M.

Praveen Kumar et al, JPBR, 2019, 7(2): 31–36 ISSN: 2347-8330

Journal of Pharmaceutical and

Biological Research
Journal Home Page: www.pharmaresearchlibrary.com/jpbr

RESEARCH ARTICLE

Formulation and Evaluation of Fast Dissolving Tablets of Risperidone

M. Praveen Kumar*1, V. Chinni Krishnaiah2, D. Swarnalatha3
1
Department of Pharmaceutics, Annamacharya College of Pharmacy, Rajampet, A.P, India.
2
Department of Pharmacology, Annamacharya College of Pharmacy, Rajampet, A.P, India.
3
Department of Pharmacognosy, Annamacharya College of Pharmacy, Rajampet, A.P, India.

ABSTRACT
The present study was aimed towards the formulation and In-vitro evaluation of Rapid release tablets by direct compression
method using Risperidone as a model drug to enhance patient compliance. Risperidone is an Antipsychotic drug, effective in
the treatment of psychosis including schizophrenic, paranoid, schizoaffective, bipolar disorder, and other psychotic disorders.
The half-life of the drug is about 4 hours and oral dose is 6 mg/day orally. Rapid release tablets provide instantaneous
disintegration of tablet after oral administration. Rapid release tablets of Risperidone were prepared by using crospovidone
and croscarmellose sodium in different concentrations as superdisintegrants. All the batches were prepared by direct
compression method. Prepared tablets were evaluated for weight variation, hardness, friability, in-vitro disintegration time,
dispersion time, thickness, drug content, wetting time and in-vitro dissolution study. By considering disintegration time and
concentration of superdisintegrant, formulation F6 (crospovidone) showed maximum drug release of 98.93% and is
considered as an optimized formulation which showed maximum percentage of drug release.
Keyword: Risperidone, Rapid release, Crospovidone, Croscarmellose sodium.

ARTICLE INFO
Corresponding Author
M. Praveen Kumar
Department of Pharmaceutics,
Annamacharya College of Pharmacy,
Rajampet, A.P, India.
MS-ID: JPBR4132 PAPER-QRCODE
A R T I C L E H I S T O R Y: Received 21 Sept 2019, Accepted 29 Oct 2019, Available Online 21 December 2019
Copyright©2019 M. Praveen Kumar, et al. Production and hosting by Pharma Research Library. All rights reserved.
This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.
Citation: M. Praveen Kumar, et al. Formulation and Evaluation of Fast Dissolving Tablets of Risperidone. J. Pharm. Bio.
Res., 2019, 7(2): 31-36.

CONTENTS
1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
2. Materials and Methods. . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3. Results and Discussion. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
4. Conclusion . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5. References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

