SR and CR

Noida Institute of Engineering and Technology
(Pharmacy Institute) Greater Noida
Sustained Release (SR) and Controlled Release
(CR) Formulations
Swarupanjali Padhi
Asst. Professor(NIET
Pharmacy Institute,
Greater Noida)
30 January 2024
Unit: 1
Swarupanjali Padhi MPH102T Unit 1
DRUG DELIVERY SYSTEMS
(MPH 102T)
( M Pharm 1st Sem)
1

Course of Study for
M. Pharm (Pharmaceutics) Semester - I
30 January 2024 2

UNIT 1:
Sustained Release (SR) and Controlled Release (CR) formulations: Introduction & basic
concepts, advantages/disadvantages, factors influencing, physicochemical & biological
approaches for SR/CR formulation, mechanism of drug delivery from SR/CR formulation.
Polymers: Introduction, definition, classification, properties and application. Dosage forms for
personalized medicine: Introduction, definition, pharmacogenetics, categories of patients for
personalized medicines: Customized drug delivery systems, bioelectronic medicines, 3D
printing of pharmaceuticals. Telepharmacy.
Syllabus
30 January 2024 3

 Course Objectives
 Course Outcomes (COs)
 Programme Outcomes (POs)
 CO PO Mapping
 Prerequisite and Recap
 Introduction
 Sustained Release (SR) and Controlled Release (CR) formulations
 Polymers
 Dosage Forms for Personalized Medicine
30 January 2024
Content
Swarupanjali Padhi MPH102T Unit 1 4

 Summary
 Daily Quiz
 Weekly Assignment
 MCQs
 Old Question Papers of AKTU
 Expected Questions for University Exam
 References and Books
30 January 2024
Content
Swarupanjali Padhi MPH102T Unit 1 5

Upon completion of this unit the students will understand
 About various approaches to develop sustained release and controlled released drug
delivery system.
 Design and develop novel drug delivery system using various types of polymer.
30 January 2024
Course Objective
6

30 January 2024 Swarupanjali Padhi MPH102T Unit 1
Programme Outcomes (POs)
Programme
Outcomes (POs)
Description
PO1 An ability to independently carry out research /investigation and
development work to solve practical problems
PO2 An ability to write and present a substantial technical
report/document
PO3 Students should be able to demonstrate a degree of mastery over
the area as per the
specialization of the program. The mastery should be at a level
higher than the
requirements in the appropriate bachelor program
7

8
Course Outcome
CO Statement Level of Bloom Taxonomy
The students will be able to -
CO1
 Design and develop novel drug delivery
system
L-3 and L-6
30 January 2024

CO PO MAPPING
CO PO1 PO2 PO3
CO1 3 3 3
9

30 January 2024
Swarupanjali Padhi MPH102T
Unit 1
Topic Wise Mapping with CO
Unit Topic Mapping With
CO1
Sustained Release
(SR) and
Controlled Release
(CR) Formulations
Sustained Release
(SR) and
Controlled Release
(CR) Formulations
3
Polymer
3
Dosage Forms for
Personalized
Medicine
3
10

Topic:-Sustained Release (SR) and Controlled Release (CR) Formulations
Objectives: the main objective of this topic are:-
1.Basics concept and definition, terminology used in the sustained release (SR) and
controlled release (CR) formulations
2. Its classification and release mechanism of sustained release (SR) and controlled
release (CR) formulations
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Unit 1
Topic Objective
11

Topic:-Polymer
1.Basics concept and definition of Polymer
2. Its classification and characteristics
30 January 2024
Unit 1
Topic Objective
12
Topic:-Dosage Forms for Personalized Medicine
1.Basics concept and definition of dosage forms for personalized medicine
2. Its classification and characteristics and different types of dosage forms for
personalized medicine

• B.Pharm (Industrial pharmacy )
Prerequisite and Recap
13

 In this unit we will discuss on various physicochemical & biological approaches
for SR/CR formulation
 SR/CR formulation are designed to continuously releasing medication over an
extended period of time after administration of the single dose to get a prolonged
therapeutic effect
 The aim of SR/CR preparation is to control the drug delivery to make certain the
safety and increase efficacy of drug with improved patient compliance
Introduction
14

