Untitled

INDEX
CHAPTER
CONTENT
Chapter 1
INTRODUCTION
PAGE.NO
1
1.1.Oral drug delivery
1.2.Controlled Release Drug Delivery Systems
1.3.Oral Controlled Released Systems
1.4.Controlled Release Through Matrix Devices
1.5.Hypertension
1.6.Drugs used as anti-hypertensive agents
1.7.Polymers
1.8.Natural polymers
Chapter 2
LITERATURE REVIEW
Chapter 3
AIM&OBJECTIVE
Chapter 4
EXPERIMENTAL WORK
9-14
15
16-45
4.1. Suitability of Drug
16
4.2. Plan of Work
17
4.3. List of Materials
18
4.4. List of Instruments
19
Drug Profile
4.5.Telmisartan
20-22
20
Polymer Profile
21-29
4.6. Moringa Oleifera
23
4.7.Mangifera Indica
25
4.8. Micro crystalline Cellulose
28
Chapter 5
4.9. Construction of Calibration curve
30
4.10. Drug-Polymer Compatibility Studies
31
4.11. Formulation of Telmisartan Matrix Tablets
33
4.12. Physico chemical evaluation of Formulated

tablets
40
4.13. In vitro Drug Release Studies of Matrix tablets
41
4.14. Stability Studies
44
EXPERIMENTAL RESULTS
5.1. Analytical Method
46
5.2. Pre formulation Studies
47
5.3. Physicochemical parameters of powder granules
51
5.4. In vitro Drug Release Studies
53
5.5. Stability Studies
54
57-59
Chapter 6
RESULTS AND DISCUSSION
Chapter 7
SUMMARY
60
Chapter 8
CONCLUSION AND FURTHUR SCOPE OF

RESEARCH
61
Chapter 9
BIBILOGRAPHY
Dedicated to
Beloved Parents
Gurus
Almighty God
&
Dear Friends
List of Tables
LIST OF TABLES
Table. No
NAME
Page. No
4.1
List of Materials Used
18
4.2
List of Instruments Used
19
4.3
Composition of Drug & Polymers (in mg)
33
4.4
Flow rate Values
37
4.5
Punches Specifications
38
4.6
39
4.7
Standard Specifications for Tablet Parameters

Recommended Stability Storage Conditions for Various
Products in Zone I and II Countries (ICH / US FDA Draft)
5.1
Calibration curve values of Telmisartan
45
46
5.2
FTIR Spectra Data for Telmisartan
48
5.3
FTIR Spectra Data for Telmisartan and mangifera indica
49
5.4
FTIR Spectra Data for Telmisartan and moringa oleifera
50
5.5
Physicochemical parameters for powdered granules
51
5.6
Post formulation parameters of Telmisartan tablets

51
5.7
In- vitro Dissolution data of Telmisartan tablets F1-F6

53
5.8
Drug content of the selected matrix tablets before and after

storage for 3 months
54
5.9
Release profile of Telmisartan matrix tablets (F6) before &

after storage for 3 months during the Stability Testing
55
iii
List of Figures
LIST OF FIGURES
FIG. No
1.1
4.1
TITLE
Matrix diffusional system before drug release
Page. No
4
Telmisartan
20
Moringa oleifera
4.2
4.3
23
Mangifera indica
25
MCC
4.4
28
5.1
FTIR Spectra of pure Drug (Telmisartan)
48
5.2
FTIR Spectra of Telmisartan with Mangifra indica
49
5.3
FTIR Spectra of Telmisartan with Moringa oleifera
50
List of graphs
Graph.no
Title
Page.no
5.1
Standard plot for Telmisartan
46
5.2
FT-IR spectra for pure drug(Telmisartan)
48
5.3
FT-IR spectra for pure drug (Telmisartan + Mangifera indica)
49
5.4
FT-IR spectra for pure drug (Telmisartan + Moringa oleifera)
50
5.5
Comparitive In-vitro drug release plots of F1-F6
54
5.6
Stability studies
56
List of photographs
Table
PAGE
No.
TITLES
NO.
Photographs of granules
35
Photographs of tablets
35
Photographs of UV-visible spectrophotometer
31
Photograph of FTIR apparatus
32
Photograph of tablet punching machine
36
Photograph of USP dissolution apparatus
41
LIST OF ABBREVIATIONS
Abbreviation
Full from
CRDDS
Controlled Release Drug Delivery System
TS
Telmisartan
MO
Moringa oleifera
MCC
IR
FTIR
H / hrs.
o
Micro crystalline Cellulose

Infra red
Fourier Transform Infrared Spectroscopy
Hour
Centigrade
Percentage
S.D
Standard Deviation
Microgram
Log
Logarithm
Gm
Gram
Microlitre
IP
Indian Pharmacopeia
BP
British Pharmacopeia
FDA
Food and Drug Administration
UV
Ultra Violet
INTRODUCTION
Introduction
The goal of any drug delivery systems is to provide a therapeutic amount of drug in
the proper site in the body to achieve and maintain the desired drug concentration. That is, the
drug delivery system should deliver drug at a rate dedicated by the needs of the body over a
specified period of treatment.
1.1Oral drug delivery:
This is the most widely used route of administration among all the routes that
have been explored for systemic delivery of drugs via pharmaceutical products of
different dosage form. Oral route is considered most natural, uncomplicated, convenient
and safe due to its ease of administration, patient acceptance and cost effective
manufacturing process2. Oral route of drug administration have wide acceptance up to 5060% of total dosage forms because of their ease of administration, self-medication, pain
avoidance and most importantly patient compliance. The most popular solid dosage forms
are tablets and capsules. But the important drawback of this dosage form is the difficulty
to swallow3.
A modified dosage form is defined as one for which the drug release characteristics
of time course and/or location are chosen to accomplish therapeutic objectives not offered
by conventional dosage forms such as solutions, ointments, or promptly dissolving
dosage forms as presently recognized4. Over the past 30 years as the expense and
complications involved in marketing new drug entities have increased, with concomitant
recognition of the controlled drug delivery, greater attention has been focused on
development of sustained or controlled release drug delivery systems. The attractiveness
of these dosage forms is due to awareness to toxicity and other properties of drugs when
administered or applied by conventional method in the form of tablets, capsules,
injectable, and ointments etc5.
Usually conventional dosage form produces wide fluctuations in drug
concentration in plasma blood stream and tissues with consequent undesirable toxicity
and poor efficacy.
1.2. Controlled release drug delivery systems 6
Controlled release drug delivery systems are those dosage formulations designed
to release an active ingredient at rates, which differ significantly from their corresponding
conventional dosage forms. The controlled release drug delivery systems are aimed at
Department of pharmaceutics, ANCP, Rajampet.
Page 1
Introduction
controlling the rate of drug delivery, sustaining the duration of therapeutic activity and/or
targeting the drug to a tissue. Controlled release drug delivery systems provided one or
more of the following advantages.
Maintenance of optimum therapeutic drug concentration in the blood with
minimum fluctuations.
Enhancement of therapeutic activity duration for drugs having short
biological half-life.
Elimination of side effects, frequent dosing and wastage of drugs.
Optimized therapy and better patient compliance.
1.3. ORAL CONTROLLED RELEASE SYSTEMS 7
The oral route has been the most popular and successfully used for controlled
delivery of drugs because of convenience and ease of administration, greater flexibility in
dosage form design and ease of production and low cost of such a system. The following are
the major types of controlled release systems intended for oral use.
1.3.1. Matrix tablets
Matrix tablets are monolithic systems in which drug is homogeneously dispersed
throughout a rate controlling medium. To control the release of the drugs, hydrophobic and
hydrophilic matrices have been used. For water soluble drugs the hydrophobic and
hydrophilic matrices are mixed. For moderately or poorly water soluble drugs, hydrophilic
matrices are used. The drug dissolution is controlled by controlling the rate of penetration of
dissolution fluid in to the matrix by altering the porosity of tablet, decreasing its wettability or
by itself getting dissolved at slower rate.
1.3.2. Mucoadhesive tablets
Mucoadhesive tablets are controlled drug delivery systems, bind to the gastric
epithelial cell surface or mucin and serve as a potential means of extending the gastric
retention time of drug delivery system in the stomach. Mucoadhesive polymers used in the
preparation of tablets utilize the property of adhesive interaction with a biological or
gastrointestinal mucosal surface. These dosage forms are readily localized in the region
applied to enhance the bioavailability of drugs.
Page 2
1.3.3. Microcapsules and Microspheres 8
Introduction
Micro particles and Microspheres are the polymeric particles ranging in size from 11000m. The mechanism of drug release is either by dissolution and diffusion of the drug
and the formulations are either as encapsulated or matrix form.
1.3.4. Ion-exchange resins
These types of systems are developed by embedding the drug molecules in the ion
exchange resin matrix. Hence, the drug release characteristics are mainly dependent on the
ionic environment of the resin containing drug.
1.3.5. Film coated tablets
Coating of tablets by using film forming polymers like HPMC, ethyl cellulose can
control the dissolution rate of the drug from the tablets. Thickness of the polymer coat is the
important parameter for the desired dissolution rate.
1.3.6. Floating tablets
Floating tablets are used for the local action in the proximal g.i.t. Increased g.i.t. transit
time is the consequent property of the floating tablets .Due to their less specific gravity they
float for extended period in the gastro intestinal fluid.
1.3.7. Swellable tablets
Swellable tablets are developed in a size, which can be swallowed and when they
reach stomach fluid, swell quickly and attain considerably larger size. The dosage form is
larger than the pylorus opening hence it cannot pass through the pylorus thereby, the
residence time in stomach increases.
1.3.8. Osmotic tablets 9
The osmotic tablets are comprised of a drug contained in a rigid, semi permeable
membrane in which an aperture is created by a mechanical drill or a laser beam. These
systems are suitable for the controlled release of water soluble drugs.
Page 3
1.3.9. Micro and Multiple emulsions
Introduction
Micro or sub-micron emulsions are having the dispersed phase diameter less than
0.1m and appears translucent or transparent and they are thermodynamically stable
compared to conventional emulsions.
1.4. CONTROLLED RELEASE THROUGH MATRIX DEVICES 10
Matrix (monolithic) devices are possibly the most common of the devices for the
controlling the release of drugs. In such a device the active ingredient is present as dispersion
with in the polymer matrix, and they are typically formed by the compression of a
polymer/drug mixture or by dissolution or melting. The dosage release properties of
monolithic devices may be dependent upon the solubility of the drug in the polymer matrix
or, in the case of porous matrices, the solubility in the sink solution with in the particles pore
network, and also the tortuosity of the network, dependent on whether the drug is dispersed in
the polymer or dissolved in the polymer.
It is common to add plasticizer (PEG), or surfactant, or adjuvant, as a means to
enhance the permeability. It was noted that the leaching of PEG acted to increase the
permeability of films as a function of PEG loading by increasing the porosity. It was
deducted that the enhancement of their permeability is a result of the effective decrease in the
thickness caused by the PEG leaching.
Drug release from matrix tablets 11:
Drug dispersed in polymer
Time-0
Drug dispersed polymer
Time-1
Fig. 1.1 Matrix diffusional system before drug release (time=0) and after partial
drug release (time=1)
Page 4
Introduction
1.4.1. Extended-release drug products: A dosage form that allows at least a twofold
reduction in dosage frequency as compared to that drug presented as an intermediate
release (conventional) dosage form.
1.4.2. Delayed release drug products: A dosage form that releases a discrete portion or
portions of drug at a time or at times other than promptly after administration, although
one portion may be released promptly after administration.
1.4.3. Targeted drug release products: A dosage form that releases drug at or near the
intended physiologic site of action.
1.4.4. Extended release drug delivery system
12
: It allows a reduction in dosing
frequency from that necessitated by a conventional dosage form, such as solution or an

