Download bangalore, karnataka. - Rajiv Gandhi University of Health Sciences

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
Annexure-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1
NAME OF THE STUDENT AND
ADDRESS
(IN BLOCK LETTERS)
SOWJANYA .A. S
J. S. S COLLEGE OF PHARMACY
S S NAGAR,MYSORE-15
2
NAME OF THE INSTITUTION
J .S. S COLLEGE OF PHARMACY.
3
COURSE OF STUDY AND
SUBJECT
DATE OF ADMISSION TO
COURSE
TOPIC OF DISSERTATION
WORK
MASTER OF PHARMACY IN
INDUSTRIAL PHARMACY
4
5
6
7
BRIEF RESUME OF THE
INTENDED WORK
6.1 Need for the study
6.2 Review of literature
6.3 Objectives of the study
MATERIALS AND METHODS.
7.1 Source of data
Laboratory based study.
7.2 Method of collection of data
(Including sampling procedure, if
any)
Laboratory investigations.
7.3 Does study require any
investigations or interventions to
be conducted on patients or other
humans or animals? If so, please
describe briefly.
7.4 Has ethical clearance been
obtained from your institution in
case of 7.3.
8
LIST OF REFERENCES
0 8– 06 – 2007
PREPARATION AND EVALUATION OF BLEND
OF HPMC AND EUDRAGIT MICROPARTICLES
LOADED WITH DILTIAZEM
HYDROCHLORIDE FOR CONTROLLED
RELEASE
--- Enclosed------ Enclosed------ Enclosed----
--- Enclosed----
--- Enclosed----
----NO-----
-----NOT APPLICABLE----
-- Enclosed----
9
Signature of candidate
10
Remarks of the guide
11
Name and designation of
11.1 Guide
Dr. D. V. GOWDA
Professor,
Dept. of Pharmaceutics,
J .S. S College of pharmacy,
MYSORE-15
11.2 Signature
11.3 Head of Department
11.4 Signature
12
12.1 Remarks of the Principal
Signature
Dr. H .G. SHIVAKUMAR
Professor & Head,
Dept. of Pharmaceutics,
J. S. S College of pharmacy,
MYSORE-15
TITLE:
FORMULATION AND EVALUATION OF BLEND OF HPMC AND EUDRAGIT
MICROPARTICLES
LOADED
WITH
DILTIAZEM
HYDROCHLORIDE
FOR
CONTROLLED RELEASE.
6.0 BRIEF RESUME OF THE NEEDED WORK
6.1 NEED FOR THE STUDY
In the past decade various conventional dosage forms are in use for the treatment of
various diseases. Because of the short half lives of the conventional dosage forms they fail
to achieve and maintain the drug at blood level in the body within the therapeutic range.
Hence, it is often necessary to take this type of dosage form several times a day. This
yields an discomfort and non compliance to the patients. To overcome this problem,
number of attempts has been made recently in developing drug delivery systems which are
capable of controlling the rate of drug delivery in the body for a long period of time
Recently controlled release microparticles has been gaining importance because of its
ability to decrease the frequency of dosing and maintain the drug level at plasma for
extended period of time and less toxic effects.
Diltiazem Hydrochloride is an antihypertensive and antianginal drug having quite
extensive first pass metabolism and shorter elimination half-lives .Due to this it should be
given more frequently .The aim of the present study is to prepare microparticles of
Diltiazem hydrochloride for controlled release by using a blend of polymers of HPMC and
Eudragit using phase separation method.
6.2 REVIEW OF LITERATURE
Kristmundsdottir, et al1., have prepared microparticles of Diltiazem HCl by spray
drying technique using acrylate methacrylate copolymers and reported that the formation
of type of microspheres and microcapsules purely depends on the solvent used for the
preparation and also their release rate can be controlled by choice of polymer and
production conditions during spray drying.
Muge Kilicarslan, et al., 2 have formulated Verapamil HCl loaded microspheres
with solvent evaporation method and studied effect of drug/ polymer ratio on properties of
Verapamil HCl loaded microspheres. They reported that the variation in drug/polymer
ratios might have an influence on the physical characteristics of the microspheres and the
increasing amount of polymer might be result in decreased drug dissolve.
Anurag sood, et al., 3 have performed the Drug release evaluation of Diltiazem CR
preparations and they observed the marketed differences in dissolution characteristics of
different dissolution media of variable pH and elucidated the mechanism of drug release
based on the best fit of release data.
B.K.Kim, et al 4., have studied antihypertensive drug filodipine microspheres
prepared by solvent evaporation method using acryl ate methacrylate copolymers and
concluded that the release profiles and encapsulation efficiencies depended strongly on the
structure of polymers used in the preparation of the microspheres.