Sustained Release (SR) and Controlled Release (CR)
formulations
15
Controlled drug delivery
 Delivers the drug at a predetermined rate, for locally or systemically, for a
specified period.
Sustained Release Dosage Form
 Designed to achieve a prolonged therapeutic effect by continuously releasing
medication over an extended period of time usually (8-12 hours )after
administration of the single dose.
Basic concept of CR/SR

Sustained Release (SR) and Controlled
Release (CR) formulations
16
Controlled Release
 Programmed Release
 Timed release
 Repository Dosage Forms
Alternative Expression
Sustained Release
 Prolonged Release
 Extended Release
 Depot Formulations
Alternative Expression of CR/SR

17
Differences Between Sustained and Controlled Drug Delivery System
Sustained release dosage form Controlled release dosage form
Provides medication over extended
period of time
Maintains constant drug levels in
blood or tissue
Generally do not attain zero order
release kinetics (slow first order)
Usually by releasing the drug in a
zero-order pattern.
Usually do not contain mechanisms to
promote localization of the drug at
active site.
Controlled dosage forms contain
methods to promote localization of the
drug at active site.

18
Comparison of Drug Profile(1)

19
Drug Release Profile
Zero Order Release:
Delivery rate remains constant until device is
exhausted of active agent.
First Order Release:
Release is directly proportional to amount of drug
loaded in device.
Higuchi model of release :
release that is linear with reciprocal of square root of
time.

20
Different Order Release Pattern(2)

21
Advantages of Sustained Release Dosage Forms
 Improved patient compliance
 Improved efficiency of treatment
 Better drug utilization
 Bio-availability of certain drugs can be increased
 Increased safety margin of high potency drugs and decreased local and
systemic side effects
 Reduces nursing and hospitalization time

22
Disadvantages of Sustained Release Dosage Form
 Increased variability among dosage units
 Some of the drugs are not having any advantages if they are formulated in
sustained release form
 The physicians having less flexibility in adjusting the dosage regimes( Lack of
dosage flexibility )
 Longer time to achieve therapeutic blood concentrations Increased variation in
bioavailability
 Enhanced first-pass effect
 Dose-dumping
 Sustained concentration in overdose cases.
 Greater expense
 Need for additional patient education Eg : “Do not chew or crush the dosage
form, swallow fully”

formulations
23
Factors to be Considered for Design
Development path
Medical rationale
 Biological factors
Selection of drug candidate physico -chemical properties
 In vitro analysis formulation optimization
In vivo data generation (BA / BE and / or CT)
 Discussion with regulatory authorities
Data submission to regulatory authorities for marketing
authorization / approval.

30 January 2024 Swarupanjali Padhi MPH102T Unit 1 24
Medical Rationale
 Frequency of dosing
 Patient compliance
 Drug intake
 Fluctuation of serum concentration reduced side effect
 Sustained efficacy
formulations

Biological Factors
 Absorption
 Absorption Window
 Distribution
 Metabolism
 Dose Dependent
 Bio-Availability
 Drug -Protein Binding
 Therapeutic Index
 Duration of Action (Half – life)
 Margin of Safety (NTI – Digoxin )
 Circadian Rhythm (ISMN, Theophylline , Nicotinic acid etc.)
formulations

Physico -Chemical Properties
 Molecular Size and Diffusivity
 Aqueous Solubility
 pKa - Ionization Constant
 Partition Coefficient
 Stability
 Protein Binding
formulations

Pharmacokinetic and Pharmacodynamic
 Considerations Dose Dumping
 First Pass metabolism
 Enzyme Induction/Inhibition upon multiple dosing
 Variability of urinary pH effect on drug elimination Prolonged drug absorption
 Variability in GI Empting and motility
formulations

Different Approaches for SR/CR Formulations:
 Chemical approach
 Biological approach
 Pharmaceutical approach
formulations

Chemical Approach:
It involves alteration of physical/ chemical properties of the drug
Complexation DC (solid) DC (solution) Absorption Ex: Drug+ ß-
CycloDextrin
Drug adsorbate Ad (solid) D Absorption Ex: acetaminophen+ glass
adsorbate
Prodrugs PD solid PD solution PD plasma Elimination Ex: Levodopa ,
Carbidopa .
formulations

