Final project power point

“DESIGN AND EVALUATION OF
BILAYER TABLETS OF CAPECITABINE
AND ONDANSETRON”
Register number: 261311006
DEPARTMENT OF PHARMACEUTICS Under the guidance of
CHERRAAN’S COLLEGE OF PHARMACY Dr. N. THIRUMOORTHY,
COIMBATORE-641039 M. PHARM, PH.D.,

It comprises of two layers, one of which is sustained release of
Capacetabine and another one is immediate release of
Ondansetron.
Hence, it uses Dual Release Drug Absorption System(DUREDAS)
technology.
 To provide once a day dosage form for the treatment of nausea
and vomiting .
 As Capacetabine having shorter half life, bilayer tablet provide
extended release of Capacetabine .
 Hence reduce dose frequency. Also, Ondansetron formulated as
an immediate release part provides initial relief as is the case with
loading dose in an extended release formulation.
 Give additive effect of used both the drugs.
 Hence reduce dose dependent side -effects. Also, Ondansetron is
able to overcome the some side effects of Capacetabine.
 The process involves reduced manufacturing steps and
manufacturing time and finally makes a cost effective formulation
1. AIM OF PRESENT WORK

2. BILAYER TABLET
 Bi-layer tablet which is made up of two Distinct
layers. compressed together with the individual
layers lying one on top of Another.
 The administration of sustained release preparation
as one layer with the immediate release preparation
as the second layer is possible. The separation of
two incompatible substances with addition of any
barrier layer between them is possible.
 DUal RElease Drug Absorption System
 (DUREDAS technology) is a bilayer tablet which can
provide immediate or sustained release of two drugs
or different release rates of the same drug in one
dosage form.

3. LITERATURE REVIEW
Researcher Research Title
M.Sowmya, M.Saritha
Has developed and optimized bilayered sustained
release matrix tablets of Valsartan.
Pandey H developed sustained release bilayer tablet of
domperidone using hydrophilic matrix material such
as HPMC, carbapol and poly-ethylene oxide.
Shirwaikar A. formulated sustained release of Diltiazem
hydrochloride tablets by utilizing the bilayer
concept using matrix material rosin and ethyl
cellulose.
Bhavesh Shiyani et
al.
The aim of this study was to prepare bi-layer tablet
of Metoclopramide Hydrochloride (MTH) and
Ibuprofen (IB) for the effective treatment of
migraine.
Jayabalan Nirmal et
al
formulated bilayer tablets consisting of
atorvastatin calcium (AT) as an immediate
release layer and nicotinic acid (NA) as an
extended release layer.

4. PLAN OF WORK
Pre-formulation studies
 Calibration curve.
 Flow properties.
 Drug excipient compatibilities.
 Preparation Of Tablets By Direct Compression Method ( IR
tablets).
 Preparation Of Tablets By Direct Compression Method (SR
tablets).
 Evaluation of the prepared tablets for various physico-
chemical parameters such as.
 Appearance.
 Hardness.
 Weight variation.
 Friability.
 Thickness.
 In vitro drug release.
 Kinetic studies.

4.DRUG PROFILE
Name Capacetabine
Brand names Xeloda
Categories
 Antineoplastic
 Antimetabolites
Indication For the treatment of patients with metastatic breast cancer
resistant to both paclitaxel and an anthracycline-containing
chemotherapy regimen.
Plasma Half life Capacetabine having shorter half life, 45-60 minutes and its
metabolites.
Mechanism of action Folate cofactor, N5-10-methylenetetrahydrofolate, bind to
thymidylate synthase (TS) to form a covalently bound
ternary complex. This binding inhibits the formation of
thymidylate from 2'-deaxyuridylate.
Absorption Readily absorbed through the GI tract (~70%).
Properties:
State
melting point
Solid
110-121 °C
polarizability 35.81
Dosage forms Tablet oral

4.DRUG PROFILE
Name Ondansetron
Description A competitive serotonin type 3 receptor antagonist. It is
effective in the treatment of nausea and vomiting caused by
cytotoxic chemotherapy drugs.
Category Antiemetics
Indication For the prevention of nausea and vomiting associated with
emetogenic cancer chemotherapy, postoperation, and
radiation.
Mechanism
of action
Ondansetron is a selective serotonin 5-HT3 receptor antagonist.
The antiemetic activity of the drug is brought about through
the inhibition of 5-HT3 receptors present both centrally
(medullary chemoreceptor zone) and peripherally (GI tract).
Absorption
Ondansetron is well absorbed after oral administration and
undergoes limited first-pass metabolism.
Protein binding 70%-76% (Plasma protein binding)
Half life 5.7 hours
State solid

