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Aravind

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Aravind

Uploaded by

Arvind Vinnu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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You are on page 1/ 35

FORMULATION AND EVALUATION OF

RANITIDINE TABLETS USING


NATURAL POLYMERS
PRESENTED BY : K.ARAVIND [207J1R0017]
CH.SRIJA [207J1R0026]
V.NICHITHA [207J1R0030]
G.LAVANYA [207J1R0020]
S.RAMYA SRI [207J1R0039]

UNDER GUIDANCE OF
RAMYA KRISHNA [M.pharm]

1
CONTENTS
 ABSTRACT
 INTRODUCTION
 LITERATURE REVIEW
 AIM&OBJECTIVES
 DRUG&EXCIPIENTS
 MATERIALS&EQUIPMENTS
 METHODOLY
 RESULT&DISCUSSION
 CONCLUSION

2
ABSTRACT:

The aim of this research is to develop a floating sustained release ranitidine hydrochloride drug delivery
system tablets. Floating tablets of drug Ranitidine hydrochloride have been prepared to prolong the
residence time in the stomach and thereby increase its bioavailability. Floating matrix tablets of ranitidine
hydrochloride was prepared by direct compression technique employing a combination of hydroxyl
propyl methyl cellulose K4M (HPMCK4M) and karaya gum as an polymers and sodium bicarbonate is
used as generating agent. The floating tablets have been assessed for weight variation test hardness
thickness , friability ,swelling index, in vitro floating ability floating lag time. This natural karaya gum
which is swellable hydrophilic polymer is used to control drug release. The results showed that the
optimized formulation F3 containing 24% karaya gum 40 mg and 20% HPMC 70 mg had good floating
property and shorter floating lag time and sustained drug release for 12 hours.

3
INTRODUCTION TO DRUG DELIVERY SYSTEM:
The treatment of acute diseases or chronic illness has achieved by delivery of drugs through different drug delivery systems such as tablets,
injectables, suspensions, creams, ointments, liquids and aerosols, Another role of the delivery systems is to allow safe application of the
drug. This include that the drug in the formulation must be chemically, physically, and microbiologically stable. Side-effects of the drug and
drug interactions should be avoided or minimized by the use of suitable drug delivery system. The delivery system also need to improve the
patient`s compliance with the pharmacotherapy by the development of convenient applications. Finally, the delivery system needs to be
reliable and its formulation needs to be technically feasible. This means the pharmaceutical quality of the delivery system needs to be
assured, drug release from the system needs to be reproducible and the influence of the body on drug release should be minimized .

4
MODIFIED DRUG DELIVERY SYSTEM

 Dosage forms can be designed to modify the release of the drug over a given
time or after the dosage form reaches the required location. drug release
occurs only after some time of the administration or for a prolonged period of
time or to a specific target in the body. Modifications in drug release are often
desirable to increase the stability, safety and efficacy of the drug, to improve
the therapeutic outcomes of the drug treatment

5
CLASSIFICATION:
Modified Release dosage form may be classified as:
 Extended Release
 Sustained Release
 Controlled Release
 Delayed Release

 Extended Release: This type of oral DDS allows the drug to be released over prolonged
time periods. By extended the release can be achieved using sustained or controlled-
release dosage forms.
 Sustained Release:This term is constantly used to describe a pharmaceutical dosage
form formulated to retard the release of the therapeutic agent such that its appearance in
the systemic circulation is delayed and prolonged and its plasma profile is sustained in
duration .The onset of its pharmacological action is often delayed ,and the duration of
its therapeutic effect is sustained. 6
ADVANTAGES OF SUSTAINED RELEASE DOSAGE FORMS

o Improved patient compliance due to reduced frequency of drug administration.


o The blood levels oscillations characteristics of conventional dosage forms is
reduced
o A less obvious advantage that the total amount of drug administered can be reduced
,thus maximizing availability with minimum dose
o Better control of drug absorption can be attained, since the high blood level peaks
that may be observed after administration of a dose of high availability drug can be
reduced by formulation in an extended action form.

7
DISADVANTAGES

 Administration of SR medication does not permit the prompt


termination of therapy.
 Less flexibility in adjusting dosage regimen.
 Sustained release forms are designed for national population, i.e., on
the basis of biological half-lives.consequently,disease states that alter
drug disposition, significant patient variation, and so forth are not
accommodated.
 Economic factors.