Biological Approach
Alteration of metabolic rate: carbidopa to prevent the metabolism of l- dopa
Alteration of elimination rate: probencid to prevent tubular secretion of
penicillin
formulations

Pharmaceutical Approach
 Dissolution controlled release system
• Drug polymer matrix formulation
• Encapsulation
 Diffusion controlled release system
• Reservoir device
• Matrix device
 Bio-erodible and combination of diffusion and dissolution system
 Ion- exchange resin-drug complex
formulations

Mechanism of Drug Delivery From SR/CR Formulation
1. Dissolution :
 Matrix
 Encapsulation
2. Diffusion :
• Matrix
• Reservoir
3. Combination of both dissolution & diffusion.
4. Osmotic pressure-controlled system
formulations

Dissolution
 Solid substances solubilizes in a given solvent.
 Mass transfer from solid to liquid.
 Rate determining step: Diffusion from solid to liquid.
 Several theories to explain dissolution –
• Diffusion layer theory (imp)
• Surface renewal theory
• Limited solvation theory.
formulations

Noyes Whitney Equation
dc/dt = kD.A (Cs – C )
dc/dt = D/h A. (Cs – C)
dc/dt = Dissolution rate,
k= Dissolution rate constant (1st order).
D = Diffusion coefficient/diffusivity
Cs = Saturation/ maximum drug solubility.
C = Conc. Of drug in bulk solution.
Cs-C= concentration gradient.
h =Thickness of diffusion layer
formulations

Matrix Type (3)
 Also called as Monolith dissolution controlled system.
 Controlled dissolution by:
• Altering porosity of tablet.
• Decreasing its wettebility.
• Dissolving at slower rate.
 First order drug release.
 Drug release determined by dissolution rate of polymer.
 Examples: Dimetane extencaps, Dimetapp extentabs.
formulations

Encapsulation(3)
 Called as Coating dissolution controlled system.
 Dissolution rate of coat depends upon stability & thickness of
coating.
 Masks colour, odour, taste, minimising GI irritation.
 One of the microencapsulation method is used. coat
 Examples: Ornade spansules, Chlortrimeton Repetabs
formulations

Diffusion
 Major process for absorption.
 No energy required.
 Drug molecules diffuse from a region of higher concentration to lower
concentration until equilibrium is attained.
 Directly proportional to the concentration gradient across the membrane.
formulations

Matrix Diffusion Types
 Rigid Matrix Diffusion
Materials used are insoluble plastics such as PVP & fatty acids.
 Swellable Matrix Diffusion
 Also called as Glassy hydrogels. Popular for sustaining the
release of highly water soluble drugs.
 Materials used are hydrophilic gums.
Examples : Natural- Guar gum, Tragacanth. Semisynthetic -HPMC,
CMC, Xanthum gum. Synthetic -Polyacrilamides.
 Examples: Glucotrol XL, Procardia XL
formulations

Matrix Diffusion Types(3)
formulations

Matrix System
Higuchi Equation
Q = DE/T (2A.E Cs)Cs.t)1/2
Where , Q=amt of drug release per unit surface area at time t.
D=diffusion coefficient of drug in the release medium.
E=porosity of matrix.
Cs=solubility of drug in release medium.
T=tortuosity of matrix.
A=concentration of drug present in matrix per unit volume.
formulations

Reservoir System
 Also called as Laminated matrix device.
 Hollow system containing an inner core surrounded in water insoluble
membrane.
 Polymer can be applied by coating or micro encapsulation.
 Rate controlling mechanism - partitioning into membrane with subsequent
release into surrounding fluid by diffusion.
 Commonly used polymers - HPC, ethyl cellulose & polyvinyl acetate.
 Examples: Nico-400, Nitro-Bid
formulations

Reservoir System(3)
formulations

Dissolution & Diffusion Controlled Release System(3)
 Drug encased in a partially soluble membrane.
 Pores are created due to dissolution Insoluble
membrane of parts of membrane.
 It permits entry of aqueous medium dissolution
into core & drug dissolution.
 Diffusion of dissolved drug out of Drug system.
 Ex- Ethyl cellulose & PVP mixture Pore created by dissolves in water & create
pores of dissolution of insoluble ethyl cellulose membrane.
formulations

