RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

M. PHARM SYNOPSIS
YEAR OF ADMISSION-OCTOBER 2011

TITLE OF THE SYNOPSIS

DESIGN AND EVALUATION OF SUSTAINED RELEASE FLOATING MATRIX
TABLETS OF AMOXICILLIN TRIHYDRATE
BY
PRAMODA.G
M. PHARM., PART-I
DEPARTMENT OF PHARMACEUTICS
UNDER THE GUIDANCE OF
Mr. P .ASHOK KUMAR, M. PHARM. (Ph.D.)
ASSISTANT PROFESSOR
DEPARTMENT OF PHARMACEUTICS

INSTITUTION
SREE SIDDAGANGA COLLEGE OF PHARMACY

B. H. ROAD, TUMKUR-572 102

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA,
BANGALORE.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.

NAME OF THE
CANDIDATE
AND ADDRESS

Ms. PRAMODA
D/o.- G.KANAKARAO
Q. No. 4-63, NEAR SBI
DIST. - KRISHNA
PIN CODE 521109
STATE ANDRA PRADESH

2.

NAME OF THE
INSTITUTION

SREE SIDDAGANGA COLLEGE OF PHARMACY

B.H. ROAD, TUMKUR- 572 102
KARNATAKA

3.

COURSE OF STUDY AND

SUBJECT

MASTER OF PHARMACY IN PHARMACEUTICS

4.

DATE OF ADMISSION

OCTOBER 2011

5.

TITLE OF THE TOPIC

DESIGN AND EVALUATION OF SUSTAINED RELEASE FLOATING MATRIX
TABLETS OF AMOXICILLIN TRIHYDRATE

6.0

BRIEF REVIEW OF THE INTENDED WORK

6.1. NEED FOR THE STUDY:
There has been considerable research over the last decade on the possibility of controlled and
site specific delivery to the GIT by controlling gastro intestinal transit of orally administered
dosage forms using GRDDS. Such as GRDDS possesses the ability of retaining the drug in
GIT particularly, in the stomach for longer periods. The idea of gastroretension stems from the
need to localize drugs at a specific region of GIT such as stomach in the body. The GRDDS
can improve the controlled delivery of the drugs which exhibit an absorption window by
continuously releasing the drug for a prolonged period before it reaches its absorption site, thus
ensuring its optimal bioavailability. 1
Floating systems or hydro dynamically controlled systems or low-density systems that have
sufficient buoyancy to float over the gastric contents and remain buoyant in the stomach
without affecting the gastric emptying rate for prolonged period of time. While the system is
floating on the gastric contents, the drug is released slowly at the desired rate from the system.
After release of drug, the residual system is emptied from the stomach. This results in an
increased GRT and better control of the fluctuations in plasma drug concentration.2
Hydro dynamically balanced drug delivery system, in either tablet or capsule form, is designed
to prolong gastrointestinal (GI) residence time in an area of GI tract. It is prepared by
incorporating a high level (20-70% w/w) of one or more gel forming hydrocolloids. On contact
with gastric fluid hydrocolloid starts to become hydrate and build a gelled barrier around the
device. This gel barrier around the device. This gel barrier controls the release of drug from the
device. 3
Amoxicillin is a moderate spectrum, bacteriolytic, beta lactam antibiotic used to treat bacterial
infections caused by susceptible microorganisms. It is usually the drug of choice within the
class because it is better absorbed, following oral administration, than other beta lactam
antibiotics. It is administered at a dose of 500 mg orally 3 times a day or 875 mg orally twice a
day for six months for the treatment of actinomycosis. Amoxicillin solubility in water at pH 7
is 4 mg/ml. The bioavailability of amoxicillin is 95% and half-life is 61.3 minutes.
Hence in the present study various polymers will be used alone or in combination, along with
gas generating agents like sodium bi carbonate and citric acid for the formulation of floating
4

7.2. METHOD OF COLLECTION OF DATA

1) Pre-formulation studies for possible drug / polymer interaction by IR/DSC analysis.
2) Preparation of the sustained release floating matrix tablets of Amoxicillin trihydrate by
wet granulation process/ direct compression.
3) Evaluation of the various properties of sustained release floating matrix tablets of
Amoxicillin trihydrate.
A) Evaluation of granules.

