FORMULATION AND EVALUATION OF ANTI MOTION

SICKNESS CHEWABLE TABLETS

SYNOPSIS FOR
M. PHARM. DISSERTATION

SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA

BY

SANDEEP.U
1 M. PHARM

DEPARTMENT OF PHARMACEUTICS
VIVEKANANDA COLLEGE OF PHARMACY
BENGALURU
2011-13

ANNEXURE- II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1.

Name of the Candidate

And Address

SANDEEP.U
I M. PHARM,
DEPARTMENT OF PHARMACEUTICS,
VIVEKANANDA COLLEGE OF PHARMACY,
RAJAJI NAGAR II STAGE,
BENGALURU-560055.
PERMANENT ADDRESS:
S/o. U.LAKSHMANA ACHARI,
DOOR NO:19-7-97B, GOPAL RAJ COLONY,RCROAD,TIRUPATI,PINCODE:517501,ANDHRA
PRADESH.

2.

Name of the Institution

3.

Course of Study and

VIVEKANANDA COLLEGE OF PHARMACY,

DR.RAJKUMAR ROAD,
RAJAJINAGAR STAGE,
BENGALURU - 560055,
KARNATAKA.
MASTER OF PHARMACY IN PHARMACEUTICS

Subject
4.

5.

Date of Admission

9 - DECEMBER 2011

Title of the project :-

FORMULATION AND EVALUATION OF ANTI-MOTION

SICKNESS CHEWABLE TABLETS

6.

Brief Resume of Intended Work:

6.1 Need of Study:
Motion sickness is an uncomfortable condition caused by exposure to unfamiliar or
unnatural motion stimuli. Situations which may provoke motion sickness include car, train,
air and sea travel and amusement park rides and it is easily recognised by the sequential
development of a general feeling of discomfort (including epigastric discomfort), pallor
(mainly facial), cold sweating, nausea and ultimately emesis. 1 and some individuals continue
to experience a certain amount of general discomfort for a few hours and a few report a
transient sensation of swinging, unsteadiness and disequilibrium even after disembarking or
on cessation of the motion stimulus, motion sickness symptomatology rapidly disappears.1
Emesis is controlled by the vomiting centre in the medulla region of the brain, an important
part of which is the chemo trigger zone (CTZ). The vomiting centre possesses neurons
which are rich in muscarinic cholinergic and histamine containing synapses. These types of
neurons are especially involved in transmission from the vestibular apparatus to the
vomiting centre.
Motion sickness principally involves overstimulation of these pathways due to various
sensory stimuli. Hence the action of anti motion sickness tablets which acts to block the
histamine and cholinergic receptors in the vomiting centre and thus reduce activity along
these pathways.2,3
At presently in the market there comes many medications used for the treatment of motion
sickness. However, an attempt will be made to develop an anti motion sickness chewable
tablet that is expected and provide a useful way of treating the symptoms of motion sickness
with the potential of much more effective treatment for children and elderly people.
Chewable tablets are intend to be chewed in the mouth prior to swallowing and are not
intended to be swallowed intact. The purpose of chewable tablet is to provide a unit dosage
form of medication which can be easily administered to children or to the elderly, who may
have problem in swallowing a tablet intact. It is also recommended to achieve rapid onset of
action. Chewable tablets are preferred for the drugs having high dose, the tablets of which
cannot be swallowed.
These tablets have advantage of portability and easy access and often provide faster delivery
systems compared to regular tablets. The other advantages, compared to solid dosage forms

intended to be swallowed, include better bioavailability through by passing disintegration

(And perhaps enhancing dissolution), patient convenience through the elimination of the
need for water for swallowing, possible use as a substitute for liquid dosage forms where
rapid onset of action is needed. Generally, active ingredients administration in this way
enjoys slower metabolic decomposition by the body4.
And some more advantages of chewable tablet: 1. Taste masking of drug
2. Protection of drug against the environment (moisture, light, heat and oxidation)
3. To increase the patient compliance.
4. Precise dosing
5. To have better therapeutic efficacy compared to conventional tablets.
6. Ease of delivery.
7.To decrease the side effect