intermediate release dosage form.
1.4.5. Characteristics of extended release products: They exhibit very slow/very fast
rate of absorption and excretion, good margin of safety, requirement of low dosage form.
1.5. HYPERTENSION13, 14
Blood pressure is defined as the pressure which pushes or forces the blood across the
blood vessels when the heart is pumping. The blood pressure (BP) is said to be normal if
the systolic blood pressure is 120 mmHg and diastolic blood pressure is 80mmHg i.e.,
120/80 mm Hg. Hypertension is defined as a physiological condition where there is an
increase in the arterial blood pressure above normal. An individual is said to be
hypertensive if the blood pressure is greater than 140/90 mmHg.
Based on etiological basis hypertension is divided into following TWO types
Primary (Essential) Hypertension:
In majority of cases , hypertension is of unknown cause and is known as primary or
essential hypertension. Although a definite cause is not known in primary hypertension,
the following factors may contribute to the elevation of BP.
1. Dietary intake of more sodium and less potassium.
2. Decrease in vascular synthesis of nitric oxide (NO).
3. In some cases primary hypertension may be hereditary.
Page 5
Secondary hypertension:
Introduction
In some cases hypertension may be secondary to other diseases like:

Endocrine disorders like Pheochromocytoma & Hyperaldosteronisism..
Kidney disorders like chronic glomerular nephritis.
Muscular disorders like contraction of aorta & Renal artery stenos.
1.6.Drugs used as Antihypertensive agents15

2. Diuretics
3. Beta- blockers
4. Calcium channel Blockers
5. Angiotensin converting enzyme inhibitor
6. Angiotensin II receptor blockers
7. Direct renin inhibitor
8. Centrally acting sympatholytics.
1.7.Natural Polymers16.17
Polymers have been successfully investigated and employed in the formulation of
solid, liquid and semi- solid dosage forms are specifically useful in the design of novel
drug delivery systems. Both synthetic and natural polymers have been investigated
extensively for this purpose. Synthetic polymers are toxic., expensive, have environment
related issues, need long development time for synthesis and are freely available in
comparison to naturally available polymers. However the use of natural polymers for
pharmaceutical applications is attractive because they are economical, readily available,
nontoxic and capable of chemical modifications, potentially biodegradable and with
few exceptions and also biocompatible.
Page 6
1.8.CLASSIFICATION OF NATURAL POLYMERS18
Introduction
1. Plant origin
Cellulose, Hemicellulose, Glucomannan, Agar, Starch, Pectin, Inuline, Rosin, Guar
gum, Gum acacia, Karaya gum, Gum tragacanth, Aloe vera gel.
2. Animal origin
Chitin, Alginates, Carageenans, Psyllium, Xanthum gum.
Polymers used in Controlled release Tablets
1. Hydrogels:
Poly hydroxyl ethy l methyl acrylate, Cross- linked poly vinyl alcohol,
Polyacrylamide.
2. Soluble polymers:
Poly ethylene glycol, Poly vinyl alcohol, Hydroxy propyl methyl cellulose.
3. Biodegradable polymers:
Poly lactic acid, Poly glycolic acid, Poly anhydrides.
4. Non- Biodegradable polymers:
Cellulose acetate, Ethyl cellulose, Poly ethylene vinyl acetate, Polyvinyl chloride.
5. Mucoadhesive polymers:
Polycarbophil, SCMC, Polyacrylic acid, Tragacanth, Pectin, Methyl cellulose.
6.Natural gums:
Xanthum gum, Guar gum, Karaya gum, Locust bean gum.
Page 7
Karaya Gum19:
Introduction
Karaya gum, also known as Indian tragacanth or Streculia gum is a vegetable gum
produced as an exudate obtained from the trees of Sterculia urens (Sterculiaceae). Karaya
gum consist of an acetylated, branched heteropolysaccharide with a high component of Dgalacturonic acid and D-glucuronic acid residues. It does not contained methoxyl groups.
Karaya gum is widely used as bulk laxative. This gum is very less expensive and currently
used in a variety of products, including cosmetics, hair sprays, and lotions, to provide bulk.
Gum is least soluble of commercial plant exudates, but it absorbs water rapidly and swells to
form viscous colloidal solutions even at low concentrations. Pharmaceutically, it is used as a
Suspending agent, emulsifying agent, stabilising and thickening agent, matrix forming agent
in sustain release tablets and it has also been used in food, paper and textile industries. The
powdered gum is used in lozenges, pastes and dental fixative powders and it has proved
particularly useful as an adhesive for stoma appliances. The cross linked Tragacanth
(Epichlorhydrin) exhibits superior wicking and swelling action and hence can be used as a
potential disintegrant.
Page 8
Literature review
LITERATURE REVIEW
1. Abitha M H (2015)20 et al., has revealed Nature has provided us a wide variety of
materials to help improve and sustain the health of all living things either directly or
indirectly. The products from natural polymers have an integral part of human health care
system because of because of some side effects and toxicity of synthetic drugs. Natural
polymers are basically polysaccharides so they are biocompatible without any side
effects. The release mechanism of drug from this polymers is by degradation diffusion
and swelling. Polymers have been in use for many years with the aim of facilitating the
effectiveness and efficacy of the drugs and their delivery. Natural polymers possesses
wide scope in food and cosmetic industries. Natural polymers can be used as the means
of achieving predetermined rates of drug delivery and their physicochemical properties
with the ease of availability provide a platform to use it as a polymer for drug delivery
systems. Gums, mucilages, resins, and plant extracts are widely used natural materials
for conventional and novel dosage forms. The present article highlights the available
information on natural polymers and their versatile use.
.
2. N.G. Raghavendra Rao (2011)21 et al., has revealed about controlled release oral drug
delivery systems. An appropriately designed controlled release drug delivery system can
be a major advance towards solving problems concerning the targeting of a drug to a
specific organ or tissue and controlling the rate of drug delivery to the target site. The
development of oral controlled release system has been a challenge to formulation
scientist due to their inability to restrain and localize the system at targeted areas of the
gastrointestinal tract. Matrix type drug delivery system is an interesting and promising
option when developing an oral controlled release system. Availability of wide variety of
polymers and frequent dosing intervals helps the formulation scientist to develop
sustained/controlled release products. Oral Sustained release (S.R) / Controlled release
(C.R) products provide an advantage over conventional dosage forms by optimizing biopharmaceutics, pharmacokinetic and pharmacodynamics properties of drugs in such a
way that it reduces dosing frequency to an extent that once daily dose is sufficient for
therapeutic management through uniform plasma concentration providing maximum
utility of drug with reduction in local and systemic side effects and cure or control
Department of Pharmaceutics, ANCP, Rajampet.
Page 9
Literature review
condition in shortest possible time by smallest quantity of drug to assure greater patient
compliance.
3. Vinod R (2013)22 et al., has revealed about mangifera indica. The purpose of the present
study was to formulate the nicorandil sustained release matrix tablets by using Mangifera
indica gum as rate controlling factor and to evaluate drug release parameters as per
various release kinetic models. The Mangifera indica gum is extracted and evaluated for
physicochemical and phytochemical property using official procedures. The tablets were
prepared by wet granulation method. The granules were evaluated for angle of repose,
loose bulk density, tapped bulk density and compressibility index, showed satisfactory
results. All the granules were lubricated and compressed and were evaluated for
uniformity of weight, content of active ingredient, thickness, friability, hardness and Invitro dissolution studies. Fourier transform infrared (FTIR) study revealed that there was
no chemical interaction between drug and the gum used. All the formulation showed
compliance with Pharmacopoeial standards. In-vitro drug release studies were carried out
using USP 35/NF 30 dissolution apparatus type II at 50 rpm (rate per minute). The invitro release study of matrix tablets were carried out for 12 hr. The prepared matrix
tablets were shown 97.8%, 96.5%, 96.8%, 90.7% and 86.5% release over a period of 12
h. A better sustained drug release of 96.8% was obtained with formulation F3 at the end
of 12 h. Optimized formulation F3 was subjected to stability studies for three months,
which showed stability with respect to release pattern. Mathematical analysis of the
release kinetics indicated that the nature of drug release from the matrix tablets was
dependent on gum concentration and it was found to be diffusion coupled with erosion.
4. N.S.K. Choudhury (2008)23
et al., has revealed about moringa oliefera. The present
study was undertaken to find out the potential of gum from Moringa oleifera to act as a
binder and release retardant in tablet formulations. The effect of calcium sulphate
dihydrate (water insoluble) and lactose (water soluble) diluent on the release of
propranolol hydrochloride was studied. The DSC thermograms of drug, gum and mixture
of gum/drug indicated no chemical interaction. Tablets (F1, F2, F3, and F4) were
prepared containing calcium sulphate dihydrate as diluent, propranolol hydrochloride as
model drug using 10%, 8%, 6% and 4% w/v of gum solution as binder. Magnesium
stearate was used as lubricant. Physical and technological properties of granules and
Page 10
Literature review
tablets like flow rate, Carr index, Hausner ratio, angle of repose, hardness, friability and
disintegration time were determined and found to be satisfactory. Tablets were prepared
by wet granulation method containing calcium sulphate dihydrate as excipient,
propranolol hydrochloride as model drug using 10%, 20% and 30% of gum as release
retardant, magnesium stearate was used as lubricant. Similarly tablets were prepared
replacing lactose with calcium sulphate dihydrate. Despite of the widely varying physicochemical characteristics of the excipients, the drug release profiles were found to be
similar. The drug release increased with increasing proportions of the excipient and
decreased proportion of the gum irrespective of the solubility characteristics of the
excipient. The values of release exponent n are between 0.37 and 0.54. This implies that
the release mechanism is Fickian. There is no evidence that the dissolution or erosion of
the excipient has got any effect on the release of the drug. The t50% values for tablets
containing calcium sulphate dihydrate were on an average 10%-15% longer than the
tablets containing lactose as excipient. These relatively small differences in t50% values
suggest that the nature of excipient used appeared to play a minor role in regulating the
release, while the gum content was a major factor.
5. Sharpe (2001)24 et al., has revealed about
Telmisartan is an angiotensin II receptor
antagonist that is highly selective for type 1 angiotensin II receptors. It was significantly
more effective than placebo in large (n >100), double-blind, randomised, multicentre
clinical trials in patients with mild to moderate hypertension. Telmisartan 20 to 160 mg
once daily produced mean reductions in supine trough systolic blood pressure and
diastolic blood pressure of up to 15.5 and 10.5 mm Hg, respectively. Maximum blood
pressure reduction occurred with a dosage of 40 to 80 mg/day. Telmisartan 40 to 120
mg/day was as effective as amlodipine 5 to 10 mg/day or atenolol 50 to 100 mg/day in
dose-titration studies. Telmisartan 20 to 160 mg/day was generally similar in efficacy to
enalapril 5 to 20 mg/day or lisinopril 10 to 40 mg/day in both titration-to-response and
other studies. Hydrochlorothiazide was coadministered in most of the titration-toresponse studies if patients remained hypertensive. Telmisartan 80 mg/day was more
effective than submaximal dosages of losartan (50 mg/day) or valsartan (80 mg/day) and
was as effective as a fixed-dose combination of losartan 50 mg plus hydrochlorothiazide
12.5 mg over the last 6 hours of the dosage interval and the whole 24-hour postdose
Page 11
Literature review
interval. In patients with severe hypertension, telmisartan 80 to 160 mg/day was as
effective as enalapril 20 to 40 mg/day (both agents could be titrated and combined
sequentially with hydrochlorothiazide 25 mg and amlodipine 5 mg). The addition of
hydrochlorothiazide to telmisartan was more effective than each agent alone at lowering
blood pressure in patients with hypertension. Telmisartan was well tolerated in patients
with mild to moderate hypertension and was significantly less likely to cause persistent,
dry cough than lisinopril
6. Kwabena Ofori-Kwakye (2015)25
et al ., studied developing extended release matrix
tablets of poorly water soluble diclofenac sodium and highly water soluble metformin
hydrochloride by direct compression using natural and synthetic polymers of cashew
gum, xanthan gum and HPMC. Extended release of diclofenac and metformin from the
matrix tablets in aqueous medium was achieved using various blends of the polymers.
7. Sonia (2013)26 et al., has revealed the advantage of administering a single dose of a drug
that is released over an extended period of time instead of numerous doses is now a days
area of interest for formulation scientists in Pharmaceutical industry. There are several
advantages of sustained release drug delivery over conventional dosage forms like
improved patient compliance due to less frequent drug administration, maximum
utilization of the drug, increased safety margin of potent drug, reduction of fluctuation in
steady-state drug levels, reduction in healthcare costs through improved therapy and
shorter treatment period. Wide varieties of polymers like Micro Crystalline Cellulose
(MCC), Carboxyl Methyl Cellulose (CMC), Ethyl Cellulose (EC), Cellulose Acetate
Phthalate, HPMC K100M, Xanthan gum, Carrageenan gum, Karaya gum, HPMC K15,
Carbopol 971P and Carbopol 974P etc. are available for retarding the release rate of
drugs hence sustains the action of drugs.
8. Sneha S.Jaiswal(2016) 27 et al., has revealed the Aqueous and ethanolic leaf extracts of
Mangifera indica leaves were evaluated against pathogenic strains of four Gram negative
bacteria Escherichia coli, Pseudomonas aeruginosa, Klebseilla pneumoniae and
Salmonella typhi and two Gram positive bacteria Bacillus subtilis and Staphylococcus
aureus. Ethanolic extract of Mangifera indica was found to be effective
against
Salmonella typhi, Staphylococcus aureus, Klebseilla pneumoniae and Pseudomonas

