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FORMULATION AND EVALUATION OF ANTIHYPERTENSIVE

ORODISPERSIBLE TABLETS
M.PHARM DISSERTATION PROTOCOL

SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES


BENGALURU, KARNATAKA
BY
PATEL DIPENKUMAR BHARATBHAI
I M.PHARM
UNDER GUIDANCE
OF
MRS. BENY BABY
M.PHARM (Ph.D)
ASSISTANT PROFESSOR

DEPARTMENT OF PHARMACEUTICAL TECHNOLOGY


KARNATAKA COLLEGE OF PHARMACY
BENGALURU-560064
(2010-2011)
0

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE


BENGALURU, KARNATAKA.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.

Name of the Candidate and


Address

PATEL DIPENKUMAR BHARATBHAI


Karnataka College of Pharmacy
# 33/2 Thirumenahalli
Hegde Nagar Main Road
Bengaluru - 560064
Karnataka.
PERMANENT ADDRESS
C/6 , vasukanan flats,
N/R, nirnay nagar garnala
Ghatlodia ,ahmedabad
Gujarat,380061

2.

Name of the Institute

KARNATAKA COLLEGE OF
PHARMACY
# 33/2 Thirumenahalli
Hegde Nagar Main Road
Bengaluru - 560064
Karnataka.

3.

Course of the Study and Subject

MASTER OF PHARMACY IN
PHARMACEUTICAL
TECHNOLOGY

4.

Date of Admission to the Course

Nov 25th 2010.

5.

Title of Topic:

FORMULATION AND EVALUATION OF ANTIHYPERTENSIVE


ORODISPERSIBLE TABLETS

6.

Brief resume of intended work:

6.1

Need for the Study:


The oral route of administration continues to be the most preferred route due to various
advantages including ease of ingestion, avoidance of pain, versatility and most
importantly patient compliance, and ease of manufacturing. The different dosage forms
include tablets and capsules. However, pediatric and geriatric patients experience
difficulty in swallowing conventional tablets, which leads to poor patient compliance.
Pediatric and geriatric people commonly suffering from dysphasia, clinical conditions
where water intake is limited, situations where water is not available and for drugs
undergoing high first pass metabolism.
Orodispersible tablets are solid single-unit dosage forms that are placed in mouth and
allowed to disperse/dissolve in the saliva without the need of water and provide

quick onset of action. Some drugs are absorbed from mouth, pharynx and oesophagus as
the saliva passes down into the stomach. In such cases, bioavailability of drug is
significantly greater than those observed from conventional tablet dosage form.
Orodispersible tablets are prepared by various techniques; mainly direct compression,
wet granulation, sublimation, lyophilisation and moulding. The simplicity and cost
effectiveness of the direct compression process have positioned this technique as an
attractive alternate to traditional granulation technologies.
There is therefore a need for dosage forms which have all the advantages of a tablet
formulation and the bioavailability and convenience of administration of a suspension. A
disintegrating tablet is one such dosage form which meets the needs. They are easy to
carry and can be reconstituted and administered to patients accurately and conveniently.
The oral tablet of antihypertensive drugs can improve symptoms and quality of patients
with respective to pediatric patients. The physical problems with swallowing (dysphagia)
can exacerbate compliance problems and undermine treatment efficacy.

6.2 Review of literature:


New approach of prepared fast-release dosage form for Carbamazepine (CBZ),
involving the use of melt granulation process for the production of tablets by using
polyethylene glycol (PEG) 4000 as a melting binder and lactose monohydrate as
hydrophilic filler. The analysis performed by means of X-ray powder diffraction (XRD)
and differential scanning calorimetry (DSC). The enhancement of drug dissolution rate
of the granulates in comparison to physical mixtures and pure drug addition of a small
amount of crospovidone gave rise to a further amelioration of the disintegration and
dissolution performances.(Beatrice P,2003)
Physical responses of powders, granules, and compacts such as powder flow and tensile
strength are determined largely by their absolute and relative densities. The purpose of
this to provide reference source and to give how these critical properties can be
measured for common pharmaceutical solids and how they can be used for monitoring
common drug product manufacturing operations. Manufacture of uniform tablet dosage
form using various tablet presses, & monitoring the compact relative remote instant
parameter.(Bruno CH,2009)
Montelukast sodium is a potent, selective and orally acting leukotriene receptor
antagonist & used in the prophylaxis and treatment of asthma. Prepared fast
disintegrating tablets of Montelukast sodium in the oral cavity with enhanced dissolution
rate. In conclusion that the rapidly disintegrating tablets with proper hardness, rapid
disintegration in the oral cavity with enhanced dissolution rate can be made using super
disintegrants.(Devi NK,2010)
Valsartan orodispersible tablet have been developed with the intension of facilitating
administration to patients which have difficulty in swallowing and improving its poor
oral bioavailability. Oral bioavailability of valsarton Orodispersible tablets was
compared to conventional tablet. It is monitored in plasma by HPLC. The relative
bioavailability calculated as the ratio of mean total area under the plasma.(Howida
KI,2010)

The factors affecting the characteristics of rapidly disintegrating tablets containing an


3

7.1 Source of Data:

The data was obtained from the literature survey and Internet source.