8
INTRODUCTION TO NATURAL POLYMERS:

Th e aim o f th is wo rk is tried to g iv e a b rief o v erv iew to th e role o f n atu ral p o ly mers in th e d ev elo p men t o f flo atin g d ru g d eliv ery sy stem. Th e u se o f n atu ral p o ly mers is v alu ab le b ased o n p ro ven bio co mp atib ility an d safety. Natu ral gu ms are amo n g th e mo st p o p u lar h y d ro ph ilic p o ly mers b ecau se of th eir co st-effectiv en ess an d reg u lato ry accep tan ce . Po ly mers are g en erally emp lo y ed in flo atin g d ru g deliv ery sy stems so as to targ et th e d eliv ery o f d ru g to a sp ecific regio n in th e g astro in testin al tract i.e. sto mach . Mo reov er, th ese p o ly mers are safe, n o n to x ic, an d cap ab le o f ch emical mo d ificatio n an d g el fo rmin g n atu re

Po ly mer:a su b stan ce wh ich has a mo lecu lar stru ctu re b u ilt up ch iefly o r co mp letely fro m a larg e n u mb er o f similar u nits bo n d ed to g eth er [mo n o mers]

9
PROPERTIES OF POLYMERS:

 Natural polymers remain attractive primarily because they are commercial, readily available,
capable of multitude of chemical modifications, potentially degradable and compatible due to
their origin.
 The greatest advantage of these degradable polymers is that they are broken down into
biologically acceptable molecules that are metabolized and removed from the body via normal
metabolic pathways
 Polymers are macromolecules having very large chains, contain a variety of functional groups,
can be blended with other low and high–molecular weight materials, and can be tailored for any
applications.
 Protein, enzymes, muscle fibers, polysaccharides and gummy exudates are the natural polymers
being used effectively in formulating the variety of pharmaceutical products. The well known
natural polymers used in
10
CLASSIFICATION:

Polymers cannot be classified into a single category due to their complicated structures, diverse
properties, and wide range of uses. The polymers are divided into 3 types depending on their
source of availability. They are Natural ,Synthetic ,Semi-Synthetic

1.Natural Polymers are present in plants and animals and exist naturally. Proteins, starch,
cellulose, and rubber are a few examples. Biodegradable polymers are also called biopolymers.

 E.g: Gelatin, fibrinogen ,chitosan ,carrageenan ,etc

2.Synthetic Polymers are man-made polymers. The most prevalent and commonly used synthetic
polymer is plastic. It is utilized in a variety of industries and dairy products, for example nylon-6,
polyethers E.g: Polyethylene glycol, vinyl acetat, etc….

3.Semi-Synthetic Polymers are produced from naturally existing polymers and then chemically
modified, for example cellulose nitrate and cellulose acetate.
11
I. E .g: Cellulose derivatives, cellulose nitrates Polymers
LITERATURE REVIEW

1.JM. Packiaraj et,al (2013) Clarithromycin ER (extended-release) tablets containing 500

mg of Clarithromycin is available in the market under the brand name BIAXINE XL


Filmtab® manufactured by AbbVie LTD. The objective of the research work is to make a
formulation equivalent which will exhibit comparative in-vitro and in-vivo drug release
profile. The objective was accomplished using a combination of Hypromellose 5 cps and
Hypromellose 15 cps as drug release rate controlling polymers with Purified Water as a
granulating fluid in a Fluid Bed Top Spray Granulation Process. The prepared ER core
tablets were film coated upto 3% w/w coating build up using 20% w/w dispersion of
Opadry II White 85F18422. Final tablets showed comparative in vitro and in vivo drug
release profile against BIAXINEXL Filmtab. The physico-chemical properties of the
finalized ER tablets of Clarithromycin was found to be stable at accelerated temperature
and humidity conditions of 40°C /75% RH for 3 months
12

1,
2. Heras J et al., (2009) found that functional dyspepsia as a highly common disorder. The
physiopathological mechanisms of this entity are not yet completely known and prokinetic
drugs seem to be useful. The aim of this study was to evaluate the prokinetic effect of
cinitapride in patients with dysmotility-like dyspepsia and delayed gastric emptying.

3. Portincasa P et al., (2009) evaluated the prokinetic effect of cinitapride in patients with
dysmotility-like dyspepsia and delayed gastric emptying. Oral cinitapride is safe and
effective in improving gastric emptying and symptoms in patients with dysmotility-like
dyspepsia and mild-to-moderate delayed gastric emptying.

