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FORMULATION, EVALUATION AND OPTIMIZATION OF ORALLY
DISINTEGRATING TABLET OF CINNARIZINE
Bhupendra G. Prajapati1,* and Satish N. Patel2
1. S.K. Patel College of Pharmaceutical Education & Research, Ganpat Vidyanagar, email: bhupen_27@yahoo.co.in, bhupen27@gmail.com
2. Ganpat University, Kherva. PIN: 382711 City: Mehsana, State: Gujarat,
Country: India.
*
Corresponding author: Bhupendra G Prajapati, Assistant Professor, S.K. Patel College of
Pharmaceutical Education & Research, Ganpat University, Ganpat Vidhyanagar, Kherva 382711, Mehsana, North Gujarat, India. Contact: bhupen27@gmail.com, Phone: (O) 9102762-286082
ABSTRACT
Objective of this study was to formulate directly compressible orally disintegrating
tablets of Cinnarizine with sufficient mechanical integrity, content uniformity, and
acceptable palatability to assist patients of any age group for easy administration.
Effect of varying concentrations of different superdisintegrants such as crospovidone,
croscarmellose sodium, and sodium starch glycolate on disintegration time was
studied. Tablets were evaluated for weight variation, thickness, hardness, friability,
taste, drug content, in vitro disintegrating time and in vitro drug release. Other
parameters such as wetting time, water absorption ratio (R), and drug-excipient
compatibility were also evaluated. The disintegration time of the optimized CP5 batch
was 25 sec. Good correlation was observed between disintegration time and water
absorption ratio (R) for each of three superdisintegrants at concentrations studied.
Considering the R values and disintegration time, crospovidone was significantly
superior compared to other two superdisintegrants tested. Release of drug was faster
from formulations containing 6% crospovidone (CP5) compared to the marketed
convetional Cinnarizine tablet. Differential scanning calorimetric studies did not
indicate any excipient incompatibility, either during mixing or after compression.
Finally concluded that directly compressible orally disintegrating tablets of
cinnarizine with lower friability, acceptable taste, and shorter disintegration times
were obtained using crospovidone at optimized concentrations.
KEYWORDS: Cinnarizine, orally disintegrating tablet, wetting time, water
absorption ratio.
INTRODUCTION
Over a decade, the demand for development of orally disintegrating tablets
(ODTs) has enormously increased as it has significant impact on the patient
compliance. Orally disintegrating tablets offer an advantage for populations who
have difficulty in swallowing. It has been reported that dysphagia 1 (difficulty in
swallowing) is common among all age groups and more specific with pediatric,
geriatric population along with institutionalized patients and patients with nausea,
vomiting, and motion sickness complications.2 Orally disintegrating tablets with good
taste and flavor increase the acceptability of bitter drugs by various groups of
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population. Orally disintegrating tablets are also called as orodispersible tablets, quick
disintegrating tablets, mouth dissolving tablets, fast disintegrating tablets, fast
dissolving tablets, rapid dissolving tablets, porous tablets, and rapimelts. However, of
all the above terms, United States pharmacopoeia (USP) approved these dosage forms
as orally disintegrating tablets. Recently, European Pharmacopoeia has used the term
orodispersible tablet for tablets that disperses readily and within 3 min in mouth
before swallowing.3United States Food and Drug Administration (FDA) defined
orally disintegrating tablet as A solid dosage form containing medicinal substance or
active ingredient which disintegrates rapidly usually within a matter of seconds when
placed upon the tongue. The disintegration time for orally disintegrating tablets
generally ranges from several seconds to about a minute.
Moreover, drug candidates that undergo pre-gastric absorption when
formulated as orally disintegrating tablets may show increased oral bioavailability 4.
From the perspective of the pharmaceutical industry, orally disintegrating tablets may
provide new business opportunities in the form of product differentiation, line
extension and life cycle management, exclusivity, uniqueness, and patent life
extension. At the present time a significant limitation of orally disintegrating tablet
formulations is product cost since manufacturing involves use of novel excipients
and technologies. In addition, specialized packaging is necessary to withstand
handling and transportation mechanics. The key parameters that are to be considered
in the process of formulating an orally disintegrating tablet are taste and the
disintegration time 5. Both of these are related either directly or indirectly to the oral
cavity.
