EFFICACIOUS COMPARISON OF THE DUAL RELEASE OF
DEXLANSOPRAZOLE WITH THE SINGLE RELEASE OF ANOTHER
PROTON PUMP INHIBITORS IN PATIENTS WITH
GASTROESOPHAGEAL REFLUX DISEASE
A Dissertation submitted to
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY, HYDERABAD
In Partial Fulfillment of the Requirements for the Award of Degree
Master of Pharmacy
In
Pharmacy Practice
Submitted By
ZEENATH ANJUM
ROLL NO: 18171S1503
Under the Guidance of Under Co-Guidance of
Dr. SHIBNATH KAMILA, PhD Dr. NITESH PRATAP
PROF & HOD DNB (Medicine) (Gastroenterology)
Dept. of Pharmacy Practice Senior Consultant KIMS Hospital
Bharat Institute of Technology
DEPARTMENT OF HOSPITAL AND CLINICAL PHARMACY
BHARAT INSTITUTE OF TECHNOLOGY
MANGALPALLY, IBRAHIMPATNAM – 501510
2018-20
CERTIFICATE
This is to certify that the project work titled “EFFICACIOUS COMPARISON OF
THE DUAL RELEASE OF DEXLANSOPRAZOLE WITH THE SINGLE
RELEASE OF ANOTHER PROTON PUMP INHIBITORS IN PATIENTS
WITH GASTROESOPHAGEAL REFLUX DISEASE” submitted to Bharat
Institute of Technology, affiliated to Jawaharlal Nehru Technological University,
Hyderabad, as a course work for the award of the Master of Pharmacy has been
successfully carried out by ZEENATH ANJUM (18171S1503) during the academic
year 2018-2020, under the Guidance of Dr. SHIBNATH KAMILA, Ph.D., and
HOD for the Department of Pharmacy Practice in the Bharat Institute of Technology,
Mangalpally, Hyderabad.
Date:
Place: Hyderabad
Head of Department (HOD)
Bharat Institute of Technology,
Mangalpally, Ibrahimpatnam - 501510
.
CERTIFICATE
This is to certify that the project work titled “EFFICACIOUS COMPARISON OF
THE DUAL RELEASE OF DEXLANSOPRAZOLE WITH THE SINGLE
RELEASE OF ANOTHER PROTON PUMP INHIBITORS IN PATIENTS
WITH GASTROESOPHAGEAL REFLUX DISEASE” submitted to Bharat
Institute of Technology, affiliated to Jawaharlal Nehru Technological University,
Hyderabad, as a course work for the award of the Master of Pharmacy has been
successfully carried out by ZEENATH ANJUM (18171S1503) during the academic
year 2018-2020, under the Guidance of Dr. SHIBNATH KAMILA, Ph.D., and
HOD for the Department of Pharmacy Practice in the Bharat Institute of Technology,
Mangalpally, Hyderabad.
Date:
Place: Hyderabad
PRINCIPAL
Bharat Institute of Technology,
Mangalpally, Ibrahimpatnam - 501510
CERTIFICATE
This is to certify that the project work titled “EFFICACIOUS COMPARISON OF
THE DUAL RELEASE OF DEXLANSOPRAZOLE WITH THE SINGLE
RELEASE OF ANOTHER PROTON PUMP INHIBITORS IN PATIENTS
WITH GASTROESOPHAGEAL REFLUX DISEASE” submitted to Bharat
Institute of Technology, affiliated to Jawaharlal Nehru Technological University,
Hyderabad, as a course work for the award of the Master of Pharmacy has been
successfully carried out by ZEENATH ANJUM (18171S1503) during the academic
year 2018-2020, under My Supervision and Guidance.
Date:
Forwarded by:-
Place: Hyderabad
Dr. SHIBNATH KAMILA, PhD
HOD
Department of Pharmacy Practice
Bharat Institute of Technology
Mangalpally, Ibrahimpatnam - 501510
CERTIFICATE
This is to certify that the project work titled “EFFICACIOUS COMPARISON OF
THE DUAL RELEASE OF DEXLANSOPRAZOLE WITH THE SINGLE
RELEASE OF ANOTHER PROTON PUMP INHIBITORS IN PATIENTS
WITH GASTROESOPHAGEAL REFLUX DISEASE” submitted to Bharat
Institute of Technology, affiliated to Jawaharlal Nehru Technological University,
Hyderabad, as a course work for the award of the Master of Pharmacy has been
successfully carried out by ZEENATH ANJUM (18171S1503) during the academic
year 2018-2020, was evaluated on found to be Satisfactory..
Internal Examiner External Examiner
Date:
DECLARATION
I ZEENATH ANJUM student of Final Year Master of Pharmacy Reg. No.