aeruginosa, while its aqueous extract did not showed any activity against all the bacteria
Page 12
Literature review
under study. Least effect of ethanolic extract was found on Bacillus
subtilis and
Escherichia coli. Thus, the ethanolic leaf extract of Mangifera indica was found to
possess more antibacterial potential than its aqueous extract.
9. Sailaja B. Srilakshmis.,(2016)28et al., has revealed the present In vitro study, starch
and protein mucilage fractions were isolated from the seed coats of Moringa oleifera. The
isolated fractions were evaluated as binder and disintegrant in the preparation of
paracetamol tablets. The prepared tablets were assessed for comparative In vitro quality
control parameters such as weight variation, hardness, friability and disintegration time.
The parameters were compared with paracetamol tablets prepared using potato starch as
binder and disintegrant. Significant variation was observed in hardness, friability, and
disintegration time among three formulations. Paracetamol tablets with protein-mucilage
fraction were found to be relatively harder, less friable, and taking more time to
disintegrate than the tablets made with potato starch. The tablets with isolated starch
fraction were found to be almost similar to tablets prepared with potato starch with
respect to hardness, friability and disintegration time. The isolated starch fraction and
protein-mucilage fractions exhibited good binding and disintegrating properties and were
natural in origin, nontoxic, biodegradable and biocompatible.
10. Amrinder Singh*, (2013)29 et al., has revealed the Telmisartan is a potent, long lasting,
nonpeptide antagonist of the angiotensin II type-1 (AT1) receptor that is indicated for the
treatment of essential hypertension. It selectively inhibits stimulation of the AT1 receptor
by angiotensin II without affecting other receptor systems involved in cardiovascular
regulation. Very high lipophilicity a unique feature of telmisartan coupled with a high
volume of distribution indicate that the compound offers the clinically important
advantage of good tissue penetration. It also activates peroxisome proliferatoractivated
receptor c (PPAR-c) and increase adiponectin protein content in adipocytes. By this
means they may improve insulin sensitivity. It belongs to a class II drug in BCS
classification i.e. low solubility and high permeability. One of the major problems with
this drug is its low solubility in biological fluids which results into poor bioavailability
after oral administration to improve the aqueous solubility and dissolution rate of the
telmisartan solid dispersions of drug using different methods were prepared and
Page 13
Literature review
investigated. Enhancement of solubility of Telmisartan was observed with solid
dispersion of drug using carriers such as Poly vinyl pyrrolidonek30, Poly ethylene glycol4000 and eta Cyclodextrin, poly ethylene glycol 6000, alkalizers, Gelucire 43/01,
Poloxamer 407, PVP K30 and HPMC E4 , PEG 6000 and NaHCO3. The observed results
showed the solid dispersion of drug greater than the pure drug.
Page 14
Aim & objective

3. AIM AND OBJECTIVES
The aim and objective of the current research work was to prepare and
characterized a control released matrix tablets for telmisartan which is an antihypertensive, Angiotensin II receptor blocker, cardiovascular agent used in the treatment
of mild to moderate hypertension.
To describe the effect of polymer composition, on the release kinetics.
To hold the therapeutic drug concentration for longer time.
To reduce the dose frequency.
To improve patient acceptance.
Hypertension is one of the current prevailing diseases in the world. For this reason
drug with polymers such as mangifera indica, moringa oleifera, hydroxyl propyl methyl cellulose
were prepared in order to improve the bioavailability by minimizing the side effects of the drug.
Page 15
Experimental work
4. EXPERIMENTAL WORK
4.1. SUITBILITY OF THE DRUG
In present study drug has the following characteristics,
It has plasma half-life of 24 hours.
Generously solubilized in methanol.
Having oral bioavailability of 42-100%.
It is rapidly absorbed through entire G.I.T.
Al the above characteristics of the drug make it to cause fluctuations in the

concentration of drug in the plasma leading to low therapeutic efficacy. By considering the
above characteristics, drug is suitable candidate for the design of CR matrix tablets.
Page 16
Experimental work
4.2. PLAN OF THE WORK

The research work consists of
Selection and collection of raw materials
Collection of literature review based on
Drug
Polymers
Formulation data
Construction of calibration curve for the drug

Drug and polymer interaction studies by FTIR
Formulation of drug matrix tablets
Physicochemical evaluation of matrix tablets of drug
Thickness
Hardness
Weight variation
Friability
Drug content
In vitro drug release studies.

