1. FORMULATION AND CHARACTERISATION OF
ORAL DISPERSIBLE TABLET OF APREPITANT
GUIDED BY:
Dr. ZANKHNA SETH
ASSISTANT
PROFESSOR and HEAD
OF DEPARTMENT
S.K.C.O.P
PRESENTED BY:
BHAKTI. M. SHAH
M.PHARM SEM IV
(PHARMACEUTICS)
ENROLLMENT NO.
132460808013
S.K.C.O.P
Department of Pharmaceutics
Sat Kaival College of Pharmacy
1

2. 2
LITERATURE REVIEW
CONTENT
2
1. AIM OF WORK &OBJECTIVE
3.RATIONAL
4. REVEIW OF LITERATURE
5. DRUG PROFILE
2. INTRODUCTION
6. PRE-FPRMUATION STUDY
7. MATERIAL & METHODOLOGY
8.RESULT
9. SUMMARY &CONCLUSION
10.COMPLANCE REPORT
11. REFRENCES

3. AIM & OBJECTIVE OF WORK
 To formulation and characterization of oral dispersible
tablets of an anti-emetic drug by direct compression.
 The oral route of drug administration is more common
and convenient where tablets and capsules emerged as
popular dosage form but many patients have dysphasia
or difficulty in swallowing which is currently affecting 35%
general population.
 Difficulty in swallowing (Dysphasia) is a common problem
of all age groups, especially the elderly and pediatrics
because of physiological changes associated with these
groups.
3

4. RATIONALE
 Aprepitant is an antiemetic drug which induced nausea and vomiting
during the treatment of chemotherapy.
 Aprepitant is neurokinin 1 receptor antagonist .
 Neurokinin 1 receptor available in brain in high concentration on
vomiting center and reflex of its create vomiting.
 In aprepitant injectable approach are available ,but this approach are
very costly , time consuming, pain full and dose not use for pediatric
and geriatric patient.
 Oral dispersible method are very easy to prepare ,patient compliance
and economic method.
 so, compare to injectable method this approach are reliable
 Hence, the present work is aimed at the formulation and evaluation
of aprepitant oral dispersible tablet
4

5. 5
What are ODT? Solid dosage form
Rapid
disintegration
on the tongue
A stable, oral dosage form
with the dosing ease of a liquid.
Fast Dissolve
Dosage Form
Oral route of
administration

6. INTRODUCTION
 Oral Dispersible tablet are solid single unit dosage forms
that are placed in mouth , allowed to disperse or dissolve
in saliva without need of water for frequently release of
drug for quick onset of action.
 Oral Dispersible tablet disappears rapidly before
swallowing.
 Disintegrates in 15 sec to 1 min.
 Also called as fast dissolving tablet, orodispersible tablet,
melt in mouth tablet, repimelts tablet, porous tablet.
6
[1,2;3}

7. Aprepitant may also be useful in the treatment of cyclic
vomiting syndrome & late-stage chemotherapy induced
vomiting.
Aprepitant use as a antiemetic, anxiolytic and anti
depressant
7

8. 8
LITERATURE
SURVEY

9. 9
LITURATURE REVIEW
Sr.
no.
Researcher Drug
Superdisntegr
ant
Dosage form Journal
1
Deshmukh, A. K. Seth.
Tejas K Ghelani,
Sharad Kumar,
Hemangi Patel, Sachin
Chauhan[1]
Famotidine
Crospovidone,
Croscarmelose
sodium
Oro dispersible tablet
Indo American
Journal Of
Pharmaceutical
Research
2
Leela Manasa K,
Ramana G and Digpati
Roy [2]
Alfuzosin
Hydrochloride
Crospovidone,
Croscarmelose
sodium
Oro dispersible tablet
Journal of
Applied
Pharmaceutical
Science
3
Milind P Wagh*, Cheta
n P Yewale, Santosh U
Zate, Paresh I Kothawa
de, Ganesh H Mahale[3]
Aceclofenac
Crospovidone,
Croscarmelose
sodium
Oro dispersible tablet
International
Journal of
Pharmacy and
Pharmaceutical
Sciences
4
*Devendra Revanand
Rane, Hemant Narhar
Gulve, Vikas Vasant
Patil, Vinod Madhaorao
Thakare, Vijay
Raghunath Patil [4]
Albendazole
Crospovidone,
Croscarmelose
sodium
Oro dispersible tablet
International
Current
Pharmaceutical
Journal

