTING OF PHARMACEUTICALS
David E.H Jones laid the
concept of 3D printing
CHUCK HULL invented a
solid process
It is known as
stereolithography
Stereolithography is a 3D
printing process that uses a
computer-controlled laser
beam, pre-programmed
using cad software
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13. INTRODUCTION
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3D printing is layer by layer production of 3D objects from digital design.
There are a wide variety of manufacturing technologies which are controlled
digitally by depositing materials to create free-form geometries.
For many years this method is extensively used in the field of bio-manufacturing.

14. Why do we need printed dosage forms?
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3D printing is highly flexible.
It is relatively simple to change the shape and size of the dosage form.
This also can be adjusted according to the patient or it enables fabricating complex
structure.
It is used intensively in the field of tissue engineering, and aerospace.

15. ADVANTAGES
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There are high production rates due to the fast operating system.
Reduction of material wastage which can save the cost of production.
An ability to create a tablet of any shape and size and ability.

16. Classification of main 3D printing technologies
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Material
Extrusion
Vat
Polymerization
Powder Bed
Fusion
Material Jetting Binder Jetting
Directed Energy
Deposition
Sheet
Lamination

17. Current 3D printing technologies are
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Inkjet printing
Zip dose
Thermal inkjet printing
Fused deposition modeling

18. Inkjet Printing
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It is also called as powder based 3D printing.
It is a combination of active ingredients and excipients (ink) are
precisely spread in small droplet via continuous jet method.
A substrate is used for spreading ink which solidifies into solid
dosage form.

19. Continued….
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It creates the model one layer at a time by spreading a layer of powder
It is mostly widely used 3-D printing technology these days

20. Zip Dose
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Zip dose technology can hold high dosage load and still maintain rapid
disintegration with just sip of water.
Zip dose technology can offer patients with swallowing difficulty an easier
way to take medicine.

21. Thermal ink jet
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1.Heat the ink: To start the process, the ink is delivered
by the cartridge to a firing chamber where electronic
resistors heat it at a rate of 1,800,032°F / 1,000,000°C per
second.
2.Generate a bubble: Once the heat from the resistors
causes the ink to reach a temperature of 644°F / 340°C,
the ink is vaporized and generates a bubble.
3.Propel the ink: As the bubble expands, the ink droplet
is propelled from the chamber and out of the nozzle.
4.Collapse the bubble: Once the droplet breaks away
from the nozzle and onto the substrate, the bubble it was
propelled by collapses. This creates a vacuum effect that
pulls more ink into the chamber, causing the entire process
to repeat.

22. Fused Deposition Modelling
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The process can be applied to multiple dosage forms that apply polymers as
part of the framework such as implants, zero-order release tablets, multi-
layered tablets.
In this process polymer required is melted and extruded through a movable
heated nozzle.
The layer-by-layer ejection of polymer is repeated along the x-y-z stage
followed by solidification to create a shape previously defined by computer-
aided design models

23. Challenges faced in 3D printing technology
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3DP technology has many anticipated advantages that are not yet proven; as
such continuous clinical development of 3DP will require vision, money, and
time.
• 1. Optimization and improvement of software performance,
• 2. Development of new excipients or assessment of old excipients for
application in 3D formulations; and
• 3. Development and optimization of manufacturing process for a wide
range of drug products.

24. • 4. Clinical studies to assess efficacy, safety and stability of new 3D-based
formulations.
• 5. Therapeutic efficacy of any drug is affected by properties like drug-excipient
interaction, polymorphic changes and stability in dosage form.
• 6. Regulatory approval.
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25. Challenges faced in 3D printing technology
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3D printed nose “mask” to deliver topical acne treatment was made from a
3D scan.
Bio Bot 1 is a bio 3D printer created by BioBots. Used to produce bioink/organic
parts using liquid feedstock.
Note: A feedstock is a chemical used to support a large scale chemical reaction.