Results and Discussion.
Conclusion.
Page 17
Experimental work
4.3. LIST OF MATERIALS:

Table.4.1. List of materials
S.no
Materials
Company
Telmisartan
Hetero drugs limited, India
Mangifera indica
Girijana Co-operative Corporation society

Tirupathi
Moringa oleifera
Girijana Co-operative Corporation society

Tirupathi
HPMC
S D Fine chem, Mumbai
Magnesium stearate
S D Fine Chem, Mumbai
Talc
S D Fine Chem, Mumbai
Page 18
Experimental work
4.4. LIST OF INSTRUMENTS
Table.4.2. List of instruments
S.NO
Name of the Equipment
Manufacturing company
Tablet compression machine
Chamunda pharma Machinery,

PVT.LTD
Weighing balance
Keroy, PVT. LTD,Varanasi
Disintegration tester
Electro lab, Mumbai
Friabilator
Roche friabilator,
Electro lab, Mumbai
Hardness tester
Monsanto hardness tester,

Biomate India PVT LTD, Delhi
Dissolution test apparatus
Electro lab, Mumbai
Page 19
Experimental work
4.5. DRUG AND POLYMER PROFILE

TELMISARTAN PROFILE
Chemical Name:[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl] methyl] 1,
1 biphenyl] 2 carboxylic acid.
Molecular formula: C33H30N4
Molecular weight: 514.61g/ml
Properties: It is white to off-white crystalline powder.
Melting range:- Between 265.0oC and 272.0Oc.
Solubility:- Practically insoluble in water, slightly soluble in methanol, sparingly soluble
inmethylene chloride, it dissolves in 1M sodium hydroxide.
Partial coefficient:- The Octanol/buffer partial coefficient (log P) for Telmisartan
isapproximately 3.20.
Storage & Stability: Stored in well-closed, light-resistant containers at 5-30C. When stored
under these conditions, Telmisartan generally is stable for 24 months after the date of
manufacture.
STRUCTURE
Page 20
Experimental work
Indication: For the treatment of hypertension.
Pharmacokinetic parameters:
Bioavailability:
42-100%
Protein binding:
99.5%
Half-life:
24hrs
Daily dose:
40-80 mg
Time for peak plasma concentration:
0.5-2hr
PHARMACOKINETIC PROPERTIES:
Absorption:
Absorption of telmisartan is rapid although the amount absorbed varies.The mean
absolutebioavailability for telmisartan is about 50 %. When telmisartan is taken with food,
the reduction in the area under
the plasma concentration-time curve (AUC0-) of
telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg

dose). By 3 hours after administration, plasma concentrations are similar whether telmisartan
is taken fasting or with food.
Linearity/non-linearity:
The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
There is no linear relationship between doses and plasma levels. Cmax and to a lesser extent
AUC increase disproportionately atdoses above 40 mg.
Protein Binding:
Highly bound to plasma proteins (>99.5%), mainly albumin and a1-acid glycoprotein.
Binding is not dose-dependent.
Distribution:
Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1
acidglycoprotein. The mean steady state apparent volume of distribution (Vdss) is
approximately 500.
Metabolism:
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Nopharmacological activity has been shown for the conjugate30.
Excretion and Elimination:
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal
eliminate ion half-life of >20 hours. The maximum plasma concentration (Cmax) and, to a
Page 21
Experimental work
smaller extent,the area under the plasma concentration-time curve (AUC), increase
disproportionately with dose. There is no evidence of clinically relevant accumulation of
telmisartan taken at the recommended dose. Plasma concentrations were higher in females
than in males, without relevant influence on efficacy.
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with
the faeces, mainly as unchanged compound. Cumulative urinary excretion is <1 % of dose.
Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic
blood flow (about 1,500 ml/min)30.
Therapeutic uses:
Telmisartan is an antihypertensive agent that acts primarily by decreasing blood pressure.
Telmisartan is used in the treatment of hypertension. It acts as a Angiotensin II receptor
blocker31.
Side effects:
Side effects are similar to other angiotensin II receptor antagonists and include tachycardia
and bradycardia (fast or slow heartbeat), hypotension (low blood pressure), edema (swelling
of arms, legs, lips, tongue, or throat, the latter leading to breathing problems), and allergic
reactions.
Dosage and administration:
The usually effective dose telmisartan is 4080 mg once daily. Some patients may already
benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved,
telmisartan dose can be increased to a maximum of 80 mg once daily.
Toxicity:
Intravenous LD50 in rats is 150-200 mg/kg in males and 200 to 250 mg/kg in females. Acute
oral toxicity is low: no deaths and no changes occurred in rats or dogs at 2000 mg/kg, the
highest dose tested. Limited data are available with regard to overdosage in humans. The
most likely manifestations of overdosage with telmisartan would be hypotension, dizziness
and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.
Contraindications: Telmisartan is contraindicated during pregnancy. Like other drugs
affecting the renin angiotensin system (RAS), telmisartan can cause birth defects, stillbirths,
and neonatal deaths. It should not be taken by breastfeeding women since it is not known
whether the drug passes into the breast milk.
Page 22
Experimental work
4.6. MORINGA OLEIFERA:
Synonyms : Moringa pterygosperma, Hyperanthera moringa, Guilandina moringa.
Species:
Polymeric
gum
obtained
from
moringa
species
includes
M.oleifera,
M.peregrina,M.stenopetala, M.drouhardii etc.

Botanical source: It is obtained from dried exudation of stem bark of plant Moringa
oleifera.
Botanical name: Moringa oleifera.
SCIENTIFIC CLASSIFICATION:
Kingdom:
Plantae
Order:
Brassicales
Genus:
Moringa
Botanical family:
Moringaceae
Parts used:
Gum
Origins:
Oman, India, Somalia, Aden, and Ethiopia
Colors:
Whitish- grey colour.
CHEMICAL COMPOSITION:
4-(-L-ramnopyranosyloxy)-benzylglucosinolate& benzyl glucosinolate, melleine,

vanillin.
-sitosterone, octacosanoic acid, -sitosterol& ramnopyranosyloxy)-benzylglucosinolate.
L-Arabinose, L-galactose, D-glucuronic acid, L-Rhamnose, D-Mannose & DXylose.
5.2.3. CHEMICAL STRUCTURE:
Page 23
Experimental work
INTRODUCTION:
Moringa oleifera is the most widely cultivated species of the genus Moringa, belongs to
family Moringaceae.It is a fast growing, deciduous tree. It can reach a height of 10-12m (3240ft) and trunk can reach a diameter of 45cm. The bark has a whitish- grey colour and is
surrounded by thick cork. Young shoots have purplish or greenish-white, hairy bark32.
ISOLATION OF MORINGA OLEIFERA GUM:

The gum was collected from trees (injured site). It was dried, ground, and and passed through
sieve no.80. Dried gum (10gr) was stirred in distilled water (250ml) for 6-8 hours at room
temperature. The supernatant was obtained by centrifugation. The residue was washed with
water and the washings were added to separate supernatant. The procedure was repeated four
more times . Finally the supernatant was made up to 500ml and treated with twice the
volume of acetone by continuous stirring. The precipitated material was washed with
distilled water and dried at 50-600c under vaccum33.
MEDICINAL USES:
Moringa oleifera is of diuretic along with lipid and blood pressure lowering constituents
make this plant highly useful in cardiovascular disorders. It contains Antihypertensive,
diuretic and cholesterol lowering activities. Moringa leaves have been extensively studied
pharmacologically and it has been found that the ethanol extract and its constituents exhibit
antispasmodic effects possibly through calcium channel blockade. It has antitumour and
anticancer activity34.
Page 24
Experimental work
4.7. MANGIFERA INDICA:
Synonyms: Phanrangia poilanei Tardie, Mangifera austro-yunnanensis.
Botanical species: Approximately 69 species are present .some of the mangifera species are;
M.acutigemma, ,M.africana, M.altissima, M.amba, M. anisodora etc,,.
Botanical source: It is obtained from dried gum exudation of stem bark of plant Mangifera
indica.
Botanical name: Mangifera indica.
SCIENTIFIC CLASSIFICATION:
Kingdom: Plantae
Order: Sapindales
Family: Anacardiaceae
Sub family: Anacardioideae
Genus: Mangifera
Parts used: Gum
Origins:India, Srilanka, Bangladesh, Myanmar, Thailand, Kampuchea, Vietnam, Laos,
China, etc,.
Colour: Yellow to dark brown.
CHEMICAL COMPOSITION35:
Mangiferin (a pharmacologically active hydroxylated xanthone c-glycoside).
Manjin, Piuri-yellow die; Benzoic acid, Citric acid. Seed contain a Fixed oil,
Oleostearin, Starch, Gallic acid, Tannin.
It contains Mangiferic acid, Resinol, Mangiferol, Mangostine, 29- hydroxyl

mangiferonic acid.
Page 25
Experimental work
CHEMICAL STRUCTURE:
ISOLATION OF MANGIFERA INDICA GUM:

