The document discusses the formulation and evaluation of risperidone fast dissolving tablets. Four formulations of risperidone FDTs were developed using different concentrations and combinations of crospovidone and croscarmellose sodium as superdisintegrants. The tablets were prepared by direct compression method and evaluated for characteristics like hardness, friability, thickness, drug content, wetting time, disintegration time and in-vitro drug release. Formulation F2 showed the most promising results with no drug-excipient interactions. Stability studies on F2 for one month also showed acceptable results, making it the optimized risperidone FDT formulation.

1. FORMULATION AND EVALUATION OF RISPERIDONE FAST
DISSOLVING TABLETS
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY
In partial fulfillment of the requirement for the award of the degree of
BACHELOR OF PHARMACY
Dr.S. RUBESH KUMAR
M.Pharm., Ph.D., FICCP., M D(AM)
Professor&HOD
Dept. of Pharmaceutical Analysis
Submitted by
D. PAVANI 12AD1R0014
N. SURAJ SINGH 12AD1R0048
Ch. DILIP KUMAR 13AD1R0011
D. SHASHI KUMARI 13AD1R0012
TEEGALA RAM REDDY COLLEGE OF PHARAMACY 1
A Dissertation Work submitted to
UNDER THE GUIDANCE OF

2. The main aim of present research investigation is to formulate the
Risperidone Fast Dissolving tablets. Risperidone, an atypical antipsychotic,
belongs to BCS Class-II and used for treating schizophrenia, bipolar mania
and autism by blocking D2 and 5-HT2A receptors. The Fast Dissolving
tablets of Risperidone were prepared employing different concentrations of
Crospovidone and Croscarmellose sodium in different combinations as a
Superdisintegrants by Direct Compression technique. The concentration of
Crospovidone and Croscarmellose sodium was selected as independent
variables, Totally four formulations were designed, preapred and are
evaluated for hardness, friability, thickness, Assay, Wetting time,
Disintegration time, In-vitro drug release.
Keywords: Risperidone, sodium starch glycolate, croscaramellose, direct
compression technique, in vitro drug release studies
ABSTRACT
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3. CONTENTS
 INTRODUCTION
 LITERATURE REVIEW
 DRUG PROFILE
 AIM AND OBJECTIVES
 PLAN OF WORK
 PRE FORMULATION STUDIES
 MATERIALS AND METHODS
 RESULTS AND DISCUSSION
 CONCLUSION
 REFERENCE
3