18171S1503 hereby declare that the project work embodied in this report entitled
EFFICACIOUS COMPARISON OF THE DUAL RELEASE OF
DEXLANSOPRAZOLE WITH THE SINGLE RELEASE OF ANOTHER
PROTON PUMP INHIBITORS IN PATIENTS WITH
GASTROESOPHAGEAL REFLUX DISEASE" is original work carried out in the
Department of Hospital and Clinical Pharmacy, Bharat Institute of Technology
affiliated to Jawaharlal Nehru Technological University, Hyderabad. As a course
work for fulfilment of award of Master of Pharmacy under the supervision of
Dr. SHIBNATH KAMILA, Ph.D., Professor and HOD for Department of
Pharmacy Practice and has not been submitted before for the award of any Diploma
or Degree of this University or any other University.
Date: -
Name of the Candidate
ZEENATH ANJUM
(18171S1503)
ACKNOWLEDGMENT
1 am Firstly and heartfully thankful to the Almighty than to my parents and my family
members for their unstinting support in doing this dissertation work, which shall be
remembered forever.
I am also extremely grateful towards my Guide's Dr. SHIBNATH KAMILA PhD.,
Professor and HOD for the Department of Pharmacy Practice at Bharat Institute
of Technology for affectionate encouragement and moral support throughout the
course of this investigation along with that my Co-Guide Dr. NITESH PRATAP,
DNB (Medicine) (Gastroenterology) Senior Consultant KIMS Hospital, allowing me
and guiding me with all necessary knowledge essential for conducting ethically the
clinical trials and also, I take place pleasure to express my sincere thanks to all faculty
and the lab assistants who gave me immense support towards accomplishing my
Project.
ZEENATH ANJUM
(18171S1503)
LIST OF CONTENTS
S.NO CONTENTS PG.NO
01 ABSTRACT 1
02 INTRODUCTION 2
03 NEED OF THE STUDY 24
04 AIM AND OBJECTIVE OF 25
THE STUDY
05 DRUG PROFILE 26
06 LITERATURE REVIEW 32
07 METHODOLOGY 35
08 RESULTS AND 38
OBSERVATION
09 DISCUSSION 42
10 CONCLUSION 44
11 BIBLIOGRAPHY 45
12 ANNEXURES 48-61
ANNEXURE I
ANNEXURE – II
ANNEXURE – III
ANNEXURE - IV
LIST OF TABLES
S.NO Table name
01 Food that triggers GERD
02 Demographic data of patients participated in the
study for dexlansoprazole
03 Demographic data of patients participated in the
study for Esomeprazole
04 Age distribution in patients for dexlansoprazole
and Esomeprazole
05 Gender distribution in patients
06 Heartburn in patients treated with dexlansoprazole
07 Heartburn in patients treated with Esomeprazole
08 Severity of the disease for dexlansoprazole
09 Severity of the disease for Esomeprazole
10 Night time heartburn and other sleep disorders for
dexlansoprazole
11 Night time heartburn and other sleep disorders for
Esomeprazole
12 Quality of life for dexlansoprazole and
Esomeprazole
13 GERD questions
14 Symptoms
15 Nocturnal symptoms
16 Follow up
LIST OF FIGURES
S.NO FIGURE NAME
01 Healthy stomach and GERD
02 Relaxation of lower esophageal sphincter
03 Severity of acid reflux
04 Prevalence of GERD
05 Risk factors
06 Food that trigger reflux
07 Esophagitis
08 Barrett’s esophagus
09 Pathogenesis
10 Pathophysiology of GERD
11 GERD symptoms
12 PPIs trail
13 Upper GI endoscopy
14 Ph monitoring
15 Esophageal manometry
16 Dexlansoprazole
17 Esomeprazole
16 Demographic data of patients participated in the study for
dexlansoprazole and Esomeprazole
18 Gender participated in the study for dexlansoprazole and Esomeprazole
19 Age distribution in patients
20 Heartburn treated in patients with dexlansoprazole
21 Heartburn treated in patients with dexlansoprazole
22 Severity of disease treated with dexlansoprazole
23 Severity of disease treated with Esomeprazole
24 Night time heartburn and other sleep disorders treated with
dexlansoprazole
25 Night time heartburn and other sleep disorders treated with
Esomeprazole
26 Quality of life for the drug dexlansoprazole and Esomeprazole
ABBREVIATIONS
GERD- gastro esophageal reflux disease LES- lower esophageal sphincter
PPI- proton pump inhibitors
FDA- food and drug administration GIT- gastrointestinal tract
EGD- erosive reflux disease
HREPT- high resolution esophageal pressure topography EMD- esophageal motility
disorder
HRM- high resolution manometry EE- Erosive esophagitis
AUC- area under curve
H pylori- helicobacter pylori
NSAID- non steroidal anti-inflammatory drugs Dexlansoprazole MR-
dexlansoprazole modified release OPD- out patient department
DEDICATED TO MY BELOVED
PARENTS AND FRIENDS
ABSTRACT
AIM AND PLAN OF
WORK
DRUG PROFILE
LITERATURE REVIEW
DESIGN AND
METHODOLOGY
RESULTS AND
OBSERVATION
DISCUSSION
BIBLIOGRAPHY