Mucilage can be extracted from plant parts by various methods like heating, solvent
precipitation. In this method the part of the plant containing gum or mucilage is selected
followed by drying grinding and sieving of the plant part. This is than stirred in distilled
water and heated for complete dispersion in distilled water and kept for 6-8 hr at room
temperature. The supernatant is obtained by centrifugation. The residue is then washed with
water and washings are added to the separated supernatant. Solvent for precipitation is
selected and finally, the supernatant mixed with twice the volume of precipitating solvent by
continuous stirring. The precipitated material is washed with distilled water and dried at 50 0600 C under vaccum. Plant material must be treated with petroleum ether and chloroform (to
remove pigments and chlorophyll) and then distilled water.
MEDICINAL USES36:
There are many medicinal uses that are attributed to mango. Mango leaves are considered
helpful for treatment of diabetes. The tender leaves can be soaked in water overnight and
squeezed and taken every morning or else dried and powdered and consumed in the mornings
and evenings. Mango leaves are also used in effective treatment of burns.
The seeds of mango should be dried and powdered and can be used for treatment of
diarrhoea. This should be given in small doses with honey and cured with the fresh juice of
mango flowers which is also used for treatment of diarrhoea. The paste of mango seeds is
used for treatment of female disorders like vaginitis and leucorrhoea. The mango bark juice
is used to control heavy bleeding during the menstrual cycle in women.
Page 26
Experimental work
Eating one or two green mangoes help in the treatment of gastro intestinal disorders and
helps with digestion and prevention of constipation, dysentery, morning sickness and piles.
The juice of mango bark is used as gargle for relief from throat diseases and diphtheria. The
juice that oozes out when mangoes are plucked can be used as a relief for bee stings and
scorpions bites. Mango leaves are dried and powdered and are used for treatment for
excreting renal stones and improving hair growth.
Mango fruit is believed strengthen the immune system of the human body. Dried mango seed
powder can be used as good toothpaste for dental problems and to strengthen the gums. The
bark is used in treatment of leucorrhoea, menorrhoea, dysmenorrhoea and other menstrual
disorders and eczema. Flowers are used in treatment of dysentery, spermatorrhoea, and they
repel mosquitoes. The gum is warmed with lime, aloe and turmeric for healing sprains and
painful joints. Leaves are considered astringent, and used in treating diabetes and cholera.
Unripe fruit of mango fruit is rich in vitamin C which is equal to that of 6 lemon fruits. It
also contains a large number of starch, and acids like citric, malic, oxalic and succinic
compounds which in turn increases bile secretion and act as antiseptic in the intestines. They
are also said to be wonders in controlling morning sickness, treating heat stroke, constipation
and indigestion. The milky juice of the plant is also prescribed for psoriasis. Scorpion bites
and ring worms, while the bark and kernel are used in treating leucorrhoea, menstrual
disorders, etc.
Page 27
Experimental work
4.8. MICRO CRYSTALLINE CELLULOSE PROFILE:
Synonym: Micro crystalline cellulose
Molecular formula: C56H108O30

Chemical name: Micro crystalline cellulose.
Molecular weight: 59.08708
Functional category: Functionally MCC is similar to hydroxy ethyl methyl cellulose
CHEMICAL STRUCTURE:
Description37:
Micro crystalline cellulose is an odorless and tasteless, white to slightly off-white, fibrous or
granular, free-flowing powder that is a synthetic modification of the natural polymer,
cellulose. Specifically, it is a modification of alkali cellulose, which is produced when
purified wood pulp is treated with 18% sodium hydroxide solution. Methyl and hydroxyl
propyl ether groups are introduced into the molecule by reacting the alkali cellulose with
methyl chloride and propylene oxide, respectively. The degree of substitution (DS) of
commercial MCC with these methoxy and hydroxyl propoxy groups will vary depending on
the commercial use and properties desired. These added groups confer on the molecule its
unique properties of being cold-water soluble, while at the same time exhibiting reversible
gelation when heated and recooled.
Page 28
Experimental work
PHYSICAL PROPERTIES38:
General properties common to the MCC are listed below. Individual type exhibits these
properties to varying degrees and may have additional properties that are desirable for
specific applications.
Apparent density: 0.25~0.70g/cm3.
Refractive index nD20: 1.336
Surface tension: Surface tensions range from 42 to 56 m N/m. The surface tension of
water is 72 m N/m; a typical surfactant has a surface tension of 30 m N/m.
Solubility: dissolve in water and some solvent. Such as, the suitable proportion of
ethanol/ water, propanol/water.
Melting point: 1600-1640 C
Moisture content: 5-6 % at 50% relative humidity.
USES:
There are many fields of application for micro crystalline cellulose, includes tile adhesives,
cement renders, gypsum products, food and cosmetics. Functionally it is similar to hydroxyl
ethyl methyl cellulose which is used in ophthalmic application. It is used as a excipient or
tableting ingredient in oral tablets and capsule formulations. It is also used as a binder39.
Page 29
Experimental work
4.9. CONSTRUCTION OF CALIBRATION CURVE BY UV METHOD40:
a) Preparation of standard stock solution:
25 mg of the pure drug was accurately weighed and dissolved in 10 ml 0.1 N NaOH
and sonicated for 15 minutes and then volume was made up to 25 ml with 0.1 N NaOH to
give standard stock solution 1000 g/ml. From this, 2.5 ml solution withdrawn and diluted
upto 25 ml with 0.1 N NaOH to get 100 g/ml which used as working stock solution and then
further dilutions were made from this stock solution to get concentration in the range of 2-12
g/ml.
b) Preparation of sample solution:

20 tablets were procured from local market and average weight was determined. The
powder equivalent to 50 mg of Telmisartan was weighed accurately and taken in separate 50
ml volumetric flask, it was dissolved in 25 ml 0.1N NaOH by sonication, filtered through
Whatmann filter paper no. 41 and volume was made up to 50 ml with 0.1 N NaOH to give
1000 g/ml stock solution. From this solution, 2.5 ml was withdrawn and diluted to 25 ml
with 0.1 N NaOH to get 100 g/ml solutions and used as working stock solution. From this
further dilution was made.
c) Calibration curve for Telmisartan:

From the standard stock solution appropriate dilutions were made to obtain
concentration in range of 2, 4, 6, 8, 10 & 12 g/ml. The spectra were recorded, absorbance
was measured at 296 nm.
Page 30
Experimental work
UV-Visible spectrophotometer
4.1.0. DRUG- POLYMER COMPATIBILITY STUDIES41:
Drug polymer compatibility studies were performed by FT-IR ( Fourier transform
infrared spectroscopy). The pure drug and mixture of it with polymers, mangifera indica,
moringa oleifera, hydroxyl propyl methyl cellulose mixed separately with IR grade Kbr and
the Kbr pellets were primed by applying 5.5 metric ton of pressure in a hydraulic press. The
pellets were scanned over a wave number range 400-4000cm-1. The IR spectra data of pure
drug, mangifera indica, moringa oleifera, and hydroxyl propyl methyl cellulose and
combination of polymers and drug were tabulated.
Page 31
Experimental work
FT-IR Spectroscopy
Page 32
Experimental work
4.11. Formulation of matrix tablet of drug

Table.4.3. Composition of drug and polymers (in mg)
S.no
Name of the
Ingredients
F1
F2
F3
F4
F5
F6
(mg)
(mg)
(mg)
(mg)
(mg)
(mg)
Telmisartan
40
40
40
40
40
40
Mangifera indica
10
20
30
Moringa oleifera
10
20
30
MCC
195.5
185.5
175.5
195.5
185.5
175.5
Magnesium
stearate
Talc
2.5
2.5
2.5
2.5
2.5
2.5
Total Weight(mg)
250
250
250
250
250
250
Page 33
Experimental work
4.11.1. Preparation of CR matrix tablets
Step 1: Weighing
The total ingredients were weighed accurately as per the formulation code.
Step 2: Pre sieving and mixing
Telmisartan was passed through #40 mesh sieve and collected in a bag. All the materials were
loaded in a mixer and mixed for 15 minutes.
Step 3: Method of granulation
The granules were prepared by wet granulation process by the following process. The binder
solution was added to the ingredients and mixed it well until obtaining dough mass.
Step 4: Drying
Wet mass was dried at 50-55 degrees centigrade by using tray dryer for 5-6hrs, until preferred
loss on drying is obtained.
Step 5: Sieving and milling
Dried granules were passed through #16 mesh sieve and over sized granules passed through
2.omm multi mill t normal speed in a head path. Finally milled granules was passed through
#16 mesh size and laden in a 2 cone blender.
Step 6: Blending
Talc was passed through #40 mesh and it was further mixed with other contents of 2 cone
blender and mixed for 10 minutes.
Page 34
Experimental work
PHOTOGRAPHS OF GRNULES AND TABLETS
Photograph. No.1. Photograph of Granules
Photograph. No. 2: Photograph of Tablets
Page 35
Experimental work
Step 7: Compression
PHOTOGRAPH OF TABLET PILOT PRESS
Blended material was weighed down in a hopper and compresses the powder
into tablets by using (cad Mach) compression machine with (9mm) standard flat
punches.
Check for weight variation, hardness, friability, to reach the parameters.
Collect the tablets in a cleaned double poly bag indicating the product and batch
number.
Page 36
Experimental work
4.11.2. PRE FORMULATION STUDIES:
The following characterization study is conducted out for 6 different formulation of granules.
4.11.2.1. Angle of repose
Angle of repose for different formulations was calculated according to fixed cone-shaped tool
repute method. First the prepared granules were passed through the funnel, which was kept at
a height h from horizontal surface. Then passed formed granules formed a pile of the height h
above the horizontal surface. The pile was measured and the () was determined for all the
formulations using the formula.
Angle of repose () = tan-1 (h/r)
Where:
h-height of the pile
r-radius of the pile
Table. No. 4.4. Flow rate values

S. No
Angle of repose() (degrees)
Flow
<25
Excellent
25-30
Good
30-40
Possible
>40
Very poor
4.11.2.2. Bulk density and Tapped density

Bulk density and tapped density were measured by using 10ml graduated cylinder. The
sample poured in the cylinder and was tapped mechanically for 100 times, then tapped
volume was noted and bulk density, tapped density were calculated.
Bulk density = Mass of powder/Bulk volume
Tapped density = Mass of powder/tapped volume
Page 37
Experimental work
4.11.2.3.Carrs index and Hausers ratio:
Compressibility index and Hausers ratio was determined according to following equations
Carrs index (%) = (Tapped density-Bulk density/Tapped density

