Download formulation and evalution of medicated chewing gum of

“FORMULATION AND EVALUTION OF MEDICATED CHEWING –
GUM OF CINNARIZINE”
MASTER OF PHARMACY DISSERTATION PROTOCOL
SUBMITTED TO THE
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA,
BANGALORE.
BY
KOTHARI PALAK MAHESHKUMAR
M.Pharm-Ι
UNDER THE GUIDANCE
Dr. Harish N.M. M. Pharm.,Ph.D.
ASSOCIATE PROFESSOR
DEPARTMENT OF INDUSTRIAL PHARMACY
SRINIVAS COLLEGE OF PHARMACY, VALACHIL, MANGALORE – 574143.
2012-2013
(MID STREAM BATCH)
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE BANGALORE,
KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
Name of the Candidate and
Mr. KOTHARI PALAK MAHESHKUMAR
Address:
1st YEAR M.PHARM,
DEPT. OF INDUSTRIAL PHARMACY,
SRINIVAS COLLEGE OF PHARMACY
VALACHIL, MANGALORE-574143.
SRINIVAS COLLEGE OF PHARMACY
2.
VALACHIL, FARANGIPETE POST, MANGALORE-
Name of the Institution:
574143.
3.
Course of Study and Subject:
MASTER OF PHARMACY
(INDUSTRIAL PHARMACY)
4.
Date of Admission:
5.
Title of the Project:
10/01/2013
“FORMULATION AND EVALUTION OF MEDICATED CHEWING
GUM OF CINNARIZINE”
6.
Brief Resume of the intended work:
6.1
Need of the study:
Pharmacologically active Agents or Drugs are formulated into variety of dosage
forms like Tablets, Injectable, Ointments, etc. considering physicochemical properties,
pharmacokinetics and pharmacodynamics parameters and biopharmaceutical aspects of Drugs;
however, recently in addition to its confectionary role, chewing gum also has proven great
value as a delivery vehicle for pharmaceutical and nutraceutical ingredients.
Many therapeutic agents are absorbed in the oral cavity. For the drugs having significant
buccal absorption, dosage forms such as Lozenges, Chewable tablets and Chewing gum permits
more rapid therapeutic action compared to per-oral dosage forms. Chewing gum today is
considering as a delivery system to administer active principle that can improve health and
nutrition1.
During the chewing gum process, most of the drug products are released into the
saliva and either absorbed through buccal mucosa or swallowed through GIT2.
Chewing Gum has been used for centuries to clean the mouth and freshen breath.
Medicated Chewing Gums are solid, single dose preparations with a base consisting mainly of
gum that is intended to be chewed but not swallowed. They contain one or more active
substance which released by chewing and are to be used for local treatment diseases of oral
cavity as well as treatment of systemic condition3.
This drug delivery system offers two absorption pathways. Drug absorbed via the buccal
membrane avoids metabolism in the gastrointestinal tract and thus the chance of first pass effect
of the liver4. Since it can be taken anywhere, a chewing gum formulation is an excellent choice
for medication5.
Cinnarizine is [1-benzhydryl-4-cinnamyl-piperazine] with half-life of 3-4 hours, It is an
antivertigo drug,and is also protective for motion sickness. It probably acts by inhibiting infux
of ca2+ from endolymph into the vestibular cells which medicates labyrinthine reflexes 6-7.
In the present work an attempt has been made to Design and evaluate medicated
chewing gum of Cinnarizine for the effective management of motion sickness.
Advantages of Medicated Chewing Gums8:
1. Dose not requires water to swallow. Hence can be take anywhere.
2. Advantageous for patients having difficulty in swallowing.
3. Excellent for acute medication.
4. Counteracts dry mouth, prevents candidacies and caries.
5. Avoids First Pass Metabolism and thus increases the bioavailability of drugs.
6. Fast onset due to rapid release of active ingredients in buccal cavity and subsequent
absorption in systemic circulation.
7. Gum does not reach the stomach. Hence G.I.T. suffers less from the effects of excipients.
8. Stomach does not suffer from direct contact with high concentrations of active principles,
thus reducing the risk of intolerance of gastric mucosa
9. Fraction of product reaching the stomach is conveyed by saliva delivered continuously and
regularly. Duration of action is increased.
Commercially available medicated chewing gums9
Trade mark
Active substance
Aim
Commercially
Available
Aspergum
Asprin
Pain relief
North America
NIcorette
Nicotine
Smoking Cessation
World wide
Brain
DHA and CCE
Enhanced
Japan
brain
activity
Stami Vitamin c
Vitamin c
General health
Australia
Vitamin
Vitamin c
General health
Australia
Stay alert
Caffine
Alertness
USA,Japan
Café Coffe
Caffine
Alertness
Japan
Travel
Dimenhydrimate
Motion Scikness
USA, Australia
V6
Xylitol
Prevention
of
formulation of dental
USA,
Australia
caries
Fluorette
FLuoride
Canostatic
USA
6.2 – Review of literature:
The literature survey on Medicated Chewing Gum is carried out by referring various scientific
journals, internet and helinet facility.