1. Introduction
Fast dissolving tablets (FDT) dissolve rapidly in the mouth compound which melts at about 37°C. Many patients
and provide an excellent mouth feel. The tablet comprises a express difficulty in swallowing tablets and hard gelatin
Journal of Pharmaceutical and Biological Research 31
M. Praveen Kumar et al, JPBR, 2019, 7(2): 31–36
capsules, tending to non-compliance and ineffective
therapy. Recent advances in novel drug delivery systems
(NDDS) aim to enhance safety and efficacy of drug
molecules by formulating a convenient dosage form for
administration and to achieve better patient compliance.
Currently these tablets are available in the market for
treating many disease conditions. More is concerned on
hypertension, migraine, dysphasia, nausea and vomiting,
Parkinson‟s disease, schizophrenia, pediatri c emergency.
FDTS are appreciated by a significan segment of
population, particularly children and elderly, which have
difficulty in swallowing conventional tablets or capsules.
Most commonly used methods to prepare fast dissolving
tablet are; freeze - drying/Lyophilization tablet molding and
direct - compression methods. Usuallay superdisintegrants
are added to a drug formulation to facilitate the break – up
or disintegration of tablet in to smaller particles that can
dissolve more rapidly than in absence of disintegrats.
Risperidone is an Antipsychotic drug, effective in the
treatment of psychosis including schizophrenic, paranoid,
schizoaffective, bipolar disorder, and other psychotic
disorders in the dose of 6 mg/day orally. Rapid release
tablets provide instantaneous disintegration of tablet after
oral administration. Fast disintegrating tablets improves the
patient compliance as it offers convenience of
administration. Rapid release tablets of Risperidone are
very useful to patients suffering from psychosis because the
drug release is not a limiting factor in case of rapid release
tablets, as the dosage form is swallowed with a glass of
water the disintegration is very rapid and once released
from dosage form, it is immediately absorbed. Thus onset
of action is shortened, which is extremely useful for
patients suffering from psychosis.
2. Materials and Methods
Materials
All the following materials were used as received,
Resperidoe obtained as a gift sample from Aurobindo
Pharmaceuticals Pvt. Ltd, Hyderabad. Croscarmellose
sodium, Crospovidone, Aspartame, Mycrocrystalline
cellulose, Lactose, Talc, Magnesium stearate, S. D fine
chem. Ltd., Mumbai.
Preparation of Fast Dissolving Tablets of Risperidone
Fast dissolving tablets of Risperidone were prepared by
direct compression. The term direct compression is defined
as the process by which tablets are compressed directly
from powder mixture of API with suitable excipients.
Pretreatment of powder blend by wet or dry granulation
procedure was not required; it was done by simple mixing
of API with suitable excipients and compress to tablets. All
the ingredients (except granular directly compressible
excipients) were passed through # 60-mesh separately.
Then the ingredients were weighed and mixed in
geometrical order and compressed into tablets of 300mg
using 9mm round flat punches on 9-station rotary tablet
punching machine.
Pre - Compression Parameters
Bulk Density (DB)
It is the ratio of total mass of powder to the bulk volume of
powder. It was measured by pouring the weight powder into
Journal of Pharmaceutical and Biological Research
ISSN: 2347-8330
a measuring cylinder and initial weight was noted. This
initial volume is called the bulk volume. From this the bulk
density is calculated according to the formula mentioned
below49. It is expressed in gm/ml. The results were
tabulated in Table no: 2.
Db = M / V b
Tapped Density (DT)
It is the ratio of total mass of the powder to the tapped
volume of the powder. Volume was measured by tapping
the powder for 750 times and the tapped volume was noted
if the difference between these two volumes is less than
2%. If it is more than 2%, tapping is continued for 1250
times and tapped volume was noted. Tapping was
continued until the difference between successive volumes
is less than 2 % (in a bulk density apparatus). It is expressed
in g/ml and is given by following formula. The results were
tabulated in Table no: 2.
Dt = M / Vt
Angle of Repose
The friction forces in a loose powder can be measured by
the angle of repose (). It is an indicative of the flow
properties of the powder. It is defined as maximum angle
possible between the surface of the pile of powder and the
horizontal plane.
Tan () = h / r
= tan-1 (h / r)
Carr’s Index (or) % Compressibility
Compressibility is an important measure obtained from the
bulk and tapped densities. It indicates powder flow
properties. It is expressed in percentage and is given by
following formula. The results were tabulated in Table no:
2.
Dt – Db
I = ------------ x 100
Dt
Hausner’s Ratio
Hausner’s ratio is an indirect index of ease of powder flow.
It is calculated by the following formula. The results were
tabulated in Table no: 2.
Dt
Hausner’s ratio = -------
Db
Post - Compression Parameters
Thickness and Diameter
Thickness and diameter were measured by using Vernier
Calipers. Thickness should not vary beyond ± 5 percent of
standard value. The results listed in the table 3.
Uniformity of Weight
20 tablets were weighed collectively and individually from
the collective weight, average weight was calculated. Each
tablet weight was then compared with average weight to
ascertain whether it is within permissible limits or not. The
tablets meet the IP test if not more than 2 tablets are outside
the percentage limit and if no tablets differs by more than 2
times the percentage limit.
The results listed in the table 3.
Hardness
Hardness of the tablet was determined using Monsanto
tester. The tester consists of a barrel containing a
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M. Praveen Kumar et al, JPBR, 2019, 7(2): 31–36
compressible spring held between two plungers. The lower
plunger was placed in contact with the tablet, and a zero
reading was taken. The plunger was then forced against a