Osmotic Pressure Controlled System
 Provides zero order release
 Drug may be osmotically active, or combined with an osmotically active salt
(e.g., NaCl).
 Semipermeable membrane usually made from cellulose acetate.
 More suitable for hydrophilic drug.
Examples: Glucotrol XL, Procardia XL
formulations

Osmotic Pressure Controlled System
Equation (Q/t) z = Pw Am/ hm (πs-πe )
(Q/t)= Rate of zero order drug release.
Pw, Am & hm= water permeability, effective surface area & thickness of
semipermeable membrane.
πs= osmotic pressure of saturated solution of osmotically active drug or salt in
system.
πe = osmotic pressure of GI fluid
formulations

Osmotic Pressure Controlled System(3)
formulations

Polymers
48
Polymers are long chain giant organic molecules are assembled from many smaller
molecules called monomers. Polymers consist of many repeating monomer units in
long chains. A polymer is analogous to a necklace made from many small beads
(monomers)
Definition of Polymer

Polymers
49
Classification of Polymers(4)

Polymers
50
Properties of Polymers
The physical properties of a polymer, such as its strength and flexibility depend on:
 Chain length - in general, the longer the chains the stronger the polymer;
 Side groups - polar side groups give stronger attraction between polymer chains, making the
polymer stronger;
 Branching - straight, unbranched chains can pack together more closely than highly branched
chains, giving polymers that are more crystalline and therefore stronger;
 Cross-linking - if polymer chains are linked together extensively by covalent bonds, the
polymer is harder and more difficult to melt.

Polymers
51
Strength of Polymers
In general, the longer the polymer chain, the stronger the polymer.
 There are two reasons for this
• Longer chains are more tangled
• There are more intermolecular forces between the chains because there are more points
of contact.
 These forces, however, are quite weak for polyethene.
 Areas in a polymer where the chains are closely packed in a regular way are said to be
crystalline .
 The percentage of crystallinity in a polymer is very important in determining its properties.
 The more crystalline the polymer, the stronger and less flexible it becomes.

Polymers
52
 When a polymer is stretched (cold-drawn), a neck forms. In the neck the polymer chains line
up producing a more crystalline region. Cold-drawing leads to an increase in strength.
 The first polyethene which was made contained many chains which were branched. This
resulted in a relatively disorganised structure of low strength and density. This was called low
density polyethene (ldpe)
 In the crystalline form, the methyl groups all have the same orientation along the chain. This
is called the isotactic form. In the amorphous form, the methyl groups are randomly
orientated. This is called the atactic form.
 Polymers with a regular structure are said to be stereoregular .
Strength of Polymer

Polymers
53
Application of Polymers(5)

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Polymers

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Polymers

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Polymers

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Polymers

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Polymers

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Polymers

Polymers
60

Polymers
61

Dosage Forms for Personalized Medicine
62
Personalized Medicine(7)
Introduction
 The concept of personalized medicine dates back many hundreds of years.
 Progresses in various field of chemistry, histochemistry and microscopy had
enabled the technologists to begin to apprehend 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 a practice

63
Personalized Medicine
Definition
 The term “personalized medicine” is often described as providing “the right patient
with the right drug at the right dose at the right time.”
 More broadly, “personalized medicine” may be thought of as the tailoring of medical
treatment to the individual characteristics, needs and preferences of a patient during all
stages of care, including prevention, diagnosis, treatment and follow-up.
 Other terms Precision medicine stratified medicine Targeted medicine
pharmacogenomics

64

65

66
Pharmacogenetics
 The study of variations of DNA and RNA characteristics as related to drug responsive is
a critically important area of personalized medicine
 Merging of developments in pharmacology and genomics
 Search for to comprehend how differences in genes and their expression affect the body’s
response to medications.
 Uses genetic information (such as DNA sequence, gene expression, and copy number)
for purposes of explaining interindividual differences in drug metabolism
(pharmacokinetics) and physiological drug response (pharmacodynamics).

67
Pharmacogenomics(8)

68
Pharmacogenetics(8)

69
Pharmacogenetics(8)

70
Categories of Patients for Personalised Medicine:
 Patients are mainly classified depending upon the genetic polymorphism
 Cytochrome p450 genetic polymorphism.
 Different families of enzymes polymorphism

71
Customized Drug Delivery Systems
Customized medicines is prepared based on each patient’s medical history, needs, genetics,
health conditions and other factors.
Different tools of Customized drug delivery systems
 Bioelectronic Medicines,
 3D Printing of Pharmaceuticals.
 Telepharmacy.

