Dedicated To My

Beloved
Parents, Family
And God
 ACKNOWLEDGEMENTS

The Almighty God, I am thankful and grateful to you for bringing me this

far and will still see me through. I bow down to you with both my hands

folded.

I take this opportunity to express my gratitude to all individuals who

have been instrumental in the successful completion of my project.

Special thanks and immense gratitude goes to Mrs. Sheeba F.R., my

esteemed research guide, for his valued supervision, consistent advice,

support and encouragement I received while undertaking this research work.

I am deeply indebted to Dr. Shiva Kumar Swamy, Principal, for his

timely help and kind guidance throughout my project as well as providing

infrastructural facilities for carrying out the research work.

I am equally grateful to my respected professors Mr. Keerthy HS, Dr.

Shivnand kalyanappa, Mrs. Richa sood, Mrs Suma, Ms Adithi, Mrs Menaka

who guided me in different subject matters and gave perpetual moral

support. I would like to thank other teaching, non-teaching and library staff

of Mallige College of Pharmacy, Bangalore, for their invaluable help during

the course of my research Work.

I remain thankful to my seniors Anoj, Kundan, Sailendra, Baijnath,

Sujan, Asha, manjula and Sunil for proper guidance and help.
 I acknowledge the co-operation and help of my colleagues Manikant,

Guddi, kempegowda, mutasim. in each and every possible manner

whenever required for this accomplishment.

I owe deepest appreciation to my dearest friends Rajendra, Manisha, Kawal,

Sivsagar, Ranjan, pappu for being pillar of strength for me.

I remain thankful to my juniors Suuny, Rajeshwar, Suryansh, Ankita,

Lavanya, Deepak, Prabhat, Dipendra, Haridwar for showing unfailing help

during my research work. I am grateful to the Recipharm Pharmaservices

drug Pvt. Ltd. for free gift sample of Montelukast Sodium and for providing

necessary facilities for carrying out accelerated stability

I am extremely gratified to my family members and relatives, whose

faith in me has always been the driving force throughout my learning

process. They never let my courage go down even in the hardship of my life

journey.

My profound admiration to my grandfather Shree Rowan dahait, my dad

Shree Ramnarayan Prasad dahait and my mom Smt. Urmila Devi for

unflinching care, encouragement and patience all these years.

I am equally grateful to my dearest brother Suman who have always

supported and energized me. I am also very much thanksful to my cousin

brother Keshraj, Saroj, Rajan, Rahul and lovely sisters Bijaylaxmi, sujita,

seema and kabina for their immense love, care and emotional support and

confidence that infused in me.

 Immense thanks and a big hug to all those gentle people associated

with this work directly or indirectly whose names I am unable to mention

here. I request to shower their blessings and love on me for my future

endeavors. Thanking one and all.

Date:
Place: Bangalore MANIS RAJ PRASAD DAHAIT
THARU
LIST OF ABBREVIATIONS USED

ABBREVIATIONS FULL FORMS

% Percentage
Abs. Absorbance
0
C Degree Celsius
% CDR Percentage cumulative drug release
Cm Centimeter
Cps Centipoise
RH Relative Humidity
Conc. Concentration
CRP Crosspovidone
DSC Diffrential Scanning Calorimetry
DT Disintegration time

ODT Oral dispersible tablet

FTIR Fourier transform infrared
GI Gastrointestinal
Gm Gram
IR Infrared
Mg Miligram
MCC Microcrystalline cellulose
Min Minutes
Ml Mililitre
Mm Milimole
RDT Rapid dissolving tablets
RPM Revolution per minute
SD Standard deviation
 Sec Second
SEM Scanning electron microscopy
SSG Sodium starch glycolate
UV Ultraviolet

Mm Millimetre
pH Negative logarithm of hydrogen ion concn.
pKa Dissociation constant
QC Quality control
RT Room temperature
q.s Quantity sufficient
t1/2 Half life
SD Standard deviation
TBD Tapped bulk density
R2 Regression Coefficient
TI Therapeutic Index
IP Indian Pharmacopeia
BP British Pharmacopeia
Vd Apparent volume of distribution
Wt Weight
L Litre
w/v Weight by volume
Λmax Absorption maxima
µg/ml Microgram per millilitre
 ABSTRACT

The purpose of this study was developed and evaluated Fast dissolving tablet of

Montelukast Sodium. It give's fast relief of Asthma in our body. The Fast dissolving

tablets were prepared by direct compression method and formulated using different

polymer combination, formulation such as (F1-F18). Various polymer like

crospovidone, Sodium starch glycolate, Guar gum, Gellan gum, Sterculia gum were

used. Formulation were subjected for precompression parameters like angle of

repose, bulk density, tapped density, carr’s index, Hausner’s ratio, and post

compression parameters like appearance, hardness, friability, disintegration,

uniformity of drug content, thickness, in-vitro drug release. All the granules of

formulation showed compliance with pharmacopoeial standards. Compatibility of the

drug with various excipients was studied by FTIR spectroscopy. FTIR concluded that

the drug maintains its identity without going any chemical interaction with polymers

used. The in-vitro drug release study revealed that formulation F9 combination of

both crospovidone and Gallen gum was the most successful formulation of the study

that disintegrate within 22 sec. and drug release within 10 minutes. Model equations

of zero order, first order, higuch and peppas intended to elucidate the drug release

mechanism and were fitted to release data. The best formulation (F9) follows the first

order kinetic which is concentration dependent.