10. 10
Researcher Drug Polymers Dosage form Journal
5
B Chandrasekhara
Rao, S Vidyadhara ,
RLC Sasidhar and YA
Chowdary[14]
Aprepitant
Polyethylene
glycol- 4000
Polyethylene
glycol- 8000
Solid dispersion
Research
Journal of
Pharmaceutical
, Biological and
Chemical
Sciences
6
P. Durga Bhavani, S.
Venkata Ramana
Reddy, Laxmidhar
Sahoo, K. Harinadha
Baba[15]
Aprepitant
Carboxy methyl
cellulose sodium
Nano suspension
International
Journal of
Advanced
Pharmaceutics

11. 11
DRUG PROFILE
Structure of Etodolac
Systematic (IUPAC) Name:
5-([(2R,3S)-2-((R)-1-[3,5-
bis(trifluoromethyl)phenyl]ethoxy)-3-(4-
fluorophenyl)morpholino]methyl)-1H-1,2,4-triazol-
3(2H)-one
Molecular formula C23H21F7N4O3
Molecular weight 534.4gm/mol
Color and appearance Off white crystalline powder
Category Anti –emetic , Neurikinin receptor bloker
BCS class Class –II
Log P 5.22
pka Acidic(9.65)
Basic(3.51)
[15]

12. 12
Solubility
Insoluble water
Sparingly soluble Ethanol
Slightly soluble in acetonitrile
Melting point 244-246 °C
Indication Mainly use for the treatment of
Anti emetic
Half life 9 -13 hours
Bioavailability(%) 60 – 65 %
Excretion Urine(5%) and feaces (86%)
Metabolism stomach
UV Absorption 210 nm

13. 13
Mechanism of action Aprepitant has been shown in animal models to
inhibit emesis induced by cytotoxic
chemotherapeutic agents, such as cisplatin, via
central actions. Animal and human Positron
Emission Tomography (PET) studies with
Aprepitant have shown that it crosses the blood
brain barrier and occupies brain NK1 receptors.
Animal and human studies show that Aprepitant
augments the antiemetic activity of the 5-HT3-
receptor antagonist ondansetron and the
corticosteroid ethasone and inhibits both the
acute and delayed phases of cisplatin induced
emesis.
Side effect abdominalpain,changedsenseoftaste,constipatio
n,diarrhea,Dizziness,dry mouth, fatigue,flushing,
headache, heartburn, loss of appetite, muscle
cramps, upset stomach, vomiting, weakness

14. 14
Mechanism of Aprepitant

15. 15
1
5
SUMMARY OF PSARSr no. PSAR Title name
1 US2013/0317016A1 APREPITANT INJECTABLE
FORMULATION
2 US8497303B2 METHOD TO ENHANCE AQUEOSUES
SOLUBILITY OF POORLY SOLUBLE
ACTIVES
3 US 2010/0092564A1 COMPOSITION OF METHOD FOR
PREPARING ORALLY DISINTEGRATING
TABLTS
4 US 739050B1 ONDASETRON ODT
5 US 2001/0014532A2 COMPRESSED TABLETS
FORMULATION
PSAR SUMMARY

16. 16
Looikng of above patent. the patent is available in injectable
approach on Aprepiatnt drug. the patent are available other
dosage form and field of chemistry. that mean s no patent are
available related to my dissertation topic aprepitant are indicated
for the nausea and vomiting . there are severable formulation are
available of aprepitant like injectable. dosage form oral dosage
method are easy to prepare , patent compliance, and economic
method . there is no available about oro dispersible tablet of
Aprepiatnt that’s why i am selecting this topic

