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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
M. PHARM SYNOPSIS
YEAR OF ADMISSION-MAY 2011
TITLE OF THE SYNOPSIS
EVALUATION OF BINDING AND SUSPENDING PROPERTY OF
NEEM GUM, BANANA PEEL MUCILAGE AND ORANGE PEEL PECTIN
AS PHARMACEUTICAL EXCIPIENTS.
BY
M RAVINDRAKULLAI REDDY
M. PHARM., PART-I
DEPARTMENT OF PHARMACEUTICS
UNDER THE GUIDANCE OF
Dr. K. MANJUNATH. M.Pharm.,Ph.D.
PROFESSOR
DEPARTMENT OF PHARMACEUTICS
INSTITUTION
SREE SIDDAGANGA COLLEGE OF PHARMACY
B. H. ROAD, TUMKUR-572 102
KARNATAKA
1
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
NAME OF THE
CANDIDATE
AND ADDRESS
Mr. M RAVINDRAKULLAI REDDY
SREE SIDDAGANGA COLLEGE OF
PHARMACY
B.H. ROAD, TUMKUR- 572102
KARNATAKA
2.
NAME OF THE
INSTITUTION
SREE SIDDAGANGA COLLEGE OF
PHARMACY
B.H. ROAD, TUMKUR- 572102
KARNATAKA
3.
COURSE OF STUDY AND
SUBJECT
MASTER OF PHARMACY IN PHARMACEUTICS
4.
DATE OF ADMISSION
MAY 2011
5.
TITLE OF THE TOPIC
“EVALUATION OF BINDING AND SUSPENDING PROPERTY OF NEEM GUM, BANANA
PEEL MUCILAGE AND ORANGE PEEL PECTIN AS PHARMACEUTICAL EXCIPIENTS.”
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6.0
BRIEF REVIEW OF THE INTENDED WORK
6.1. NEED FOR THE STUDY:
The oral route of administration is the most preferred route than other routes of
administration due to various advantages including self administration, compactness,
avoidance of pain, versatility and most importantly patient compliance.1 Solid oral dosage
forms represents the preferred class of product, as tablet represents a unit dosage form in
which one usual dose of the drug has been accurately placed. It avoids errors in the total dose
to be taken when the drug is self administered by the patient.
Pharmaceutical suspensions are biphasic liquid dosage forms of medicament in which the
finely divided solid particles are dispersed in a liquid or semisolid vehicle. The internal phase
(solid) is dispersed throughout the external phase (fluid). The addition of suspending agents
is essential in order to stabilize these systems. These suspending agents increase the stability,
easy redispersibility, enhance pourability and prevent compact cake formation.
Gums, mucilages and pectins are having variety of applications in pharmaceutical field. Gum
is a by product obtained as a result of metabolic mechanisms of plants. Gums are readily
dissolved in water. Gums are used in pharmaceutical field as tablet binders, disintegrants,
emulsifiers, suspending agents, gelling agents, stabilizing agents and thickening agents. The
sources of gums are marine origin: agar, carrageenans, alginic acid and laminarin. Plant
origin: (1) shrubs/tree exudates—gum arabica, gum ghatti, gum karaya, gum tragacanth,
khaya and albizia gums; (2) seed gums—guar gum, locust bean gum, starch, amylose,
cellulose; (3) extracts—pectin, larch gum; (4) tuber and roots—potato starch.2 Neem gum is
obtained from Azadiracta indica belongs to family Meliaceae. Neem gum is clear, bright and
amberd coloured material, non-bitter in nature and is soluble in cold water. It contains
mannose, glucosamine, arabinose, galactose, fructose, xylose and glucose. Very little
information about usage of neem gum as binding agent3 and suspending agent is available in
literature. In the present study attempts shall be made to utilize the neem gum as binding and
suspending agent.
Mucilages are polysaccharide complexes formed from sugar and uronic acid units. Mucilages
will form slimy masses with water. Mucilages are used as binding agent, suspending agent
and thickening agent2. The sources of mucilage are musaparadisical pulp, acacia senegal,
Abelmoschues esculentus mucilage etc.4 Botanical name of banana fruit is Musa paradisiaca
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belongs to family Musaceae. Banana peel is thickening and adhesive in nature. In the present
study, attempts shall be made to utilize dried powder of banana peel mucilage as suspending
and binding agent.
Pectin is a structurally heteropolysaccharide contained in the primary cell walls of terrestrial
plants. Pectin mainly consists of partial methyl esters of polygalacturonic acid and their
sodium, potassium, calcium and ammonium salts. Pectins have been used in food industry in
jams and jellies but recently they are being explored for their other pharmaceutical
applications as binding agent5 and suspending agent. The sources of pectin are orange, apple,
quince, plume, gooseberry, cherries and grapes etc. Botanical name of orange fruit is Citrus
sinensis belongs to family Rutaceae. Orange peel consists of pectin, essential oils, cellulose,
proteins and simple carbohydrates. Pectin occurs as a white to light brown powder or
granules. It has advantages like binding, suspending and thickening agent. The synthetic
pectins used as excipients have many disadvantages such as high cost, toxicity and nonbiodegradable. Natural pectins are easy to extract, purify, non toxic and biocompatable.
Non-steroidal anti-inflammatory drugs (NSAID) that possess analgesic and anti
inflammatory actions for the treatment of rheumatoid arthritis and osteoarthritis. Any one of