6.2Review of literature
1. Chewable tablet of levamisole were prepared by wet granulation technique using sodium
starch glycolate lactose and mannitol. From the disintegration studies, it was observed
that the formulation containing 1.6% w/w of sodium starch glycolate shows minimum
disintegration time whereas formulation having no or less concentration of sodium starch
glycolate shows increase in disintegration time. It was observed that the formulation
containing lactose shows less disintegration time than formulation containing mannitol.5
2. Albendazole chewable tablets (400 mg) were prepared by three methods viz. non
aqueous granulation, aqueous granulation and direct compression. The study on the
dissolution profile revealed that product prepared by direct compression method had
faster dissolution rate while compared to remaining batches and marketed product. Assay

values were within the limits of 90% to 110%.6

3. Formulation of chewable tablets of sodium feredetate (sodium iron edenate) with a
chewable base that comprises a combination of sugar alcohol and disintegrants. The
chewable tablets of the present disclosure are breakage resistant yet quickly disintegrate
in the mouth and are devoid of the metallic taste normally associated with iron
supplements7.
4. Chewable tablets were formulated by the combination Of effervescenting agent and
chewable base with flavoring agent improves the taste characteristic of the medicament
in oral administration8.
5. A study showed that compressing at reduced fraction of the coating used for masking the
unpleasant taste of the active ingredient, thus convex-shaped chewable tablets were
softer than conventional chewable table, which results in improvements in product taste,
mouthfeel and ease of chewing. The convex tablet geometry significantly reduces tablet
friability at a given compression force, this reduction in tablet friability allows for the
use of lower compression forces and lower tablets hardness9.
6. A process developed for preparing a chewable tablet comprising a micronized form of
an active ingredient, the method comprising the steps of combining the active ingredient
with tablet Excipients by geometric dilution to form a final mixture and applying direct
compression at least a portion of the final mixture to form at least one tablet10.
7. A study on development of oral chewable tablets which suppressed the bitter taste of
acetaminophen. Corn starch/lactose, cacao butter and hard fat (Witepsol H-15) were used
for matrix bases, and sucrose, cocoa powder and commercial bitter masking powder
mixture made from lecithin were used for corrigents against bitter taste11.
8. An invention relates to compressed tablet, such as an antacid tablet, which is breakage
resistance, yet quickly disintegrates in the mouth to smooth creamy pleasant tasting
emulsion, devoid of the grittiness normally associated with antacid and other chewable
tablets12.

.
6.3 Objectives of the Study:
The objectives of proposed study are:
1. To identify suitable excipients for formulation.
2. To evaluate for pre-compression characteristics like Bulk Density, Tapped Density, Angle
of Repose, Carrs Index, and Compressibility Index for tablet mixture.
3.

To evaluate the tablet for various tablet characteristic like Hardness, Thickness,
Weight Variation, friability, content Uniformity and Assay.

4. To perform In-vitro dissolution studies and compare with any market product or
Pharmacopoeia specification.
5. To perform the stability study under accelerated conditions as per the ICH guideline.

7.

Materials and methods

7.1 Drug: Selective anti motion sickness drug.
Polymers:
The following polymers will be used making the tablets
1. Lactose.
2. Mannitol.
3. sodium saccharin.
4. And suitable ingredients which are useful for formulation.

7.2 Methodology:
Direct compression method or any suitable methods such as wet granulation, dry granulation.
7.3 Source of the data:
The preliminary data required for the experimental study is obtained from
CD-Rom search available at National Center for Scientific Information (NCSI),
Indian institute of Sciences (IISc), Bengaluru,
1. Journals,
2. Analytical chemistry Books ,
3. Library,
4. Relevant Books,
5. Internet Sources ,
6. Scientific abstracts.

7.4 Method of collection of data:

Data pertaining to the physiological, pharmacological and physico-chemical properties of
the drug will be collected from standard sources of information like the standard
pharmacopoeias, standard books, journals and databases like Medline, Science direct etc.
Experimental data pertaining to the formulation will be collected from the experimental methods
envisaged to be carried out which include the following:
1. Preformulation studies on the drug and excepients to be used in the formulation followed
by selection of inert, compatible, excepients and rate controlling components.
2. Physico-chemical characterization and in vitro evaluation
3. Optimization of the formulation based on its in vitro performance.

7.5 Does the study require any investigation or interventions to be conducted on patients
or other human or animals? If so please describe briefly:
Not applicable.
7.6 Has ethical clearance been obtained from your institute in case of 7.3?
Not applicable.
8.

