FORMULATION AND EVALUATION OF FAST DISSOLVING

TABLETS OF ANTI-EPILEPTICS
DISSERTATION PROTOCOL
Submitted to the
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.

BY
A. SRINIVAS.
M.Pharm, PART- I.
DEPARTMENT OF PHARMACEUTICS.

UNDER THE GUIDANCE OF

Dr.N.S.CHANDRASHEKAR, M.Pharm,Ph.D
PROFESSOR
DEPARTMENT OF PHARMACEUTICS.
Vivekananda College of Pharmacy,
Dr.Rajkumar Road, Rajajinagar Stage,
Bengaluru (Dist)-560055
2010

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA,

BENGALURU.
Annexure II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.

Name of the candidate and

address:-

A.SRINIVAS.
DEPARTMENT OF PHARMACEUTICS,
VIVEKANANDA COLLEGE OF PHARMACY,
DR.RAJKUMAR ROAD,
RAJAJINAGAR STAGE,
BENGALURU(DIST) - 560055,

2.

Name of the institution:-

KARNATAKA.
VIVEKANANDA COLLEGE OF PHARMACY,
DR.RAJKUMAR ROAD,
RAJAJINAGAR STAGE,
BENGALURU(DIST) - 560055,
KARNATAKA.

3.

Course of study & subject:-

MASTER OF PHARMACY IN
PHARMACEUTICS.

4.

Date of admission to course:-

5.

Title of the topic:-

29TH NOVEMBER 2010.

FORMULATION AND EVALUATION OF FAST DISSOLVING

TABLETS OF ANTI-EPILEPTICS

9.

10.

11.

12.

BRIEF
6.2 REVIEW
RESUME
OF OF
LITERATURE:
THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
1. Sheetal Malke et.al. Were prepared fast dissolve tablets of Oxcarzepine by wet
granulation method by using Avicel PH 102, as a diluents and Ac-Di-Sol as a
The conventional dosage
forms (tablet
andtasting
capsule)
wide
acceptancecontaining
upto 50superdisintegrant.
An effective,
pleasant
andhave
stable
formulation
60 % of 12%Ac-di-sol,25%
the total dosage forms.
Tablet
still and
most8.5%
popular
dosage
form existing
forms
Avicel
PHis102
Starch
as binder
was found
to have
existing good
because
of
ease
of
self
administration,
compact
in
nature,
easy
to
manufacture
2
hardness of 4-4.5 kg/cm , disintegration time of 285 seconds and and
drug
14 solid dosage form is difficulty in
it can berelease
delivered
in
accurate
dose.
One
drawback
of
of not less than 90% within 30 min.
swallowing (dysphasia) and chewing in some patients particularly in geriatric and
paediatric
patients. The
of choking
is common
in geriatric
patientsthree
2. Patel.D.M,
et.alproblem
was studies
in formulation
of phenomenon
ODTs of Rafecoxib
by using
1
due to fear
of
choking,
hand
tremors.
different superdisintegrants croscarmellose sodium, crospovidone and sodium
starch glycolate by wet granulation method, from result it can be concluded that the
The
concept
of mouth
dissolvingexhibit
drug delivery
system(MDDDS)
withand
Signature
of candidate:
tablets
containing
crospovidone
quick disintegration
timeemerged
6 seconds
an objective
to improve
patients15compliance. These dosage forms rapidly disintegrate
wetting
time 5 seconds.
and/or dissolve to release the drug as soon as they come in contact with saliva, thus
3. Srirwaikar.A.A,
et.al.
was administration,
formulated fast an
disintegrating
Atenolol
obviating
the need for water
during
attribute thattablets
makes of
them
highly using
Remark
of
the
guides:
2
three
different
superdisintegrants
croscarmellose
sodium,
crospovidone
and sodium
attractive for paediatric and geriatric patients , and also have been found to be choice
for
glycolate
by direct
compression
Croscarmellose
sodium
was
found
psychiatric
as well
as patients
suffering
thyroid
disorder,
Parkinsons
disease
Thestarch
above
given
information
is
truefrom
and stroke,
thismethod.
work
will
be
done under
my guidance.
3
to
be
best
among
the
three
superdisintegrants.
At
8%w/w
concentration
level
it
and multiple sclerosis and motion sickness.
showed the best disintegration time of 312 seconds and highest release of more
16
than
98%
of theimportance
drug in 10 was
minutes.
Their
growing
underlined
recently when European
Dr. N.S.CHANDRA
SHEKAR
pharmacopoeia
adopted
the
term