the suitable anti-inflammatory drug will be utilized as model drug in this study.
Today, the pharmaceutical industry is mainly depending on only few natural gums such as
acacia, tragacanth, guar gum and veegum, but prices of these few gums are increasing
constantly. Pharmaceutical gums such as acacia and veegum maintain sizable markets in
spite of fluctuations in their availability. India has been importing majority of gums due to
lack of availability of them. Traditionally supply of gum arabic has relied on Sudan and
West-African countries. In order to save the Indian economy and to reduce the import of
gums, there is need to find alternative binding and suspending agents. Therefore, a suitable
substitutes (gums, pectins, mucilages) would be welcomed both for local and international
use. In view of the disadvantages of synthetic polymers used as expients in pharmaceutical
formulations, there is a need to find suitable substitute from natural sources.
The objectives of the present study is to investigate feasibility of utilizing neem gum, orange
peel pectin and banana peel mucilage as binding and suspending agents in formulation of
tablets and suspensions employing any one of suitable anti-inflammatory drug.
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6.2. REVIEW OF LITERATURE:
Paracetamol tablets were prepared by wet granulation technique using mangifera indica gum
as a tablet binder was formulated by Anoop KS et al. The prepared tablets were evaluated for
their quality control tests. Friability of the tablets range from 1.12 to 0.26 % and the
disintegration time from 3 to 8 min. The binding efficacy of the mangifera indica gum was
compared with the standard binder gum acacia at similar concentration (5% w/w). The tablets
hardness prepared from mangifera indica gum varies from 6.3 to 6.8 kg/cm2 which are
comparable with the standard binder, gum acacia (4.8 kg/cm2). It was concluded that
mangifera indica gum can be used as a binding agent in the formulation of tablet dosage
forms.6
Study was carried out to find out the potential of almond gum as a tablet binder and release
retardant in formulations designed by Sarojini S et al. Seven formulations were prepared by
wet granulation method by using diclofenac sodium as model drug. The release effects of
almond gum and polyvinylpyrrolidine (PVP) on the diclofenac sodium was studied by using
2, 4, 6, 8 and 10% w/v of almond gum solution and 2, 4% w/v of PVP gum solution. The
results showed that drug release was increased with almond gum when compared to synthetic
gum concentration of 2 and 4%. Tablet at 2% w/v binder concentration showed optimum
results as tablet binder. They concluded that almond gum was found to be useful for the
preparation of uncoated tablet dosage form.7
Dendropthoe falcata mucilage was evaluated as a binder for pharmaceutical dosage forms
developed by Kothawade SN et al. Tablets were prepared with dendropthoe falcata mucilage
and evaluated for tablet characteristics. Wet granulation technique was used for the
preparation paracetamol granules. The tablet binder concentrations used in formulations were
2, 4, 6 & 8 % w/w. The evaluation of granules showed 32 to 34º angle of repose. Tablets
were compressed to hardness at about 6.6 to 6.9 kg/cm2 with friability 0.98 to 0.53 % and 10
to 17 min of disintegration time and more than 90 % dissolution in 70 min. Tablets at 6 %
w/w binder concentration showed more optimum results as tablet binder. Thus dendropthoe
falcata mucilage was found to be useful for preparation of uncoated tablet dosage form.8
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Plantain starch obtained from the unripe fruit of the plant musa paradisiaca L. (Musaceae)
was used to as binding agent and paracetamol tablets were prepared. Mechanical and
disintegration properties of these tablets were compared with tablets in which corn starch BP
using a 23 factorial experimental was design by Akin-Ajani OD et al. Tablets containing
plantain starch had lower tensile strength and disintegration time values than those containing
corn starch, but showed better ability to reduce the lamination and capping tendency in
paracetamol tablet formulation. They concluded that plantain starch could be useful as an
alternative binding agent to cornstarch, especially where faster disintegration is required and
the problems of lamination and capping are of particular concern.9
Isolated pectin from mango peel utilized as superdisintegrating agent along with sodium
starch glycolate was designed by Rishiabha M et al. Tablets prepared with mango peel pectin
showed comparatively lesser release of drug as compared to sodium starch glycolate for a
specific period of time. They concluded that mango peel pectin can not be used as
superdisintegrating agent but due to its good solubility and higher swelling index, it may be
used in fast dispersible formulations.10
Preliminary trials were made to isolate pectin from dried orange fruit peel to assess its
binding property in tablets using paracetamol as model drug was formulated by Pranati S