Jung-Hwa Lee, et al5., have prepared microspheres of water soluble drugs by
w/o/w double emulsion solvent diffusion method using anionic acrylic acid resin and
surfactants and reported release profile of drug largely depends on PHof the medium used.
Nilofer Yuk sel, et al6., have prepared microspheres of Nicardipine HCL by
solvent evaporation method using acrylic polymers eudragit RS and L and they
investigated that the interaction between the Nicardipine hydrochloride and polymers in
molecular level with their blends by using different methods and concludes that
Nicardipine and acrylic polymers blend preparation of controlled release microspheres
retard and enhance drug release rate at different ph solutions.
P.M.Satturwar, et al7., have developed a novel method for the preparation of
eudragit RL microcapsules. The technique is based on the principle of solvent evaporation
using Diclofenac sodium as a model drug for micro encapsulation .The prepared
microspheres obtained are uniform and free flowing particles and the release rate was more
sustained by increasing the polymer concentration and reported rapid and convenient
method for the preparation of eudragit RL microcapsules.
M.Hombreiro-perez, et al 8., have
prepared matrix type of microparticles
comprising a solid dispersion of drug with an amino acryl ate copolymer and ethyl
cellulose binary blend for controlled release of poorly water soluble drug Nifidipine and
evaluated their properties using different methods.
6.3 OBJECTIVES OF THE STUDY
1. To prepare microparticles of Diltiazem hydrochloride by using phase separation
method.
2. To characterize the prepared microparticles for micromeritic properties.
3. To evaluate the prepared microparticles for polymer drug compatibility by FTIR
and DSC, Surface morphology by SEM.
4. To carry out invitro release studies and compared with commercially available oral
preparation.
5. To perform stability studies of the prepared microparticles.
6.4 METHOD OF PREPARATION
Coacervation phase separation technique will be selected for the preparation of
microparticles.
7.0 MATERIALS AND METHODS
7.1 SOURCE OF DATA
A. Journals and publications.
B. Internet and Medline
C. Laboratory based study
DRUG TO BE USED IN THE FORMULATION
Diltiazem hydrochloride
MATERIALS
Eudragit
HPMC
Solvents
Other excipients etc.,
EVALUATION
1. Drug polymer compatibility studies by FTIR and DSC
2. Surface morphology by SEM
3. Drug loading capacity
4. Invitro release studies
5. Stability studies
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
NO
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Not applicable
REFERENCES
1. Kristmundsdottir T, Gudmundsson O S, Ingvarsdottir K. Release of Diltiazem from
Eudragit microparticles prepared by spray drying. Int .J. Pharm. 1996; 137:159-65.
2. Muge Kilicarslan and Tames Baykara. The effect of the drug /polymer ratio on the
properties of the Verapamil HCl loaded microspheres. Int. J .Pharm. 2003; 252;
99-109.
3. Anurag sood and Ramesh panchagnula.Drug release evaluation of Diltiazem controlled
Release preparations.Int. J. Pharm.1998; 175:95-107.
4. Kim BK, Hwang S J,Park JB,Park HJ. Preparation and characterization of drug loaded
polymethacrylate microspheres by an emulsion solvent evaporation method.
J microencapsulation. 2002; 19: 811-22.
5. Jung-Hwa Lee, Tae Gwan Park, Hoo-Kyun choi. Effect of formulation and processing
variables on the characteristics of microspheres for water soluble drugs prepared by
w/o/w double emulsion solvent diffusion method.Int .J. Pharm. 2000; 196: 75-83.
6. Nilofer Yuk sel, Teoman Tincer , Tamer Baykara. Interaction between nicardipine
hydrochloride and polymeric microspheres for a controlled release system.
Int. J. Pharm. 1996; 140: 145-54.
7. Satturwar PM, Mandagode P M. A Novel method for preparation of Eudragit RL
microcapsules.J Microencapsulation.2002; 19:407-13.
8. Hombreiro-perez M, Siepmann J. Non-degradable microparticles containing a
hydrophilic and /or lipophillic drug: preparation, characterization and drug release
modeling. J.controlled release 2003;88:413-28
9. Thomas wai-y-P.Lie, Joseph R Robinson, Remington: The Science and Practice of
Pharmacy, 2000, 1, 20, 903-29.
10. Lean Lachman, Herbert A.Lieberman, Joseph L kanig. The Theory and Practice of
Ind.Pharmacy.1987, 3: 430-56.
11. Controlled Drug Publication. Indian Pharmacopoeia.1996; 1:256-57.