Farhad M, Piyush T10 had formulated and Charaterised Natural biodegradable
Chewing Gum of corn zein. Corn zein as a gum base offers nonadhesive and
biodegradable property.Various plasticizer are used for formulation of corn zein gum.
The study shows corn zein is best suited to be used as biodegadable gum base which can
be developed as acceptable product for consumers.

Farhad M, Piyush T11 had formulated and characterised texture of medicated chewing
gum delivery of Dimenhydrinate Hydrochloride for the treatment of nausea occurs
immediately or with very short warning.

Shivanand P, Manish G, Viral D12 had studied the Development, in-vitro evaluation and
physical characterization of medicated chewing gum using Chlorhexidine Gluconate
and concluded that in concentration of 50% synthetic gum base gives promising result
with the water soluble drug Chlorhexidine gluconate for steady release.

Rajnikanth V, Seth AK, Sachin C, Parth P, Pratik K, Chainesh S et al.13 Formulated and
evaluated novel gum base drug delivery system of an antiemetic (Meclizine
hydrochloride) drug prepared by direct compression method and where characterized by
pre-compression character, post compression character, buccal absorption study, drug
content and in-vitro release studies.

Shivang AC,Alisagar FS14 had formulated and evaluated medicated chewing gum of
cetrizine for quick relief of common cold by using elastomer,softners,bulking agents
and chew out test was carried out by in vitro drug release studies.The studies showed
that salivary dilution and invoulantry swallowing are the main resons for in variability
in absorption rates.

Gunjal PR, Kalmegh TS, Gadhave M, Jadhav S15 has reviewed on Medicated chewing
gum as Novel drug delivery system and concluded that Chewing gum is an excellent
drug delivery system for self-medication.

Patel Y, Shukla A, Saini V, Sharma P16 studied about Chewing Gum as a Drug delivery
system holds tremendous potential not only in smoking cessation and oral care areas but
also in other indications.

Upendra RM, Prasanthi G, Ramesh Y17 has formulated and evaluated medicated
chewing gum of promethazine hydrochloride using polyvinyl pyrrolidone synthetic
sgum and glycerol & castor oil as plasticiser and concluded that using castor oil as
plasticiser gives better release of drug than glycerol.

Yamini M,William JI, Paul XB, Rick SC, Barbara RC18 had studied release of nicotine
from conventional gums and from gums made using a directly compressible gum base
was studied using the European Pharmacopoeia apparatus for testing of medicated
chewing gums.It was found that gum base and the method of preparation used in a
formulation were important factors when controlling the release of drugs from chewing
gum.
6-3 OBJECTIVES OF THE STUDY:
1. To formulate the medicated chewing gum containing Cinnarizine for the treatment of
motion sickness.
2. To check drug-excipient compatibility by FTIR.
3. To evaluate the physical characteristics of formulated medicated chewing gum.
4. To study the drug release profile.
5. To carry out stability studies for the formulated chewing gums as per ICH guidelines.
Materials and Methods:
Materials:

Drug
: Cinnarizine.

Ingredients
: Gum base, Polyvinyl pyrrolidine, Glycerol, Fillers, Sodium
Carbonate anhydrous, Flavours, etc.
All other materials used will be of analytical grade.
Methods: Any one of following method mention as below.
Different methods can be employed for the manufacturing of chewing Gum can be broadly
classified into three main classes namely:
Conventional/Traditional method19.

Freezing, Grinding and Tableting method19.

Direct compression method19.
7.
7.1 Source of data:
1. Review of literature from
•
Journals such as
 International Journal of ChemTech Research
 International Journal of Pharma Professional’s Research
 Journal of Chemical and Pharmaceutical Research
 Indian Journal of Pharmaceutical Sciences
 Journal of Global Pharma Technology
 International Journal of Pharmaceutical Sciences Review and Research
 International Journal of Pharmacy and Pharmaceutical Sciences
 Journal of Pharma Research
•
Internet Browsing.
•
Laboratory based studies.
2. Laboratory based experiments and evaluation.
7.2 – Method of Collection of Data:
•
An Overview of Medicated Chewing Gum.
•
Formulation of Medicated chewing gum of Cinnarizine.
•
Preformulation Studies:-
•
Purity of drug by FTIR
•
pH
•
Melting point
•
Lambda max.
•
Evaluation of formulated cinnarizine medicated chewing gums, as follows12:
 Pre-compression characteristics.