17. 17
Preformulation
Study
Formulation of
dispersible tablet
Optimization Study
Stability
Studies
EXPERIMENTAL
WORK

18. 18
Pre-formulation study
Observed
value
Standard
value(17)
245˚C 244-246˚C
Melting point

19. 19
SR NO. SOLVENT SOLUBILITY
1 Water Insoluble
2 Ethanol Sparingly
3 Aceto nitrile Slightly
4 Di- methyl formide(DMF) Soluble
Solubility of Aprepitant

20. 20
IR spectrogram of Etodolac
Interpretation of FT-IR Spectra
3. FTIR

21. Data for Calibration Curve
Calibration Curve of Aprepitant data
21
Concentration
(μg/ml)
Abs(nm)±SD
5 0.071±0.016
10 0.194±.0017
15 0.321±0.018
20 0.473±0.018
25 0.614±0.017
30 0.728±0.014
35 0.907±0017
4.Calibration curve

22. 22
y = 0.0268x - 0.0427
R² = 0.9995
0.000
0.200
0.400
0.600
0.800
1.000
0 10 20 30 40
Absorbance
Aprepitant at 210nm
Concentration(μg/ml)
Calibration Curve of Aprepitant

23. 23
Materials &Method
Materials uses
Aprepitant Drug carrier
Polyplasdone XL 10 superdisintegrant
Polyplasodone XL superdintegrant
Polyplasdone INF10 superdisintegratint
Crosscarmelose sod ium superdisintegratint
SSG superdisintegratint
Spray dried lactose filler
Mannitol diluent
Sodium stearyl fumarate lubricant
Straw berry flavour Flavour
Aspatartame Swetner

24. 24
SR NO. EQUIPMENT COMPANIES NAME
1 Electronic weighing balance Metter Toledo PG
403-S,Denver Instrument
2 Melting point appratus VMP-1(VEEGO)
3 Hot air oven Hicon,ELE Insrument
Pvt.ltd
4 Disintegration appratus Krishna engineering
5 Tablet compression machine Hicon Insrument
6 Dissolution Appratus VDA-6D USPStd.
(VEEGO)
7 U.V.Visible
Spectrometer
UV-1700(Shimadzu Inc.
Japan)
8 Hardness tester Hicon
9 Roche friability Electro Lab
10 Digital bulk density Mitutoyo
11 Vernier calipers Electro lab bulk density
tester USP,ETD-1020

25. 25
S1 Aprepitant : SSG ( 1:1)
S2 Aprepitant : SSG (1:3)
S3 Aprepitant : SSG (1:5)
S4 Aprepitant : CROSPOVIDONE (1:1)
S5 Aprepitant : CROSPOVIDONE (1:3)
S6 Aprepitant : CROSPOVIDONE (1:5)
P1 Aprepitant : SSG (1:5)
P2 Aprepitant : CROSPOVIDONE (1:5)
D Pure Drug
Solid dispersion
(kneading method)

26. 26
Time (min) Cumulative Drug Release
S1 S2 S3 P1 D
5 91.81±1.01 98.04±0.11 87.82±0.13 34.59±0.93 0
10 102.01±0.13 98.04±0.58 91.25±0.95 41.25±0.48 10.57±0.77
20 101.67±0.56 101.0±0.91 95.02±0.78 42.99±0.19 19.78±0.37
30 98.79±0.49 100.32±1.01 94.26±0.79 52.79±0.63 30.11±0.93
45 98.63±0.69 100.32±0.35 95.77±1.17 63.35±0.17 45.59±0.18
60 99.29±1.12 100.32±0.51 91.25±0.95 76.18±0.49 52.68±0.83
IN VITRO DISSOLUTION STUDY OF SOLID DOSAGE FORM
 Solid dispersion by kneading method in 6.8 buffer pH solution.