et al. The tablets prepared with pectin were compared with a reference batch of starch as
binding agent. On the basis of drug release behavior it was said that release of all four
batches under study was less than that of reference batch. They concluded that orange peel
was better binder over commercially used synthetic binders.11 These studies indicates usage
of orange peel pectin as binding agent, however, further investigations are need in assessing
other quality parameters.
The suspending property of Khaya senegalensis (Family Meliaceae) gum in Co-trimoxazole
suspension was evaluated by Mahmud HS et al. The gum obtained from corresponding plant
was processed and its physicochemical properties such as solubility, water sorption, pH and
rheology were determined. The gum was used to formulate 4.8% w/v co-trimoxazole
suspension in concentrations of 0.2-5.0% w/v. Acacia senegal gum was used as a standard for
comparison. The prepared suspensions were stable, pourable and redispersible with no
evidence of crystal growth. Khaya senegalensis gum at 0.2% w/v was able to suspend co6
trimoxazole. The suspensions remained flocculated, aesthetic in appearance and stable
throughout the four weeks period of storage. They concluded that Khaya senegalensis gum
was potential to be used at 0.2% w/v concentrations as suspending agents.12
In order to select a new cheap, effective alternative natural suspending agent for
pharmaceutical suspensions Raj D et al., performed comparative studies between the
Leucaena Latisiliqua seed gum and other gums like tragacanth, acacia. Leucaena Latisiliqua
seed was boiled and the seed gum was extracted with acetone, dried and powdered. Different
type of zinc oxide suspensions were prepared by using Leucaena Latisiliqua seed gum,
tragacanth and acacia. Further effect of type and concentration of suspending agent on
sedimentation volume, viscosity and particle size were studied. Result showed that
sedimentation volume, viscosity, and the particle size were found directly proportional to the
concentration of suspending agent and inversely proportional to the flow rate. The
suspending ability of the suspending agents were in the order of Leucaena Latisiliquagum >
tragacanth > acacia. It was concluded that the gum of Leucaena Latisiliqua can be employed
as stabilizer and thickener of choice when high viscosity is desired.13
In order to find a cheap and effective natural excipient for pharmaceutical suspensions the
mucilage from the pods of Abelmoschus esculentus was extracted by Ravi K et al. The
mucilage extracted was devoid of toxicity. Suspensions of paracetamol were prepared and
compared with different concentrations (1%, 2%, 3% and 4% w/v) of Abelmoschus
esculentus mucilage, sodium carboxy methyl cellulose and tragacanth gum. Their
sedimentation profile, redispersibility, degree of flocculation and rheolgical behavior were
also compared. The mucilage under study was found to be a superior suspending agent than
tragacanth and is comparable to sodium caboxy methyl cellulose. Studies indicated that the
mucilage of Abelmoschus esculentus may be used as a suspending agent at 4% w/v. It was
concluded that mucilage of Abelmoschus esculentus can be employed as stabilizer and
thickener of choice when high viscosity is desired especially in pharmaceutical and food
industries.14
The Tamarind seed polysaccharide (TSP) possesses properties like high viscosity, broad pH
tolerance, no carcinogenicity, mucoadhesive nature, and biocompatibility. In literature an
attempt was made by Deveswaran R et al., to use TSP as suspending agent in nimesulide
suspension. The obtained suspensions were compared with the marketed product. The
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suspensions prepared with TSP were redispersed uniformly without any deposits. The
average size of the particles in the suspension was found to be 35.4 μm and the drug content
of all the formulations were in the range of 95-98%. The rheological study of the
formulations indicated that as the rpm increased the viscosity decreased, confirming the shear
thinning nature of the suspension. The suspension was found to be stable during the entire
period of study. They concluded that isolated TSP powder can be used as an effective
suspending agent.15
Suspending properties of different natural polymers (tamarind seed polysaccharide,
tragacanth, acacia and gelatin) were evaluated and compared with each other was designed
by Rishaba M et al. Different polymers at concentration range of 1, 4, 5 % w/v are used to
prepare paracetamol suspension. Sedimentation volume (%), rheology and particle size
analysis were employed as evaluation parameters. On the basis of results obtained
suspending ability of the polymers was graded and found to be in the specific order:
Tragacanth gum > Acacia gum > Gelatin > tamarind seed polysaccharide. They concluded
that, due to the high viscosity of tragacanth gum, it can be a stabilizer of choice when high
viscosity is desired.16
6.3. OBJECTIVES OF THE STUDY:
Following are the objectives of the present study