EXCIPIENTS
POVIDONE Enhancer; tablet Disintegrant;
dissolution binder.
MAGNESIUM STEARATE Tablet and capsule lubricant .
CROSS POVIDONE (CP) Tablet disintegrant. and dissolution
agent.
SODIUM STARCH GLYCOLATE
(SSG)
Tablet and capsule disintegrant.
Microcrystalline cellulose (MCC) Adsorbent; suspending agent; tablet
and capsule diluent; tablet
disintegrant.
Hydroxy Propyl Methyl Cellelose
(HPMC) Minimize interaction problems when
used in acidic, basic,
Polyvinyle pyrrolydine (PVP)
Binder in wet granulation
Ethyl Cellelose (EC)
Coating agent,
Sodium Lauryl Sulphate (SLS)
Excipient in dissolvable dosage forms.
Talc Lubricant

5.PREFORMULATION & FORMULATIONS STUDY
.PREFORMULATION STUDY:
◦ Organoleptic properties
◦ Solubility
◦ Density
◦ Carr’s compressibility index & Hausner’s ratio
◦ Angle of repose(ɵ)
◦ Compatibility studies
◦ F.T.I.R
 FORMULATIONS
 The bilayer tablet was prepared by direct compression method.
 As shown in Table powder mixtures of Capacetabine,
microcrystalline cellulose, polymers and binder were dry
blended for 20 min followed by addition of Magnesium Stearate
and Talc.
 The mixtures were then further blended for 10 min., 400mg of
resultant powder blend was manually compressed using KBr
hydraulic press at a pressure of 1 ton, with a 12mm punch and
die to obtain the tablet.

a) First layer fill ; b) First layer tamping;
c) Upper punch withdrawal; d) second layer fill;
e) main compression; f) Ejection;

Ingredien
ts
F1 F2 F3 F4 F5 F6 F7 F8 F9 F10
Capacetabi
ne (mg)
150 150 150 150 150 150 150 150 150 150
HPMC
K4M(%)
10 -- -- -- -- -- 5 -- -- --
HPMC
K100M(%)
-- 10 -- -- 15 20 15 15 15 20
HPMC E15
(%)
-- -- 10 -- -- -- -- 5 -- --
EC(%) -- -- -- 10 -- -- -- -- 5 5
PVP K30
(%)
5 5 5 5 5 5 5 5 5 5
Talc (%) 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
Magnesium
stearate(%
)
2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
MCC(mg) Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S
Total
weight
(mg)
400 400 400 400 400 400 400 400 400 400
COMPOSITION OF SUSTAINED RELEASE LAYER
Table no 1 formulation table for sustained release layer

5.PREFORMULATION & FORMULATIONS STUDY
 DIRECT COMPRESSION FOR IMMEDIATE LAYER
All the ingredients were passed through sieve and
mixed in a motor and pestle for 30min for uniform
mixing. The addition of ingredients was done in a
geometrical manner. Then the ondansetron layer was
compressed using 8mm round punch.
COMPOSITION OF IMMEDIATE RELEASE LAYER

Table no2: formulation table for immediate release layer
Ingredi
ents
(mg)
F1 F2 F3 F4 F5 F6 F7 F8 F9
Ondans
etron
8 8 8 8 8 8 8 8 8
HPC
(%)
5 5 5 5 5 5 5 5 5
SSG(%) 5 -- -- -- -- -- -- -- --
CCS(%) -- 5 -- 7.5 10 12.5 10 10 10
CP(%) -- -- 5 -- -- -- -- -- --
Lactose
monohy
drate
Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S
Magnesi
um
stearate
(%)
2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
Talc
(%)
2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
SLS(%) -- -- -- -- -- -- 0.5 1 1.5

BILAYERED TABLET PUNCH
After the batch was optimized in both immediate release layer ( F8) and
sustained release layer (F7).The optimized batch in both was
compressed by using same ingredients
Flow Properties
Angle of Repose
Bulk density:
Tapped density
Compressibility index and Hausner ratio
TABLE NO 3 : ACCEPTANCE CRITERIA OF FLOW PROPERTIES
Flow properties Angle of repose(θ) Compressibility
Index (%)
Hausner ratio
Excellent 25-30 <10 1.00-1.11
Good 31-35 11-15 1.12-1.18
Fair 36-40 16-20 1.19-1.25
Passable 41-45 21-25 1.26-1.34
Poor 46-55 26-31 1.35-1.45
Very poor 56-65 32-37 1.46-1.59
Very very poor > 66 >38 >1.6

