This document provides an overview of personalized medicines and various approaches related to personalized drug delivery. It discusses several key points: 1) Personalized medicine aims to integrate a patient's genetic information to select the most appropriate preventative measures or therapies tailored to that individual. 2) New technologies like custom drug delivery systems, 3D printing, and telepharmacy can help develop personalized treatments by optimizing drug efficacy and minimizing side effects. 3) Pharmacogenomics plays an important role in personalized medicine by using genetic data to inform drug development and identify responders, non-responders, and optimal dosages for individuals.

1. DOSAGE FORMS OF PERSONALISED MEDICINES
Under the Guidance of
Dr. H.N Shivkumar
KLE college of pharmacy
Bangalore. Pin-560061.
By Subham Roy
M.Pharma
Department of Pharmaceutics.

2. CONTENTS
(A)Personalised Medicines:-
1) Dosage forms for Personalised Medicines.
2) Categories for patients Personalised medicines.
(B) Customised drug delivery system.
(C) 3D printing of pharmaceuticals.
(D) Telepharmacy.
(E) Bioelectic Medicines.

3. INTRODUCTION.
• Personalized medicine also referred as precision medicine holds great promise to
improve health care.
• According to the "National Cancer Institute “ personalized medicine integrates
information about person's genes, proteins, diagnosis and treat disease.
• It is the form of medicine that uses information from patient's genotype to; Initiate a
preventative measure against the development of disease or condition.
• Select the most appropriate therapy for a disease or condition that is suited to that
patient.
•The concept of personalized medicine dates back many hundreds of years.•
Developments in chemistry, histochemistry and microscopy allowed scientists to
begin to understand the underlying causes of disease.
• Sequencing of the human genome at the turn of the 21st century set in motion the
transformation of personalized medicine from an idea to practice.

4. ASSOCIATED DEFINATIONS
• Genomics- Study of the entire set of genetic instructions found in a cell
(DNA).
• Pharmacogenomics (PGx)- It is a branch of pharmacology concerned with
using DNA and amino acid and sequence data to inform drug development
and testing.
•
• Application of genomics to study human variability in drug response.
• Pharmacogenetics (PGt)- The study or clinical testing of genetic variation
that assists in individual patient's differentiation response to drugs.
• Effect of genetic variation on drug response.
• PGx and PGt are expected to play important role in development of better
medicines with improved benefits/risk ratio for individuals.

5. DEFINATION OF PERSONALISED
MEDICINES.
•Personalized medicine is defined as of medical treatment to the
individual characteristics of each patient that not only improves
our ability to diagnose and treat disease, but also offers the
potential to detect disease at an earlier stage and to treat it
effectively.
•Understanding human genome.
•Simpler methods identify genetic information .
•Genetic information specific to individual.
•Preselect the effective drug.
•No toxicity ,less trial & error.

6. NEEDS FOR PERSONALISED MEDICINES
•Similar symptoms but different illness.
•Medical interventions may work in some people but not in
others.
•40% of drugs that are taken are not effective.
•Advances in genomics helps to treat a patient precisely and
effectively .
•To avoid any allergic and adverse effect.

7. PHARMACOGENOMICS
•Pharmacogenomics can play an important role in identifying
responders and non-responders to medications, avoiding adverse
events, and optimizing drug dose.
• Pharmacogenomics is the field of study & examines impact of
genetic variation & drug responses via biomarkers.
• Personalized Medicine utilizes the biomarkers, which are simply
genes and proteins that can be measured to diagnose diseases.
•Pharmacogenomics shows how genes determine individual
variability to drug response.
•Pharmacists would easily predict how a patient may respond to
drug, with the help of a genetic test before prescribing a drug.

8. GOALS-
•Optimizing proper drug therapy, dosage for patients -
increasing efficacy & safety.
• Other benefits are by monitoring biomarkers - reduces
time, cost & failure rates in clinical trials in developing
new medications and increases opportunities to develop
novel therapeutics.
•Example: Genotyping variants of Cytochrome P450
involved in metabolism of warfarin.