27. 27
Time (min) Cumulative % Drug Release
S4 S5 S6 P2 D
5 97.28±0.27 94.26±0.61 99.55±0.19 24.39±0.79 0
10 101.43±0.8
9
103.55±1.1
6
97.34±0.87 39.89±0.19 10.57±0.77
20 99.55±0.61 101.85±1.0
7
98.85±0.29 41.25±0.48 19.78±0.37
30 98.79±0.94 100.98±0.5
8
97.33±0.64 49.02±0.87 30.11±0.93
45 97.74±1.06 100.98±0.4
8
92.62±0.35 55.81±0.58 45.59±0.18
60 98.5±0.73 99.56±0.83 94.12±1.03 64.11±0.49 52.68±0.83

28. 28
-20
0
20
40
60
80
100
120
0 20 40 60 80
%CDR
TIME(min)
S1
S2
S3
P1
D
Figure no: dissolution profile of solid dispersion S1,S2,S3 in
comparision with pure drug and physical mixture(P2) in 6.8
buffer pH.

29. 29
-20
0
20
40
60
80
100
120
0 20 40 60 80
%CDR
Dissolution Profile of solid dispersion
S4
S5
S6
P2
D
Figure no: dissolution profile of solid dispersion S4,S5,S6 in
comparison with pure drug and physical mixture(P2) in 6.8
buffer pH.

30. 30
TRIAL
BATCHES

31. 31
INGREDIENTS(mg) A1 A2 A3 A4 A5 A6 A7 A8 A9 A10
Aprepitant 80 80 80 80 80 80 80 80 80 80
Mannitol 68 62 68 62 68 62 68 62 68 62
Spray.dried lactose 44 40 44 40 44 40 44 40 44 40
Polyplasdone XL 20 30 - - - - - - - -
Polyplasdone XL 10 - - 20 30 - - - - - -
Polyplasdone INF 10 - - - - 20 30 - - - -
Cross carmeloss
sodium
- - - - - - 20 30 - -
Sodium starch
glycolate
- - - - - - - - 20 30
Arosil 200 5 5 5 5 5 5 5 5 5 5
Mg.Stearate. 2 2 2 2 2 2 2 2 2 2
Powder Flavoure
(strawberry)
1 1 1 1 1 1 1 1 1 1
Total 220 220 220 220 220 220 220 220 220 220

32. 32
FACTORIAL
BATCHES

33. 33
LEVAL
FACT OR
-1 0 +1
POLYPLASDONE
XL10
26mg 30mg 34mg
MANNITOL 50mg 56mg 62mg
32 FACTORIAL DESIGN
Independent variables:
 Polyplasdone XL10
 Mannitol
Dependent variables:
 Disintegration time(sec)
 Wetting time(sec)

34. 34
BATCH NO. X1 X2
F1 -1 -1
F2 -1 0
F3 -1 +1
F4 0 -1
F5 0 0
F6 0 +1
F7 +1 -1
F8 +1 0
F9 +1 +1

35. 35
INGREDIENT
(mg)
F1 F2 F3 F4 F5 F6 F7 F8 F9
Aprepitant 80 80 80 80 80 80 80 80 80
Mannitol 50 56 62 20 56 62 50 56 62
Spray dried
lactose
44 40 44 40 44 40 44 40 44
PolyplasdoneXL
10
26 26 26 30 30 30 34 34 34
Aerosil200 5 5 5 5 5 5 5 5 5
Mg.Stearate 2 2 2 2 2 2 2 2 2
Powder flavour
(straw berry)
1 1 1 1 1 1 1 1 1
Factorial Design Batches

36. 36

37. 37
Evaluation Parameter
for Tablet
Pre-compression
parameters
Bulk density
Tapped Density
Carr’s Index
Hausner’s ratio
Angle of repose
Post-compression parameters
Tablet Thickness
Tablet Hardness
Weight variability
Friability
Drug content uniformity
In-Vitro Drug Release Study