Hausers ratio = Tapped density/Bulk density
4.11.2.4. Compression:
Compress the lubricated blend using punches mentioned in table
Table. No.4.5. Punches specifications
S. No
Punch diameter
9.00 mm
Punch shape
Flat punches
Upper punch
Plain
Lower punch
Plain
Page 38
Experimental work
Table. No.4.6. Standard specifications for tablet parameters
S. No
Parameters
Specifications
Description
Brown and half-yellow color, uncoated

tablets, flat, plain on both sides
Theoretical mass of tablets
350mg
Average mass
249.00mg
Uniformity of mass
NMT 2/20 individual mass deviate from

7.5% of the average mass and none by
15% of the average mass
Diameter
10.160.20mm
Thickness
5.260.3mm
Hardness
6KP/60N
Friability
NMT 1.0% m/m
Page 39
Experimental work
4.12. EVALUATION:
The tablets are evaluated for Appearance, Weight variation, Thickness, Diameter and
Friability to meet the pharmacopeia standards.
4.12.1. Weight variation of the tablets
20 tablets were chosen at systematic manner from each batch and were weighed accurately.
Average weights of each batch were calculated. The standard deviation was calculated to
determine the deviations by using the formula
Percentage deviation = (Avg wt- Individual wt/Avg wt) X100
Limit for weight variation is 10%
4.12.2. Hardness of the tablets
From each batch of the formulation randomly 5 tablets were selected and hardness is
measured by using Monsanto Hardness Tester. Then standard deviation and average was
determined, hardness was calculated.
4.12.3. Thickness and Diameter of the tablets
10 tablets were randomly preferred from every group and measured by using Vernier
calipers. The average thickness, diameter and standard deviation were calculated.
4.12.4. Friability of the tablets
From each batch of the formulation, 20 tablets were selected and friability was determined by
using Roche friabilator. A pre-weighed tablet sample was positioned in Roche type friabilator
and started for 100 revolutions (25rpm). Then redust the tablets and again re-weighed. The %
friability was calculated by using the formula
Friability index = (Initial wt-Final wt) x100
Limit not more than 1%
Page 40
Experimental work
4.12.5. Drug content
Three tablets were chosen aimlessly from each batch and taken separately into three 100ml
volumetric flasks. In each flask 10oml of Hcl buffer of pH-1.2 was poured and kept for 24hrs.
After filtering the solutions, the absorbance of the filtrate was measured at 296nm. From this
absorbance, drug content was determined and average and standard deviation were
calculation.
Drug content = Concentration x Dilution factor x Conversion factor x Amount of stock
solution
4.13. In-Vitro drug release studies42:
These tests serve 2 important functions. First, data from such tests are
necessary as a guide for formulation during the development stage, prior to clinical testing.
Second, In-Vitro testing is necessary to ensure batch to batch uniformity in the production of
a proven dosage form.
Dissolution
Instrument
: UV-spectrophotometer
Wavelength
: 296nm
In- Vitro Dissolution Apparatus
Page 41
Experimental work
Dissolution parameters:
Medium
: Phosphate buffer PH 7.5 & 0.1M HCL
Volume
: 900ml
Apparatus
: USP Type-II (paddle)
Time intervals
75 rpm
Temperature
37.0 0.50c
Sample preparation:
Transfer one tablet into each dissolution bowels and run the dissolution apparatus as per
dissolution apparatus. Withdraw 10ml of sample through auto sampler containing free flow
filter, at the sampling time. Replace aliquots withdrawn for analysis with equal volumes of
dissolution medium which is holed at 37 0.50c.
Standard solution:
An accurately weighed 40mg of drug was dissolved in phosphate buffer and volume was
made upto 100ml in a volumetric flask (Stock solution-I 1000g/ml). From this 10ml of
solution were pipette out and the volume was making upto 100ml (Stock solution-II ,
100g/ml). Then the absorbence was calculated at 296 nm by using UV- Spectrophotometer.
% release of Drug per tablet can be calculated by using the formula
Test/Std X Std(wt)/100 X 900/20 X potency/100
For all formulations the results of In- Vitro profile were fitted into three kinetic models of
data treatment as follows:
1. Cumulative percentage drug released versus time (zero- order kinetics model).
2. Cumulative percentage drug released versus sq of t (Higuchis model).
3. Log cumulative percentage dug released versus (Korsmeyer- Peppas).
Page 42
Experimental work
In- vitro drug release studies:
Dissolution studies were conducted using a USP II paddle method (75 rpm, 37 C, and 900
ml dissolution medium) with a Tablet dissolution tester . Telmisartan tablet (80mg) was
exposed
in a medium (pH7.5 phosphate buffer). Samples were withdrawn from the
dissolution medium at predetermined intervals (10, 15, 20, 30, 45 and 60 min) and then drug
concentration was determined by UV (Shimadzu) at 296nm. An equivalent amount of fresh
medium was added to maintain a constant dissolution volume. The reference product and a
selected batch(F6 ) were again taken for a dissolution study in a different media(4.5pH
Phosphate buffer, 0.1N HCl, 4.5pH acetate buffer) to compare dissolution profile of a
selected batch with a reference product.
4.13.1. Drug release kinetics for prepared matrix tablets

To learn the release kinetics, data obtained from drug release by In-vitro method were plotted
in various kinetic models.
a) Zero order equation
The graph was plotted as %drug release Vs time in days
C=Ko t
Where:
Ko= Zero order rate constant in conc/time
T=Time in days
The graph gives a straight line with a slope equal to ko and intercept the origin of the axis.
The obtained outcomes were tabulated and graph was plotted.
b) First order equation
The graph was plotted s log cumulative % drug remaining Vs time in days.
Log C=log Co-Kt/2.303
c) Higuchi kinetics
The graph was plotted as cumulative drug release % Vs sq. of t
Q=Kt1/2
Where:
K = Constant reflecting design variable of systems (Differential rate constant)
Page 43
Experimental work
t = Time in days. (95)
Hence the charge of drug release is comparative to the mutual of sq of t. If plot gives
a straight line, slope is one; the dosage form is measured to follow Higuchi Kinetics.
Hence the results are tabulated.
d) Korsmeyer-Peppas equation
To estimate the release of drug mechanism, it was additionally plotted in Peppas
equation as log cumulative % of drug release against time.
Mt/M = Ktn
Log Mt/M = log K+n log t
Where:
Mt/M= Fraction of free drug (time t)
K= Kinetic constant (incorporating structural and geometric characteristics of
preparation)
n= diffusional proponent indicates the method of drug release
4.15. STABILITY STUDIES

After determining drug content, the tablets are charged for stability studies according
to ICH guidelines (402C and 7555 RH) for a period of 3 months in stability
chambers. The samples were taken after three months and evaluate for drug content,
dissolution, related substances and physical parameters like hardness and friability.
Page 44
Experimental work
Table. No. Recommended stability storage conditions for various products in
Zone I and II Countries (ICH/USFDA Draft)
S. No.
Product
Accelerated
Intermediate
Long term
Solid oral dosage forms,
40 C/ 75%
30 C/ 80% RH
25 C/80% RH
lyophilized powders in vials
RH
Liquids in glass bottles,
40 C/ ambient
30 C/ ambient
25 C/ ambient
vials, ampoules
humidity
humidity
humidity
Drug products in
40 C/15% RH
30 C/40% RH
25 C/40% RH
-15 C15 C
semipermeable and
permeable containers
4
Drug intended to stored at
25 C/60%RH
refrigerator temperatures
or 25 C/
ambient
humidity for
liquid
products
Stability storage for
5 C3 C/
5 C3 C with
products intended to stored
ambient
monitoring, but
at freezer temperatures
humidity
not control of
humidity
Stability storage conditions
Additional
Additional
Additional
for some inhalation products
storage
storage
storage
conditions
conditions
conditions
(40 C/ 75%
(40 C/ 75%
(40 C/ 75%
RH)
RH)
RH)
Page 45
Experimental results
5. EXPERIMENTAL RESULTS
5.1. Construction of calibration curve
Table. No. 5.1. Calibration curve values of Telmisartan
S.NO.
concentration
Absorbance
0.08
0.16
0.23
0.31
10
0.39
12
0.45
Graph. No. 5.1. Calibration curve of Telmisartan
Absorbance
Calibration curve of Telmisartan

0.5
0.45
0.4
0.35
0.3
0.25
0.2
0.15
0.1
0.05
0
0
10
12
14
Concentration (g/ml)
Page 46
5.2 PREFORMULATION STUDIES
The Pre formulation studies are the first step in the development of any formulation. The
major goal of this study is to establish compatibility of drug with polymers.
5.2.1 DRUG POLYMER COMPATABILITY BY FT-IR SPECTRAL STUDIES
Drug polymer compatibility studies were performed by FTIR (Fourier transform infrared
spectroscopy). FT-IR absorption spectra of Drug, moringa oleifera, mangifera indica and
Hydroxyl propyl methyl cellulose and the combination of drug and polymers were shows no
significant between Drug and polymer.
Page 47
Graph No.5.2. FTIR Spectrum of pure Drug (Telmisartan)
Table. No. 5.2. Interpretation of pure drug (Telmisartan)