9. ADVANTAGES OF
PHARMACOGENOMICS.
•To predict a patient's response to drugs.
•To develop "customized" prescriptions.
•To minimize or eliminate adverse events.
•To improve efficacy and patient compliance.
•To improve rational drug development.
•Pharmacogenetics test need only be conducted once during the life
time.
•To improve the accuracy of determining appropriate dosage of
drugs to screen and monitor certain diseases.
•To develop more powerful, safer vaccines.
•To allow improvements in drug discovery and development.

10. PHARMACOGENTICS
•PHARMACOGENETICS = Pharma and genetics
•Pharma the Greek word i.e. PHARMACON, related to Drugs.
•Genetics related to genes / genome.
•The study of the genetic basis for variation in drug response
VARIATIONS.
•Single mutant gene- Genetic Polymorphism
•Polygenic influences

11. GENETIC POLYMORPHISM.
•When a nucleotide change is very rare, and not present in many individuals, it is often called
a mutation.
•In contrast to mutation, genetic polymorphism are usually consider normal variants in
population. When a specific allele occur in at least 1% of the population, it is said to be
genetic polymorphism.
• Allele -Each of two or more alternative form of a gene that arise by mutation and are found
at the same place on chromosome.
• Types of Polymorphisms Single Nucleotide Polymorphisms (SNPs) -single base change in
DNA
AAGCCTA
AAGCTTA
• SNPs arise as a consequence of mistake during normal DNA replication
• Insertion/Deletion:
AAGCCTTAAG
AAGCC( )AAG

13. POLYGENIC INFLUENCES.
Polygenic influences and environmental factor are responsible for normal biological
variations.
VARIATIONS EXAMPLES
• VARIATIONS - Acetylation, fast
•EFFECTS - Needs for higher or more frequent doses of drugs that are more aceylated (e.g.,
isoniazid) to produce the desired therapeutic response.
•VARIATIONS - Acetylation, Slow(drug Personalized medicine inactivation by hepatic N-
acetyl transferase).
• EFFECT - Increased susceptibility to adverse effect of drug that are aceylated (e.g. with
isoniazid, peripheral neuropathy).
•VARIATIONS- G6PD deficiency
•EFFECT-With use of oxidant drugs, such as certain antimalarials (e.g. chloroquine,
primaquine) increased risk of haemolytic anemia.
•VARIATIONS- Genetic polymorphisms of CYP2C9 and vitamin k epoxide reductase
• EFFECT - Increased action of warfarin, increased risk of bleeding.

14. CATEGORIES OF PETIENT’S FOR PERSONALISED
MEDICINES.
•Patients are mainly classified depending upon the genetic polymorphism.
•Cytochrome P450 genetic polymorphism.
•Different families of enzymes polymorphism.
•Focusing on genomics, we have identified three categories:-
• (A)Optimizing drug response: gene-drug interactions-
• A person's genetic constitution can be determined in order to address gene-drug
interactions. The aim is to optimize drug efficacy and to minimize adverse events
from drug treatment.
•Applications include genetics-based and genomics based tests that commonly target
medicines that are administered to populations with a specific gene variant.
•In gene-drug interactions, the focus is directed to either metabolism genes or genes
related to the immune system.

15. •(B) Gene-based drug targeting:-
• Another area of individualization is the development of
molecular mechanism specific treatment, also called gene-
based drug targeting.
• Most research efforts are seen in the field of oncology
(somatic variations) and increasing attention is being paid
to genetically based diseases, such as Cystic Fibrosis.
•Apart from this, many research efforts are undertaken in
disease areas in which there is a significant genetic
association with the disease, as in the case with the
VKORC1 gene in thrombosis patients.

16. •(C) Prediction and diagnosis:-
•Lastly, individualization efforts are undertaken to
• Diagnose more accurately (detailed disease characterization or
diagnosis of hereditary diseases that are not well-understood yet)
•Predict risk of disease
•These efforts provide greater insight into a patient's
constitution, contributing to a better diagnosis.

17. •Diabetes:-
•Diabetes also concerns a large patient group.
•While diabetes is divided into two clinical categories (type I and type
II), there are at least 27 single gene mutation sub-types of diabetes
that have been identified.
•The genetic make-up determines the clinical categorization which
has been shown for several genes that cause of the syndrome
designated as maturity onset diabetes of the young (MODY).
•MODY patients with specific mutations often have high sensitivity to
sulfonylurea's (e.g. Glipizide).
•Treatment of these patients could be improved by changing the
insulin regimen into a sulfonylurea's therapy.