Angle of repose

Bulk density

Compressibility index

Total porosity

B) Evaluation of tablets.

Weight variation

Hardness

Friability

Thickness

Drug content

In vitro buoyancy studies

4) In vitro drug release studies by using suitable model.

5) To carry out short term stability studies on the most satisfactory formulation.

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

BIBILOGRAPHY
1)

Mayur AC, Senthilkumaran K, Hemanth H, Gangurde, Tamizharasi. Floating drug

delivery system: A versatile approach for gastric retension. International Journal of
Pharmaceutical Frontier Res 2011;1(3):96-112.

2) Azhar DK, Meenakshi B. Floating drug delivery: An overview. Int.J. PharmTech Res
2010;2(4):2497-2555.
3) Chien YW. Novel drug delivery systems. 2nd ed. New york: Informa Healthcare USA
2009:164
4) Kotwal A,Pathak AK. Formulation and evaluation of intragastric buoyant gastric tablets
of amoxicillin tri hydrate. Int. J. of Pharm. & Life Sci 2011;2(2):546-50.
5) Enas ME, Gehanne AS. Awad, Samar Mansour, Abd El-Hamid A. El. Shamy. Release
mechanisms behind polysaccharides- Based famotidine controlled release matrix
tablets. AAPS Pharm SciTech 2008;9(4);1230-9.
6) Salve PS. Devolopment and in vitro evaluation of gas generating floating tablets of
metformin hydrochloride. Asian J. Res. Pharm. Sci 2011;1(4):105-12.
7) Senthil A, Suresh kumar P, Narasimha raju CH, Mohideen S. Formulation and
evaluation of gastric oral floating tablet of glipizide. International Journal of Biological
& Pharmaceutical Research 2010;1(2):108-13.
8) Viral FP, Natavarlal MP. Statistical evaluation of influence of xanthan gum and guar
gum blends on dipyridamol release from floating matrix tablets. Drug devolopment and
Industrial Pharmacy 2007;33:327-34.
9) Subash chandra bose P, srikanth reddy P, Valluru ravi, Saritha D, pramod kumar TM.
Formulation and evaluation of sustained release of floating tablets of diltiazem HCl
using xanthan gum. Research Journal of Pharmaceutical, Biological and Chemical
sciences 2011; 2(2): 319-28.
6

10) Gangadarappa HV, Balamuralidhara V, Pramod kumar TM. Formulation and in vitro
evaluation of atenolol floating tablets. Jounal of Pharmacy Research 2010;3(6):1450-5.
11) Umesh LC, Shashikant DB, Rajesh GP, Chandrashekhar BB, Prathibha AM, Prafulla
DC. Formulation design and evaluation of Atorvastatin calcium floating tablets by
using pectin as a release modifying agent. International Journal of Phramaceutical
Research and Devolopment 2011;3(10):143-51
12) Ramesh Bomma, Rongala Appala swami Naidu, Madhusudhan Rao Yamsani, Kishan
Veerabrahma. Devolopment and evaluation of Gastroretensive floating tablets of
Norflaxacin. Acta Pharm 2009;59:211-21.

9.

SIGNATURE OF CANDIDATE

10.

REMARKS OF GUIDE

11.

NAME AND DESIGNATION

OF
11.1 GUIDE

RECOMMENDED

MR. P. ASHOK KUMAR, M. Pharm., (Ph.D.)

Assistant Professor,
Department of Pharmaceutics

11.2 SIGNATURE
----------------11.3 CO-GUIDE (If any)
-----------------11.4 SIGNATURE
11.5 HEAD OF
DEPARTMENT

Dr. Suresh V. Kulkarni, M. Pharm., Ph.D.

Professor & Head,
Department of Pharmaceutics

11.6 SIGNATURE
12.

12.1 REMARKS OF THE

CHAIRMAN AND
PRINCIPAL

Forwarded to university for approval.

12.2 SIGNATURE
Dr. S. Badami, M.Pharm, Ph.D
Principal
Sree Siddaganga College of Pharmacy, Tumkur