EVALUATION’S PARAMETERS
 Appearance
 Weight variation test
 Thickness test
 Hardness test
 Friability test
 Development of analytical methods
 In-vitro studies
 Swelling index
 Drug content(assay of tablet)
 Release of kinetics
 Stability study

6. RESULT & DISCUSSION
 Pre-compression parameters:
 Preformulation studies:
 Capacetabine(API)
 Physical characterization:
 physical characterization of Capacetabine was
studied.
 Density and flow properties of drug:
the drug having the excellent flow properties.
 Evaluation of Formulated blend: Bulk density,
Tapped density, Carr’s compressibility index ,
Hausner’s ratio and Angle of repose are
studied .the values are within the limits. And
the Formulation blend was good flow property

6. RESULT & DISCUSSION
 Preparation of standard calibration
curve of Ondansetron: in 0.1N HCl
calibration curve of Ondansetron in 0.1N HCl
 Standard Graph of Capacetabine (0.1 N
Hcl):
calibration curve for Capacetabine in 0.1N HCl
at 303nm
 Standard Graph of Capacetabine in
6.8pH phosphate buffer :
calibration curve for capacetabine in 6.8pH
phosphate buffer at 304nm

COMPATIBILITY STUDIES
 (FTIR) was used for infrared analysis of samples to intercept the
interactions of drug with polymers and other ingredients. The powder
sample along with KBr was used for FTIR studies. The samples were
analyzed between the wave numbers 4000 and 400 cm2.
 Fig no 1: FTIR spectra of Capecitabine pure drug

Fig no 2: FTIR spectra of Ondansetron pure drug

Fig no 3: FTIR spectra of bilayered tablet

EVALUATION OF PRE COMPRESSION PARAMETERS FOR
SUSTAINED RELAESE LAYER OF CAPACETABINE
 Formulations
 Angle of Repose (θ)
 Loose Bulk
 Density (g/ml)
 Tapped Bulk
 Density (g/ml) %
 Compressibility
 Hausner’s ratio

 INVITRO DISSOLUTION STUDIES FOR SR TABLETS -
 DISSOLUTION STUDY ( SR TABLETS) :
 Acidic Stage:
 Medium : 0.1N HCL
 Type of apparatus : USP - II (paddle type)
 RPM : 50
 Volume : 900ml
 Temperature : 37ºC± 0.5
 Time : 2hrs
 Buffer Stage:
 Medium : 6.8pH phosphate buffer
 RPM : 50
 Volume : 900ml
 Time : 24hrs
 In vitro dissolution for SR tablets were done initially in 0.1N HCL for 2hrs
and next in 6.8 phosphate buffer for 12hrs

In-Vitro Drug Release Studies for SR tablets:
Table no 4. Cumulative Percentage Drug Release of Sustained Layer
Time
(hrs)
F1 F2 F3 F4 F5 F6 F7 F8 F9 F10
Dissolution medium 0.1N HCL
1 38.5 45.9 80.4 32.4 25.5 19.6 25.5 34.5 35.6 26.3
2 45.7 72.2 95.6 45.5 39.9 24.3 39.2 42.1 40 33.2
6.8pH phosphate buffer
3 53.8 80.7 -- 67.4 43.4 31.4 46.5 52.7 49.7 40.1
4 70.4 92.4 -- 72.6 59.4 45.9 55.2 60.3 53.9 45.6
5 84.9 -- -- 85.4 78.2 57.3 68.5 72.4 63.8 55.2
6 93.6 -- -- 95.8 94.2 80.7 75.9 78.3 70.4 63.8
8 -- -- -- -- -- 94.9 81.3 80.1 75.8 73.6
12 -- -- -- -- -- -- 96.5 -- 84.9 80.4

Fig No 4- dissolution graph for sustained release formulations
0
20
40
60
80
100
120
0 2 4 6 8 10 12 14
Cumulative%drugrelease
Time in Hrs
F1
F2
F3
F4
F5
F6
F7
F8
F9
F10