18. •Asthma:-
•Inhaled ẞ2-adrenergic (e.g. Salbutamol) and corticosteroids (e.g.,
Beclomethasone) is the cornerstone of asthma treatment.
•One of the characteristics of asthma is resistance or reduced
responsiveness to treatment.
•Until now, pharmacogenetic studies have mainly concerned the
ẞ2-adrenegic receptor gene.
•Additional research is needed in order to evaluate the clinical
utility of genomic testing.

19. CUSTOMISED DRUG DELIVERY
SYSTEM
•Customized drug delivery, also termed personalized medicine, is a
medical procedure that separates patients into different groups-with
medical decisions, practices, interventions and/or products to the
individual patient based on their predicted response or risk of disease.
•The terms personalized medicine contains P4 medicines.
•The Person:-
• Their DNA.
•Exposure to environmental factors.
•Types and amount of stress they experiences.
•What they eat.

20. BENEFITS.
•Better matching patients to drugs instead of "trial and error".
•Customized pharmaceuticals may eliminate life threatening
adverse reactions.
•Reduce costs of clinical trials by .
•Quickly identifying total failures.
•Favorable responses for particular backgrounds.
•Improved efficacy of drugs.

21. •DNA POLYMORPHISMS:-
•It is the natural variations in our genes that plays a role in risk of
getting or not getting certain diseases.
•The combination of these variations across several genes affects
each individual's risk.
•SNPS-a major source of variation-
•Single Nucleotide Polymorphisms (SNPs).
•Single base change in DNA.
AAGCCTA
AAGCTTA.
•SNPs arise as a consequence of mistakes during normal DNA
replication.
•Average frequency 1/1000bp Other sources of variation are-
•Insertions, deletions, translocation, duplications.

23. 3D PRINTING IN PHARMACEUTICALS.
•3D printing is layer by layer production of 3D objects from digital
design.
•It include wide variety of manufacturing technologies which are all
based on digitally controlled depositing of materials to create free-form
geometries.
•This methods extensively used in field of bio-manufacturing (specially
for bone and tissue-engineering).
•It became a standard tool in automotive, aerospace and consumer
goods industries.
•More recently 3D printing has gained traction in pharmaceutical
manufacturing illustrated by FDA approval of 3D printed drug product
in August 2015.
•It can be used for customized drug delivery system.

24. •Advantages and Applications of 3D Printing in Pharmaceutical
Drug Delivery:-
•(a) High production rates due to its fast operating systems.
•(b) Ability to achieve high drug-loading with much desired
precision & accuracy especially for potent drugs that are applied
in small doses.
•(c) Reduction of material wastage which can save the cost of
production.
•(d) An ability to broad types of pharmaceutical active ingredients
including poorly water-soluble, peptides and proteins, as well as
drug with narrow therapeutic windows.

25. •Current 3D printing technologies in pharmaceutical drug delivery:-
•1.Inkjet printing
•2.Zip dose
•3.Thermal inkjet printing.
•4.Fused deposition modeling
•1. Inkjet- printing:-Powder is used as substrate for spreading ink which solidifies into
solid dosage form.

26. •2.Zip- dose:- Provide a personalized dose in addition to delivery of high drug loaded with
high disintegration and dissolution levels by manufacturing highly porous material.
3.Thermal ink-jet 4.Fused depositing model.

27. TELEPHARMACY.
•Telepharmacy is the delivery of pharmaceutical care via
telecommunications to patients in locations where they may not have
direct contact with a pharmacist.
•It is an instance of the wider phenomenon of telemedicine, as
implemented in the field of pharmacy.
•PURPOSE AND SCOPE-
• In order to maintain or make pharmacy services available in areas
that have lost their pharmacy or are in failure of losing their
pharmacy, rules are necessary to permit telepharmacies.