The mucosa in the oral cavity presents a surface area of about 100 cm2 and
three different types of oral mucosa are recognized: the masticator mucosa, the lining
mucosa, and the specialized mucosa. Of the total oral mucosa, 15% of it consists of
specialized mucosa, which is present on the dorsum of the tongue. It is mainly
involved in identifying the taste of the formulation 6. The saliva plays an important
role in disintegration of orally disintegrating tablets and primarily secreted in the oral
cavity by parotid, submandibular (sub maxillary), sublingual glands, and also by
numerous minor glands. Saliva is mainly constituted by water (99.5% w/v) and the
remaining 0.5% w/v is constituted by dissolved compounds 7. The principal
components of saliva are inorganic electrolytes (0.2% w/v), gases (CO2, N2, and O2),
nitrogen products, such as urea and ammonia, vitamin C, creatinine, and mucins. The
accepted range of normal salivary flow is comprised from about 0.1 to 0.2 mL/min
and reaches 7 mL/min upon stimulation 8.
Motion sickness is the uncomfortable dizziness, nausea, and vomiting that
people experience when their sense of balance and equilibrium is disturbed by
constant motion. Riding in a car, aboard a ship or boat, or riding on a swing all cause
stimulation of the vestibular system and visual stimulation that often leads to
discomfort. While motion sickness can be bothersome, it is not a serious illness, and
can be prevented. 9, 10, 11 cinnarizine is the drug which is used in treatment of
vertigo/meniere's disease, nausea and vomiting, motion sickness and also useful for
vestibular symptoms of other origins. Cinnarizine inhibits contractions of vascular
smooth muscle cells by blocking calcium channels. Cinnarizine increases erythrocyte
deformability and decreases blood viscosity. Cinnarizine inhibits stimulation of the
vestibular system.
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MATERIAL
Cinnarizine was purchased from Rakshit Pharma, Mumbai, Pearlitol SD
200, a directly compressible vehicle, was obtained from Signet Chemical Corporation
(Mumbai, India); Crospovidone (CP), Croscarmellose Sodium (CS), Sodium Starch
Glycolate (SSG), Sodium Stearyl Fumarate (SSF), aspartame, and peppermint flavor
were gifts from were obtained from (Welable healthcare, Mehsana, India), Avicel PH
102 and colloidal silicon dioxide Aerosil were purchased from Span Pharma Private
Limited (Hyderabad, India) and nigrosine RM 247, a water soluble dye, was
purchased from Hi Media Laboratories Private Limited (Mumbai, India). All other
chemicals were of analytical grade.
METHOD
Assignment of Formulation Codes Various formulations of cinnarizine orally
disintegrating tablets were designed utilizing three superdisintegrants, crospovidone
(CP), croscarmellose sodium (CCS), and sodium starch glycolate (SSG) each varied at
three different levels (4, 6, and 8%). All of the other ingredients were kept constant. A
total of such nine formulations prepared were designated with their codes and will be
referred with the same in further sections. The assigned formulation codes were as
follows, CCS1, CCS2, CCS3, CP4, CP5, CP6, SSG7, SSG8, and SSG9.
Preparation of Orally Disintegrating Tablets
All of the formulation components other than the lubricant and glidant were
accurately weighed passed through a 40# sieve and mixed in a V-blender for 15 min.
The obtained blend was lubricated with sodium stearyl fumarate and Aerosil for
another 5 min and the resultant mixture was directly compressed into tablets. The
amount of all tablet components other than superdisintegrants and Pearlitol SD 200
(filler) were kept constant. Round biconvex tablets of 100 mg in weight and 6 mm in
diameter were prepared by RIMEK Rotary Machine (Karnavati eng. Ahmedabad).
EVALUATION
Weight Variation
Twenty tablets from were randomly selected from each formulation and
weighed using a Shimadzu digital balance. The mean SD values were calculated. 12
Thickness Variation
Ten tablets from each formulation were taken randomly and their thickness
was measured with a digital screw gauge micrometer (Digimaticmicrometer,
Mitutoyo, Japan). The mean SD values were calculated. 12
Hardness and Friability
Hardness or crushing strength of the tested orally disintegrating tablet
formulations was measured using the dial hardness tester (Model no 1101, Shivani
Scientific India). The friability of a sample of 20 orally disintegrating tablets was
measured utilizing a USP-type Roche friabilator (Camp-bell Electronics, Mumbai).