spring by turning a threaded bolt until the tablet fractures.
As the spring was compressed a pointer rides along a gauge
in the barrel to indicate the force. The results listed in the
table 3.
Friability
Roche friability test apparatus consists of a circular plastic
chamber, divided into 2 compartments. The chamber was
rotated at a speed of 25 rpm and dropped the tablets by a
distance of 15cms. Pre weighed tablets were placed in the
apparatus which was given 100 revolutions after which
tables were weighed once again. The difference in two
weights represents friability. The weight loss should not be
more than 1 %. The results listed in the table 3.
Content Uniformity
Ten tablets were weighed and powdered, 1mg equivalent of
Risperidone weighed and dissolved in suitable quantity of
0.1N Hcl. Solution was filtered, diluted and analyzed for
drug content at 238 nm using UV-Visible
spectrophotometer. The results were tabulated in Table no:
3.
Wetting Time
A piece of tissue paper folded twice was placed in a small
petridish (ID = 6.5cm) containing 6ml of 0.1N Hcl. A tablet
was put on the paper and the time for complete wetting was
measured. The results were tabulated in Table no: 3.
Disintegration Test
Fast disintegrating tablets should disintegrate within 40
seconds. 6 tablets of each formulation were taken and
placed in 6 tubes of disintegration apparatus. 0.1N Hcl was
used as medium for the disintegration. The results were
tabulated in Table no: 3.
In-Vitro Dissolution Studies
In vitro dissolution study was performed in 500 ml 0.1N
Hcl using USP type II (paddle) apparatus at 50 rpm for 25
minutes (37 ± 0.5°C). Aliquots of the dissolution medium
(10 ml) were withdrawn at specific time interval (5, 10, 15,
20, and 25min) and replaced immediately with equal
volume of fresh medium. The samples were analyzed for
drug content by using UV spectrophotometer and
absorbance was measured at 238 nm. Drug concentration
was calculated from the standard calibration curve and
expressed as cumulative percent drug dissolved.
Comparative dissolution profiles of all six formulations
were shown in Table no: 4. Comparison of dissolution
profiles of croscarmellose sodium formulations and
crospovidone formulations were represented graphically in
figures 1 and 2 respectively.
3. Results and Discussion
The present study was undertaken with an aim to formulate
and evaluate Fast Dissolving Tablets of Risperidone using
direct compression method using croscarmellose sodium
and crospovidone as a superdisintegrants.
Superdisintegrants are generally used by formulation
scientists for developing FDTs or for improvement of
solubility of drugs. The primary requirement for these
dosage forms is quicker disintegration. The total 6
Journal of Pharmaceutical and Biological Research
ISSN: 2347-8330
formulations (RCS-I, RCS-II, RCS-III, RCP-IV, RCP-V,
RCP-VI) were prepared using different concentration of
croscarmellose sodium and crospovidone to study its effect
on disintegration time. Lactose acts as diluents.
Microcrystalline cellulose act as both disintegrant and
diluent. Aspartame acts as sweetening agent. Talc acts as
glidant. Magnesium stearate acts as lubricant.
The flow of the powder mixture was analyzed before
compression of the tablets. The values of Preformulation
parameters evaluated were within prescribed limits and
indicated good free flowing property was given in Table no:
2. The results of bulk density and tapped density ranged
from (0.44 ± 0.07 gm/cm3 to 0.49 ± 0.04 gm/cm3) and (0.54
± 0.04 gm/cm3 to 0.63 ± 0.01 gm/cm3) respectively. Using
these two densities Hausner’s ratio and compressibility
index were calculated. Hausner’s ratio ranged from (1.22 ±
0.05 to 1.29 ± 0.02) the compressibility index (%) ranged
from (18.15 ± 0.06 to 22.58 ± 0.05). Good flow ability of a
powder blend was also evidenced with angle of repose
ranged from (26˚23̕ ± 0.54 to29˚43̕ ± 0.62). The results of
angle of repose (< 30˚) and compressibility index indicates
good flow properties of powder blend. All the formulations
showed good blend properties for direct compression and
hence tablets were prepared by direct compression
technology.
The values of post compressional parameters evaluated
were given in the table no: 3. Tablet mean thickness was
almost uniform in all the formulations. The thickness varies
between 2.10 ± 0.02 mm to 2.14 ± 0.03 mm. The prepared
tablets in all the formulations possessed good mechanical
strength with sufficient hardness in the range of 3.0 ± 0.14
kg/cm2 to 3.3 ± 0.11 kg/cm2. Friability values below 1%
were an indication of good mechanical resistance of the
tablets. All the tablets from each formulation passed weight
variation test, as the % weight variation was within the
Pharmacopoeial limits. The weight variation in all the
formulations was found to be 298.4 ± 0.89 mg to 302.2 ±
0.29 mg. The percentage drug content of all the tablets was
found to be between 98.51 to 99.81 percent of Risperidone
which was within the acceptable limits. The wetting time
for all the formulations was performed in triplicate. The
time for all formulations varied between 19.46 ± 0.06 to
46.66 ± 0.03 sec. The wetting time of the tablets were also
considerably reduced in tablets containing crospovidone
which may be attributed due to the wicking and swelling
type of disintegrants thus facilitating the faster
disintegration. The In-vitro drug release studies were
performed on the prepared formulations (RCS-I, RCS-II,
RCS-III, RCP-IV, RCP-V and RCP-VI) using 0.1N Hcl for
25 min. The percentage release of Risperidone at 25 min for
formulations RCS-I, RCS-II, RCS-III, RCP-IV, RCP-V and
RCP-VI showing 88.82%, 91.84, 94.66%, 90.84%, 93.64%,
98.93% respectively. From the above results the
formulation RCP-VI showed faster and, maximum drug
release than the other formulations. The comparative
release of six formulations was showed in the Table no: 4.
Comparison of dissolution profiles of croscarmellose
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 M. Praveen Kumar et al, JPBR, 2019, 7(2): 31–36 ISSN: 2347-8330
sodium formulations and crospovidone formulations were represented graphically in figures 1 and 2 respectively.

