Download rajiv gandhi university of health sciences, karnataka

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. Name of the Candidate
:
&Address
Abhishek kumar
S/O Mr. Sandeep kumar
Haldaur
Dis-Bijnor
U.P.- 246726
2. Name of the Guide
:
Mr. Ganesh N. S.
Asst. Professor
Department of Pharmaceutics,
Bharathi College of Pharmacy,
Bharathi Nagara,
Mandya-571422.
3. Name of the Institute
:
Bharathi College of Pharmacy,
Bharathi Nagara,
Mandya-571422
4. Course of the Study
:
Master of Pharmacy in Pharmaceutics.
5. Date of Admission
:
June-2007
6. Title of the Topic
:
Formulation and Evaluation of
Floating Drug Delivery System
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7. Brief Resume of the Intended Work
7.1 General discussion
Oral route has been the commonly adopted and most convenient route for the drug administration
has been received more attention in the pharmaceutical field because of the more flexibility in the
designing of dosage form than drug delivery design for other route.
The oral drug delivery design depends on various factors such as type of delivery system, disease being
treated, the patient, the length of therapy and the properties of drug, most of the oral controlled drug
delivery system release on diffusion, dissolution or combination of both mechanisms to release the drug
in a controlled manner to the gastrointestinal tract.
The goal of a targeted oral drug delivery system is to achieve better therapeutic success compared
to conventional dosage form of the same drug. This could be achieved by improving the
pharmacokinetic profile, patient convenience and compliance in therapy, some of the advantage of
Targeted oral drug delivery system (TODDS) are.
 Reduced dosing frequency
 Better patient compliance
 Less fluctuation plasma drug level
 More uniformity drug effect
 Less total dose
 Better stability of the drug
On the other hand (TODDS) suffers from a numbers of potential disadvantages.
 Higher cost
 Relatively poor in vitro in vivo correlation, possible dose dumping
 Reduced potential for dose change or withdrawal in the events of toxicity
Targeting of drug through oral route involves control of time of release of location of release on the
basic of environmental, anatomical and physiological factors1.
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7.2 Review of literature
1. Yoele, P.G.,et al., 2005. Presented a review article about floating drug delivery system need and
development, to achieving a prolong ed and predictable drug delivery profile in the
gastrointestinal tract to control the gastric residence time, using gastro retentive dosage forms
that will provide us with new and important therapeutic option3.
2. Brijesh,S.D.,et al.,2004. Have Prepared a review article about Gastro retentive drug delivery
system of ranitidine hydrochloride formulation and in vitro evaluation .The result is of the full
factorial design indicated that a low amount of citric acid and a high amount of staric acid favors
sustained release of ranitidine hydrochloride from a gastro retentive formulation .a theoretical
dissolution profile was generated using pharmacokinetic parameters of ranitidine hydrochloride
and concluded that addition of gel forming polymer HPMC K4M and gas generating agent
sodium bicarbonate was essential to achieve in vitro buoyancy4.
3. Basak, S.C.,et al.,2004. Prepared a review article about development and in vitro evaluation of
an oral floating matrix tablet formulation of Ciprofloxacin, which batter absorbed in stomach and
upper small intestine was formulated as floating matrix tablet using gas generating agent (sodium
bicarbonate)and hydrophilic polymer (Hydroxy Propyl Methyl Cellulose) and concluded that in
vitro drug release study of these tablet indicated controlled sustained release for Ciprofloxacin
and 80-89% release at the end of 8h6.
4. Jaimini,M.,et al.,2007. Study on formulation and evaluation of famotidine floating tablets to
prepare a gastro retentive drug delivery system of famotidine .by using different grades of
methocel K100 and methocel K 15MBY effervescent technique and showing good in vitro
buoyancy5.
5. Patel,V.F.,et al.,2005. Study on formulation and evaluation of ranitidine tablet and optimized
formulation for type of filler, different viscosity grades of HPMC and they used avicel pH 102
and taboettos 80 as filler. And concluded that the different viscosity grades of Hydroxyl Propyl
Ethyl Cellulose namely K100LV, K4M andK15M were used. It was observed that viscosity had a
major influence on drug release from hydrophilic materials as well as on floating property11.
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6 Shoo,S.K.,et al,2007. Formulation of floating micro spheres of ciprofloxacin hydrochloride by
cross linking technique .to increasing the gastric residence time and controlled release by using
polymeric mixture of sodium alginate and hydroxyl bicarbonate was used as the gas form are
enhance buoyancy and controlled release properties of sodium bicarbonate containing micros
hers made them an excellent candidate for floating drug dosage form9.
7. Shweta,A.,2005. Presented a review article about floating drug delivery system ,to recent
developments of floating drug delivery system including the physiological and formulation
variables affecting gastric retention, to design single unit and multiple unit floating system and
concluded that drug absorption in the gastrointestinal tract is a highly variable procedure and
prolonging gastric retention of dosage form extends the time for drug absorption .floating drug
delivery system promises to be a potential approach for gastric retention13.
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7.3 Scope
Floating drug delivery system (FDDS) or hydrodynamically balanced systems (HBS) are
among the several approaches that have been developed in order to increase the gastric residence time of
dosage forms. Gastric retention will provide advantage such as the delivery of drug with narrow
absorption window in the small intestinal region. Also longer residence time could be advantageous for
local action in upper part of the small intestine.