Pre-weighed tablets were placed in a plastic chambered friabilator attached to a motor
revolving at a speed of 25 rpm for 4 min. The tablets were then de-dusted, reweighed,
and percentage weight loss (friability) was calculated. 13
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W0 W
100
W0
W= initial weight of 20 tablets
W= weight of 20 tablets after 100 revolutions
% Friability
12
(1)
Water Absorption Ratio (R)
The weight of the tablet prior to placement in the Petri dish was noted (Wb)
utilizing a Shimadzu digital balance. The wetted tablet was removed and reweighed
(Wa). Water absorption ratio, R, was then determined according to the following
equation. Where Wb and Wa were tablet weights before and after water absorption,
respectively. 14
(Wb - Wa)
R
X 100
(2)
Wa
Wetting Time
Five circular tissue papers were placed in a Petri dish of 10 cm diameter. Ten
milliliters of water containing 0.5% nigrosine, a water-soluble dye, was added to the
petri dish. The dye solution was used to identify complete wetting of the tablet
surface. A tablet was carefully placed on the surface of the tissue paper in the petri
dish at 25oC. The time required for water to reach the upper surface of the tablets and
to completely wet them was noted as the wetting time. These measurements were
carried out in replicate of six. Wetting time was recorded using a stopwatch. 14
In Vitro Disintegration Time
In vitro disintegration time (DT) of the orally disintegrating tablets was
determined following the procedure described by Gohel at al (2004). 10 mL of water
at 25oC was placed in a petri dish of 10 cm diameter. The tablet was then carefully
positioned in the center of the petri dish and the time required for the tablet to
completely disintegrate into fine particles was noted. Measurements were carried out
in replicates of six tablet (n=6) and mean SD values were recorded. 15
In Vitro Release Studies
In Vitro release studies of Cinnarizine from different formulations were
performed according to USP XVIII apparatus II, paddle method (Dissolution test
apparatus-TDT-06T, Electrolab, Mumbai, India). Paddle speed was maintained at 50
rpm and 900 mL of 0.1N HCl was used as the dissolution medium. Samples (10 mL)
were collected at predetermined time intervals (1, 2, 3, 5, 10 and 15, min) and
replaced with equal volume of fresh medium, filtered through a 0.45 m filter and
analyzed with a UVVisible spectrophotometer (Shimadzu, Japan) at = 254 nm.
Drug concentration was calculated from a standard calibration plot and expressed as
cumulative % drug dissolved. The release studies were performed in replicates of six.
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Assay
Orally disintegrating tablet formulations were assayed for drug content. Ten
tablets were randomly selected from each formulation and pulverized to a fine
powder. Weighed aliquots containing an amount of powder equivalent to a single dose
were taken in triplicate and assayed for the drug content utilizing a UV-VIS
spectrophotometer (Model Systronics 2201 UV/Visible double beam
Spectrophotometer, Shimadzu, Japan) at a wavelength of 254 nm. 17
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Comparison of Dissolution Profiles
The similarity factor (f2) given by SUPAC guidelines for modified release
dosage form was used as a basis to compare dissolution profile. The dissolution
profiles of products were compared using a similarity factor (f2). This similarity
factor is calculated by following formula,
2 0.5
(2)
f 2 50X log 1 wt Rt Tt X 100
n
Where, n is the number of dissolution time points
Rt The reference profile at the time point t
Tt - The test profile at the same point.
Differential Scanning Calorimetric (DSC)
DSC was used to characterize the thermal properties of the drug, bulking
agent, physical mixture, and the compressed orally disintegrating tablet formulation.
The DSC thermo grams were recorded using a differential scanning calorimeter
(DSC- Shimadzu 60, Japan). Ultrahigh pure nitrogen was used at a flow rate of 20
mL/min. Samples were analyzed in crimped aluminum pan and heated from 50
300C at a linear heating rate of 10C min1.
Stability Study
Accelerated stability study carried out at 4020c in a humidity chamber having
75%RH for 1 month.