38. 38
Post formulation study
Batches Avg. Wt
(mg) ±SD
Hardness
(kp) ±SD
Thickness
(mm ) ±SD
Friability
(%w/w)
Drug
content%±SD
A1 220.12±0.01 4.91±0.77 3.91±0.05 0.64 98.19±0.01
A2 219.85±.001 4.88±0.79 3.87±0.05 0.69 97.23±0.01
A3 219.82±0.04 4.18±0.96 3.89±0.06 0.79 97.76±0.01
A4 220.05±0.01 4.67±1.08 3.92±0.06 0.94 97.89±0.04
A5 219.78±0.02 4.62±2.97 3.91±0.04 0.89 97.26±0.03
A6
A7
219.83±0.01
219.95±0.01
4.09±1.10
4.52±0.85
3.90±0.04 0.97 97.48±0.02
3.63±0.03 0.75 98.02±0.01
A8 220.10±0.01 4.65±0.72 3.85±0.04 0.93 97.65±0.02
A9 219.87±0.02 4.95±0.81 3.73±0.05 0.72 98.15±0.01
A10 219.98±0.01 4.23±0.73 3.78±0.04 0.86 97.59±0.03
##±SD=n=20 ###±SD=n=10

39. 39
Batches Bulk density
(gm/cm3)
±SD
Tapped
density
(gm/cm3)
±SD
Hausner's
ratio
%±SD
Carr’s
Index(%)
±SD
Angle of
repose
(Ɵ) ±SD
A1 0.51±0.01 0.60±0.01 1.31±0.01 23.71±0.01 23.29±0.01
A2 0.45±0.01 0.52±0.01 1.15±0.01 14.41±0.01 22.47±0.02
A3 0.45±0.03 0.54±0.04 1.18±0.01 15.6±0.02 20.18±0.01
A4 0.49±0.01 0.55±0.01 1.13±0.02 11.76±0.02 21.8±0.03
A5 0.43±0.02 0.51±0.03 1.19±0.01 16.38±0.01 23.89±0.01
A6 0.41±0.01 0.49±0.01 1.18±0.02 15.83±0.01 23.8±0.02
A7 0.42±0.02 0.53±0.01 1.17±0.01 17.23±0.02 22.57±0.02
A8 0.47±0.01 0.57±0.02 1.16±0.02 13.52±0.01 20.42±0.01
A9 0.44±0.01 0.56±0.01 1.21±0.01 18.21±0.01 24.2±0.01
A10 0.46±0.02 0.59±0.03 1.23±0.01 12.29±0.02 21.56±0.03
Preliminary screening batches pre-
formulation study
##±SD=n=3

40. 40
Disintegration time(sec) Wetting time(sec)
A1 48.±2 52.±3
A2 43.±1 50±2
A3 37.±3 41±1
A4 36.±4 38±2
A5 38.±5 43±1
A6 40.±2 44±3
A7 61.±3 64±2
A8 63.±1 66±3
A9 56.±2 59±1
A10 58.±1 61±2

41. 41
Bulk density
gm/cm3±SD
Tapped
density
(gm/cm3)
±SD
Hauser
ratio
±SD
Carr's
index%±SD
Angle of repose
(Ɵ) ±SD
F1 0.20±0.01 0.30±0.01 1.15±0.06 20.7±0.012 26±0.03
F2 0.17±0.01 0.31±0.01 1.19±0.01 22.6±0.016 21±0.01
F3 0.21±0.02 0.35±0.02 1.18±0.03 23±0.020 24.2±0.01
F4 0.19±0.01 0.29±0.01 1.17±0.04 20±0.019 22.3±0.02
F5 0.16±0.02 0.26±0.01 1.15±0.01 18.2±0.016 24.5±0.01
F6 0.22±0.01 0.32±0.02 1.19±0.03 21.5±0.023 23.6±0.01
F7 0.18±0.01 0.34±0.01 1.16±0.02 19.6±0.013 25.1±0.01
F8 0.17±0.02 0.28±0.01 1.17±0.01 20.5±0.015 22±0.01
F9 0.24±0.01 0.33±0.01 1.18±0.01 21±0.014 23±0.02
PRECOMPRESION PARAMETER OF FACTORIAL BATCHES