Table No: 1 Composition of fast Dissolving Tablets of Risperidone

Ingredients
S.NO (mg) RCS-I RCS-II RCS-III RCP-1V RCP-V RCP-VI

1. Risperidone 2 2 2 2 2 2
_ _ _
2. Croscarmellose sodium 2.5 5 7.5
_ _ _
3. Crospovidone 2.5 5 7.5

4. Aspartame 2.5 2.5 2.5 2.5 2.5 2.5

5. Microcrystalline cellulose 173 173 173 173 173 173

6. Lactose 110 107.5 105 110 107.5 105

7. Talc 2 2 2 2 2 2

8. Magnesium stearate 1 1 1 1 1 1

Total weight 300 300 300 300 300 300

Table No: 2 Preformulation Studies of Powder Blend

S. No Formulation Bulk density Tapped density Compressibility Angle of Hausner’s
(gm/cm3) (gm/cm3) index (%) repose index

1. RCS-I 0.47 ± 0.05 0.60 ± 0.03 21.66 ± 0.04 28˚29’± 0.92 1.27 ± 0.04

2. RCS-II 0.48 ± 0.03 0.62 ± 0.01 22.58 ± 0.05 29˚43’± 0.62 1.29 ± 0.02

3. RCS-III 0.44 ± 0.07 0.54 ± 0.04 18.51 ± 0.02 27˚63̕ ± 0.63 1.22 ± 0.05

4. RCP-IV 0.49 ± 0.04 0.63 ± 0.01 22.22 ± 0.03 28˚35’± 0.71 1.28 ± 0.03

5. RCP-V 0.46 ± 0.02 0.57 ± 0.03 19.29 ± 0.02 27˚35’± 0.71 1.23 ± 0.04

6. RCP-VI 0.45 ± 0.03 0.55 ± 0.02 18.15 ± 0.06 26˚23’± 0.54 1.22 ± 0.06

Table No: 3 Post Compressional Parameters of Prepared Tablets

S. No Formulation Thickness Hardness Friability Weight Drug Wetting time Disintegration
(mm ± SD) (Kg/cm2±SD) (% ± SD) variation content (sec ± SD) Time
(mg ± SD) (%) (sec ± SD)

1. RCS-I 2.10±0.02 3.3±0.11 0.51 ± 0.16 301.1 ± 0.41 98.51 46.66 ± 0.03 26 ± 0.18

2. RCS-II 2.13±0.01 3.2±0.01 0.54 ± 0.16 300.4 ± 0.89 98.78 39.66 ± 0.02 22 ± 0.12

3. RCS-III 2.11±0.04 3.0±0.14 0.66 ± 0.16 298.6 ± 0.93 99.21 22.66 ± 0.05 19 ± 0.09

4. RCP-IV 2.14±0.03 3.3±0.17 0.52 ± 0.16 302.2 ± 0.29 98.99 43.33 ± 0.06 24 ± 0.12

5. RCP-V 2.13±0.03 3.1±0.21 0.56 ± 0.16 299.6 ± 0.28 99.54 34.33 ± 0.05 21 ± 0.17
6. RCP-VI 2.12±0.02 3.2±0.13 0.68 ± 0.16 300.8 ± 0.92 99.81 19.46 ± 0.06 17 ± 0.11