Dissolution Medium for SR tablets
Table no 5: Dissolution profile of bilayered tablet
S.NO Sampling time
Percentage drug released (%)
ONDANSETRAN CAPACETABINE
1 15mins 80.7 4.2
2 30 mins 99.8 6.6
3 1hr -- 20.6
4 2hr -- 37.7
5 3hr -- 45.4
6 4hr -- 53.8
7 5hr -- 69.7
8 6hr -- 77.9
9 8hr -- 89.0
10 12hr -- 97.3Discussion for in-vitro release of Capacetabine layer SR
From the table, it was confirmed that the F1, F2, F3, F4, F5, F6 and F8 of SR layer
does not fulfill the sustained release theory up to 12 hrs. And also from the table,
it was also confirmed that the formulation made with combination of HPMC K100
and HPMC K4M (F7) showed maximum drug release up to 12hrs.

 KINETIC RELEASE MODELS:
 Drug release kinetics and mechanism:
 To analyze the mechanism of drug releasefrom
the formulation, the dissolution profile of all
the batches were fitted to zero order, first
order, Higuchiand Peppasmodels to ascertain
the kinetic modelling of drug release.
• Zero Order: Q = K0 t
• First order: Log Qt = Log Qo+ K1t /
2.303
• Peppas model: Mt/M∞ = ktn
Higuichi model: Q = K2 t1/2

y = 1.523x + 0.6649
R² = 0.6341
0
0.5
1
1.5
2
2.5
0 0.2 0.4 0.6 0.8 1 1.2
L
O
G
%
C
D
R
LOG TIME
PEPPAS
y = 8.1531x + 15.432
R² = 0.8791
0
20
40
60
80
100
120
0 5 10 15
%
C
D
R
TIME IN HRS
ZERO ORDER
Fig no 5 - kinetic release graph for F7 sustained release formulation

Table no 6:
 EVALUATION PARAMETERS FOR IMMEDIATE RELEASE
LAYER OF ONDANSETRANPRE COMPRESSION
PARAMETERSFormulation
s
Angle of
Repose (θ)
Loose Bulk
Density
(g/ml)
Tapped Bulk
Density
(g/ml)
%
Compressibil
ity
Hausner’s
ratio
F1 23.90 0.3 0.35 14.29 1.17
F2 24.20 0.38 0.45 15.56 1.18
F3 27.20 0.53 0.62 14.52 1.17
F4 25.50 0.57 0.68 16.18 1.19
F5 23.80 0.43 0.49 12.24 1.14
F6 24.10 0.37 0.45 17.78 1.22
F7 29.40 0.43 0.5 14.00 1.16
F8 22.100 0.44 0.51 13.73 1.16
F9 26.40 0.4 0.47 14.89 1.18From the above pre-compression parameters it was clear
evidence that drug and excipients has good flow properties and
suitable for direct compression.

Post-compression parameters:
Post compression evaluation parameters for immediate
release formulation
 The results of the uniformity of weight, hardness,
thickness and friability of the tablets are given in
Table.
 All the tablets of different batches complied with the
official requirements of uniformity of weight as their
weights varied between 147 to 152mg.
 The hardness of the tablets ranged from 3.1 to
3.6kg/cm2 and the friability values were less than
0.5% indicating that the matrix tablets were compact
and hard.
 The thickness of the tablets ranged from to 2.1 to
2.5mm. Thus all the physical attributes of the prepared
tablets were found be practically within control.

Table no 7. Post compression parameters for
immediate release tablets
Formulation
s
Average weight
(mg)
Hardness
Kg/cm2
Thickness
(mm)
Friability (%)
F1 149 3.4 2.1 0.29
F2 147 3.5 2.3 0.25
F3 150 3.1 2.5 0.30
F4 152 3.3 2.2 0.41
F5 150 3.6 2.4 0.52
F6 150 3.2 2.2 0.49
F7 148 3.1 2.5 0.44
F8 149 3.4 2.4 0.43
F9 150 3.3 2.3 0.42

Table No 8. Dissolution for immediate release
tablet of Ondansetran
Time
in
mins
F1 F2 F3 F4 F5 F6 F7 F8 F9
5 25 22 14 22 36 31 40 65 48
10 37 38 26 42 57 59 67 70 63
15 45 49 40 56 65 65 79 84 80
30 50 56 54 63 72 72 86 96 94
45 48 72 63 78 88 86 94 -- --
60
62 80 75 89 93 95
--
-- --