42. 42
Avg. Wt
(mg)±SD
Hardness
(kp) ±SD
Thickness
(mm) ±SD
Friability
(%w/w)
±SD
Drug
content
±SD
F1 220.20±2.30 4.45±0.71 3.89±0.03 0.398 98.07±0.12
F2 219.80±2.10 4.04±0.79 3.91±0.05 0.430 99.01±0.57
F3 220.50±2.64 3.99±0.84 3.91±0.04 0.532 98.00±0.98
F4 220.40±1.90 3.90±0.75 3.87±0.03 0.521 97.90±0.7
F5 219.80±1.62 4.78±0.21 3.93±0.02 0.562 99.1±.0.22
F6 220.1±1.20 4.33±0.82 3.93±0.03 0.432 99.45±0.14
F7 218.90±1.85 3.52±0.45 3.90±0.02 0.356 99.56±0.28
F8 220.90±1.73 4.30±0.80 3.91±0.01 0.486 98.14±0.91
F9 221.10±1.85 4.31±0.70 3.93±0.02 0.512 99.21±0.45
POST COMPRESION PARAMETER OF FACTORIAL BATCHES

43. 43
Factorial batches Disintegration
time(sec)
Wetting time(sec)
F1 35.±2. 36±1
F2 28.±1 30.±1
F3 31.±1. 32±4
F4 34.±2 35±2
F5 27.±1 28.±2
F6 29.±1. 31.±1
F7 32.±2 33.±2.
F8 23.±2. 23±3.
F9 24.±1. 25.±1

44. 44
R square 0.9903
Adjusted R square 0.9741
SOURCE
COEFFICIENT P – value
β0 +27.55 0.0032
β1 -2.40 0.0032
β2 -2.93 0.0018
β12 -1.59 0.0453
β22 +4.69 0.0023
STATITICAL ANALYSIS
The response (Y) is measured for each trial.
Y = B0 + B1X1 + B2X2 + B12X1X2 + B1
1X1
2 + B2
2X2
2
REGRESION OF Y1(DISINTEGRTION TIME)

45. 45
Design-Expert® Software
Factor Coding: Actual
R1 DT (sec.)
Design points above predicted value
Design points below predicted value
35
23.02
X1 = A: A conc of polyplasdone XL 10
X2 = B: B conc. of mannitol
-1
-0.5
0
0.5
1
-1
-0.5
0
0.5
1
22
24
26
28
30
32
34
36
R1DT(sec.)
A: A conc of polyplasdone XL 10 (mg)
B: B conc. of mannitol (mg)
Full model equation
Y1= 27.55-2.40X1-2.93X2-1.5X12 +4.69x22

46. 46
R square 0.9743
Adjusted R square 0.9316
SOURCE
Coefficient P value
β0 +28.26000 0.0136
β1 -2.77000 0.0086
β2 -2.52333 0.0112
β12 -0.81000 0.2374
β12 -1.36000 0.1789
β22 +4.87000 0.0082
REGRESION OF Y2
(WETTINGTIME)

47. Design-Expert® Software
Factor Coding: Actual
R2 WT (sec.)
Design points above predicted value
Design points below predicted value
36.23
23.39
X1 = A: A conc of polyplasdone XL 10
X2 = B: B conc. of mannitol
-1
-0.5
0
0.5
1
-1
-0.5
0
0.5
1
22
24
26
28
30
32
34
36
38
R2WT(sec.)
A: A conc of polyplasdone XL 10 (mg)
B: B conc. of mannitol (mg)
47
Full model equation
Y2= +28.26 -2.77X1-2.93X2 – 0.81X1X2-1.36X1
2+4.87X2
2
Reduced model equation on the basis of P value
Y2= 28.26-2.77X 1-2.52X2 + 4.87X2
2

