PERSONALIZED
MEDICINE& 3D PRINTING
PHARMACEUTICALS
AND TELEPHARMACY

Presented by

ASWINKUMAR A M

M.Pharmacy First Year,

Department of Pharmaceutics,

College of Pharmacy,

Madras Medical College,

Chennai-600003.

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CONTENT

➢ Personalized medicine

ⱷ Definition

ⱷ Advantages

ⱷ Applications

ⱷ Pharmacogenetics and pharmacogenomics

ⱷ Categories of Patients for Personalized Medicine

ⱷ Bio electronic Medicines

➢ 3D Printing of Pharmaceuticals

➢ Telepharmacy

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PERSONALIZED MEDICINE

➢Personalized medicine, sometimes referred to as precision

or individualized medicine.

➢Emerging field of medicine.

➢It often help to assess which medical treatments and

procedures will be best for each patient.

➢The progress in study of human diseases at molecular

level advances in molecular diagnostics and drug

development based on genomics, proteomics,

metabolomics and biomarkers.

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Cont….

➢ 1990 -Human genome project launched and – FDA approves first

personalized medicine(Trastuzumb) with a companion diagnostic,

for the treatment of HER2 positive breast cancer.

➢ 2000- Human Genome Project completed for first targeted therapies

for lung cancer, leukemia,HIV, and many other diseases.

DEFINITION:

➢ The term personalized medicine is described that the ability to offer “

The Right Drug to the Right Patient, for the Right Disease, at the

Right Time with the Right Doseˮ.

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Cont….

➢ Personalized medicine is based on individuals genetic profile to make
the best therapeutic choice by facilitating predictions about whether
that person will benefits from a particular medicine or suffer serious
side effects.

➢ Drugs are generally tested on a large population of people and the
average is response is noted and reported. This sort of evidence based
medicine(that is medical decision making based on empirical data)
relies on the law of averages.

➢ Personalized medicine, on the other hand, recognizes that no two
patients are alike.

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➢ Personalized medicine involves identifying,

Physiological information,

Genetic information,

Clinical information.

All this three information allows the predictions to be made
about a persons susceptibility of developing diseases, course of
diseases and its response to a treatment.

➢ Personalized medicine is not a genetic medicine. Because it only
examines the individual genes and their effects as they related to
biology and medicine.

➢ In personalized medicine we study about the DNA polymorphisms

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DNA POLYMORPHISM :
➢ It is the natural variations in our genes that plays a role in our risk of

getting or not getting certain diseases.

➢ The combination of this variations across several genes affects each
individual risk.

➢ DNA polymorphisms leads to detect the differences in, How the
drugs are absorbed, used and metabolized in the different patients.

GENES :

➢ It gives a rise to proteins that play key role in biological process.

➢ Malfunctioning of this leads to genetic diseases or syndrome. Such
disorders are termed as monogenic.

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ADVANTAGES OF PERSONALIZED MEDICINE
FOR PATIENTS
➢ Effective and specific therapies.

➢ Low risk of adverse effects.

➢ No time in lost with trial and ineffective drugs.

➢ Improvement of quality of life.

ADVANTAGES OF PERSONALIZED
MEDICINE FOR CLINICIANS

➢Avoidance in trial and error approach in selection of drugs.

➢Less complication of treatment and adverse effect of drugs

➢Advances in medicine and translation of new biotechnologies
in to clinical practice.

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PERSONALIZED MEDICINE
MECHANICS
➢ Natural variation(DNA polymorphisms) plays a role in our risk of

getting or not getting certain diseases.

➢ External factors such as,

Enviroment

Diet

Exercise can also determine an individual risk for diseases.

➢ Natural genetic variations can plays a major role in determining drug
efficacy.

➢ Variations in DNA can leads to differences in pharmacodynamic and
pharmacokinetic in the individual patient.

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BASIC TECHNOLOGIES USED FOR
DEVELOPING PERSONALIZED MEDICINE:

➢ Based on the patients individual genetic expression, the following
techniques are used to detect the best medication for the patient.

➢ Molecular diagnostics particularly Single Nucleotide Polymorphism
(SNP).

➢ Pharmacogenomics – the application of genomics( variations of
DNA as well as RNA) for drug discovery and development.

