SR/CR formulations

1. Presented By : Facilitated To:
Sachin.J.Gaddimath Dr. Anita Desai
M.Pharm 1st year HOD and Professor
Dept. of Pharmaceutics Dept. of Pharmaceutics
HSKCOP, BAGALKOT. HSKCOP, BAGALKOT
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2. CONTENTS
 Personalized medicine.
1) Dosage forms for personalized medicine.
2) Categories of patients for personalized medicine.
 Customized drug delivery systems.
 3D printing of pharmaceuticals.
 Telepharmacy.
 Bioelectric Medicines
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3. DOSAGE FORMS FOR PERSONALIZED MEDICINE:
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.
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4. Definition:
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
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 effective drug
No
toxicity
Less trial &
error
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5. Associated Definitions:
1. Genomics- Study of the entire set of genetic instructions
found in a cell (DNA)
2. 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.
3. 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.
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6. Pharmacogenomics:
 The study of how genes affect a person’s response to
drugs.
PHARMACOLOGY
(Science of Drugs)
GENOMICS
(Study of genes and
their functions)
PHARMACOGENOMICS
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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.
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8. Pharmacogenomics Goals are:
1. Optimizing proper drug therapy, dosage for patients –
increasing efficacy & safety.
2. 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.
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9. 9

10.  Drug Response: Environmental factors and genetic
factors.
• Pharmacogenetic disorders (ex: plasma cholinesterase
deficiency, drug acetylation deficiency)
• Pharmacogenomic tests: ex: (Tests for variations in
(HLA) genes)
• Genes influencing drug metabolism.
• Drug targets such as the epidermal growth factor
receptor HER2, tyrosine kinase inhibitors and the
main target for warfarin is vitamin K epoxide reductase
(VKOR).
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11.  Pharmacogenetics:
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12. 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.
 Pharmacogenetic 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.
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13. PHARMACOGENETICS IN CLINICAL PRACTICE:
• The development has been slowed by various scientific,
commercial, political and educational barriers.
 3 major types of evidence that should accumulate in
order to implicate a polymorphism in clinical care.
1) Screens of tissues from multiple humans linking the
polymorphism to a trait;
2) Complementary preclinical functional studies
indicating that the polymorphism is linked with the
phenotype;
3) Multiple supportive clinical phenotype/genotype
studies
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14. CATEGORIES OF PATIENTS FOR PERSONALISED
MEDICINE:
 Patients are mainly classified depending upon the
genetic polymorphism:
 Cytochrome p450 genetic polymorphism.
 Different families of enzymes polymorphism.
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15. Focusing on genomics, we have identified three
categories:
1) 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.
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16. 2) 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.
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17. 3) Prediction and diagnosis:
 Lastly, individualization efforts are undertaken to
 1. Diagnose more accurately (detailed disease
characterization or diagnosis of hereditary diseases
that are not well-understood yet)
 2. Predict risk of disease
 3. These efforts provide greater insight into a patient’s
constitution, contributing to a better diagnosis.
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18. Asthma:
 Inhaled β2-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 β2-adrenegic receptor gene. Additional
research is needed in order to evaluate the clinical
utility of genomic testing.
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19. 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
subtypes 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.
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20. CUSTOMIZED DRUG DELIVERY SYSTEMS:
 INTRODUCTION
 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
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21. 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.
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22. 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
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23. Most common
SNP
Deletion
Insertion
Translocation
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24. 3D printing in pharmaceuticals
 Introduction:
 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
biomanufacturing (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

25. Advantages and Applications of 3DP 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.
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26. Current 3D printing technologies in
pharmaceutical drug delivery:
1. Inkjet printing
2. Zip dose
3. Thermal inkjet printing
4. Fused deposition modeling
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27. 1) Inkjet printing:
 Powder is used as substrate for spreading ink which
solidifies into solid dosage form.
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28. 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.
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29. 3) Thermal inkjet printing:
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30. 4) Fused depositing modeling:
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31.  Examples of pharmaceutical formulation that
were developed using 3D technology:
3Dprinting Technology Dosage form Active pharmaceutical
ingredients
Inkjet 3DP Nanosuspension Folic acid
Inkjet 3DP Implant Levofloxacin
Thermal injecting printer Solution Salbutamol sulphate
3DP extrusion based printing Encapsulated within polymer
(PLGA) (PVA)
Dexamethasone -21-phosphate
disodium salt
Fused depositing model Tablet 5-aminosalysilic acid (5-ASA
mesalazine) and 4-
amionosalysilic acid
Desktop 3D printer Tablet Guaifenesin
Laboratory scale 3D printing
machine
Capsule Pseudoephedrine hydrochloride
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32.  TELEPHARMACY & BIOELECTRIC MEDICINES
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33. Telepharmacy:
 Audio and video
 Still image capture
 Store and forward
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.
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34. OPERATIONS
-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.
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35.  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.
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36. 36

37. There are 4 types of telepharmacies:
1. Inpatient (remote order-entry review)
2. Remote dispensing (retail/outpatient/discharge)
3.IV admixtures
4.Remote counseling
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38. 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.
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39. 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.
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40. 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.
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41. 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.
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42. 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
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43. Disadvantages:
 Complexity and function variation
 Requires additional staff training and technical help
 Downtime system failure and inflexibility
 Cost and space issues
Automated medication dispensing devices:
 Small system
-Pyxis medstation
-Baxter ATC 212 dispensing system.
-SCRIPT-PRO 200
 Larger system
-Baker cells
-Baxter international
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44.  Bioelectric Medicines:
 Bioelectric medicine is an instrument, apparatus,
implement, machine, implant , invitro reagent or
other similar or related article, including a component
part
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45. 45

46. BIOSENSORS:
 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.
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47.  Components:
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49.  Elements of biosensors:
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50. Response
Analysis Signal
Detection
Sample
handling/preparation
Analyte
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51. 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.
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52. Advantages:
 Highly Specific.
 Independent of Factors like stirring, pH, etc.
 Linear response, Tiny & Biocompatible.
 Easy to Use, Durable.
 Rapid, Accurate, Stable & Sterilizable.
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53. Types:
Based on bioreceptors:
1) Enzyme biosensors
2) Microbial biosensors
3) Affinity biosensors
Based on transduser:
1) Potentiometric
2) Amperometric
3) Conductometric
4) Optical
5) Piezoelectric
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54. Applications of Biosensors
 Food Analysis.
 Study of Biomolecules & 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.
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55. REFERENCES
 U.S 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
 Science Direct; THE Faces of personalized medicine
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56. THANK YOU
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