List of References:
1) Gordon CR, Shupak A. Prevention and treatment of motion sickness in children. CNS
Drugs. 1999 Nov;12(5):369-81.
2) Reason JT, Brand JJ. Motion sickness. London: Academic Press; 1975.
3) Reason JT. Motion sickness adaptation: a neural mismatch model. J R Soc Med; 1978. P.
819-29.
4) Herbert A, Liberman, Leon Lachman, Joseph B. Schwartz R. Pharmaceutical Dosage
forms: Tablets. 2nd ed. Newyork(NY): Marcel Dekker; 1989, p. 367-414.
5) Swati Jagdale, Mahesh Gattani, Dhaval Bhanudas KUchekar, Aniruddha Chabukswar.
Formulation and evaluation of chewable tablet of levimasole. Int J.Res Pharm Sci
2010;1(3):282-289.
6) Sukhbir lal khokra, Bharat parashar. Formulation decelopment and evaluation of
albendazole by different techniques. Int J Pharm Pharm Sci 2011;1(3):461-464.

7) Sumit Madan, Vikas Batra, Vinod Kumar Aror. Sodium Feredetate Chewable Tablets.
Ipcom [serial online] 1999 Aug 16[cited 1999 AUG 21]. Available from:
URL:http://www.Priorartdatabaseip.com.
8) Ian J. Bolt, David R. Merrifield, Paul L. Carter. Pharmaceutical Formulation. U.S. Patent
1993 Jul 6;5:197,225.
9) Ronni L Robinson, James R. Domon, James R. Mossop, Michael D. Palmer. Soft
Chewable Tablets Having Convexed shaped Face Surfaces. U.S. Patent 2002 Oct 29 6;
B2:471,991.
10) Ajmal Ali Khan, Eddie Brunson. Chewable Tablet and Method of Formulation. U.S
Patent. 2008 Jun 19:A1:0145423.
11) Hiroyuki Suzuki, Hiraku Onishi, Yuri Takahashi, Masanori Iwata, Yoshiharu Machida.
Development of Oral Acetaminophen Chewable Tablets with inhibited bitter taste. Int J
Pharm 2003;1(3): 123-132.
12) Wayne J Puglia, Kanit J Patanasinth, Andrew T Lombardo, Walter Vink. Compressed
Chewable Antacid Tablets and Method for Forming Same. US Patent 1982 Apr 27:4327,
077.

9.

Signature of the candidate:

10

Remarks of the Guide:

11

Name and Designation of

11.1 Guide

SANDEEP.U
Recommended for research and submission of
dissertation.

Dr. N.S.CHANDRA SHEKAR M.Pharm, Ph.D

DEPARTMENT OF PHARMACEUTICS
VIVEKANANDA COLLEGE OF PHARMACY
Dr.RAJKUMAR ROAD, RAJAJINAGAR II STAGE,
BENGALURU -560055,KARNATAKA.

11.2 Signature
N.S. CHANDRA SEKHAR
11.3 Co-Guide if any

11.4 Signature
11.5 Head of the department

11.6 Signature

D.RANGARAJU, M.Pharm, (Ph.D)

DEPUTY MANAGER
NON PARENTRALS DEPARTMENT
KARNATAKA ANTIBIOTICS &
PHARMACEUTICALS LIMITED
BANGALORE.
D.RANGARAJU
PROF. D.NARASIMHA REDDY,M.Pharm,
DEPARTMENT OF PHARMACEUTICS,
VIVEKANANDA COLLEGE OF PHARMACY
Dr.RAJKUMAR ROAD, RAJAJINAGAR II STAGE,
BENGALURU-560055,KARNATAKA.
D.NARASIMHA REDDY

12

12.1 Remarks of the Principal

The above-mentioned information is correct and I
recommend the same for approval.

12.2 Signature

D.NARASIMHA REDDY

From

SANDEEP.U,
M.Pharm, PART I
Dept.Pharmaceutics,
Vivekananda college of pharmacy,
Dr.rajkumar road, Rajajinagar II stage.
Bengaluru -560055
To
The Registrar (Evaluation),
Rajiv Gandhi University of Health Sciences,
Karnataka Bangalore,
4th T Block, Jayanagar,
Bengaluru-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 ANTI MOTION SICKNESS CHEWABLE TABLETS for registration in
M.Pharm (Pharmaceutics) Of Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka.
Kindly accept the same and acknowledge.
Thanking you,
Yours Faithfully,
SANDEEP.U
.
Place:Bengaluru.
Date: 23-06-2012
Guide:
Dr. N.S.CHANDRA SHEKAR M.Pharm,Ph.D,
PROFESSOR,
DEPARTMENT OF PHARMACEUTICS,
Vivekananda college of pharmacy,
Rajkumar road, rajajinagar II stage,
Bengaluru-560055, karnataka.

PRINCIPAL
Vivekananda college of pharmacy,
Raj kumar road, rajaji nagat II stage,
Bengaluru-560055, Karnataka.