S.NO
Group assigned
Frequency cm-1
-OH stretching
3448.72
C-H stretching
3035-3059
(aromatic)
3
C-H stretching
2927-2958
(aliphatic)
4
C=O stretching
1654.92
R-NH
1408.04
C-N stretching
1130.29
Page 48
Graph No.5.3.
FT-IR Spectrum of Telmisartan + Mangifera indica
Table. No. 5.3. FT-IR Interpretation of Telmisartan+Mangifera
S.NO
Group assigned
Frequency cm-1
C=C bending
813-864
O-H bending
1230.58
C=C stretching
1411-1600
C-O stretching
1693.50
Page 49
Graph No.5.4.
FT-IR Spectrum of Telmisartan + Moringa oleifera
Table. No. 5.4. FT-IR Interpretation of Telmisartan+Moringa
S.NO
Group assigned
Frequency cm-1
O-H bending
1230.58
C=O stretching
1697.36
C-H stretching
2850-2866
C-N stretching
3680-3849
Page 50
5.3. EVALUATION OF THE GRANULES
Table.no. 5.5. Physico-chemical parameters of powdered granules:
Formulation
Angle of
code
repose
Bulk density
Tapped
Carrs index
density
Hausners
ratio
F1
28.410.15
0.3820.011
0.4190.014
8.831.82
1.0910.05
F2
25.260.12
0.3780.021
0.4260.017
9.561.75
0.1050.07
F3
25.780.21
0.3820.023
0.4220.021
9.471.61
1.1040.03
F4
26.930.18
0.3570.022
0.3880.022
7.991.56
1.0820.01
F5
27.380.16
0.3610.025
0.3980.026
9.301.25
1.010.03
F6
28.470.14
0.3600.024
0.3870.027
9.561.30
1.1050.09
Page 51
5.4. PHYSICOCHEMICAL PARAMETERS OF TABLETS
Table.5.6.Physicochemical parameters of tablets
Formulation
Weight
Code
Variation
(mg)
Thickness
Hardness
Friability
(mm)
(Kg/cm3)
(%)
Drug
content
(%)
F1
2480.13
3.600.03
4.060.11
0.760.04
98.440.36
F2
2520.45
3.540.31
4.020.07
0.690.02
99.740.51
F3
2480.16
3.530.23
3.980.14
0.870.05
99.660.46
F4
2510.21
3.520.08
4.000.16
0.740.01
98.560.65
F5
2480.17
3.330.16
4.090.04
0.840.03
99.570.30
F6
2490.32
3.360.12
4.030.12
0.890.04
98.450.55
Page 52
5.5. IN-VITRO DRUG RELEASE STUDIES:
Table no. 5.7. In-vitro drug release data of formulation F1-F6

Time(hrs)
F1
F2
F3
F4
F5
F6
8.550.17
9.050.15
10.70.19
9.30.16
9.250.18
10.90.16
12.640.14 16.220.11 18.350.15 17.260.17 12.750.23
23.50.18
17.80.15
19.560.18
26.40.16
26.40.23
21.520.16
27.20.14
36.650.16 33.540.21 33.650.25 36.650.23
20.70.12
32.120.12 41.650.21 41.260.23 43.530.11 41.650.11
32.640.13 42.430.11 51.960.23 49.630.23 54.790.16 51.960.19
49.230.13 50.190.14 62.260.16 55.280.14 59.670.19 62.260.17
51.020.21 59.250.12 67.460.11 60.270.16 65.390.19 67.460.19
56.830.23 68.120.18 70.230.24 75.340.19
10
59.810.24 71.020.14 72.960.22 79.250.21 79.620.21 84.750.21
11
68.010.19
82.90.14
12
26.520.19 23.260.22
72.50.15
78.120.24
78.120.16 81.050.22 81.620.25 92.450.25

85.90.23
84.230.16 83.920.25 99.950.11
Page 53
5.5. In-vitro drug release plots of Telmisartan tablets (F1-F6)

In- vitro drug release plots of Teimisartan tablets ( F1-F6)
100
90
Cumulative % drug release
80
70
F1
60
F2
50
F3
40
F4
30
F5
20
F6
10
0
0
10
12
Time in hrs
5.7 STABILITY STUDIES

Table No.5.8: Drug content of the selected matrix formulation before and after storage for three
months period
Percentage Drug content(X S.D)
Formulation
Before storage
F6
98.450.55
After storage
97.8910
Significant Difference
P > 0.05
Page 54
Table.no.5.9. Release profile of Drug Controlled release tablets (F6) before and
after storage for three months period during the stability Testing
Time (h)
Percentage of Telmisartan released

Before Storage
After Storage
10.9 0.16
9.7 0.03
23.5. 0.18
22.35 0.16
26.4 0.23
25.4 0.16
36.650.23
35.5 0.17
41.65 0.15
40.55 0.12
51.96 0.11
51.96 0.22
62.260.19
61.26 0.21
67.46 0.17
66.46 0.25
78.12 0.24
77.12 0.25
10
84.75 0.21
83.50 0.28
11
92.45 0.25
91.450.22
12
99.95 0.11
98.89 0.10
Page 55
Graph.no.5.6. Stability studies
Cumulative % drug release
120
stability studies
100
80
60
40
20
0
0
10
12
14
Time in hr
Page 56
Results and Discussion

6. RESULTS AND DISCUSSION
Matrix tablets of drug were formulated by wet granulation method by using polymers like
mangifera indica, moringa oleifera and micro crystalline cellulose. The formulated matrix tablets
were characterized for their physicochemical parameters like Weight variation, Thickness,
Hardness, Friability, % Drug content. The results were shown in the table
6.1 Drug-polymer compatibility studies by FTIR
The FTIR spectra of Drug, mangifera indica, moringa oleifera and MCC and blend of
drug and polymers were shows no interaction between drug and polymer. The FTIR spectras are
shown in the figure
6.2 Preformulation Studies
The flow properties and the derived properties evaluated for all the 6 formulations were
proved to be within the limits showing good flow properties. The physical properties like tapped
density, bulk density, angle of repose, compressibility index and Hausers ratio of all the
formulations were complied with standard specification and the results tabulated as in the table
6.3 Physicochemical properties
The drug Matrix tablets are characterized based upon their physicochemical individuality
like Hardness, Weight Variation, Friability, % Drug content. The physicochemical characteristics
of all the formulations were complied with standard specifications and the results tabulated as in
the table
6.4 Hardness
The difference in the hardness of the prepared tablets ranges from 4.090.15 to 3.980.04
KP released by the course of action of diffusion.
6.5 Thickness
The thickness of the tablet was observed by using digital Vernier caliper and found to be
in the range from 3.640.31 to 3.360.12.
Page 57

6.6 Weight Variation
The Weight variation of the prepared tablets was bringing into within the range of
2510.02 to 2480.35.
6.7 Friability
The strength of the prepared tablets was tested by using Roche Friabilator. The friability
of all the formulations was observed within the range of 0.860.05 to 0.690.02.
6.8 Drug Content
The drug content of all the formulations were observed within the range of 99.740.55 to
97.440.36
6.9 In-vitro drug release study
The In-vitro drug release study were conducted using phosphate buffer pH 7.5 as
dissolution medium and the results tabulated as and also represented graphically by taking
Time12 (hrs.) on X-axis and Cumulative percentage drug release on Y-axis.
In formulation F1 the Drug tablet were prepared with 40mg drug and 10mg mangifera
indica and 195.5mg of MCC, they shown drug release of 68.010.19 in phosphate buffer at the
end of 11 hours. In formulation F2 the Drug tablet were prepared with 40mg drug and 20mg
mangifera indica and 185.5mg of MCC, they shown drug release of 82.90.14 in phosphate
buffer at the end of 11 hours. In formulation F3 the Drug tablet were prepared with 40mg drug
and 30mg mangifera indica and 175.5mg of MCC, they shown drug release of 85.90.23 in
phosphate buffer at the end of 12hours.
In formulation F4 the Drug tablet were prepared with 40mg drug, 10mg moringa oleifera
and 195.5mg MCC, they shown drug release of 84.230.16in phosphate buffer at the end of 12
hours. In formulation F5 the Drug tablet were prepared with 40mg drug, 20mg moringa oleifera
and 185.5mg of MCC, they shown drug release of 83.920.25 in phosphate buffer at the end of
12
hours. In formulation F6 the Drug tablet were prepared with 40mg drug, 30mg moringa
oleifera and 175.5mgof MCC, they shown drug release of 99.950.11in phosphate buffer at the
end of 12 hours.
Page 58

Among all the formulations (F1-F6), F6 formulation shows superior drug release
which is obtained in the graph
6.10 In vitro release kinetics:
Data of In-vitro drug release were fitted into dissimilar equations and kinetic models used
to elucidate the release kinetics of drug from controlled release tablet. The kinetic models used
are zero-order equation, Higuchis model and Peppas models. The obtained outcome in these
formulations were plotted and are as follows i.e. Cumulative % release of drug Vs sq of t
(Higuchis) and Log cumulative percentage drug release Vs log t (Peppas). To know the method
of drug release drug release from tablet, the release of drug data was fit into Higuchis models.
6.11 Mechanism of drug release:
Kinetic results shown in table explains that all prepared formulations follows zero-order
kinetics as correlation coefficient (r2) values are revealed than that of first-order release kinetics.
For drug release were between 0.723-0.848 with a correlation coefficient (r2) values >0.93,
suggests that drug release mechanism from matrix tablets followed non-Fickian (anomalous)
transport mechanism.
6.12 Stability Studies:
The stability studies were conceded according to ICH guidelines for the optimized
formulation i.e. F6 under accelerated stability studies (402C/ 755%RH). The tablets are
crammed in blister packing. Then tablets were stored under 3 conditions and the tablets are
withdrawn at every month and evaluate the tablet parameters like description, assay and
dissolution. The tablets showed the same results as that of initial result at accelerated stability
condition. It shows slight changes in drug release, but it was in acceptable limits. Study of
percentage drug remaining in the best formulation reveals that there no definite changes
observed to justify for drug degradation were shown in the table.
Page 59
Summary
7. SUMMARY
Drug is an anti-hypertensive agent use as treatment of heart diseases. It has relatively
short biological half-life of 24 hrs. Oral bioavailability is less than 42 %. It dose is 40mg twice
daily. It is rapidly absorbed in the upper part of G.I. tract and rapidly eliminated which results in
the change in drug concentration of plasma, so therapeutic amount of drug needed for the
treatment will not reach the site of action. In order to hold the therapeutic amount of the drug is
needed to prolong the release of drug which can be obtained by novel drug delivery system.
In the current revision an attempt was made to prepare Matrix tablets by wet granulation
method using different polymers. Different types of polymers such as Mangifera indica, MCC
and Moringa oleifera are used as drug release retard polymers as they gave optimum drug release
as well as long acting effect. It was also found that the tablet formulations retarded the release of
drug for 12hrs.
Prepared Matrix tablets of Drug were evaluated for hardness, Weight variation, Friability,
Thickness, Enlargement Index and Stability studies. The release of drug from F6 formulation
having 30mg of Moringa oleifera, 175.5mg of MCC was governed by Non-Fickian transport and
zero order release. Among the formulations F6 shows drug release of 99.95% at 12hr. Hence it is
optimized formulation, Stability studies has not shown any significant changes during the period
of 3 months.
Page 60
Conclusion and future scope of work