26. Bioelectronic Systems
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27. Bioelectronic Systems Introduction
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Bioelectronics is an approach to treat and diagnose the injury and other vital
functions.
All the major organ of the body are innervated allowing the brain to both
monitor and regulate organ function
Bioelectronics medicine uses device technology to read and modulate the
electrical activity within the body nervous system

28. Definition
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Bio electronic medicines are a tiny implanted device treating disease by changing the
electric pulses in nerves to and from specific organs.
The vision for bio electronic medicines is one of miniature, implantable devices that can
be attached to individual peripheral nerves
Such devices will be able to decipher and modulate neural signalling patterns, achieving
therapeutic effects that are targeted at single functions of specific organs.

29. Arthritis
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Bioelectronics potentially treat arthritis: the nervous system triggers production of
protein that cause an immune response and lead to inflammation of the joints. A small
device could be attached to a nerve to potentially stop that chain reaction.

30. Asthma
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The device is attached to a pulmonary nerve to potentially block the signals that cause
the lungs to constrict.

31. Bioelectric treatment for Type 1 diabetes
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As we know pancreas is a visceral organ with exocrine
function for digestion and endocrine function and in case of
diabetes type 1 islets of endocrine gets dysfunctioned.
Using the electrical stimulation to augment parasympathetic
signalling may provide a way to control pancreatic endocrine
function
Simultaneous modulation of liver and digestive function along
with pancreatic function provide differential signals that work
to both raise and lower blood glucose
Targeted pancreatic vagus nerve stimulation may provide a
solution to minimize off target effects.

32. Closed loop Bio electrics for diabetes
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33. Next Generation Neuromodulation
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Next-generation neuromodulation devices are expected to improve four key areas:
1) Sensitivity, i.e. able to sense signals from neurons in the cortex and nerve fascicles
and fibres in the periphery, in a highly sensitive manner against other background
interference.
2) Selectivity, i.e. able to precisely target nerves near visceral organs central in chronic
diseases with clear endpoints.
3) Responsiveness, i.e. form closed-loop around recording of neural signatures and
detection of biomarkers (several communicating devices may be needed for the
close-loop biomarker detection and stimulation)

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4) Acceptance. i.e. miniaturized low power devices that can be delivered with
minimally invasive implantation thereby reducing patient burden.

35. Clinical issues and education
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 Clinical issues : on the physician’s side, neuromodulation is not a medical discipline
.cardiologists or neurologist are not “neuromodulators”.
 How do we connect the dots its very difficult to find physician who knows how to
implant a device!
 We need simpler, faster implant procedure , that can be performed by physician at lower
cost.
 Will patient accept therapy ? ,patient don’t want to deal with their device , just to be
healthy.
 People in Research and development need to go out and talk to patient and physician ,
so that they don’t lose sight of reality.

36. Tele pharmacy
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37. Definition
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Tele pharmacy is the delivery of pharmaceutical care via
telecommunications to patients.
Tele pharmacy services include drug therapy monitoring, patient
counselling, prior authorization and refill authorization for prescription
drugs, and monitoring of formulary compliance.
Remote dispensing of medications by automated packaging and labelling
systems can also be through of as an instance of telepharmacy.
Tele pharmacy services can be delivered at retail pharmacy sites.

38. Types of tele pharmacy
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There are 4 types of tele pharmacies :
1 Inpatient (remote order-entry review)
2 Remote dispensing (retail/outpatient/discharge)
3 IV admixture
4 Remote counselling

39. 1) Inpatient (remote order-entry review)
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Definition
Inpatient tele pharmacy refers to a pharmacist at a remote location performing remote order-entry services for an
inpatient pharmacy at a hospital. The remote pharmacist reviews medication orders before the hospital staff
administers the drugs to the patient.
Uses
Hospitals and health systems benefit from inpatient tele pharmacy as it allows for real-time medication order
review and verification.
Remote order-entry review in a health system serves as an extension of the in-house pharmacy.
With inpatient tele pharmacy, remote pharmacists are able to provide 24/7 coverage to strengthen pharmacy.