4. LITERATURE REVIEW
Bhaskaran, S et al.,8 The present research work has been carried out for an optimized formulation of co-processed
directly compressible vehicles in the preparation of the Acetaminophen mouth fast dissolving tablets (MFDTs).
Acetaminophen was chosen due to its poor compression properties. Di-calcium Phosphate (DCP) was incorporated
in the neutralized aqueous starch dispersion to prepare co-processed excipient. Co-processed direct compressible
DCP and Starch used as co-processed excipient were taken in good formulation ratio such as (25:75) and Cross
Povidone used as super disintegrant. The effects of other superdisintegrants were studied in the best formulation
F5. Formulation F5 was found to be optimum compressibility characteristics hardness 3.62±0.40 to 4.68±0.31
kg/cm2 with fast disintegration (10 sec) compare to other formulations.
Devrajan, P.V et al., 9 The purpose of this research was to develop mouth dissolve tablets of cinnarizine by
effervescent, superdisintegrant addition and sublimation methods. All the three formulations were evaluated for
disintegration time, hardness and friability, among these superdisintegrant addition method showed lowest
disintegration time; hence it was selected for further studies. Further nine batches (B1-B9) were prepared by using
crospovidone, croscarmellose sodium and L-HPC in different concentrations such as 5, 7.5 and 10%. All the
formulations were evaluated for weight variation, hardness, friability, drug content, in vitro disintegration time,
wetting time, in vitro dissolution. Formulation with 10% L-HPC show the less disintegration time (25.3 s) and less
wetting time (29.1 s). In vitro dissolution studies showed total drug release at the end of 6 min.
Kuchekar, B.S et al.,10 To formulate antiepileptics into such a delivery system, which provide immediate relief.
Hence, the present investigation was undertaken with a view to develop mouth-dissolving tablets of
oxcarbazepine, which offers a new range of product having desired characteristics and intended benefits. In this
study, the mouth dissolving tablets were prepared using two different technologies, direct compression method and
solid dispersion technology. Tablets produced by direct compression method contain crospovidone as a
superdisintegrant and aspartame as a sweetener. Solid dispersions of oxcarbazepine with polyvinylpyrrolidone K-
30 and polyethylene glycol 6000 in different weight ratios were prepared with a view to increase its water
solubility.
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5. AIM:
The aim of this study is “Formulation and
Evaluation of Risperidone fast dissolving
tablets”.
OBJECTIVES
The medical and pharmaceutical communities are
seeing increasing opportunities and benefits from
the ability to deliver immediate release dosage
forms.
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6. DRUG PROFILE
Name: Risperidone
Synonym: Risperidal
Description: Schizophrenia and various mood disorders are thought to be caused by an excess of
dopaminergic D2 and serotonergic activity
Structure:
IUPACName: 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-
tetrahydropyrido[1,2-a]pyrimidin-4-one
Chemical Formula: C23H27N4 O2 F
Molecular weight: 410.48 g/mol
Chemical Abstract Number: 106266-06-2
PHYSICAL PROPERTIES:
Boiling point: 572.4.C
Melting point: 170.C
Solubility: DMSO: ≥ 5mg/ml
Colour : white to off-white
Category : Anti psychotic
PHARMACOKINETICS
Bioavailability: 70 %
Half life: 3 hours
Metabolism: Hepatic
Route of elimination: Urine
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7. INTRODUCTION
Fast dissolving tablets are usually formulated to improve chemical stability
of drug, mask the unpleasant taste and in instances where a liquid dosage
form is preferred (easier to swallow, flexibility of administration in a range of
doses) over
a solid dosage form
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8. Tablet manufacturing methods:
1] Wet Granulation
Wet granulation is the process in which a liquid is added to a
powder in a vessel equipped with any type of agitation that will produce
agglomeration or granules. These granules after drying are compressed to
form tablets.
2] Dry Granulation
In this technique, there is no use of liquids. The process involves
the formation of slugs. Then the slugs are screened or milled to produce
granules. The granules formed are then compressed to form tablets.
3) Direct compression
The term direct compression is used to define the process by which
tablets are compressed directly from powder blends of active ingredient
and suitable excipients, which will flow uniformly in the die cavity &
forms a firm compact.
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9. PLAN OF WORK
1.Literature review
2.Pre formulation studies
3.Formulation development of fast dissolving tablets
4.Evaluation of fast dissolving tablets
5.stability studies of optimised formulation
6. result
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10. Pre-compression studies
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11. S.NO. INGREDIENTS
F1
(mg)
F2
(mg)
F3
(mg)
F4
(mg)
1 Risperidone 3 3 3 3
2 Croscaramellose sodium 10 15 - -
3 Sodium starch glycolate - - 10 15
4
Microcrystalline
Cellulose
82 77 82 77
5 Magnesium stearate 3 3 3 3
6 Talc 2 2 2 2
7 Total wt 100 100 100 100
Formulation of risperidone fast dissolving tablets
Evaluation of tablets
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12. PROCEDURE
 Preparation of risperidone by direct compression
method
 Weigh all the ingredients
 Triturate the above ingredients in mortar and pestle
for 10 minutes to get fine powder
 Sieve the material (#no.60)
Transfer the material into a blender for proper
mixing and add lubricant mix well
Perform the micrometric studies(pre compression)
compression
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13. Post compression studies
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14. RESULTS AND DISCUSSION
Pre-formulation studies
(a)API Characterization-Risperidone
Pre-formulation properties of Risperidone
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15. List of Micromeritic properties of directly compressible powder of Risperidone
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16. Calibration curve of Risperidone
Fourier Transformation Infra-red (FTIR) analysis of Risperidone
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17. FT-IR graph for Risperidone Pure drug
Evaluation Parameters for Optimized formulation
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18. In-vitro dissolution Profiles for tablets
Evaluation Parameters for Optimized formulation
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19. Stability Studies of Optimized Formulation
In-vitro dissolution Profiles for tablets
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20. The present investigation was to develop an optimized formula for fast
dissolving tablet containing Risperidone for the management of
schizophrenia. After pre-formulation studies it was decided to prepare
tablets prepared by direct compression method. In the formulation of
immediate release sodium starch glycolate and croscarmellose sodium were
used as super disintegrants. Prior to compression the powder were
evaluated for angle of repose, bulk density, tapped density, compressibility
index, Hausner’s ratio. The compressed fast dissolving tablets were also
evaluated for weight variation, hardness, friability, drug content,
disintegration time and in vitro drug release.
From the studies F2 formulation showed promising results. It was further
supported by FTIR analysis which showed that F2 had no interaction with
excipients. The stability studies were carried out for the optimized batch F2
for one month and it showed acceptable results. So F2 formulation was
considered as the optimized formulation. Hence the formulated dosage form
can be used for the treatment of schizophrenia with further research.
CONCLUSION
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REFERENCE
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