Digital Library RGUHS Library, Bangalore.

Library, Karnataka College of Pharmacy, Bangalore.

The data was obtained on experimental work.

7.2 Method of Collection of Data (including sampling procedure, if any) :


Data will be collected from the prepared formulations; in-vitro dissolution
studies and stability studies. In-vitro dissolution studies will be used as criteria for
assessing the different formulation for their therapeutic efficacy and drug release. And
stability studies for their stability property.
7.3 Method of Screening:
7.3 Does the study require any investigations or interventions to be conducted on
patients or other human or animals ? If so please describe briefly
DOES NOT REQUIRE

7.4 Has the Ethical Clearance been obtained from your Institution in case of 7.3 ?
NOT APPLICABLE

LIST OF REFERENCES:1.

Beatrice P, Fulvio R, Mariarosa M, Dario V. Formulation design of


carbamazepine fast-release tablets prepared by melt granulation technique. Int J
Pharm 2003;256:5363.

2.

Bruno CH, Joshua TC, Matthew PM, Andrey VZ. The Relative Densities of
Pharmaceutical Powders, Blends, Dry Granulations and Immediate-Release
Tablets. Pharma Tech 2009 Apr:64-80.

3. Devi NK, Rani AP, Mrudula BS. Formulation and evaluation of oral
disintegrating tablets of montelukast sodium: effect of functionality of
superdisintegrants. J Pharm Res 2010;3(4):803-8.
4. Howida KI, Doaa AE. Valsartan orodispersible tablets: Formulation,in vitro/in
vivo characterization. AAPS Pharm Sci Tech 2010 Mar;11(1):189-96.
5. Masaaki S, Toru M, Shinji N, Koji Matsubara, Hiroyuki Y. Factors affecting the
characteristics of rapidly disintegrating tablets in the mouth prepared by the
crystalline transition of amorphous sucrose. Int J Pharm 2005;296:64-72.
6. Mukesh PR, Mohanta GP, Lokesh U. Review On: Fast Dissolving Tablet.
J Pharm Res 2009 Jan;2(1):5-12.
7. Okuda Y, Irisawa Y, Okimota K, Osawa T, Yamashita S . A new formulation for
orally disintegrating tablets using a suspension spray-coating method. Int J
Pharm 2009;382:807.
8. Praveen K, Kamlesh D, Venkateswarlu BS. Formulation and evaluation of
mouth dissolving tablets of atenalol. IJPT 2011 Mar;3(1):1876-88.
9. Rahul C, Zahra H, Farhan A, Alan MS, Afzal RM. The role of formulation
excipients in the development of lyophilized fast-disintegrating tablets. Eur J
Pharm Biopharm 2009;72:11929.
10. Sameer GL, Yi YY, Ajay KB. Effects of disintegration-promoting agent,
lubricants and moisture treatment on optimized fast disintegrating tablets. Int J
Pharm 2009;365:411.
11. Sandra K, Michael FW, Thomas Z, Norma LB, Juanelle LL, Michael GR, Kevin
JE, Charles MB.
Improving glyburide solubility and dissolution by
complexation with hydroxybutenyl- cyclodextrin. JPP 2009;61: 2330.
12. Tamnoy G, Amitava G, Devi P. A review on generation orodispersible tablets and
its future prospective. Int J Pharm Pharm Sci 2011;3 (17):1-7.
13. Ziya B, Cetin T, Umut T, Halil E, Cansel KO, Ayhan S, Yalcin O. Formulation of
zolmitriptan sublingual tablets prepared by direct compression with different
polymers: In vitro and in vivo evaluation. Eur J Pharm Biopharm. 2011 Feb:in
press.
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8.

Signature of the Candidate

9.

Remarks of the Guide:


The topic selected for dissertation is satisfactory. Adequate equipment & chemicals are
available to carry out the project work.

(PATEL DIPENKUMAR BHARATBHAI)

10. Name & Designation (in BLOCK LETTERS)


11. 11.1 Guide
11.2 Signature of Guide

MRS. BENY BABY. M.PHARM (Ph.D)


ASST. PROFESSOR
DEPT. OF PHARMACEUTICAL TECHNOLOGY
KARNATAKA COLLEGE OF PHARMACY

11.3 Co-Guide

11.4 Signature of Co-Guide

(Mrs. ROHINI R. M.)


NOT APPLICABLE

11.5 Head of the Department


NOT APPLICABLE
11.6 Signature of HOD:

Dr. B. PRAKASH RAO


PROFESSOR AND HEAD
DEPT. OF PHARMACEUTICAL TECHNOLOGY
KARNATAKA COLLEGE OF PHARMACY

12. 12.1 Remark of the Principal:


All the required facilities will be provided to carry out dissertation work under the
supervision of the guide.
12.2 Signature of the Principal

( DR. K.RAMESH )

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