4.Juan M. Aceves et al (1999) studied the release patterns from Furosemide Eudragit
controlled release systems. They prepared Solid dispersions and physical mixtures and
dissolution rate was determined in order to follow the behavioural changes of the system.
Scanning electron microscopy showed the presence of micro spheres within the polymeric
matrix, and the channels formed due to the Furosemide dissolution inside the Eudragit. 13
AIM & OBJECTVES

1.To formulate sustained release tablets of ranitidine to improve its oral bioavailability and
to reduce its dosing frequency.

2.To optimize optimum concentration of various sustained release polymers

3.To perform various quality control evaluation parameters for prepared tablets.

14
DRUG & EXCIPIENT PROFILE

Drug name: Ranitidine hydrochloride


IUPAC Name: N-(2-[(5-[(Dimethylamino)methyl]furan-2-yl)methylthio]-N-methyl-2-nitro-
1,1-diamine
Synonyms: Zantac,azantac, raniplex ranidil.
Description:
Ranitidine hydrochloride is a competitive inhibitors of histamine H2- receptor ,drug of choice
in the treatment of duodenal ulcer,gastriculcer ,Zollinger-Ellison Syndrome (ZES)
gastroesophageal reflux disease (GERD),and erosive esophagitis .the recommended adult oral
dosage of 150 mg twice daily or 300mg onces daily .A conventional dose of 150 mg can
inhibit gastric acid secretion upto 5 hours but upto 10 hours .an alternative dose of 300mg
leads to plasma fluctuations ; thus a sustained release form of ranitidine HCL is desirable.
Solubility: Ranitidine was synthesized in 1976, but due to its poor solubility in water it was
replaced by ranitidine hydrochloride in 1977. The solubility of the ranitidine hydrochloride in
water is 660 mg/mL
15
Structure:

Molecular Formula: C13H23ClN4O3S

Molecular Wieght : 350.87 g/mol

Bioavailability : Bioavailability is 50%(by mouth)

Half-Life : 2.5 – 3 hours

16
PHARMACOLOGY:

Ranitidine Tablets, USP is a competitive, reversible inhibitor of the action of histamine at the
histamine H2-receptors, including receptors on the gastric cells. Ranitidine Tablets, USP does
not lower serum Ca++ in hypercalcemic states. Ranitidine Tablets, USP is not an
anticholinergic agent.
PHARMACOKINETICS:

Absorption: Ranitidine is rapidly absorbed with peak concentrations reached within 1-3 hours

after administration, and varying greatly among patients. Bioavailability is about 50%-60%

due to hepatic metabolism. In a pharmacokinetic study of healthy males, the AUC 0-infinity

was about 2,488.6 ng x h/mL and the median T max was 2.83 hours. Food or antacids have

limited effects on absorption. One clinical study found that the administration of a potent

antacid (150 mmol) in subjects in the fasted state led to decreased absorption of ranitidine. 17
Distribution: The apparent volume of the distribution for terminal phase is about 1.16–1.87
L/kg.14,15,21,25,33 Ranitidine has a low protein binding of about 15%.
METABOLISM&EXCRETION:

major metabolite in the urine is N-oxide, which represents less than 4% of the dose. Other
metabolites of ranitidine include S-oxide (1%) and desmethyl ranitidine (1%). The feces contain
the remainder of the excreted ranitidine dose. Liver dysfunction has been shown to cause small,
but clinically insignificant, changes in various ranitidine pharmacokinetic parameters.

The principal route of excretion is the urine, with approximately 30% of the orally administered
dose collected in the urine as unchanged drug in 24 hours. Renal clearance is about 410 mL/min,
indicating active tubular excretion. The elimination half-life is 2.5 to 3 hours. Four patients with
clinically significant renal function impairment (creatinine clearance 25 to 35 mL/min)
administered 50 mg of ranitidine intravenously had an average plasma half-life of 4.8 hours, a
ranitidine clearance of 29 mL/min, and a volume of distribution of 1.76L/Kg. In general, these
parameters appear to be altered in proportion to creatinine clearance 18
Adverse Effects:
These adverse effects for ranitidine have been reported as
events in clinical trials:
Central nervous system:

Rare reports have been made of ranitidine


causing , dizziness, somnolence, insomnia, and vertigo. In
severely ill, elderly patients, cases of reversible mental
confusion, agitation, depression, and hallucinations have been
reported
.
Cardiovascular:
Arrhythmias such as tachycardia, bradycardia, atrioventricular
block, and premature ventricular beats have also been reported

Liver:
Cholestatic hepatitis, liver failure, hepatitis, and jaundice have
been noted, and require immediate discontinuation of the
drug.Blood tests can reveal an increase in liver
enzymes or eosinophilia, although in rare instances, severe 19

cases of hepatotoxicity may require a liver biopsy.