Journal of Pharmaceutical and Biological Research 34

M. Praveen Kumar et al, JPBR, 2019, 7(2): 31–36 ISSN: 2347-8330

Table No: 4 Comparative In-Vitro Drug Release Data of Formulations

CUMULATIVE PERCENTAGE DRUG RELEASE
S.NO TIME
(min) RCS-I RCS-II RCS-III RCP-IV RCP-V RCP-VI

1. 0 0 0 0 0 0 0

2. 5 26.72 36.27 41.17 35.88 41.03 46.83

3. 10 51.05 61.31 68.96 57.30 63.72 71.27

4. 15 67.49 72.54 81.23 70.99 76.24 83.21

5. 20 79.23 83.67 89.71 81.06 85.93 92.81

6. 25 88.82 91.84 94.66 90.84 93.64 98.93

conventional dosage forms. Fast dissolving tablets of

Figure no: 1 In-vitro comparative dissolution profiles of
Risperidone FDTs formulated with different concentrations
of croscarmellose sodium (RCS-I, RCS-II, RCS-III).
Risperidone were prepared by direct compression method
using various concentrations of croscarmellose sodium and
crospovidone as superdisintegrants. From the results and
discussions, amongst the 6 different formulations
designated as RCS-I, RCS-II, RCS-III, RCP-IV, RCP-V,
RCP-VI. The crospovidone formulations were found to be
better in terms of rapid disintegration and maximum
percentage drug release characteristics with increasing the
concentration of superdisintegrant. So it was concluded that
crospovidone act as best superdisintegrant than the
croscarmellose sodium. Fast dissolving tablets of
Risperidone is successfully prepared by using direct
compression method, will surely enhance the patient
compliance, low dosing, rapid onset of action, increased
bioavailability, low side effect, good stability and its
popularity in the near future. Further investigations are
needed to confirm the in-vivo efficiency.

5. References
[1]
[2]
[3]
[4]
Figure no: 2 In-vitro comparative dissolution profile of
Risperidone FDTs formulated with different concentrations
of crospovidone (RCP-IV, RCP-V, RCP-VI).
[5]
4. Conclusion
Fast dissolving tablet is a promising approach with a view
of obtaining faster action of drug and would be
advantageous in compared to currently available
Journal of Pharmaceutical and Biological Research
Shukla D, Chakraborty S, Singh S, Mishra B.
Mouth dissolving tablets: An overview of
formulation technology. Sci Pharm. 2009, 77: 309-
26.
Habib W, Khankari R, Hontz J. Fast-dissolving
drug delivery systems, critical review in
therapeutics, Drug Carrier Systems, 17(1), 2000,
61-72.
Clarke A, Jankovic J. Selegiline orally
disintegrating tablet in the treatment of
Parkinson’s disease. Therapy. 2006, 3(3): 349-56.
Hitesh Jagani, Ravi Patel, Pratik Upadhyay,
Jitendra Bhangale, SatishKosalge. Fast Dissolving
Tablets: Present and Future Prospectus. Journal of
Advances in Pharmacy and Healthcare Research.
2011, 2(1): 57-70.
Debjit Bhowmik, B. Chiranjib, Krishnakanth, R.
Margret Chandira. Fast Dissolving Tablet: An
Overview, Journal of Chemical and
Pharmaceutical Research, 2009, 1(1): 163-177.
35
M. Praveen Kumar et al, JPBR, 2019, 7(2): 31–36 ISSN: 2347-8330
[6] Chue P, Welch R, Binder C. Acceptability and
disintegration rates of orally disintegrating
risperidone tablets in patients with schizophrenia
or schizoaffective disorder. Canadian Journal of
psychiatry. 2004, 49(10): 701-3.
[7] Freedman SB, Adler M, Seshadri R, Powell EC.
Oral Ondansetron for gastroenteritis in a pediatric
emergency department. New England Journal of
Medicine. 2006, 354(16): 1698-1705.
[8] Suresh B, Rajendar KM, Ramesh G, Yamsani MR.
Orodispersible tablets: An overview. Asian J
Pharm. 2008, 2: 2-11.
[9] Fu Y, Yang S, Jeong SH, Kimura S, Park K.
Orally fast disintegrating tablets: Developments,
technologies, taste-masking and clinical studies.
Critical reviews in therapeutic drug carrier
systems. 2004, 21(6): 433-76.
[10] Panigrahi R, Behera S. A Review on Fast
Dissolving Tablets. Webmed Central quality and
patient safety, 29 sept, 2010, 1(9): WMC00809.
[11] Aurora J, Pathak V. Oral disintegrating
technologies: Oral disintegrating dosage forms: An
overview. Drug Deliv Technol, 2005, 5(3): 50-54.
[12] Yourong Fu, Schicheng Yang, Susuma Kimura.
Orally Fast Disintegrating tablets: Developments,
Technologies, Taste-masking and clinical studies,
2004, 21(6): 433-475.
[13] Anon, Flavors and Flavoring, Int J Pharm
Compounding; 1:1997, 90-92.
[14] Chang RK, Guo X, Burnside BA, Couch RA. Fast
dissolving tablets. Pharm Tech, 2000, 24(6): 52-
58.

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