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With inpatient tele pharmacy, remote pharmacists are able to provide 24/7 coverage
to strengthen pharmacy.
Remote order-entry review in a health system serves as an extension of the
in-house pharmacy.

41. 2) Remote dispensing (retail/outpatient/discharge)
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Definition
A remote-dispensing site, or retail community tele pharmacy, is a licensed brick-and-mortar pharmacy
staffed by a certified pharmacy technician . A pharmacist supervises the technician, reviews
prescriptions and performs his or her duties from a remote location via technology.
Uses
Typically used in retail community pharmacy and outpatient/ discharge pharmacy settings, telepharmacy
gives patients convenient access to a pharmacist and prescription medication.
Remote dispensing allows healthcare organizations to open retail telepharmacy sites in areas where a
traditional pharmacy would not be feasible by sharing the cost of a pharmacist across multiple stores.

42. 3) IV ADMIXTURE
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Definition
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) defines IV admixture as, ‘the preparation of
pharmaceutical product which requires the measured addition of a medication to a 50ml or greater bag or bottle of intravenous
fluid.’ In layman’s terms, IV admixture is the mixture of IV solution administered to patients in a hospital setting.
Uses
Hospital pharmacies can save time and money by implementing tele pharmacy in the IV-admixture cleanroom.
If a pharmacist can review the IV admixture remotely, they save the time needed to suit up and enter the cleanroom to review
the solution A.

43. 4) Remote counselling
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Definition
Remote- patient counselling equates to pharmacists providing patient counselling and interactive video session, or
by some means through telecommunications.
Uses
Remote-patient counselling allows pharmacists to consult and provide a variety of pharmacy-care services to
patients via secure, live video calls . Beyond being beneficial to retail independents, community, clinic and
hospital-based pharmacies.
Remote counselling also provides opportunities for discharge counselling and various clinical interactions with
pharmacists.

44. Advantages
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Improve efficiency (reduce work load)
Improve accuracy (reduce errors)
Improve documentation
Enhance security(authorized access only)
Reduce job stress and staff turnover
Improve timeliness for medication delivery

45. Disadvantages
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Complexity and function variation
Requires additional staff training and technical help
Downtime system failure and inflexibility
Cost and space issues

46. References
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3d printing of pharmaceutials edited by Abdul w. Basit, Simon Gaisford Advances in the pharmaceutical science
series 31 springer publication
3D printing & pharmaceutical Manufacturing Opportunities & challenges International Journal of Bioassays
Assraa H., Jassim J., Moses O. “3D Printing Technology in Pharmaceutical Drug Delivery:Prospects and
Challenges.” Journal of Biomolecular Research and Therapeutics. 4(4);2-6.
Stratified, personalised or P4 medicine: a new direction for placing the patient at the centre of healthcare and
health education.
Egnew, Thomas (1 Mar 2009). "Suffering, Meaning, and Healing: Challenges of Contemporary Medicine“

47. References
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"Personalized Medicine 101" Personalized Medicine Coalition.
Personalized medicine – Wikipedia
Personalized medicine -- science daily
Birmingham K., Gradinaru V., Anikeeva P., Warren m., Pikov V. “Bioelectronic medicines: a research roadmap.” Nature reviews/Drug
discovery 2014. vol 13:339-400.
Kevin J. Tracey. “Molecular mechanism of Bioelectronic Medicines.” Alexandria Centre for Life Science.
Tele pharmacy: a pharmacist’s perspective on the clinical benefits and challenges DOVEPRESS WEBSITE

48. References
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Tele pharmacy – sm journal
Patient care through tele pharmacy by adam cheslar
Tele pharmacy – Wikipedia
Time to study tele pharmacy – uspharmacist website

49. THANK YOU
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