RESULTS AND DISCUSSION
Formulation Rationale
An objective of a directly compressible orally disintegrating tablet is that it
disintegrates or disperses in the saliva within a matter of seconds. To achieve such a
formulation most of the excipients selected are inherently required to be watersoluble. Pearlitol SD 200 utilized in the formulation is a directly compressible grade
of mannitol with good flow properties and provides a refreshing or cooling mouth feel
due to its negative heat of solution. Pearlitol SD 200 was thus used as a bulking agent
to achieve the desired tablet weight. Avicel PH 102 was included in the formulation as
a disintegrate and a diluents. This grade of microcrystalline cellulose is granular in
nature and thus displays excellent flow properties. To impart pleasant taste and
improve mouth feel, aspartame and peppermint were included as sweetening and
flavoring agents, respectively. Sodium stearyl fumarate was employed as a lubricant
instead of magnesium stearate not only because of the metallic taste of the latter, but
also due to its water solubility and directly compressible features. Colloidal silicon
dioxide (Aerosil), which acts both as a glidant and lubricant, also helps in appreciably
decreasing tablet friability. This may be due to Aerosil helping in restoring the
bonding properties of the excipients. In this study, effectiveness of CP, CCS, and SSG
in the Cinnarizine orally disintegrating tablet formulations was evaluated at three
different concentrations. Other formulation components were kept constant. CP is
dens cross-linked homopolymers of Nvinyl 2-pyrrolidones. Their porous particle
morphology enables them to rapidly absorb liquids into the tablet by capillary action
and to generate rapid volume expansion and hydrostatic pressures that result in tablet
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disintegration. CCS swells rapidly up to 48 times its original volume on contact with
water. Similar to CP, it is also used as a dissolution aid. SSG, a sodium salt of
carboxymethyl ether of starch, is usually employed at concentrations between 28%
w/w and a concentration of 4% may be optimum in most cases.
Quality Control Tests
In all the formulation weight variations was within 2%, hardness is within
0.5%.all the formulation passes the drug content assay. Uniformity of drug contents
was within 99.0% 2%.
Friability data represent that as the concentration is increases %friability of the
formulation is also increases. Except CCS3, CP6, SSG9 batches all the formulation
passed %friability limit.
Wetting time was determined for all of the formulations. Wetting time of all
the formulation were more than 45 sec, except CP5 (6%w/w) having the wetting time
35sec was less compared to all formulations due to its rapid water absorbing nature
involving both capillary and swelling mechanisms of crospovidone.
Disintegration time is an important criterion for selecting an optimum orally
disintegrating tablet formulation. It was observed that increasing the superdisintegrant
concentration from 4 to 8% resulted in a decrease in DT as depicted. CCS3, CP6 and
SSG9 batches having the lower disintegrating time as compared to other formulation
but these batches did corss the friability limit, so while considering friability and
disintegrating time CP5 batch having 6% concentration was optimized batch with 25
sec disintegrating time and 0.94% friability.
Water absorption ratio, R, of formulations containing SSG and CCS were
greater than that of CP containing formulations and SSG demonstrated greater R
values compared to CCS. Water absorption ratio R increased with an increase in
superdisintegrants concentrations from 4-8 % .A linear relationship was observed for
each of the superdisintegrant types. The increase in R was most likely due to
increased water uptake capacity of the superdisintegrants at higher concentrations.
In Vitro Release Studies
Dissolution methods for orally disintegrating tablets are similar to approaches
taken for conventional tablets, unless taste masking is required. All of the orally
disintegrating tablet formulations released more than 90.0% of the drug within 15
min. CP5 (6%) batch having 6% released 99.45% drug within 15 min whereas the
marketed cinnarizine formulation released 75.2% in the same period. In Vitro
Disintegration Time Considering wetting time, R value, in vitro DT, %friability and
cumulative % drug released, formulations containing CP5 (6%) was considered to be
better than those containing CCS and SSG. CP5 (6%) was considered as the optimal
orally disintegrating tablet formulation among all of the 9 formulations tested in this
study.
Differential Scanning Calorimetric (DSC)
Drug-excipients compatibility was evaluated using a differential scanning
calorimeter. Samples were collected prior to mixing, during mixing and after
compression. The endotherms of pure drug and excipients were recorded separately,
as a physical mixture and in the compressed form. No shifts in the melting
endotherms were noted. These results indicate that the drug is compatible with the
excipients used and does not undergo any change during processing.
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Stability study
Short term stability study orally disintegrating tablet of cinnarizine was carried
out for 1 month at specified condition. All the data are mentioned in the Table 3.
Stability study revealed that no any major changes taken place throught the stability
study for three months so we can say that the formulation having the good stability.
CONCLUSION
In Vitro Disintegration Time Considering wetting time, R value, in vitro DT,
%friability and cumulative % drug released, formulations containing CP5 (6%) was
considered to be better than those containing CCS and SSG. CP5 (6%) was
considered as the optimal orally disintegrating tablet formulation among all.
REFERENCES
1. Lindgren S, Janzon L. (1993) Dysphagia: Prevalence of swallowing
complaints and clinical finding. Med Clin North Am, 77:3-5.
