PROJECT REPORT

IN THE PARTIAL FULFILLMENT OF THE REQUIREMENT OF THE DEGREE OF

BACHELOR OF PHARMACY ON

FORMULATION AND EVALUTION

OF

DICLOFENAC SODIUM MICROBEADS BY EXTRUSION TECHNIQUE

by

AISHWARYA TYAGI
Under the guidance of :-

MR. GURUSHARAN, M.PHARM. (Ph.D), PGDPRA

DEPARTMENT OF PHARMACEUTICS

IIMT COLLEGE OF MEDICAL SCIENCES

MEERUT 250001
UTTAR PRADESH, INDIA JUNE 2013

ENDORSEMENT BY THE DIRECTOR OF INSTITUTION

This is to certify that the project report entitled Formulation and Evaluation of Diclofenac Sodium Microbeads by Extrusion Method is bonafide and genuine research work done by Ms.AishwaryaTyagiunder the guidance of Mr. Guru sharan, Asst. Prof., Dept. of Pharmacy, IIMT College of Medical Sciences, Meerut.

Date: Place:- Meerut

Prof . (Dr.) T. S. EASWARI M.Pharm, Ph.D, MBA Director

ENDORSEMENT BY THE HOD OF INSTITUTION

This is to certify that the dissertation/ thesis entitled Formulation and Evaluation of Diclofenac Sodium Microbeads by Extrusion Method is bonafide and genuine research work done by Ms.AishwaryaTyagiunder the guidance of Mr. Guru Sharan, Asst. Prof., Dept. of Pharmacy, IIMT College of Medical Sciences, Meerut.

Date: Place:- Meerut

Dr.Mr.Vikesh Kumar Shukla

M.Pharm, Ph.D, PGDPRA ASSISTANT DIRECTOR

CERTIFICATE BY THE GUIDE

This is to certify that the dissertation/thsesis entitled FORMULATION AND EVALUATION OF DICLOFENAC SODIUM MICROBEADS BY EXTRUSION METHOD submitted inpartial fulfilment of requirement for the degree of Bachelor of Pharmacy. IIMT College of Medical Science Meerut is bonafideand genuine research work done by AishwaryaTyagiunder the guidance and supervision of Mr. Guru Sharan, Asst. Prof., department of Pharmaceutics during the academic session 2012-13.

Date: Place:- Meerut

MR. GURUSHARAN M.Pharm, (Ph.D), PGDPRA Assistant Professor

ACKNOWLEDGEMENT
Words are very poor comforters to express the deep debt of gratitude which one feels in ones corner of the heart when one is helped to achieve the ultimate goal, in the

boundless and the endless field of research work . I wish to take this opportunity to thank the following who have assisted with the completion of this project: I extend my sincere thanks to our Chairman Mr.Yogesh Mohan Gupta, IIMT College of Medical Sciences, in acknowledging all the facilities provided to us at institution and ambling to do a work of this magnitude. It is my honour to thank Prof. (Dr.) T.S. EASWARI, Director, IIMT College of Medical Sciences, Ganga Nagar, Meerut, who is committed in providing the highest professional and ethical standards of pharmacy to consummate this thesis. I take this opportunity to express deep senses of my gratitude to my guide Mr.GuruSharan ,Asst. Prof., Department of Pharmacy,Mr.Umesh Kumar and Mr.VivekVerma, Asst. Prof., Department of Pharmacy, IIMT College of Medical Sciences, Meerut, for his guidance, valuable suggestion, help and encouragement to materialize the work . I also thank to my friends HimaniTyagiand RaginiJaiswalfor their valuable suggestion, timely support and mental support. Lastly I would like to salute the lady power behind the screen, my parents due to whom I feel the real meaning of life and work , the silent encouragement and great deal patience of my remaining family members are precious in this reward devoid of which the thesis could not have seen the light of day.

Place: Date:

Meerut

AISHWARYA TYAGI

DEDICATED TO MY BELOVED PARENTS

CONTENTS
CHAPTER 1 TOPIC INTRODUCTION DRUG RELEASE MECHANISM & KINETICS INTRODUCTION TO DRUG DELIVERY SYSTEM INTRODUCTION OFCONTROL DRUG DELIVERY SYSTEM TYPES OF CDDS LIMITS AND ADVANTAGES OF CDDS GOALS OF MORE SOPHISTICATED DRUG DELIVERY TECHNIQUE INTRODUCTION OF MICROBEADS CDDS DRUG DELIVERY SYSTEM COMPOSITION OF SYSTEM PAGE NO. 1-11

2 3

LITERATURE REVIEW DRUG PROFILE INTRODUCTION PHARMACOLOGY CHEMISTRY SYNTHESIS

12-15 16-22

MATERIALS AND METHODS MATERIALS WHICH ARE USED LIST OF EQUIPMENTS USED FOR THE PRESENT STUDY METHODS APPLIED FOR FORMULATION AND EVALUATION RESULT REFERENCES RESULT AND DISCUSSIONS CONCLUSIONS REFERENCE

23-31

5 6 7

32-37 38 39-40

Abstract
In this research work, we are formulating a batch of microbeads using Diclofenac sodium which is used as an NSAIDs in the treatment of fewer primary dysmenorrheas, Arthritis, analgesic, inflammation and pain.Extrusion-spheronization is an established technique for the production of pellets for pharmaceutical applications. In this study, the feasibility and influence of the incorporation of acacia, by itself and in combination with tragacanth, on the ability of formulations containing 2 model of drugs Diclofenace sodium to form spherical pellets by extrusion-spheronization was investigated. Material and Methods: Formulations containing different ratios of acacia and tragacanth (8:2, 9:1, and 10:0) and different drug concentrations (20%, 40%, and 60%) were prepared. Extrusion-spheronization is an established technique for the production of pellets for pharmaceutical applications. In this study, the feasibility and influence of the incorporation of acacia, by itself and in combination with tragacanth, on the ability of formulations containing 2 model of drugs diclofenac to form spherical pellets by extrusion-spheronization was investigated Formulations containing different ratios of acacia and tragacanth (8:2, 9:1, and 10:0) and different drug concentrations (20%, 40%, and 60%) were prepared, on the basis of a 32 full factorial design. Pellet properties, such as aspect ratio, sphericity (image analysis), crushing strength and elastic modulus (mechanical tests), mean dissolution time, and dissolution profiles were evaluated. The effect of particular factors on responses was determined by linear regression analysis.

Results: The sphericity, drug release rate, and the mechanical properties of the pellets were affected by the amounts and types of the drugs, and the ratio of the gums. Acacia, relative to tragacanth, produced pellets with higher mechanical strength and a faster drug release rate. Addition of small amounts of tragacanth to ibuprofen formulations resulted in matrix pellets with slow drug release.

Conclusion: The results showed that acacia and tragacanth can be used successfully as 2 natural binders in the pellet formulations.

Keywords:

Diclofenac

sodium;

microbeads,

Sodium

alginate,

calcium

chloride,

Superdisintegrants(HPMC); Direct high pressure extrusion method ,Natural gums, Extrusionspheronization, Pelletization

CHAPTER 1

INTRODUCTION

CHAPTER 2

LITERATURE REVIEW

CHAPTER 3

DRUG AND POLYMER PROFILE

CHAPTER 4

MATERIALS AND METHODS

CHAPTER 5

RESULTS & DISCUSSIONS

CHAPTER 6

CONCLUSION