8. CONCLUSION
The formulations prepared with drug: polymer ratio 1: 3 (Telmisartan 40mg &
Moringa oleifera 30mg) shows 99.95 % drug release in 12 hrs and formulations prepared with
drug: polymer ratio 1: 3 could retard the drug release up to desired time period. The tablets
containing polymers mangifera indica and moringa oleifera retard the drug release. From the
release study it was observed that as we increase the concentration of polymers may be due to
increased viscosity which might have helped to releasing the drug for 12 hrs. Among these
formulations F6 shows 99.95% release in 12 hrs and the release profile follows zero order
kinetics, then value of the formulations shows that the release profile obeys non fickian diffusion
which shows that drug is released via diffusion.
The present research work reports that the development of matrix tablets for sustained
release of Telmisartan following oral administration. It can be conclusively stated that the matrix
tablet appears to the promising system for the delivery of controlled release Telmisartan for the
treatment of Cardio vascular disease. The best formulation is F6 which has maximum drug
release of 9.95 % up to 12hrs (controlled drug release).
8.1. FURTHURE SCOPE OF WORK

Marketed product comparison studies
In- vivo studies
In vitro and In- vivo correlation
Page 61
Bibliograhy
9. BIBILOGRAPHY
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Biopharmaceutics and Pharmacokinetics a treatise, 1995, 335-375.

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from swellable matrix tablets, J Pharm Sci. 991-997.
9. Desai SJ, 1966. Investigation of factors influencing release of solid drug dispersed
in inert matrices. J Pharm Sci. 598-602.
10. Donald L Wise, Hand book of pharmaceutical controlled release technology, 466471, 738-739.
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of Valsartan by using seed mucilage of Ocimum Bacilim Linn, Vol-5(4), P- 21282133, 2014.
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Dept. of pharmaceutics, ANCP, Rajampet.
Bibliograhy
16. Kulkarni. Vishakha et al., Natural polymers, IJRPBS, 2012, Vol-3(4), P-1597-1598.
17. S.Shanmugam et al., Natural polymers and their applications, Natural product
Radiance, P-480, 2005.
18. Amelia, et al., recent investigations of plant based natural gums, mucilages and
resins in NDDS, Ind J Phm Edu Res, Vol-45, pp-85, 2011.
19. Abitha M H*, Flowerlet Mathew, et al., Natural polymers in Pharmaceutical
Formulation, International Journal of Institutional Pharmacy and Life Sciences,
5(1), 2015.
20. Abitha M H; et al., Natural polymer in pharmaceutical formulation, www.
ijipls.com, 2015.
21. N.G Raghavendra Rao*, Shrishail M. Ghurghure et al., Formulation and Evaluation
of controlled release Gas powdered system using hydrophilic polymer; IRJP.2 (3)
2011.86-94.
22. Vinod R*1 et al., Formulation and Evaluation of Nicorandil sustained release matrix
tablets using natural gum mangifera indica as release modifier; ISSN 2249-622X,
2013.
23. D.C.Sahoo*1,S.Dash2, C.Das3, Dr.N.S.K.Choudhury 4 et al., Ethanobotany,
Phytochemistry and Pharmacology; 2011, vol. 2(2) 73-93.
24. Sharpe et al., A review on Telmisartan; 2001, vol.61, Issue 10, pp. 1501-1529.
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of pharmaceutics; vol. 484, Issues 1-2, pages. 1-292.
26. Sonia et al., Formulation and Evaluation of sustained release tablets; International
journal of pharmacy. 2013; 3 (1): 73-76.
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studies of mangifera indica leaves; 2016, vol-5, Issue 2, 1220-1226.
28. Sailaja B. Srilakshmis et al., Isolation and Evaluation of seed coat constituents of
Moringa oleifera; 2016; 6(1):1-6.
29. Amrinder Singh*, K. K. Jha, Anuj Mittal, Amit Kumar et al., A review on
Telmisartan; Journal of scientific and Innovative research; 2013, vol-2 ,Issue-1.
30. Amrinder Singh*, K. K. Jha, Anuj Mittal, Amit Kumar et al., a review on
Telmisartan; Journal of scientific& Innovate research vol-II, (Issue-1), 2013.
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31. Pratikumar A. Patel and Vandana B. Patravale1et al., Commercial Telmisartan
Tablets; A Comparative Evaluation with Innovator Brand Micardis ; International
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the gum of Moringa oleifera; Malaysian Journal of Pharmaceutical Sciences Vol.
11, No. 2, 4147 (2013).
33. Patil Basawraj s*, Soodam Srinivas P, Kulakarni Upendra, Korwar Prakassh G. et
al., Evaluation of Moringa oleifera gum as binder in tablet formulation; Patil B S et
al/IJRAP 2010, 1 (2) 590-596.
34. Kalaiyarasi.L1, Fauzia Ahmed2 and Mubeen Sultana D3 et al., role of two
commonly available plants in combating harmful bacteria; IOSR Journal of
Pharmacy and Biological Sciences (IOSR-JPBS) e-ISSN: 2278-3008, p-ISSN:
2319-7676. Volume 9, Issue 3 Ver. IV (May -Jun. 2014), PP 05-12.
35. Bhoomika R Goyal2 and Anitha A Mehta2* et al., phytopharmacology of Moringa
oleifera, Natural product Radiance, Vol.6 (4), 2007, PP. 347-353.
36. Patil Basawaraj S *; Soodam Srinivas R., Kulkarni Upendra, Korwar Prakassh.G et
al., Formulation & Evaluation of Moringa oleifera gum as a binder in tablet
formulation; IJRAP 2010, 1 (2). 590-596.
37. Farooq Anwar1, Sajid Latif1, Muhammad Ashraf2 and Anwarul Hassan Gilani3* et
al., Moringa oleifera a plant food with multiple medicinal uses; 1725 (2007).
38. Kajal Ghosal, Subrata Chakrabarty and Arunabha Nanda et al., Hydroxy profile
methyl cellulose in Drug Delivery; Der Pharmacia Sinica, 2011, 2 (2): 152-168.
39. Dipti Phadtare*, Ganesh Phadtare, Nilesh B*, Mahendra Asawat* et al.,
Hypromellose-A Choice of polymer in Extended Release Tablet Formulation; Vol.3,
2014, Issue 9, 551-566.
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Dosage form ; Vol .6 , Issue 4, 2013.
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Chapter 1
Introduction
Chapter 2
Literature Review
Chapter 3
Aim & Objectives
Chapter 4
Experimental Work
Chapter 5
Experimental Results
Chapter 6
Discussion of Results
Chapter 7
Summary
Chapter 8
Conclusion
&
Further scope of Work
Chapter 9
Bibliography

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INDEX

1.1.Oral drug delivery

1.2.Controlled Release Drug Delivery Systems

1.3.Oral Controlled Released Systems

1.4.Controlled Release Through Matrix Devices

1.6.Drugs used as anti-hypertensive agents

4.1. Suitability of Drug

4.2. Plan of Work

4.3. List of Materials

4.4. List of Instruments

4.6. Moringa Oleifera

4.8. Micro crystalline Cellulose

4.9. Construction of Calibration curve

4.10. Drug-Polymer Compatibility Studies

4.11. Formulation of Telmisartan Matrix Tablets

4.12. Physico chemical evaluation of Formulated

4.13. In vitro Drug Release Studies of Matrix tablets

4.14. Stability Studies

5.2. Pre formulation Studies

5.3. Physicochemical parameters of powder granules

5.4. In vitro Drug Release Studies

5.5. Stability Studies

RESULTS AND DISCUSSION

CONCLUSION AND FURTHUR SCOPE OF

List of Materials Used

List of Instruments Used

Composition of Drug & Polymers (in mg)

Flow rate Values

Standard Specifications for Tablet Parameters

Calibration curve values of Telmisartan

FTIR Spectra Data for Telmisartan

FTIR Spectra Data for Telmisartan and mangifera indica

FTIR Spectra Data for Telmisartan and moringa oleifera

Physicochemical parameters for powdered granules

Post formulation parameters of Telmisartan tablets

In- vitro Dissolution data of Telmisartan tablets F1-F6

Drug content of the selected matrix tablets before and after

Release profile of Telmisartan matrix tablets (F6) before &

FTIR Spectra of pure Drug (Telmisartan)

FTIR Spectra of Telmisartan with Mangifra indica

FTIR Spectra of Telmisartan with Moringa oleifera

Standard plot for Telmisartan

FT-IR spectra for pure drug(Telmisartan)

FT-IR spectra for pure drug (Telmisartan + Mangifera indica)

FT-IR spectra for pure drug (Telmisartan + Moringa oleifera)

Comparitive In-vitro drug release plots of F1-F6

Photographs of UV-visible spectrophotometer

Photograph of FTIR apparatus

Photograph of tablet punching machine

Photograph of USP dissolution apparatus

Controlled Release Drug Delivery System

Micro crystalline Cellulose

Food and Drug Administration

Department of pharmaceutics, ANCP, Rajampet.

1.3.3. Microcapsules and Microspheres 8

Department of pharmaceutics, ANCP, Rajampet.

1.3.9. Micro and Multiple emulsions

Drug dispersed in polymer

Drug dispersed polymer

: It allows a reduction in dosing

frequency from that necessitated by a conventional dosage form, such as solution or an

Department of pharmaceutics, ANCP, Rajampet.

In some cases hypertension may be secondary to other diseases like:

1.6.Drugs used as Antihypertensive agents15