Orodispersible
tablet
as
a
tablet
that
to be placed in the
M.Pharm,
Ph.D
PROFESSOR,
Name4.&Sarasija
Designation
of et.al. Prepared mouth dissolving tablet of Salbutomol
Suresh
sulphate by
mouth
where
it
disperses
rapidly
before
swallowing.
According
to
European
DEPARTMENT OF PHARMACEUTICS,
(in blockwet
letters)
granulation
process
using
sublimable
components
camphor
and
sodium
4
pharmacopoeia,
the ODT should disperse/disintegrate
in less than three
minutes.
VIVEKANANDA
COLLEGE
OF
11.1
Guide
bicarbonate. Evaluation of the tablets showed that all the tablets were found to be
PHARMACY
within official limits and disintegration time from 5-40 seconds. Among all, the
United states Food and Drug Administration
(USFDA)
had also approved these
Dr.RAJKUMAR
ROAD,
formulation containing microcrystalline
cellulose and sodium
bicarbonate showed
dosage forms
as
term
Orodispersible
tablet
and
defined
as
A
solid
dosage form
RAJAJINAGAR
II
STAGE,
17
the least disintegration time of 5 seconds.
containing medicinal substances or an active BENGALURU
ingredient along
with -560055.
super disintegrants,
(DIST)
5
which
help
them
to
dissolve
the
tablets
with
in
a
minute.
KARNATAKA
.
5. Ravi Kumar et.al. Prepared ODTs of Aceclofen
by wet granulation
technique using
camphor as subliming agent and sodium starch glycolate together with
Fast dissolving
tablets
offer
all advantagesThe
of camphor
solid dosage
forms
and
crosscarmellose
sodium
as superdisintegrants.
was sublime
and
forms
11.2
Signature:
6
liquid
dosage
forms
along
with
special
advantages,
which
include
porous granules. All the formulation showed low weight variation with dispersion
time less than 50 seconds and rapid in vitro dissolution (97.4-99.1%). The result
1. Some
drugs
are absorbed
fromsubliming
the mouth,agent
pharynx
esophagus
as the
revealed
that
the tablets
containing
had aand
good
dissolution
profile.18
saliva
passes
down
into
the
stomach;
in
such
cases
bioavailability
of
drugs
is
11.3 Co-guide (if any):
increases. et.al. have worked on the mouth dissolved tablets of
6. Mahajan.H.S,
sumatriptan succinate were prepared using superdisintegrants
11.4 Signature:
2. Pregastric
absorption
can result
in improved
bioavailability
and sodium
as a result and
of
sodium
starch
glycolate,
carboxy
methyl
cellulose,
reducedagar
dosage,by
improved
clinical
performance through
a reduction
treated
direct
compression
method.
Theof tablet
11.5 Head
disintegrates
of the
Department
invitro and in vivo
PROF.
within
D.NARASIMHA
10 to 16 second
REDDY,
and 12 to
unwanted
effects.
18 seconds respectively. Almost
90% of drug
release from all
DEPARTMENT
OFwas
PHARMACEUTICS,
19
the
withinto10
minutes.
VIVEKANANDA
COLLEGE
3. formulations
Ease of administration
patients
who refuse to swallow
a tablet,OF
such as
PHARMACY
pediatric, geriatric, mentally ill, disabled
and uncooperative patients.
7. Raghavendra rao.N.G et.al. have
worked onROAD,
the mouth dissolved
Dr.RAJKUMAR
tablets
of
carbamazepine
were
prepared
by
using
croscarmellose
STAGE,
4. Convenience of administration andRAJAJINAGAR
accurate dose asIIcompared
to liquids.
sodium and mannitol as super
disintegrating
agent
BENGALURU (DIST) -560055. by solid
dispersion
and found
that formulations
SM4 convenient
that contain
KARNATAKA
.
5. No needtechnique
of water to swallow
the dosage
form, which
is highly
10%feature
CCS for
and
mannitol
as
carrier
was
better
one
shows
99.71%
patients who are traveling and do not have immediate access
to
drugwater.
release in 8 minutes.20
8. Patel.M.M, et.al. have worked on the mouth dissolved tablets of
11.6 Signature:
6. Good mouth feel property of ODTs helps to change the psychology of
veldecoxib using super disintegrants namely polyethylene
medicationpolyvinyl
as bitter pill
particularly
in pediatric
patients. were prepared
glycol4000,
pyrolidone
K-12
and mannitol
and they
found
that &drug containing
PVP K-12 information
showed maxium
12.1 Remarks
of the
Chairman
The above-mentioned
7. Ability
to provide
advantages
of liquid
medication
in the form
of solidis correct
drug
release.F1
when
compared
with
marketed
products
Principal:
and
I
recommend
the
same
for
approval.they
preparation.
found
that 100% drug release in 20 minutes.21
8. Rapid
dissolution ofet.al.
drug and
whichfast
maydissolving
produce rapidtablets
onset of of
9.
Shirsand.S.B,
have
prepared
3absorption,
action.
clonazepam
by direct
12.2 Signature:
compression method by using crospovidone, croscarmellose
Drug selection
criteria:7
sodium
and mannitol.
From all the three formulations the formulation which was

From
A.SRINIVAS,
M.Pharm, PART I
Dept.Pharmaceutics,
Vivekananda college of pharmacy,
Dr.rajkumar road, Rajajinagar II stage.
Bengluru (Dist) -560055
TO
The Registrar (Evaluation),
Rajiv Gandhi University of Health Sciences,
Karnataka Bangalore,
4th T Block, Jaynagar,
Bangalore-560 041
(Through Proper Channel)
Sub: Submission of Synopsis of Dissertation Regarding.
Respected Sir,
Herewith, I am submitting synopsis of dissertation work FORMULATION AND EVALUATION
OF FAST DISSOLVING TABLETS OF ANTI-EPILEPITICS for registration in M.Pharm (Pharmaceutics)
Of Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka.
Kindly accept the same and acknowledge.
Thanking you,

Yours Faithfully,
(A.SRINIVAS)
Place: Bengaluru.
Date:
Guide:
Dr.N.S.CHANDRA SHEKAR M.Pharm,Ph.D
PROFESSOR
DEPT OF PHARMACEUTICS,
Vivekananda College of Pharmacy,
Dr.Rajkumar road, Rajajinagar II stage,
Bengaluru (Dist) -560055.

PRINCIPAL
Vivekananda College of Pharmacy,
Dr.Rajkumar road, Rajajinagar II stage,
Bengaluru (Dist) 560055.