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“FORMULATION AND INVITRO EVALUATION OF
CONTROLLED RELEASE TABLETS OF MILNACIPRAN

HYDROCHLORIDE”
A Dissertation submitted to
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY

HYDERABAD
In the partial fulfillment of the requirements for the degree of
BACHELOR OF PHARMACY
By
AKHILESH KUMAR
15S81R0007
Under the Esteemed Guidance of

Mr R.Rajender, M.Pharm
Asst. Professor
JJ COLLEGE OF PHARMACY
Maheshwaram – R. R. Dist – 501 359
2020-2021
ENDORSEMENT BY THE
HOD/PRINCIPAL
This is to certify that this dissertation “FORMULATION AND INVITRO

EVALUATION OF CONTROLLED RELEASE TABLETS OF
MILNACIPRAN HYDROCHLORIDE”is a bonafide and genuine research
work carried out by the following students under the guidance of
Mr.R.Rajender M.Pharm Asst. Professor in the Department of Quality Assurance
And Pharma Regulatory Affairs JJ College of Pharmacy, Maheshwaram, Ranga
Reddy Dist.
AKHILESH KUMAR 15S81R0007
Seal and Sign of the Principal
Place: Maheshwaram
Date:
CERTIFICATE BY THE GUIDE
This is to certify that this dissertation entitled “FORMULATION AND
INVITRO EVALUATION OF CONTROLLED RELEASE TABLETS OF
MILNACIPRAN HYDROCHLORIDE”is a bonafied and genuine research
work carried out by the following students at Department of Quality Assurance
And Pharma Regulatory Affairs, JJ College of Pharmacy, Maheshwaram,
Ranga Reddy Dist in partial fulfilment of the requirement for the Degree of
Bachelor in Pharmacy
Place: Maheswharam Research Guide
Date: Mr.R.Rajender M.Pharm

Asst. Professor
DECLARATION BY THE CANDIDATE
This is to certify that this dissertation entitled “FORMULATION AND
INVITRO EVALUATION OF CONTROLLED RELEASE TABLETS OF
MILNACIPRAN HYDROCHLORIDE”is a bonafide and genuine research
work carried out by us under the guidance of Mr.R.Rajender M.Pharm Asst.
Professor in the Department of Quality Assurance And Pharma Regulatory
Affairs JJ College of Pharmacy, Maheshwaram, Ranga Reddy Dist.
Signature and Name of the Student
Date:

ACKNOWLEDGEMENT
Let me express my profound sense of gratitude and heartful thanks to my

esteemed research guide Mr.R.Rajender M.Pharm Asst. Professor in the
Department of Quality Assurance And Pharma Regulatory Affairs JJ College of
Pharmacy, Ranga Reddy Dist for her/his tolerance in every step, keen interest, regular
observations, kind cooperation, affectionate encouragement throughout this work has
brought up this dissertation entitling ““FORMULATION AND INVITRO
EVALUATION OF CONTROLLED RELEASE TABLETS OF MILNACIPRAN
HYDROCHLORIDE”
I express my hurtful thanks to Dr. N. SRINIVAS, Professor and Principal, JJ

College of Pharmacy, Ranga Reddy for his valuable suggestions and help during the
course of study.
I express my grateful thanks to Ms. P. S. SASIKIRAN, Chairperson, and

Mr. A. HARI KRISHNA, Director JJ College of Pharmacy, Ranga Reddy for their
support of my study, kind cooperation, tangible and always support throughout work,
have brought up the dissertation in this shape.
I express my sincere gratitude to all the faculty members and Non-teaching staff
for their support and encouragement.
I extend my thanks to S RAJINI, Sura Pharma Labs, Dilsukhnagar, Hyderabad

for their kind cooperation and help extended during my research work.
Date:
Place: Maheshwaram
AKHILESH KUMAR
TITLE
FORMULATION AND INVITRO

EVALUATION OF CONTROLLED
RELEASE TABLETS OF
MILNACIPRAN HYDROCHLORIDE
ABBREVIATIONS
Conc. = Concentration

C = Degree centigrade
% = Percentage
hrs = Hours
mg = Milligram
gm = Gram
µg/mL = Microgram per millileter
min = Minute
mL = Milliliter
mM = Millimolar
cm = Centimeter
mm = Millimeter
nm = Nanometer
rpm = Revolution per minute
Sec = Second
S.D = Standard deviation
R2 = Regression coefficient
n = Diffusion coefficient
pH = Negative logarithm of hydrogen ion concentration
USP = United States Pharmacopoeia
IP = Indian Pharmacopoeia
UV = Ultraviolet
F = Formulation
FTIR = Fourier transmission infrared spectroscopy
Fig = Figure
HPMC = Hydroxypropyl Methylcellulose
HPC = Hydroxypropyl Cellulose
HEC = Hydroxyethyl Cellulose
ABSTRACT
The present study involves in the formulation and evaluation of Controlled release tablets of
Milnacipran Hydrochloride (12.5mg). The objective of the present study was to formulate
Milnacipran Hydrochloride Controlled release tablets by Direct compression method by using
HPMC K 15M, HPC 2M and HEC 2M. Lactose was used as diluting agent, Magnesium stearate
was used as a lubricant and Aerosil was used as a glident. This Controlled release the drug up to
12 hours in predetermined rate. The formulated powder blend was evaluated for bulk density,
tapped density, compressibility index and angle of repose. The formulated tablets were evaluated
for physical characteristics of Controlled release tablets such as thickness, hardness, friability,
weight variation and drug content. The results of the formulations found to be within the limits
specified in official books. The tablets were evaluated for In-vitro drug release studies by using
USP type II dissolution test apparatus. The dissolution test was performed in 0.1 N HCL for 2 hr
and phosphate buffer pH 6.8 for 12hrs. The in-vitro cumulative drug release profile of all
formulations F1-F12 hours showed good drug release. Hence, Formulation F7 was the most
promising formulation as it gives satisfactory release (98.29 %) for 12 hours and F7 found to be
the best formulation.
KEYWORDS: Milnacipran Hydrochloride, HPMC K 15M, HPC 2M, HEC 2M and Controlled
release tablets.
MATERIALS
List of Materials Used
Name of the material Source
Procured From Torrent Pharmaceuticals, Bhatt,