➢ Pharmacogenetics- concern the study of influence of genetic factors
on response to drugs.

➢Pharmacogenetics is being used to learn ahead of time what
the best drug or the best dose of a drug will be for a person.
Also called pharmacogenomics.

➢Biomarkers

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Cont…
BIO MARKERS:

➢ Biomarkers are utilized for stratifying patients into types and subtypes of disease,

determining the acute and chronic disease,and assesment of disease occurance.

➢ There are different roles played by a biomarkers based on different characteristics,

namely preventative, diagnostics, prognostics. This is used for specific diagnosis

and treatment.

➢ Examples : everything from blood pressure and heart rate to basic

metabolic studies and x-ray findings to complex histologic and genetic

tests of blood and other tissues. Biomarkers are measurable and do not

define how a person feels or functions

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Cont…

MOLECULAR DIAGNOSTICS:

➢ Use of diagnostic testing to understand the molecular mechanism of

an individual patient’s disease, will be pivotal in the delivery of safe

and effective therapy for many diseases in the future.

ROLE OF MOLECULAR DIAGNOSTICS:

➢ Early detection and selection of appropriate treatment.

➢ Integration of Molecular Diagnostics with therapeutics.

➢ Monitoring of therapy.

Nucleic acid isolation and quantification, PCR amplification,

sequencing, and STR analysis.

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PERSONALIZED MEDICINE

Understanding human
genome

identify genetic
information

Genetic information
specific to individual

No No trial &
Preselect

toxicity error
effective drug

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CATEGORIZES OF PATIENT FOR
PERSONALIZED MEDICINE

➢Age related

1.Adult patient

2.Elderly patient

➢Diseases related

➢Genetically determined susceptibility

➢Individual physiological status

➢Sex related

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PHARMACOGENETICS

INTRODUCTION:

➢ Pharmacogenetics into clinical practice has the potential to improve

efficacy and reduce toxicity, by choosing “the right drug for the right

patient in the right disease at the right dose”.

➢ Primaquine induced hemolysis in patients with G6PD (Glucose-6-

Phosphate Dehydrogenase ) deficiency, was the first

pharmacogenetic discovery.

➢ Wherein personalized medicine, it is described that the study of the

linkage between the individual’s genotype and individual’s ability to

metabolize a foreign compound.
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DEFINITION:

➢Pharmacogenetics is the study of genetic basis for variability in drug

response.

➢The effect of genetic variation on drug response, including

disposition(PK), safety, tolerability and efficacy(PD).

➢Pharmacogenetics helps to determine, What the right medicines is

for you,based on your own genes. So the physician can provide a

more appropriate dose. So the patient can receive better and safer

drugs.

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ROLE OF PHARMACOGENETICS IN DRUG
DEVELOPMENT

➢ Studying drug metabolism and pharmacological effects

➢ Predicting genetically determined adverse reactions (ADRs)

➢ Drug discovery and development and as an aid to planning

clinical trials

➢ Decrease costs and time to bring drug to market

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DIVISIONS OF PHARMACOGENETICS

➢ The pharmacokinetics of a drug can be altered by sequence variations

in drug-disposition genes.

➢ The pharmacodynamics of a drug can be changed by sequence

variations in drug-target genes. Drug-disposition
Pharmacogenetics

Pharmacogenetics

Drug-target
Pharmacogenetics

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DRUG-DISPOSITION PHARMACOGENETICS
➢ A drug’s disposition includes its absorption, metabolism, distribution, and

excretion (ADME).

➢ The plasma concentrations of the parent drug or its active metabolites may

be affected by a genetic polymorphism altering the function of a protein that

is involved in the disposition of a drug.

➢ For example, if a genetic polymorphism leads to lower activity of a

metabolizing enzyme, the plasma concentrations of the parent drug may

increase and plasma concentrations of metabolites may decrease. If only the

parent drug exhibits pharmacologic activity, the genetic polymorphism will

potentiate the drug response, including adverse drug reactions.

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Cont…

➢ If only the metabolites have pharmacologic activity, then the genetic

polymorphism may reduce the drug response.

 Examples:

➢ Warfarin and CYP2C9 polymorphisms

➢ Tamoxifen and CYP2D6 polymorphisms

➢ Thiopurine drugs and Thiopurine S-methyltransferase (TPMT)
polymorphisms

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TAMOXIFEN AND CYP2D6
POLYMORPHISMS

➢ Tamoxifen is commonly used for breast cancer treatment.