72
Bioelectronic Medicines(9)

73
Bioelectronic Medicines(9)

74
3D Printing Technology (10)
Current 3D printing technologies in
pharmaceutical drug delivery:
1. Inkjet printing
2. Zip dose
3. Thermal inkjet printing
4. Fused deposition modeling

30 January 2024
Unit 1
75
Three-dimensional (3D) printing is an additive manufacturing method, where successive
layers of material are deposited or solidified to form a 3D structure. It uses computer
aided drafting technology and programming to produce 3D object by layering material on
to a substrate. A variety of 3D printing technologies have been developed to fabricate
novel solid dosage forms, which are among the most renowned and distinct products
today. The present review focussed on briefing various techniques, applications of 3D
printing in pharmaceutical technology.
Thermal Ink-Jet Printing In thermal inkjet printing, the aqueous ink fluid is converted to
vapour form through heat and expands to push the ink drop out of a nozzle. 6 It is used in
the preparation of drug-loaded biodegradable microspheres, drug-loaded liposomes 7,
patterning microelectrode arrays coating and loading drug eluting stents. 8 It is also an
efficient and practical method of producing films of biologics without compromising
protein activity.

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Inkjet printing In this technique, the Ink is deposited onto a substrate either in the form
of Continuous Inkjet printing (CIJ) or Drop on Demand (DoD) printing, hence it
provides a high resolution printing capability15 (Table 2).Inkjet printing is also called as
‘mask-less’ or ‘tool-less’ approach because the formation of desired structure

30 January 2024
Unit 1
78
mainly depends upon the movement of inkjet nozzle or movement of the substrate for an
accurate and reproducible formation. It has a low processing cost, rapid processing rates,
generation of minimal waste, it gives CAD information in a ‘direct write’ manner and it
process material over large areas with minimal contamination

30 January 2024
Unit 1
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Fused deposition modelling (FDM) Fused deposition modelling (FDM) is commonly used
technique in 3D printing, in which the materials are soften or melt by heat to create objects
during printing (Fig 3),Hence there are several dosage forms listed in Table 3. FDM 3D printing
helps in manufacturing delayed release printlets without an outer enteric coating, and also
provides personalised dose medicines. FDM 3D printing however, indicates several limitations
of the system such as lack of suitable polymers, slow and often incomplete drug release
because the drug remain trapped in the polymers, and the miscibility of the drug and
additives with the polymers used was not evaluate Fig 3: Fused deposition

30 January 2024
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Zip dose is the world’s first and only FDA-validated, commercial-scale 3DP in new
therapeutic areas for drug manufacturers. (Fig 4) It has a unique digitally coded layering
and zero-compression processes, which is used for formulating a tablet with high dose and
rapid disintegration .Hence it helps in overcoming a difficulty in swallowing. 62 Spritam®
(Antiepilipsey drug) is an orodispersible tablet, marketed by Aprecia Pharmaceuticals based
on powder bed fusion by layer-by-layer production system. In which it consists of the
active ingredient, excipients and a binder liquid to produce a matrix tablet.

30 January 2024
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81
Extrusion 3D printing In this technique the material is extruded from the automated
nozzle on to the substrate and it does not require any higher support material. It is only
used to fabricate tablet containing Guaifenesin as expectorant. The materials that can be
extruded are molten polymers, suspensions, semisolids, pastes.

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Hot melt extrusion (HME) Hot melt extrusion (HME) is the process of melting polymer and
drug at high temperature and the pressure is applied in the instrument continuously for
blending (Fig 6).It is a continuous manufacturing process that includes several operations
such as feeding, heating, mixing and shaping. In recent years, it has proved that HME has the
ability to improve the solubility and bioavailability of poorly soluble drugs

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Stereolithography Stereolithography is the technique in which a computer controlled laser
beam is used to solidify the liquid polymer or resin, thereby creating a 3D structure89 (Fig
7).SLA has some advantages over other types of 3DP, mainly it’s remarkable resolution and
the avoidance of thermal processes can be detrimental for certain drug molecules. 90 Some
of the drugs prepared by Stereolithography are given in Table 7.

