TABLE OF CONTENTS

Chapter

Title

Page
No.

INTRODUCTION

II

AIM, OBJECTIVE & PLAN OF

WORK

35

III

LITERATURE REVIEW

37

IV

DRUG PROFILE

40

EXCIPIENTS PROFILE

44

VI

MATERIALS AND METHODS

48

VII

RESULTS& DISCUSSION

56

VIII

SUMMARY& CONCLUSION

65

IX

FUTURE WORK PROPOSED

66

BIBLIOGRAPHY

67

LIST OF TABLES
TABLE NO.
1

TITLE OF THE TABLE

Excipientsand their uses in the manufacture of ODT using Freeze

PAGENO.
6

2
3

drying technique
Various pre-blend compositions and drugs used in floss process
List Of Suitable Drug Candidates For MDT

10
20

Comparison of Conventional Solid Dosage Forms and ODTs

21

List of Patented Technologies Based Branded Products

21

ODTS UNDER DEVELOPMENT

22

List of Superdisintegrants

25

weight variation tolerances for uncoated tablets

26

Materials used

48

10
11
12

Equipments used
CalibrationdataofPhenytoin Sodium
Formulae for ODT
Pre-Compression Parameters

48
56
57

Results of general appearance evaluation

Post-Compression Parameters For The Formulations
In-vitro Dissolution studies
Comparison of dissolution profile of formulation F5 with Dilantin

58
59
61
64

13
14
15
16
17

58

LIST OF FIGURES
FIGURENO.

TITLE OF FIGURE

PAGENO.

1
2

Steps involved in sublimation

Disintegration of tablet by wicking and swelling

9
23

Disintegration of tablet by deformation and repulsion

24

4
5
6

Measurement of wetting time and water absorption ratio of a tablet.

Structure for Phenytoin Sodium
UVSpectrumof Phenytoin Sodium(max)
Calibrationcurve for Phenytoin Sodium using Phosphate Buffer pH

28
40
56

57

8
9
10

6.8
Wetting Time Chart
Disintegration Time Chart
Comparative Zero Order Plots For Formulations F1-F9

11

Comparative First Order Plots For Formulations F1-F9

62

12

Comparative Higuchi Plots For Formulations F1-F9

63

13

Comparative Korsmeyer Peppas Plots For Formulations F1-F9

63

14

ComparativeIn-vitro Dissolution Profiles of F5, Dilantin

64

61
62
62

LIST OF ABBREVATIONS
%
% CDR

: Percentage
: Percentage cumulative drug release

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

C
CCS
CRP
DT
ODT
FTIR
GI
Gm
H
IR
Lit
Mg
Mcg
MCC
Meq
Min
Ml
N
RDT
RPM
SD
Sec
SSG
UV
USP
WHO
Wt
W/W
W/V

:
:
:
:
:
:
:
:
:

Degree Celsius/ Degree Centrigrade

Cross carmellose sodium
Cross povidone
Disintegration time
Oral disintegrating tablets
Fourier Transformer Infra Red
Gastro intestinal
Gram
Hour
Infra red
Litre
Milligram
Microgram
Micro crystalline cellulose
Milliequivalent
Minutes
Milliter
Normality
Rapid dissolving tablets
Revolution per minute
Standard deviation
second
Sodium starch glycolate
Ultra violet
United states pharmacopoeia
World health organisation
Weight
Weight by weight
Weight by volume