2. Sastry SV, Nyshadham JR, Fix JA. (2000) Recent technological advances in
oral drug delivery: A review. Pharm Sci Technol Today, 3:138-45.
3. Fu Y, Yang S, Jeong SH, Kimura S, Park K. (2004) Orally fast disintegrating
tablets: Developments, technologies, taste-masking and clinical studies. Crit
Rev Ther Drug Carrier Sys, 21:433-76.
4. Virely, P., & Yarwood, R. (1990, February). Zydisa novel, fast dissolving
dosage forms. Maniac., Chem. 3637.
5. S.K.Battu, Michael A. Repka, Madhusudan Rao Y Formulation and
Evaluation of Rapidly Disintegrating Fenoverine Tablets (2007) Effect of
Superdisintegrants, Drug Development and Industrial Pharmacy, 33:1225
1232.
6. Song, Y., Wang, Y., Thakur, R., Meidan, V. M., & Michniak, B. (2004)
Mucosal drug delivery: Membranes, methodologies, and applications. Crit.
Rev. Ther. Drug Carrier Syst, 21(3), 195256.
7. Saracco G, C. E. (1993). In Dobrosielski-Vergogna (Ed.), Biology of the
salivary glands (pp. 1114). Boca Raton: CRC Press.
8. Rossi, S., Sandri, G., & Caramella, C. (2005). Buccal drug delivery: A
challenge already won? Drug Discovery Today: Technologies 2(1), 5965.
9. Lack, F. O. (May 2002) "Maternal Susceptibility to Nausea and Vomiting of
Pregnancy: Is the Vestibular System Involved?" American Journal of
Obstetrics and Gynecology 185, Supplement 5: S204-S209.
10. os, J. E., W. Bles, and B. de Graaf. (May 2002) "Eye Movements to Yaw,
Pitch, and Roll About Vertical and Horizontal Axes: Adaptation and Motion
Sickness." Aviation, Space, and Environmental Medicine 73, 434-444.
11. Hamid, Mohamed, (2002) MD, PhD, and Nicholas Lorenzo, MD. "Dizziness,
Vertigo, and Imbalance." eMedicine September 17,
12. Indian Pharmacopoeia, (1996) 4th edition, Ministry of Health and Family
http://e-jst.teiath.gr
15
e- &
e-Journal of Science & Technology (e-JST)
16
Welfare, Govt. of India. The controller of publications, New Delhi.: A-54.
13. Lachman.L, Lieberman.A, Kinig.J.L. (1991) The Theory and Practice of
Industrial Pharmacy, 4th edition, Varghese Publishing House, Bombay. 67-68.
14. Battu SK, Repka MA, Majumdar S, Rao MY. (2007) Formulation and
evaluation of rapidly disintegrating tablet Fenoverine tablets: Effect of
superdisintegrants. Drug Dev Ind Pharm, 33:12251232.
15. Gohel, M., Patel, M., Amin, A., Agrawal, R., Dave, R., & Bariya, N. (2004).
Formulation design and optimization of mouth dissolve tablets of nimesulide
using vacuum drying technique. AAPS Pharm. Sci. Tech., 5(3), e36.
16. British pharmacopoeia (2005), the stationary office of the medicine and
healthcare products regulatory agency, Great Briton, Volume-1:695-697
17. Bi, Y., Sunada, H., Yonezawa, Y., Danjo, K., Otsuka, A., & Iida, K. (1996).
Preparation and evaluation of a compressed tablet rapidly disintegrating in the
oral cavity. Chem. Pharmaceut. Bull. (Tokyo), 44(11), 21212127.
18. Adel M, Aly M, Semreen A, Mazen K. (2005) Superdisintegrants for solid
dispersion toproduce rapidly disintegrating tenoxicam tablets via camphor
sublimation, Pharm Tech.,4:23-25.
19. Klancke J. Dissolution testing of orally disintegrating tablets. (2003)
Dissolution Technol, 10(2): 6-8.
20. Mishra DN, Bindal M and Singh SK. (2004) Rapidly disintegrating oral
tablet of valdecoxib, Indiandrug, 41(9): 554...
21. Chaudhari PD, Chaudhari SP, Lanke SD, Patel N. (2007) Formulation and in
vitro evaluation of taste masked orodispersible dosage form of
Levocetirizine, Indian J Pharm Educ Res., 41:319-28.