➢ Endoxifen, a metabolite of tamoxifen, is 100 times more potent than

the parent drug as a selective estrogen receptor modulator and

exhibits about 7 times higher plasma concentrations than the other

active metabolites at steady state.

➢ CYP2D6 is involved in generating endoxifen from tamoxifen.

➢ CYP2D6 have been associated with variability in plasma

concentrations of endoxifen among individuals.

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DRUG-TARGET PHARMACOGENETICS

➢ Pharmacologic effects of drugs are exerted by modulating activities

of enzymes or receptors.

➢ Genetic polymorphisms of drug-target enzyme or receptor may alter

the drug response.

➢ Fewer genetic polymorphisms in pharmacodynamic genes have been

recognized by FDA, including…

ß1-adrenergic receptor gene polymorphisms (ADRß1) and ß-

blocker response

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ADRB1 AND ß-BLOCKER RESPONSE

➢ Ser49Gly and Arg389Gly are two common SNPs in ADRß1.

➢ It is hypothesized that hypertensive patients carrying Ser49 or

Arg389 would have greater reduction in blood pressure with ß-

blocker therapy.

➢ Several studies have found that hypertensive patients with

Ser49Arg389 had the greatest reduction in blood pressure with oral

metoprolol.

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BIO ELECTRONIC MEDICINES

INTRODUCTION

➢ Bio-electronic medicine has the potential to be superior to drugs in

terms of efficacy, cost and safety.

➢ Because, it directly modulates the natural language of the body’s

nervous systems—electrical impulses and action potentials.

DEFINITION

➢ A branch of science that deals with electronic control of physiological

function especially as applied medicine to compensate for defects of

the nervous system.

➢ Bio electronic medicines are ‘A tiny implanted device treating disease

by changing the electric pulses in nerves to and from specific organs’.
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HOW DOES BIO-ELECTRONIC MEDICINE
WORK?

➢ Consider that virtually all the cells in the body are directly or

indirectly controlled by neural input and that peripheral neural

circuits play a pivotal role in maintaining homeostasis.

➢ Physiological and molecular changes in the body are sensed and

informed to the central nervous system by the peripheral sensory

neural circuits , which in turn activates a motor response reinstating

the homeostasis in the target tissue.

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Cont…

➢ Neural signals mediating information about the biological activity of

each cell are transmitted.

➢ As electric information in the form of action potentials traveling

along axonal fibers to and from the innervated tissues and organs.

➢ Use of bio-electronic devices in a broad spectrum of disorders,

including traumatic brain injury, stroke, neurodegenerative disorders,

gastro – intestinal disorders, hemorrhage and inflammatory diseases.

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APPLICATIONS OF BIOELECTRONICS
➢ There are wide applications for bioelectronics as known till this day

and many more which are still to be invented to implement painless

cure in medical science…

PACEMAKERS

➢ Also called artificial pacemakers, have been a boon to patients by regulating

their heart beats.

➢ A pacemaker consists of a battery, a computerized generator, and

wires with sensors at their tips. (The sensors are called electrodes.)

➢ The battery powers the generator, and both are surrounded by a thin

metal box. The wires connect the generator to the heart.

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Cont…
➢ A pacemaker helps monitor and control the heartbeat.

➢ The electrodes detect the heart’s electrical activity and send data through the

wires to the computer in the generator.

➢ If the heart rhythm is abnormal, the computer will direct the generator to

send electrical pulses to the heart.

➢ The pulses travel through the wires to reach the heart.

➢ Newer pacemakers can monitor blood temperature, breathing, and other

factors.

➢ The pacemaker’s computer also records the heart’s electrical activity and

heart rhythm, doctor will use these recordings to adjust the pacemaker so it

works better for patient.

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BLOOD GLUCOSE METER

➢ A blood glucose meter is an electronic device for measuring the

blood glucose level.

➢ A relatively small drop of blood is placed on a disposable test strip

which interfaces with a digital meter.

➢ Within several seconds, the level of blood glucose will be shown on

the digital display.