84
3D Printing Technology (9)

85
Use of electronic information and
communication technologies to provide
pharmaceutical care when distance separates
the pharmacist and the patient. Telepharmacy
often includes electronic health record
integration,audio-video connections, and
increased patient access to pharmaceutical
care
Telepharmacy(11)

• Youtube/other Video Links
Faculty Video Links/ Youtube & NPTEL Video Links and
Online Courses Details (if any)
https://www.youtube.com/watch?v=jJ2GyH2A
KtA

Summary
This unit covers the
 Basics of controlled and sustained release dosages forms
 The various physico-chemical and biological factors affecting SR/CR drug
delivery system
 Definition, properties and application of polymers
 Concepts of personalized medicine
87

Daily Quiz
Sl No. Question
1.
What are the different type of 3D printer used in drug delivery
system?
2. State the different properties of proteins.
3.
State the different biological factors to be considered for SR/CR
formulation.
4. Enlist the various classification of polymer.
5. What is pharmacogenetics?
6. Differentiate between controlled release and sustained release.
7 Differentiate between pharmacogenetics and pharmacogenomics.
88

Weekly Assignment
Sl No Question
1. Describe the biosensors.
2. Write note on telepharmacy.
3. Describe mechanism of drug delivery from SR/CR formulation.
4. Write a brief note on Polymers
5
Describe the personalized medicine.
89

MCQs
1.Controlled release follows………………………. Kinetics.
a. First order
b. Zero order
c. Second order
d. None
Q.2. Which one of the following is NOT true?
Mass and density
a.Drug release from reservoir systems is controlled by diffusion
b) Drug release from matrix systems is controlled by diffusion
c) Drug release from reservoir systems normally follow zero-order kinetics
d) Drug release from matrix systems normally follow zero-order kinetics
Q.3. When the release of drug from a dosage form satisfies Higuchi’s equation, the release of drug can be
considered as
a. Absorption rate controlled
b. Diffusion rate controlled
c. Dissolution rate controlled
d. Dosing rate controlled
Q.4. A matrix type diffusion sustained release dosage for fits which kinetic model
a. Higuchi model
b. first
c. zero
d. second 90

MCQs
Q.5. Current 3D printing technologies in pharmaceutical drug delivery
a. Inkjet printing
b Zip dose
c. Thermal inkjet printing
d. All of the above
Q.6. Different tools of Customized drug delivery systems
a. Bioelectronic Medicines,
b. 3D Printing of Pharmaceuticals.
c.Telepharmacy.
d. All of the above
Q.7. Strength of polymer depends on
a. Chain length
b. Branching
c. Crosslinkings
d. All of the above
91

Old Question Papers of AKTU
92

Q1. Describe 3D printing in personalized medicine
Q2.Write the classification, properties and application of polymer.
Q3. Explain in detail the mechanism of drug release.
Q4. Enumerate the various physicochemical & biological approaches for SR/CR
formulation.
Q5. Describe in detail about the bioelectronic medicines.
Expected Questions for University Exam
93

References and Books to be followed
94
1. https://www.slideshare.net/IreneDaniel8/personalized-medicine-ppt

References and Books to be followed
1. https://www.slideshare.net/PrinceDivyesh/controlled-and-sustained-release-dosage-
formcontrolled-release-dosage-formsuistained-release-dosage-form
2. http://www.authorstream.com/Presentation/v.ramani007-1635467-ch-1-controlled-
sustained-release-dosage-forms/
3. https://www.slideshare.net/gaurav11288/controlled-release-oral-drug-delivery
4. https://www.slideshare.net/janhavizope/polymers-47362631
5. https://www.slideshare.net/RonakkB17/polymer-in-pharmacy-and-application-of-
polymers
6. https://www.slideshare.net/suraiyaoyshe/polymers-final3
7. https://blog.crownbio.com/pdx-personalized-medicine
8. https://www.slideshare.net/micheldumontier/personalized-medicine-5853949
9. https://www.slideshare.net/SachinG19/personalized-medicines-176733523
10. https://www.sciencedirect.com/science/article/pii/S1818087618307852
11. https://yrf.ipsf.org/d/27-telepharmacy
95

Noida Institute of Engineering and
Technology
(Pharmacy Institute) Greater Noida
96

SR and CR

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