MATERIALS &EQUIPMENTS

Ranitidine Hcl gift sample obtained from Medrich pharma Bengaluru, Carbopol 934, Chitosan,
and sodium alginate obtained from Lobachemi, Pvt Ltd. Mumbai, Dichloro methane obtained
from Qualigens Fine Chem Pvt Ltd, Mumbai, Calcium carbonate obtained from Qualikems
fine chem. Pvt ltd, New Delhi Tween 80 obtained from Qualigens Fine Chem Pvt Ltd,
Mumbai. Glacial acetic acid obtained from Medilise chemicals Kannur. Conc Hydrochloric
acid obtained from Flora chemicals, Mumbai Potassium bromide obtained from Flora
chemicals Mumbai.
Hardness tester Sisco,Mumbai,India.

Vernier callipers Mitutoyo,Japan

Roche Friabilator Labindia,Mumbai,India

Dissolution Apparatus Labindia,Mumbai,India

UV-Visible Spectrophotometer Labindia,Mumbai,India

pH meter Labindia,Mumbai,India

FT-IR Spectrophotometer Per kin Elmer ,United States of America.


20
METHODOLOGY

Chemicals: Hydroxypropyl methylcellulose, Ethyl cellulose, Xanthan gum, Lactose, Talc


(glidant) and Magnesium stearate (lubricant) were purchased by Merck. Moreover,
Hydrochloric acid, Potassium hydrogen and sodium hydroxide phosphate were also procured
by Merck and the drug Ranitidine HCl was gifted by Akson Pharmaceutical, Mirpur. All
chemicals were of analytical grade.
Method of preparation: Eight preparations of non-effervescent floating tablets of Ranitidine
HCl were formulated by using direct compression method using polymers namely
Hydroxypropyl methyl cellulose, Ethyl cellulose, Xanthan gum, excipients such as lactose,
magnesium stearate and talc. Firstly, all ingredients were weighed accurately on weighing
balance and were then passed through sieve no. 40. The drug, HPMC, EC, XG and lactose
were mixed properly in a pestle and mortar in an attempt to get auniform tablet blend. Finally,
talc and magnesium stearate were mixed with the so obtained blend. The blend was
compressed into round tablet using Rotary tablet punch machine (Mahapatra & Vidyasagar).
The different formulations were labeled as F1–F8, the formulae of which are given in table
no. 1.

21
Pre-compression studies: Formulations prepared for compression were subjected for pre-
compression parameters to study the flow properties of powders (repose angle, tapped density,
bulk density, Hausner’s ratio and compressibility index).
Angle of Repose: To measure repose angle of weighed powder, method of fixed funnel was
used. Funnel was stationary with the help of a supporting stand such that the tip of the funnel
remained at 10cm above the horizontal surface. A circular-dish of known radius (r) was
positioned on a plane horizontal surface centered beneath funnel tip, having sharp edges, and
the diameter of its cone base was denoted was filled in the funnel and the funnel tip was
obstructed with thumb which was then immediately removed. Powder was permitted to fall
through a funnel over a petri dish till the excess powder slide down at the sides of the petri
dish. Vertical height (h) of the heap was obtained. The repose angle was calculated by given
formulae (Lachman et al., 1976).
Ɵ = tan−1 (2\HD) Eq (1)
Bulk Density: Apparent bulk density was evaluated by torrential drug excipients mixture into
a graduated cylinder and computing the weight and volume
Db = M/Vb
Whereas, Db depicts bulk density, M for mass and Vb is bulk volume. The unit of bulk 22
density is g/ml
Tapped Density: To find out the tapped density the graduated cylinder was mechanically
tapped containing the powder sample. The initial powder volume was observed, marked at
the graduated cylinder and was tapped on to the hard and smooth impervious surface, until
the mass or volume changes became constant. The tapped density was determined by
following formula