BILAYERED TABLET COMPRESSION
 After the batch was optimized in both immediate release layer (F8) and sustained release
layer (F7).The optimized batch in both was compressed by using same ingredients.
 DISSOLUTION STUDY (BILAYERED TABLETS) :
 Dissolution Medium for IR tablets
 Acidic Stage:
 RPM : 50
 Volume : 900ml
 Time : 30min
In vitro dissolution for IR tablets were done in 0.1N HCL for 30 minutes.
 Dissolution Medium for SR tablets
 Acidic Stage:
 RPM : 50
 Volume : 900ml
 Time : 2hrs
 In vitro dissolution for SR tablets were done in 6.8 pH for 12hrs.

Table no 9 : Dissolution profile of bilayered tablet
S.NO Sampling time
Percentage drug released (%)
ONDANSETRAN CAPACETABINE
1 15mins 80.7 4.2
2 30 mins 99.8 6.6
5 1hr -- 20.6
6 2hr -- 37.7
7 3hr -- 45.4
8 4hr -- 53.8
9 5hr -- 69.7
10 6hr -- 77.9
11 8hr -- 89.0
12 12hr -- 97.3

Stability Studies
 Stability of a drug has been defined as the ability of a particular formulation, in
a specific container, to remain within its physical, chemical, therapeutic and
toxicological specifications.
 The purpose of stability testing is to provide evidence on how the quality of a
drug substance or drug product varies with time under
the influence of a variety of environmental factors such as
temperature, humidity, light, and enables recommended
storage conditions.
 Overall observations from different evaluation studies such as drug-polymer
interactions, evaluation of prepared formulations and drug release studies
were carried out.
 Based on the obtained results best formulation was subjected for further
stability study.
 The stability study was conducted as per ICH guidelines for the period of six
months at various accelerated temperature and humidity conditions of
25°C/65%RH, 40°C/75%RH.
 The accelerated stability study of the best formulations was carried out as per
the ICH guidelines

Table 10 :STABILITY DATA OF OPTIMIZED FORMULATION
S.No
Time points
(min)
Initial
Cumulative % Drug Release (mean SD) (n=3)
25C/60%RH 40C/75%RH
1st Month 3rd Month 1stMonth
3rd
Month
1
0.5 99.8
99.4 98.2 98.0 97.7
2
1
20.6 20.1 19.8 20.5 19.1
3
2
37.7 35.1 35.0 34.8 34.2
4
3
45.4 45.2 44.7 45.0 44.6
5
4
53.8 52.1 51.9 50.5 50.7
6
5
69.7 67.2 67.1 66.7 66.2
7 6 77.9 77.1 76.3 77.2 76.1
8 8 89.0 88.8 87.4 88.4 86.4
9 Assay 99.7 99.3 99.4 99.2 98.7

SUMMARY & CONCLUSION
 The Bilayered tablets containing Capacetabine SR and
Ondansetron IR were successfully prepared by direct
compression method respectively.
 Various formulations were prepared and evaluated with an
aim of presenting Capacetabine as sustained release and
Ondansetron as immediate release for improving the patient’s
compliance.
 The physiochemical evaluation results for the granules of all
trials pass the official limits in angle of repose,
compressibility index.
 The prepared blend for IR layer tablets and SR layer tablets
were also maintained the physiochemical properties of tablets
such as thickness, hardness, weight variation, friability.
 The optimized formulation F8 in IR formulations contains the
average thickness of 2.4mm, average hardness of 3.4 kg/cm2,
average weight of 149mg, friability of 0.43%.

SUMMARY & CONCLUSION
 The optimized formulation F7 in SR formulations contains the
average thickness of 2.3mm, average hardness of 7.3 kg/cm2,
friability of 0.41%.
 The F7 formulation which releases the capacetabine in sustained
manner in 1st hour it releases 25.5% but the remaining drug
release was sustained up to 12 hours and ondansetron immediate
release F7 formulation showed 96 % drug release with in 30 min.
 With the data of kinetic analysis, F7 formulation showed best
linearity in Higuchi’s Equation plot indicating that the release of
drug from matrix tablet follows Non Fickian diffusion.
 The dissolution study was carried out for optimized bilayer tablet
and it correlates with the drug release of individual release layer
formulations.
“Hence it may be summarized that the tablets prepared by direct
compression method for sustained release layer and immediate
release layer might be a perfect and effective formulation to
prevent the side effects in treating cancer”.

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