Bulk density.

Tapped density.

Compressibility index.

Hausner’s ratio.

Angle of repose.
 Post-compressional characterisation.

Hardness.

Weight variation.

Estimation of drug content.
 In-vitro drug release studies.
 To carry out stability study 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
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
-
NOT APPLICABLE
8.0
List of references:
1. Nilam T, Karishma P. A review on medicated chewing gum as a novel drug delivery
system. J Pharm Res 2011; 4(3):848-51.
2. Asija R, Patel S, Asija S. Oral dosage form Medicine containing chewing gum: A
review. J Drug Del Thera 2012; 2(6):90-105.
3. Basani G, Venkata RD, Madhusudan YR. Medicated chewing gum-A novel approach to
improve patient compliance. Int J Res Pharm Bio Sci 2011; 2(1):23-32.
4. Sabera K, Bishwajit KS. Medicated chewing gum: An unconventional drug delivery
system. Int Curr Pharm J 2012; 1(4):86-91.
5. Ezhumalai E, Ilavarasan P, Rajalakshmi AN, Sathiyaraj U, Murali RM. Medicated
chewing gum-A novel drug delivery technique for systemic and targeted drug delivery.
Int J Pharm Tech 2011; 3(1):725-44.
6. Cinnarizine Drug Bank. www.drugbank.ca/drugs/DB00568.
7. Tripathi K.D. Essentials of medical pharmacology,6th edition:pg.no-642.
8. Shashank N,Shweta K,Srinivas H,Ramkrishna S.Medicated chewin gum:A boon to oral
dosage forms.Am.J.PharmTch Res.2012;2(6):150-61.
9. Vilcy PW,Milind T. A comprehensive review on:Medicated chewing gum.Int.J.of Res.
Pharm Biomed sci.2012;3(2):894-907 .
10. Farhad M,Piyush T.
Formulation And Characterization Of Natural Biodegradable
Chewing Gum.Int J Pharm Tech Res 2012;4(3):889-99.
11. Farhad M, Piyush T. Formulation and texture characterization of medicated chewing
gum delivery of Dimenhydrinate Hydrochloride. Sch Res Lib 2011; 3(6):179-92.
12. Shivanand P, Manish G, Viral D. Development, in-vitro evaluation and physical
characterization of medicated chewing gum: Chlorohexidine Gluconate. Sch Res Lib
2009; 1(2): 286-92.
13. Rajnikanth V, Seth AK, Sachin C, Parth P, Pratik K, Chainesh S et al., Formulation and
evaluation of novel gum based drug delivery system of an antiemetic drug. Int J Pharm
Res Tech 2012; 2(2):16-20.
14. Shivang AC, Alisagar FS. Directly compressible medicated chewing gum for quick
relief of common cold Int J Pharm Inve 2012;2(3):123-33.
15. Gunjal PR, Kalmegh TS, Gadhave M, Jadhav S. A review on medicated chewing gum
as a novel drug delivery system. Int J Uni Pharm L Sci 2012; 2(4):194-206.
16. Patel Y, Shukla A, Saini V, Sharma P. Chewing gum as a drug delivery system. Int J
Pharm Sci Res 2011; 2(4):748-57.
17. Upendra RM, Prasanthi G, Ramesh Y. Formulation and evaluation of medicated
chewing gum of Promethazine hydrochloride. J Pharm Res 2011; 4(9):3247-50.
18. Yamini M,William JI, Paul XB, Rick SC, Barbara RC.In vitro release of nicotine from
chewing gum formu Diss tech 2004:12-15.
19. Pratik S, Asif K, Ramana MV, Mitul P, Mahesh K. Chewing gum: A modern era of
drug delivery. Int Res J Pharm 2011; 2(10):07-12.
9.
Signature of the candidate
(KOTHARI PALAK MAHESHKUMAR)
10.
Remarks of the Guide
The work, which is assigned to
Mr. KOTHARI PALAK MAHESHKUMAR is under
my guidance.
DR.HARISH N.M.M.PHARM,Ph.D.
Associate professor
11. 11.1 Name and Designation of
Department of industrial pharmacy,
Srinivas college of Pharmacy
the
Guide
Valachil, Mangalore-574143.
11.2 Signature
11.3 Head of the Department
Dr. HARSH N.M.M.Pharm., Ph.D.
HOD
Department of Industrial Pharmacy
Srinivas College of Pharmacy,
Valachil, Mangalore- 574143
11.4 Signature
12.
12.1 Remarks of the Principal
Recommended and forwarded for favourable
consideration.
Dr. A. R. SHABARAYAM.Pharm., Ph.D.
12.2 Signature
Principal and Director
Srinivas College of Pharmacy,
Valachil, Mangalore- 574143