Milnacipran Hydrochloride India. Provided by SURA LABS, Dilsukhnagar,
Hyderabad.
HPMC K 15M
Jaxani Pharma, (Ahmedabad), India
HPC 2M
Merck Specialities Pvt Ltd, Mumbai, India
HEC 2M Merck Specialities Pvt Ltd, Mumbai, India
Lactose
Loba Chemicals., Mumbai, India
Aerosil
Merck Specialities Pvt Ltd, Mumbai, India
Magnesium Stearate Merck Specialities Pvt Ltd, Mumbai, India

List of Equipment’s used
Name of the Equipment Manufacturer
Weighing Balance Sartourious
Tablet Compression Lab Press

Machine (Multistation) Limited, India.
Hardness tester Monsanto, Mumbai, India.
Vernier callipers Mitutoyo, Japan.
Roche Friabilator Labindia, Mumbai, India
DissolutionApparatus Labindia, Mumbai, India
UV-Visible
Labindia, Mumbai, India
Spectrophotometer
pH meter Labindia, Mumbai, India
FT-IR Spectrophotometer AGILENT

LIST OF CONTENTS
CHAPTER TITLE PAGE NO
1-15
1 INTRODUCTION
16-21
2 LITERATURE REVIEW
22
3 AIM & OBJECTIVE
23
4 PLAN OF WORK
24-28
5 DRUG PROFILE
29-40
6 EXCIPIENTS PROFILE
41-49
7 METHODOLOGY
50-63
8 RESULTS & DISCUSSION
64
9 CONCLUSION
REFERENCES 65-68

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“FORMULATION AND INVITRO EVALUATION OF

CONTROLLED RELEASE TABLETS OF MILNACIPRAN

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY

In the partial fulfillment of the requirements for the degree of

Under the Esteemed Guidance of

This is to certify that this dissertation “FORMULATION AND INVITRO

AKHILESH KUMAR 15S81R0007

Seal and Sign of the Principal

This is to certify that this dissertation entitled “FORMULATION AND

INVITRO EVALUATION OF CONTROLLED RELEASE TABLETS OF

MILNACIPRAN HYDROCHLORIDE”is a bonafied and genuine research

work carried out by the following students at Department of Quality Assurance

And Pharma Regulatory Affairs, JJ College of Pharmacy, Maheshwaram,

AKHILESH KUMAR 15S81R0007

Place: Maheswharam Research Guide

Date: Mr.R.Rajender M.Pharm

This is to certify that this dissertation entitled “FORMULATION AND

INVITRO EVALUATION OF CONTROLLED RELEASE TABLETS OF

MILNACIPRAN HYDROCHLORIDE”is a bonafide and genuine research

work carried out by us under the guidance of Mr.R.Rajender M.Pharm Asst.

Professor in the Department of Quality Assurance And Pharma Regulatory

Affairs JJ College of Pharmacy, Maheshwaram, Ranga Reddy Dist.

Signature and Name of the Student

AKHILESH KUMAR 15S81R0007

Let me express my profound sense of gratitude and heartful thanks to my

I express my hurtful thanks to Dr. N. SRINIVAS, Professor and Principal, JJ

I express my grateful thanks to Ms. P. S. SASIKIRAN, Chairperson, and

I extend my thanks to S RAJINI, Sura Pharma Labs, Dilsukhnagar, Hyderabad

FORMULATION AND INVITRO

List of Materials Used

Name of the material Source

Procured From Torrent Pharmaceuticals, Bhatt,

HEC 2M Merck Specialities Pvt Ltd, Mumbai, India

Magnesium Stearate Merck Specialities Pvt Ltd, Mumbai, India

Name of the Equipment Manufacturer

Weighing Balance Sartourious

Tablet Compression Lab Press

Hardness tester Monsanto, Mumbai, India.

Vernier callipers Mitutoyo, Japan.

Roche Friabilator Labindia, Mumbai, India

DissolutionApparatus Labindia, Mumbai, India

pH meter Labindia, Mumbai, India

FT-IR Spectrophotometer AGILENT

CHAPTER TITLE PAGE NO

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