Collection, purification and determination of the physicochemical properties of neem
gum.

Collection, extraction and characterization of the banana peel mucilage and orange
peel pectin.

Preparation of tablets and suspensions of anti-inflammatory model drug by using
neem gum, banana peel mucilage and orange peel pectin and their evaluation.
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7.0
MATERIALS AND METHODS
Materials
Tablet:
Drug
: Any one of suitable anti-inflammatory drug.
Natural Binding agents
: Neem gum, Orange peel pectin and Banana peel mucilage.
Synthetic binding agents
: Polyvinyl pyrrolidine, Hydroxy methyl propyl cellulose etc.
Excipients
: Micro crystalline cellulose, Talc, Magnesium stearate etc.
Suspension:
Drug
: Any one of suitable anti inflammatory drug.
Natural Suspending agents
: Neem gum, Orange peel pectin, Banana peel mucilage.
Synthetic Suspending agents
: Sodium carboxy methyl cellulose etc.
Excipients
: Amaranth, Glycerine, Methyl paraben, Benzoic acid etc.
Methods:

Development of conventional tablets of anti-inflammatory drug by using neem
gum, banana peel mucilage and orange peel pectin as binding agents following
wet granulation technique.

Formulation of anti-inflammatory drug suspension by using neem gum,
banana peel mucilage and orange peel pectin as suspending agents by using
general suspension methods.
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7.1. SOURCE OF DATA:
a) Journals such as,
Asian Journal of Pharmaceutical sciences.
Indian Journal of Pharmaceutical Education & Research.
Advances in Biological Research.
International Journal of Pharm Tech Research.
International Journal of Pharmaceutical Sciences and Research.
Journal of Scientific & Industrial Research.
International Journal of Pharmaceutical Sciences Review and Research.
(b) Library : Siddaganga College of Pharmacy.
(c) J-gate@Helinet.
7.2. METHOD OF COLLECTION OF DATA:

Collection of the natural gum from Azadirachta indica.

Purification of neem gum.

Evaluation and physicochemical properties of neem gum such as pH.

Extaction and characterization of mucilage from Banana peel.

Extraction and characterization of pectin from Orange peel.

Formulation of granules using anti-inflammatory drug as a model drug by wet
granulation method.

Evalution of granular properties:
1. Bulk density.
2. Angle of repose.
3. Compressibility index.
4. Total porosity.

Compression of prepared granules into tablets.
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
Evalution of tablets :
1. Hardness.
2. Weight variation.
3. Friability.
4. Thickness.
5. Drug content.
6. Disintegration time.
7. Dissolution studies.

Comparision of these properties with tablets prepared from synthetic binder as
reference batch.

Preparation of suspension by using neem gum, banana peel mucilage and
orange peel pectin concentrations using anti-inflammatory drug.

Evaluation of suspension properties:
(a) Sedimentation volume and rate of sedimentation.
(b) Degree of flocculation.
(c) Re-dispersibility.

Comparison of these properties with suspension prepared from a suitable
reference suspending agent.