➢ The ingredients of a typical test strip are as follows:

➢ 29% w/w glucose oxidase (from Aspergillus niger, a fungus), 20U/mg

➢ 32%w/w potassium ferriccyanide

➢ 39% w/w nonreactive ingredients

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Cont…

➢ On each strip, there are about 10 layers, including a stiff plastic base

plate, and other layers containing chemicals or acting as spacers.

➢ For instance, there is a layer containing two electrodes (silver or

other similar metal).

➢ There also is a layer of the immobilized enzyme, glucose oxidase,

and another layer containing microcrystalline potassium ferricyanide,

[K3Fe(CN)6].

➢ These layers are suitably separated by the spacers to allow a small

amount of blood to enter.

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Cont…

➢ When the end of a strip is touched to a droplet of blood (usually on a

fingertip), the blood flows in by capillary action.

➢ A digital display on the screen “counts down” the seconds till the

concentration of glucose is displayed.

CHEMICAL REACTION OF THE GLUCOSE SENSOR:

➢ The glucose in the blood sample reacts with the glucose oxidase to

form gluconic acid, which then reacts with ferricyanide to form

ferrocyanide.

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Cont…

➢ The electrode oxidizes the ferrocyanide, and this generates a current

directly proportional to the glucose concentration.

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3D PRINTING OF PHARMACEUTICALS

INTRODUCTION:

➢ Powder-liquid three-dimensional printing (3DP) 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.

➢ 3D printing is expected to modernize medicine.

➢ The first 3D printed pill, an anti-epilepsy drug called Spritam, was

approved by the FDA.

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DEFINITION

➢ Three-dimensional (3D) printing is a manufacturing method in which

objects are made by fusing or depositing materials in layers to

produce a 3D object.

➢ This process involves 3D prototyping of layer by layer fabrication

(via Computer Aided Design- CAD) to formulate drug materials into

the desired dosage form.

➢ This process is also referred to as additive manufacturing (AM),

rapid prototyping (RP), or solid free-form technology.

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ADVANTAGES OF 3D PRINTING

➢Designing simple, cheap

➢Accurate, flexible

➢High production rates

➢Reduction of material wastages

➢Ability to achieve high drug loading (up to 1,000 mg) with much

desired precision and accuracy.

➢Applicable to broad types of pharmaceutical active ingredients

including poorly water soluble, peptides and proteins, as well as drug

with therapeutic narrow window.

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TYPES OF 3D PRINTING

Fabrication of 3D objects can be achieved through a number of
techniques,

➢ Inkjet based fabrication

➢ Laser based writing system

➢ zip dose

➢ Fused deposition modeling

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INKJET BASED FABRICATION

➢ Different combinations of active ingredients and excipients (ink) are

precisely sprayed in small droplets (via drug on demand) or

continuous jet method in varying sizes layer by layer into a non-

powder substrate.

➢ Powder based 3D printing that uses a powder substrate for the sprayed

ink, it solidifies into a solid dosage form.

➢ Ex: levofloxacin implants, acetaminophen tablet

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LASER BASED WRITING SYSTEM

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 Based on the principle of photo-polymerisation, in
which the free radicals are released after the photo
initiator and UV light.

 UV light is aided by baffles, axes x and y, to traverse
the surface of liquid resin, in order to accurately
represent the 3D model.

 When a layer solidifies, the lifting platform descends
its position to the height of a new layer of liquid resin,
again beginning the procedure, until the manufacture
of the 3D product is finished in a layer by layer way.

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ZIP DOSE

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ZIP DOSE

➢ Aprecia developed the zipdose platform, which is designed to enable
delivery of high dose medications in a rapidly disintegrating form.

➢ It produces a product layer by layer without using compression forces,
punches or dies.

➢ First, a powder blend is deposited as a single layer. Then an aqueous

binding fluid is applied and interaction between the powder and
liquid bind these material together.

➢ This process is repeated several times to produce solid, yet highly
porous formulations, even at high dose loading.

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FUSED DEPOSITION MODELING

➢ The polymer of interest is melted and extruded through a movable

heated nozzle.

➢ The layer by layer ejection of the polymer is repeated along x-y-z

stage, followed by solidification to create a shape previously defined

by the CAD models.

➢ This process can be applied multiple dosage forms that apply

polymers as part of the framework such as implants, zero order

release tablets, multilayered tablets and fast dissolving devices.