48. 48
TIME(min) F1 F2 F3 F4 F5 F6 F7 F8 F9
0 0.000
± 0.0
0.000
± 0.0
0.000
± 0.0
0.000
± 0.0
0.000
± 0.0
0.000
± 0.0
0.000
± 0.0
0.000
± 0.0
0.000
± 0.0
5 46.51
± 0.65
52.16
± 0.25
52.69
± 0.65
45.34
± 0.41
54.18
± 0.99
54.42
± 0.56
48.38
± 0.75
55.67
± 0.55
56.13
±0.89
10 60.49
± 0.83
62.45
± 0.91
63.99
± 0.29
65.12
± 0.47
65.44
± 0.59
65.86
± 0.53
66.87
± 0.63
67.23±
0.45
69.85
± 0.31
15
74.43
± 0.43
74.97
± 0.87
76.56
± 0.95
77.86
± 0.91
78.15
± 0.74
79.12
± 0.65
79.16
± 0.61
80.49
± 0.54
82.53±
0.78
20
82.67
± 0.52
83.69
± 0.32
85.20
± 0.86
85.25
± 0.82
86.45
± 0.38
86.72
± 0.25
86.86
± 0.28
89.2 ±
0.55
90.23
± 0.67
25
89.49
± 0.67
91.52
± 0.85
93.64
± 0.45
94.61
± 0.49
95.79
± 0.86
96.27
± 0.65
97.20
± 0.12
98.42±
0.64
99.25
± 0.3
30
90.52 ±
0.89
93.21±
0.42
96.56±
0.78
97.40±
0.25
97.98±
0.02
98.34±
0.85
99.51±
0.42
99.99±
0.25
99.78±
0.48
In Vitro Drug Release study of Dispersible tablet (F1-F9)
In 6.8 buffer pH solution
±SD=n=6

49. 49
0
20
40
60
80
100
120
0 5 10 15 20 25 30 35
%CDR
time(min)
F1
F2
F3
F4
F5
F6
F7
F8
F9
In vitro drug release profile

50. 50
TIME(min) INITIAL AFTER 30 DAYS
0 0 0
5 55.67 55.45
10 67.23 66.78
15 80.49 79.86
20 89.2 88.74
25 98.42 98.15
30 99.83 99.76
STABILITY STUDY
0
20
40
60
80
100
120
0 10 20 30 40
%CDR
Time (min)
INITIAL
AFTER 30 DAYS

51. 51
Stability at 40ºc /75%RH
Batch no F8 optimsed Initial After 30 days
Avg.wt 220.0.2 219.98
Hardness 4.30 4.19
Thickness 3.91 3.89
Friaility 0.484 0.462
Disingration time (sec) 20.83(1.23) 21.45(1.86)
Wetting time(sec) 21.56(1.47) 20.63(0.75)

52. 52
SUMMARY
AND
CONCLUSION

53.  Aprepitant is an anti emetic drug which is in used in
nausea and vomiting in chemotherapy.
 It is a BCS class-II drug so, increases solubility solid
dispersion was carried out using kneading method. In
6.8 buffer pH in vitro dissolution was carried out .
 For trial batchesA1-A10 were taken respectively. using
different superdisintegrant in which after evaluation It
was concluded that A4 was optimsed and polyplasdone
XL10 is used as superdisintegrant.
 For the optimisation of tablet factorial design 32 was
carried out. In which independent variable are
polyplasdone XL10 and Mannitol . And dependent
variable were time and wetting time were carried out.
And design was applied. 5353
Summary

54.  the dissolution was carried out for to increases
solubility of aprepitant in 6.8 buffer pH .
 Stability study was carried out .F8 was
optimisable batch stablisable on evaluation of
it.
54

55. 55
CONCLUSION
 The method of preparation of Oral dispersible tablet of
Aprepitant presented in this research work is simple. All
formulation showed good physicochemical properties like %
Drug release, hardness, thickness, disintegrating time etc.
 The in-vitro release data showed that drug release from the
tablet formulation have been affected by types of
superdisintegrant and other exepients
 These studies indicated that as the concentration of
superdisintegrant increased the tablet was decreased
disintegration time and increase wetting time.
 It was concluded that batch F8 was found to be excellent among
all evaluation parameter..

56. 56

57. 57
COMPLAINCE REPORT
SR. NO COMMENT
FULL FILLMENT OF
COMMENT
YES/NO
1
1.Taste masking ----
2.Stability study Yes
3.Experimental design Yes
4.Through research on polyplasdone Yes
5. Statically analysis Yes

58. 58

59. 59
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62. 62