22. Seager H. (1998) Drug delivery products and the zydis fast dissolving dosage
forms, J Pharm Phamacol., 50(4): 375-382.
23. Chang, R.-K., Guo, X., Burnside, B. A., & Couch, R. A. (2000). Fastdissolving tablets. Pharm. Technol., 24(6), 5259.
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Table: 1 Quantitative Composition of Cinnarizine Orally Disintegrating Tablets
(Mg/Tablet)
FORMULATION
CODE
Drug
Avicel PH 102
Cross carmellose
sodium
Crospovidone
Sodium
starch
glycolate
Aspartame
Flavour
(pipermint oil)
Aerosil
Sodium stearyl
fumarate
Pearlitol SD 200
Total Weight
(100 mg.)
CCS
1
25
15
CCS
2
25
15
CCS
3
25
15
CP
4
25
15
CP
5
25
15
CP
6
25
15
SSG
7
25
15
SSG
8
25
15
SSG
9
25
15
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.5
q.s
q.s
q.s
q.s
q.s
q.s
q.s
q.s
q.s
100
100
100
100
100
100
100
100
100
Table 2: Evaluation Parameters of Orally Disintegrating Tablets of Cinnarizine
Batch
No.
Weight
Variation
(mg)
(N=20)
Thickness
Variation
(mm)
(N=20)
Hardness
variation
Kg/cm2
(N=10)
Diameter
variation
(mm)
(N=10)
Drug
content
(N=20)
CCS1
100.250.01
3.10.1
3.00.5
6.1
99.340.5
CCS2
99.850.02
3.00.1
3.00.5
6.1
97.150.3
CCS3
100.020.03
3.20.1
3.00.5
6.1
99.520.21
CP4
100.560.02
3.10.1
3.00.5
6.1
98.760.11
CP5
100.350.03
3.10.1
3.00.5
6.1
99.450.25
CP6
99.890.02
3.10.1
3.00.5
6.1
97.850.56
SSG7
99.760.01
3.20.1
3.00.5
6.1
98.250.32
SSG8
100.210.02
3.30.1
3.00.5
6.1
96.030.48
SSG9
100.100.02
3.20.1
3.00.5
6.1
97.560.12
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Table 3: Evaluation Parameters of Orally Disintegrating Tablets of Cinnarizine
Batch No.
Friability (%)
N=20
CCS1
CCS2
CCS3
0.620.1
0.910.0.5
1.600.1
Disintegrating
Time
(sec)
N=6
331
301
252
CP4
0.650.02
CP5
Wetting time
(sec)
(N=6)
Water
absorption
ratio
Q15
472
484
571
140
152
160
91.950.21
95.140.60
96.080.84
351
463
91
92.862.35
0.940.01
252
352
105
95.600.81
CP6
1.620.05
211
553
110
96.630.67
SSG7
0.530.04
391
491
149
91.820.45
SSG8
0.820.05
321
542
191
94.360.63
SSG9
1.400.1
301
442
202
95.290.12
Table 4: Stability Parameter Orally Disintegrating Tablets of Cinnarizine
Parameters
Hardness
Disintegrating time(sec)
Wetting time(sec)
Dissolution(%CPR)
F2 value
Initial
3.00.5
25
35
95.60
1 week
3.00.5
27
40
92.30
71.45
2 week
3.00.5
30
42
91.10
56.43
3 week
3.00.5
31
49
85.32
59.44
4 week
3.00.5
35
51
82.1
51.93
Disintigrating time
45
40
35
30
25
20
15
10
5
0
4
Concentration
CCS
CP
SSG
Figures 1 : Comparative profile of disintegrating time of ODT of Cinnarazine
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60
W etting tim e
50
40
30
20
10
0
4
Concentration
ccs
CP
SSG
Figure 2: Comparative profile of wetting time of ODT of Cinnarazine
250
200
150
100
50
0
4
Concentration
CCS
CP
SSG
Figure 3: Comparative profile of water absorption ratio of ODT of Cinnarazine
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120
100
%CPR
80
60
40
20
0
0
10
12
14
16
TIME(mins)
CCS1
CCS2
CCS3
CP4
CP5
CP6
SSG7
SSG8
SSG9
MARKETED FORMULATION
Figure 4: Comparative profile of dissolution study of ODT of Cinnarazine with
marketed formulation (Conventional)
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e -Journal of Science & Technology (e-JST)
e- &
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Figure 5 DSC study of ODT formulation
http://e-jst.teiath.gr
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