DT=M/VT Eq (3)
Whereas, Dt depicts tapped density, M for mass and Vt is for tapped volume.
Carr’s Compressibility Index: It was calculated by importing previously received data of
bulk and tapped density into the following equation.
C.I = (Dt – Db )/Dt ×100 Eq (4)
Hausner’s Ratio: It was calculated by inducing values of bulk and tapped density into the
following formula:
H.R = Dt ⁄ Db Eq (5)
Post compression studies: Different post formulation tests like thickness, diameter, hardness,
weight variation and friability for each batch were conducteas “D”. eparately. Moreover, In- 23
vitro buoyancy test and dissolution were conducted on 8 formulations.
Thickness and diameter: Ten tablets were selected randomly from each formulation.
Thickness and diameter were measured by using digital vernier calipers .
Weight variation: From each batch twenty tablets were selected randomly and their average
weights were determined. Percentage weights and their deviations were calculated and were
compared with USP specifications .
Hardness test: Ten tablets were nominated randomly and determined tablet hardness from
each batch, by using the Eurweka hardness tester. Unit of hardness was Kg/cm² .
Friability test: It was performed according to the USP specifications using Roche Friabilator.
Tablets weight was less than 650 mg so a random sample of whole tablets corresponding to
6.5grams was de-dusted and then was accurately weighed. After weighing, tablets were de-
dusted and placed in a drum of Roche Friability Tester. Drum was rotated for 4 minute at 25
rpm and tablets were removed after 4 minutes, de-dusted and then were accurately weighed.
The percentage weight loss was determined by using this equation .
F = Winitial − Wfinal ⁄ Winitial × 100 Eq (6)
Percentage loss of tablets less than 1% is considered acceptable according to the USP.
In vitro buoyancy test: In vitro buoyancy was attaining by floating lag time (FLT). 3 tablets
from each formulation were randomly selected. The tablets were taken in a beaker having 200 24
ml of 0.1 NHCl
The time necessary for the tablet to go up to the surface and then float was floating lag time (FLT). The time
stage at which tablets remain buoyant was measured as Total Floating Time (TFT)
Content uniformity: The prepared formulation of Ranitidine HCl was weighed and crushed. Powder
equivalent to Ranitidine HCl (150mg) was weighed and shaken with 100 ml of 0.1 NHCl in 100ml
volumetric flask and filtered with Wattsman filter paper No. II. The aliquot (1ml) was taken and its volume
was made with0.1N HCl upto 100ml having pH 1.2 while absorbance was taken at 313nm using UV
spectrophotometer. Content of drug was evaluated by using standard curve of Ranitidine HCl .
Preparation of standard curve of Ranitidine HCl: Ranitidine Hydrochloride was dissolved in 0.1 NH Cl
and volume was made up to 100 ml in volumetric flask. From the stock solutions 5 dilutions (10, 20, 30, 40
and 50μg/ml) were prepared. Each solution absorbance was measured at 313 nm using UV
spectrophotometer by using reference standard of 0.1N HCl. The standard curve was plotted by applying
data in MS Excel format as presented in figure 1
In vitro dissolution test: The rate of release of Ranitidine from floating tablets was evaluated by paddle
method from United States Pharmacopoeia (USP) dissolution apparatus II (paddle method). The dissolution
test was performed using 0.1 NHCl (900ml) at 37C0.5 for 6 hours at 50rpm. Aliquot equal to 5ml was
taken at particular time intervals and the samples were substituted with renewed dissolution medium. The
samples were filtered and diluted to a suitable concentration with 0.1 NHCl. These solutions absorbance was
measured at 313 nm using a UV spectrophotometer. Cumulative percentage of release of25 drug was
determined using the equation obtained from a standard curve.
Analysis of release pattern: Drug release analysis mechanism from a dosage form is
significant but complex procedure and is almost obvious in floating systems cases. The release
drug from FDDS was defined by using zero, first order kinetics and Higuchi release model. The
mode of action of release of drug from FDDS was studied by using Korsemeyer Peppas quation
.

FTIR spectroscopic analysis: Fourier transform infrared spectroscopy (FTIR) was performed
for pure Ranitidine HCl, HPMC, EC, xanthan gum and sample formulation F5. Samples of
floating tablet, pure Ranitidine HCl, HPMC, EC and xanthan gum were rumpled in an agate
mortar with pestle. The crumpled material was mixed with potassium bromide (Merck IR
spectroscopy grade) in 1:100 ratios and dried at 40˚C. Then the mixture was crushed to a 12
mm semitransparent disc by applying 65 kN pressure (by Pressure gauge, Shimadzu) for
2minutes. The FTIR spectrums, over the range of 4000-400 cm-1 wavelength were documented
using FTIR spectrum.

