CONTENTS

CHAPTER NO.

1.

TOPIC NAME

INTRODUCTION

PAGE NO.

1-42

LITERATURE REVIEW

43-45

AIM AND OBJECTIVES

46

PLAN OF WORK

47

MATERIALS AND EQUIPMENTS

48-49

DRUG AND EXCIPIENTS PROFILE

50-56

EXPERIMENTAL WORK

57-76

RESULTS AND DISCUSSION

77-80

CONCLUSION

81

10

REFERENCES

82-86

LIST OF TABLE LEGENDS

Table
No.
1.1

Title

Page no.

Excipients and their uses in the manufacture of ODT using

06

Freeze drying technique

1.2
1.3

Various preblend compositions used in floss process

Oral disintegrating tablets currently available in market

11
22-26

1.4
1.5
1.6
1.7

List of Superdisintegrants
Relationship between % compressibility and flowability
Angle of Repose as an Indication of Powder Flow Properties
As per USP specifications, weight variation tolerances for

30-31
32
33
34

uncoated tablets
5.1

List of Materials used

48

5.2

List of Equipments used

49

7.1
7.2
7.3

Calibration curve for the estimation of Zolpidem Tartarate

Formulation codes of ODT
Formulae of Zolpidem Tartarate ODTs prepared by direct

57
60
64

compression method with various superdisintegrants

7.4
7.5
7.6

Preformulation characteristics of Zolpidem Tartarate ODTs

Tabletting characteristics of Zolpidem Tartarate ODTs
Cumulative percent Zolpidem Tartarate released from ODTs
containing

varying

concentrations

of

65
66
68

different

superdisintegrants
7.7

Formulae of Zolpidem Tartarate ODTs prepared with

70

combination of superdisintegrants
7.8

Preformulation characteristics of Zolpidem Tartarate ODTs

71

prepared with combination of superdisintegrants

7.9

Tabletting characteristics of Zolpidem Tartarate ODTs

71

prepared with combination of superdisintegrants

7.10

Cumulative percent Zolpidem Tartarate released from ODTs

prepared by varying concentrations of combination of
superdisintegrants

73

LIST OF FIGURE CAPTIONS

Figure
Title
No.
1.1
Steps involved in sublimation
1.2
Disintegration of tablet by wicking and swelling

Page
No.
10
28

1.3

Disintegration of tablet by deformation and repulsion

29

1.4

A simple Method for the Measurement of Wetting Time and Water

36

Absorption Ratio of a Tablet.

3.3

Graphical

representation

TartarateODTsprepared

of
by

wetting
varying

time

of

Zolpidem

concentrations

67

of

superdisintegrants
3.4

Graphical representation of disintegration times of Zolpidem

Tartarate

ODTs

prepared

by

varying

concentrations

67

of

superdisintegrants
7.1
7.6

7.7

7.8

Calibration curve for the estimation of Zolpidem Tartarate

Graphical representation of Cumulative percent Zolpidem
Tartarate released from ODTs containing varying concentrations of
crosspovidone
Graphical representation of cumulative percent Zolpidem Tartarate
released from ODTs containing varying concentrations of
crosscarmellose sodium.
Graphical representation of Cumulative percent Zolpidem

58
69

69

70

Tartarate released from ODTs containing varying concentrations of

sodium starch glycolate.
7.10

7.11

Graphical representation of witting time of Zolpidem Tartarate

ODTs prepared by varying concentrations of combination of
superdisintegrants
Graphical representation of disintegration times of Zolpidem

72

73

Tartarate ODTs prepared by varying concentrations of combination

of superdisintegrants
7.13

Graphical representation of Cumulative percent Zolpidem Tartarate

released from ODTs containing varying concentrations of CP +
CCS

74

Figure
No.

Title

Page
No.

Graphical representation of Cumulative percent Zolpidem Tartarate

7.14

released from ODTs containing varying concentrations of CP +

75

SSG
7.15

FTIR spectra of Zolpidem Tartarate

76

LIST OF ABBREVIATIONS
Abs

Absorbance

avg.

Average

BP

British Pharmocopoeia

Degree centigrade

CAS

Chemical Abstract Service

Cm

Centimeter

cm

-1

Centimeter inverse

cm3

Centimeter cube

CMC

Carboxy Methyl Cellulose

Conc.

Concentration

CR

Controlled Release

Cum.

Cumulative

DSC

Differential Scanning Calorimetry

e.g.

For example

EC

Ethylcellulose

Eur. Ph.

European Pharmacopiea

Fig.

Figure

F Crit.

Critical value for F distribution

FT-IR

Fourier

Transform

Infra-Red

spectroscopy
GET

Gastric Emptying Time

GIT

Gastro Intestinal Tract

gm

Gram

GRT

Gastric Retention Time

GRDDS

Gastro retentive drug delivery system

Hour

HCl

Hydrochloric acid

HEC

Hydroxy Ethylcellulose

HPC

Hydroxy Propylcellulose

HPMC

Hydroxy Propyl Methyl Cellulose

ICH

International

Conference

Harmonization
IP

Indian Pharmacopoeia

i.e.

That is

KBr

Potassium Bromide

mg

Milligram

mL

Milliliter

min

Minute

Microgram

Micrometer

Korsmeyer release exponent

NDDS

Novel Drug Delivery System

nm

Nanometer

No.

Number

o/w

Oil in water

P value

Probability value

PBS

Phosphate Buffer Solution

PVA

Polyvinyl alcohol

R2

Regression Correlation Coefficient

RH

Relative Humidity

rpm

Revolutions per minute

RH

Relative Humidity

R.S.D.

Relative Standard Deviation

S.D.

Standard Deviation

S.R.

Sustained Release

SEM

Scanning Electron Microscopy

Sec.

Second

TLC

Thin Layer Chromatography

TPP

Tripolyphosphate

SR

Sustained release

USP

United State Pharmacopoeia

on

USFDA

United

State

of

Food

Drug

Administration
USP-NF

United States Pharmacopiea and the

National Formulary

UV

Ultra Violet

v/v

Volume by volume

WHO

World Health Organization

w/o

Water in oil

w/v

Weight by volume

max

Maximum absorbance

>

Greater than

Greater than equal to

<

Less than

Less than equal to

Plus or minus