➢ EX: 5-amino salicylic acid tablet

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Cont…

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MEDICAL APPLICATIONS OF 3D

PRINTING

The current medical uses of 3D printing can be organized into

several categories,

➢ Tissues and organ fabrication

➢ Creating prosthetics, implants

➢ Pharmaceutical research concerning drug discovery, delivery and

dosage forms.

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TELEPHARMACY

INTRODUCTION

➢ Rural communities have always had difficulty in recruiting health

professionals.

➢ It will be difficult to introduce the pharmacist activities into rural and

remote area, given the shortage of pharmacists.

➢ Indeed, the shortage in these areas has often resulted in the role of

providing pharmacy services to rural and remote communities being

shifted to doctors, nurses, indigenous and other healthcare workers.

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Cont…

➢ Tele-pharmacy delivers clinical pharmacy services and the

dispensing of a prescription at a remote location without the physical

presence of a pharmacist.

➢ Telepharmacy acts as a potential alternative to around-the clock on-

site pharmacist medication review for remote hospitals.

➢ This has been adopted by many healthcare institutions where 24-

hours pharmacy services are not available.

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➢ The topic of telepharmacy was first introduced at the January 35,

2000, at the North Dakota State Board of Pharmacy .

DEFINITION

➢ The National Association of Boards of Pharmacy defines as

“Telepharmacy that the provision of pharmaceutical care to patients

at a distance through the use of telecommunications and information

technologies”.

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CLINICAL BENEFITS OF TELEPHARMACY

➢Easy access to healthcare services

➢Economic benefits – one skilled pharmacist for multiple

sites

➢Patient satisfaction- Missing their appointments, they

didn’t want to go out of their home

➢Effective patient counselling – through webcam they

provide better privacy and longer duration of counselling.

➢Minimal scarcity of pharmacists – It addresses pharmacist

shortage in rural areas and improves patient access to

pharmacy services.
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DISADVANTAGES
 More time, effort and money – Hardware, Software,

Connectivity and Operational cost
 Security – Handling of privacy information about

patients
 Reluctance to use technology
 Continuity of care
 Operational difficulties – limited high speed digital

connection

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HOW DOES TELEPHARMACY WORK?

Nurse/Healthcare professionals
(Patient prescription by fax)

Central pharmacist
(reviews & releases the appropriate items)

Nurse
(scans the bar code & verify the label)

Central pharmacist can visually monitor the technician’s work
(to ensure that the right medications have been
filled and dispensed)

Central pharmacist provides a two-way video consultation for the
patient
(to ensure that they understand the intended medication

use and administration)

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TYPES OF TELEPHARMACY MODELS

REMOTE CONSULTATION SITES:

➢ Prescriptions are prepared at the central pharmacy and are delivered

to the rural sites.

➢ Audio and video computer links are used to deliver patient counseling and

education.

HOSPITAL TELEPHARMACY

 Hospital pharmacist in urban reviews processes and verifies the

prescription that are issued and electronically sent from rural

hospitals.

 Using ADM delivers drugs and at the rural end , Nurses double

checks the label and deliver to patients.

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ADMS (AUTO DISPENSING MECHINES):

➢ ADM or automated drug storage and dispensing device used in the

health care settings like hospitals and nursing home.

➢ Pharmacist at a central location upon receiving drug order

(electronically or by fax).

➢ confirms the patient profile.

➢ conducts proper drug utilization review, and finally instructs the

ADM to release the medication with the help of audio and video

computer links, patient counseling is then conducted.

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REFERENCES
➢Chart Pack value of Personalized Medicine Spring 2015

➢ Telepharmacy: a pharmacist’s perspective on the clinical benefits and

challenges published in Integrated Pharmacy Research and Practice

➢ www.ncbi.nlm.nih.gov.in

➢ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1885075

➢http://www.medscape.com/viewarticle/590270

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Cont…

➢The future of dosage form: a brief review published in

world journal of pharmaceutical research.

➢Applications of 3D Printing in BioMedical Engineering

PPT by Debanjan Parbat, School of Bioscience &

Engineering, Jadavpur University, Kolkata-32

➢Pharmacogenetics by Dr.Sourav Chakrabarty

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