26
RESULTS & DISCUSSION
1 Pre-compression studies:
Formulations prepared for compression were subjected for pre-compression parameters to
study the flow properties of powders (repose angle, tapped density, bulk density, Hausner’s
ratio and compressibility index). Results are described in table 2.
2 Post compression parameters:
Different parameters after compression like thickness, hardness, diameter, weight variation,
friability and content uniformity were evaluated. Results are described in table
3. In vitro buoyancy studies:
All the tablet formulations were prepared by non-effervescent approach. In vitro buoyancy of
tablets was determined in 0.1 NHCl and the results were presented in Table
4 In vitro dissolution studies:
In vitro dissolution studies were performed in 0.1 NHCl (pH 1.2) by using USP type II
dissolution apparatus (paddle apparatus). Effects of various ingredients and their concentration
on drug release were studied and presented in table 5. 27
Fourier transform infrared spectroscopy studies:
The peaks attained in the spectra of each formulation associates with drug spectrum peaks, given
in figure 2.

28
29
DISCUSSION
Powder was evaluated for repose angle value which was found within the range of 27.28-30.25
indicating powder flow for all the eight formulations were excellent. Bulk density for all eight
formulations was found to be in the range of 0.46-0.65 while tapped density was in range of
0.56|\69. The percent compressibility index for all eight formulation was found to be 6-19.
These results indicated that the powder had well to fairly acceptable flow property. The
thickness of tablet indicates that, die fill was uniform result obtained were within acceptable
limits. According to pharmacopoeia. The result obtained was similar to studies were prepared
floating tablet of Ranitidine Hcl. The tablet were manufactured using diverse polymers like
HPMC 4K, Xanthan gum, HPMC 100K, Moringa gum and guargum in different ratios and
result of post compression parameters of different formulations were nearly similar to the
result being presented in the study.the thickness depended on the size of the punches (8mm)and
the weight of the tablet (300mg).the weight variation test for all the formulations depicted too
low values of standard deviation showing excellent. The thickness of tablet of formulation (F2)
was found to be 0.18 ± 0.5mm and the hardness was found to be 4-5kg/cm2. It has good
mechanical strength . percentage weight loss of the 10 tablets of each formulations was
measured and found to be within the range of 0.42-0.82% which was not acceptable i.e.in
between 0.5-1%.these results obtained were comparable to study of who prepared floating 30
The formulations batch containing higher value of HPMC and xanthan gum and lower value
of ethyl cellulose showed higher floating properties, due to its hydrophobicity which in turn
decreases its density letting the tablet to float. Form the result obtained, it was experimental
that the increased concentration of ethyl cellulose augmented the floating
properites,Buoyancy of the tablets was provided by ethyl cellulose agent,which swelled and
increased water uptake capacity of tablet because of hydrophilic properties.the tablet of batch
F3 and F4exhibited buoyancy lag time of 14 and 12 seconds ,respectively, and did float for 5
hours and 6hours. The tablets of batch F7 and F8 showed lag time of 6and 12 seconds
respectively, but the total buoyancy time was 4 and 3 hours. The tablet F1,F5 and F4 showed
high buoyancy time. The result obtained were comparable to basha et al. studies who
prepared matrix floating tablet of Tinidazole and Ofloxacin combination using EC and
HPMC and Xanthan gum as polymers. Tablets of formulations F9were float for 10 hours
which containing HPMC 15% EC 8% and xanthan gum 8% which is nearly similar to F5 of
present study which also float for 10 hours with HPMC 18% and EC8% and Xanthan gum
6%. The study does not show any well -defined interaction between Ranitidine HCL and
excipients. No change in peak showed that there was no interaction between drug and
polymers . N-H stretching of primary amine, C-H stretching, C-S stretching ,C-H
deformation N-H out of pain bending of pure ranitidine hcl with polymer were almost in the
same region of wave number ranging from 400 and 4000 31
Conclusion:
The novel drug delivery non effervescent based floating system is an emerging approach for
receiving In-vitro buoyancy. Gastric retention time of Ranitidine HCl was increases up to 10
hours hence enhancing its antiulcer usefulness.

32
REFERENCE:

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4. Daly M, Humphray JM and Stables R 1981. Some in vitro And in vivo actions of the new histamine
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9. Kumar S, Das M, Gupta K, Kumar R, Chongdar A and Ghosh L 2013. Design, development,
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pharmacy. Lea & Febiger Philadelphia.

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