Ex: Peptic ulcer disease, further more improve bioavailability is expected for drugs that are absorbed
readily upon release in GIT.
Many drugs categorized as once a day delivery have been demonstrated to have sub optimal
absorption due to dependence on the transit time of dosage form in the stomach making traditional
extended release development a challenging task. Therefore a system designed for longer gastric
retention will extend the time within which drug absorption can occur in small intestine.
Certain types of drugs can be fit for using gastric retentive device which include:
a.
Drugs acting locally in the stomach.
b.
Drug that are primarily absorb in the stomach.
c.
Drug those are poorly soluble at an alkaline pH
d.
Drug with narrow window of absorption.
e.
Drug absorbed rapidly from GI tract.
f.
Drug that degrade in colon.
7.4 Objectives of the study
The present study is aimed to formulate and evaluate gastric floating tablet of a model category of drug
used in peptic ulcer and in H.pylori infection 2. By using the excipients like hydroxyl propyl methyl
cellulose(HPMC) different grades, carbapol different grades, ethyl cellulose(EC), NaCMC, NaHCO3
effervescent mixture etc. for optimum delivery of floating drug.
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7.5
Plan of work
Based on the objective the plan of work is as follows.
1.
2.
3.
Preformulation studies
Preparation of floating drug
Evaluation of floating drug
8. Materials and methods:
Materials
Polymers
Drugs
Hydroxyl propyl methyl cellulose
Carbapol
Ethyl cellulose
Sodium CMC
NaHCO3 . etc.,
In peptic ulcer,
H.pylori infection,
Anti bacterial antibiotics.etc.,
Methods
I. Preformulation studies:
a. Solubility.
b. Compatibility.
c. Calibration.
II. Preparation studies:
Prepration of floating tablet by using the polymers like
hydroxypropylmethylcellulose(HPMC) different grades, carbapol different grades, ethyl
cellulose(EC), NaCMC, NaHCO3 effervescent mixture etc. for optimum delivery of
floating drug.
III. Evaluation studies
In vitro buoyancy studies
In vitro dissolution studies
Bulk density
Angle of repose
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9. References
1. Vyas,S.P.,Roop,K.K.2005.Study of floating drug under controlled oral administration in
controlled drug delivery concept and advances, pp 156-195.
2. Dr.Jose,G.R,Hossein,C.,Khalid,S.2003. Progresses in gastro retentive drug delivery system,
Business Briefling Pharmatech.1-4. http://www.touchbriefings.com.
3. Yeole,P.G.,Shagufta,K.,Patel,V.F.2005.Floating drug delivery system need and development,Ind
J.pharma,67(3), 256-272.
4. Brijesh,s.d.,Avani,F.A.,Madhabhai,M.P.2004. Gastro retentive drug delivery system of
Ranitidine hydrochloride, formulation and in vitro evaluation, AAPS Pharmascitch,5(2),1-6.
5. Jamini,M.,Rana,A.C.,Tanwar.Y.S.2007.Formulation and evaluation of Famotidine floating tablet,
current drug delivery,4(1),51-55.
6. Baksar,S.C.,Nageswara,K.R.,Manavalan,R.,Rama,P.R.2004.Development and in vitro evaluation
of an oral floating matrix tablet formulation of Ciprofloxacin, Ind J.pharma.sci,66(3),313-316.
7. Narendra,C.,Srinath,M.S.,Ganesh,B.2006.optimization of bilayer floating tablet containing
Metoprolol tartrate as a model drug for gastric retention,AAPS pharmsciTech,7(2),E1-E7.
8. Ashish,K.J.,Sunil,K.J.,Awesh,Y.,Govinol,P.A.2006.Controlled release calcium silicate based
floating granular delivery system of Ranitidine hydrochloride ,current drug delivery ,3(4),367372.
9. Sahoo,S.K.,Mohapatra,S.,Dhal,S.K.,Behera,B.C.,Barik,B.B.2007. Formulation of floating micro
spheres of Ciprofloxacin hydrochloride by crosslinking technique, The Indian pharmacist,
58(4),65-68.
10.Sunil,K.J.,Govind,P.A.,Narendra,K.J.2006.Evaluation of porous carrier based floating orlistat
micro spheres of gastric delivery ,AAPS pharmascitech,7(4),E1-E8.
11.Patel,V.F.,Patel,N.M.,Yeole,P.G.2005. Study of formulation and evaluation of ranitidine floating
tablet,ind J.pharma.sci,67(6)703-709.
12.Muthusamy,K.,Govindrazan,G.,Ravi,T.K.2005. Preparation and evaluation of
lonsoprazole floating micro pellets,67(1)75-79.
13.Shweta,A.,Javed,K.,Alka,A.,Roop,K.,Sanjula,B.2005.Floating
review,AAPS pharmascitech ,6(3)E372-E390.
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drug
delivery
system
a
10. Source Of Data:
1. Library: Bharathi College of Pharmacy
2. e-library: Bharathi College of Pharmacy
11. Does the study require any investigation or intervention to be conducted on patients or other
humans or animals? If so please describe briefly.
-No.-
12. Signature of the Candidate:
13. Remarks of the Guide:
Signature of the Guide
14. Remarks of Head of the Department:
Signature of Head of the Department
15. Remarks of the Principal:
Signature of the Principal
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