Stability studies as per ICH guidelines.
7.3 - Does the study require any investigations or interventions to be conducted on patients or
other humans or animals? If so, please describe briefly.
“NOT APPLICABLE”
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7.4 - Has ethical clearance been obtained from your institution in case of 7.3?
“NOT APPLICABLE”
8.0
REFERENCES:
1. Ravi PR, Ganga S, Saha RN. Design and study of lamivudine oral controlled release
tablets. AAPS PharmSciTech 2007;8(4):1-9.
2. Girish KJ, Dhiren PS, Vipul DP, Vineet CJ. Gums and mucilage: versatile excipients
for pharmaceutical formulations. Asian J Pharm Sci 2009;4(5):309-23.
3. Gangurde AB, Malode SS, Bhambar RS. Preliminary evaluation of neem gum as
tablet binder. Indan J Pharm Edu Res 2008;42(4):344-7.
4. Rishiba M, Pranati S, Kulkarni GT. Applications of mucilages in drug delivery-A
review. Advan Biol Res 2011;3(4):241-7.
5. Sarath SM, Basavaraj BV, Bharath S, Deveswaran R, Madhavan V. Formulation and
evaluation of ibuprofen tablets using orange peel pectin as binding agent. Der Pharma
Lett 2011;5(4):1-7.
6. Anoop KS, Vipul KS, Paneer SR, Sivakumar T. Evaluation of mangifera indica gum
as tablet binder. Int J Pharm Tech Res 2010;2(3):2098-100.
7. Sarojini S, Deepthi SK, Manavalan R, Jayanthi B. Effects of natural almond gum as a
binder in formulation of diclofenac sodium tablets. Int J Pharm Sci Res 2010;1(3):5560.
12
8. Kothawade SN, Shinde PB, Agarwal PD, Kamble HV. Preliminary evaluation of
dendropthoe falcate mucilage as tablet binder. Int J Pharm Tech Res 2010;2(2):14746.
9. Akin-Ajani OD, Itiola OA, Odeku OA. Effects of plantain and corn starches on the
mechanical and disintegration properties of paracetamol tablets. AAPS PharmSciTech
2005;6(3):E458-63.
10. Rishaba M, Pranti S, Mayank B, Pramod KS. Mango peel pectin as a
superdisintigrating agent. J Sci Ind Res 2010;69:688-90.
11. Pranati S, Rishaba M, Giriraj TK. Formulation and evaluation of paracetamol tablet to
assess binding property of orange peel pectin. Int J Pharm Sci Rev Res 2010;3(1):304.
12. Mahmud HS, Oyi AR, Allagh TS, Gwarzo MS. Evaluation of suspending property of
khaya snegalensis gum in co-trimaxazole suspension. Res J Appl Sci Eng Technol
2010;2(1):50-5.
13. Raj D, Sankar C, Azeem AK, Mani LM, Mathew L, Senthil V et al. Evaluation of
suspending properties of Leucaena Latisiliqua seed gum. Der Pharm Lett
2010;2(5):67-4.
14. Ravi K, Patil MB, Sachin RP, Mahesh SP. Evaluation of Abelmoschus esculentus
mucilage as suspending agent in paracetamol suspension. Int J Pharm Tech Res
2009;1(3):658-65.
15. Deveswaran R, Bharath S, Furtado S, Sindhu A, Basavaraj BV, Madhavan V.
Isolation and evaluation of tamarind seed polysaccharide as a natural suspending
agent. Int J Pharm Bio Arc 2010;1(4):360-3.
16. Rishaba M, Pranati S, Upendra K, Bhargava CS, Sharma PK. Formulation and
comparision of suspending properties of different natural polymers using paracetamol
suspension. Int J Drug Dev Res 2010;2(4):886-91.
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9.
SIGNATURE OF CANDIDATE
10.
REMARKS OF GUIDE
11.
NAME AND DESIGNATION OF
11.1 GUIDE
11.2 SIGNATURE
RECOMMENDED
Dr. K.MANJUNATH,
M. Pharm., Ph.D.
Professor, Department of Pharmaceutics
------------------
11.3 CO-GUIDE (If any)
11.4 SIGNATURE
11.5 HEAD OF
DEPARTMENT
-----------------
Dr. SURESH V KULKARNI,
M. Pharm., Ph.D.
Professor, Department of Pharmaceutics
11.6 SIGANTURE
12.
12.1 REMARKS OF THE
CHAIRMAN AND
PRINCIPAL
Forwarded to university for approval.
12.2 SIGNATURE
(Dr. S. BADAMI)
Principal
Sree Siddaganga College of Pharmacy
Tumkur.
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