28. OPERATIONS IN TELEPHARMACY.
• The remote site is considered to be under the personal charge of
the pharmacist at the central pharmacy.-A remote site shall be
connected to its central pharmacy via computer link, video link &
audio link.
•A remote site should use its central pharmacy's processing unit.
•A pharmacist at the central pharmacy must approve each
prescription before it leaves the remote site.
•Counseling must be done by a pharmacist via video and audio
link. The pharmacist must counsel the patient or the patient's agent
on all new prescriptions and refills.
•A pharmacist must complete monthly inspections of the remote
site.
•Inspection reports must be included in the policies and procedures
for the site.
•The inspection reports must be maintained until the next Board of
Pharmacy Inspection.

29. •There are 4 types of telepharmacies:-
•1.Inpatient (remote order-entry review)
•2. Remote dispensing (retail/outpatient/discharge).
•3.IV admixtures.
• 4.Remote counseling.

30. •1) Inpatient (remote order-entry review).
•Definition-
•Inpatient Telepharmacy 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 Telepharmacy as
it allows for real-time medication order review and verification.
•With inpatient Telepharmacy, remote pharmacists are able to provide
24/7 coverage hours to help supplement and strengthen the inpatient
pharmacy.

31. •2) Remote dispensing (retail/outpatient/discharge).
•Definition-
• A remote-dispensing site, or retail community Telepharmacy, 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-
•It is used in retail community pharmacy and outpatient/
discharge pharmacy settings, Telepharmacy gives patients
convenient access to a pharmacist and prescription medication.
•Telepharmacy works to reduce readmission rates by improving
patient adherence, helps improve financial performance and
creates a better patient experience.

32. •3) IV admixture-
•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
Telepharmacy in the IV-admixture clean room, they save the time
needed to suit up and enter the clean room to review the solution.
• Freeing up pharmacists time allows them to focus on clinical
activities.

33. •4) Remote counseling-
•Definition-
•Remote-patient counseling equates to pharmacists providing
patient counseling and interactive video session, or by some
means through telecommunications.
•Uses-
•Remote-patient counseling 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
counseling also provides opportunities for specialty counseling,
discharge counseling and various clinical interactions with
pharmacists.

34. • Advantages:-
• 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.
• Disadvantages:-
•Complexity and function variation .
•Requires additional staff training and technical help.
•Downtime system failure and inflexibility.
•Cost and space issues.

35. BIO-ELECTRIC MEDICINES.
•Bioelectric medicine is an instrument, apparatus,
implement, machine, implant, in vitro reagent or
other similar or related article, including a component
part.
•Bio-electronic Medicine focuses on electrical
signaling in the nervous system. Insights into the
regulatory functions of the nervous system and
technologies that record, stimulate, or block neural
signaling to affect specific molecular mechanisms are
the primary focus of the journal.

36. BIO-SENSORS.
It is a sensor that integrates a biological element with a
physiochemical transducer to produce an electronic
signal proportional to a single analyte which is then
conveyed to a detector.
Examples- Pregnancy test sensors.
Glucose monitoring sensors.

39. WORKING PRINCIPLE:-
•Analyte diffuses from the solution to the surface of the
Biosensor.
•Analyte reacts specifically & efficiently with the Biological
Component of the Biosensor.
•This reaction changes the physicochemical properties of the
Transducer surface.
•This leads to a change in the optical/electronic properties of
the Transducer Surface.
•The change in the optical/electronic properties is
measured/converted into electrical signal, which is detected.

41. ADVANTAGES OF BIO-SENSOR
1. Highly Specific.
2. Independent of Factors like stirring, pH,
etc.
3. Linear response, Tiny & Biocompatible.•
Easy to Use, Durable.
4. Rapid, Accurate, Stable & Sterilizable.

42. APPLICATIONS
•Food Analysis.
•Study of Bio-molecules & their Interaction.
•Drug Development
•Crime Detection.
•Medical Diagnosis (Clin & Lab).
•Environmental Field Monitoring.
•Quality Control.
•Industrial Process Control.
•Detection Systems for Biological Warfare Agents.
•Manufacture of Pharmaceuticals & Replacement
organs.

43. •REFERENCES-
•US food and administration. Paving the way for personalized
medicine.
• Kevin J Tracey 'Molecular Mechanism of Bioelectrical Medicine.
• 3D printing technology in pharmaceutical drug delivery .
•Three dimensional printing in pharmaceutics.
•Personalized medicine-NCBI-NIH.