“FORMULATION DEVELOPMENT, STATISTICAL OPTIMIZATION

AND EVALUATION OF EXTENDED RELEASE TABLET FOR

ANTIDEPRESSANTDRUG”M. Pharm Project

(Pharmaceutics)SUBMITTED

BY UDIT MISHRAM.PHARM. III

SEM

SUBMITTED TONAVEEN SINGHALAssistant Professor

SANJEEVAN COLLEGE OF PHARMACY, DAUSA

(Raj.)

CHAPTER NUMBER

CHAPTER NAME

1 INTRODUCTION

2 LITERATURE SURVEY

3 RESEARCH ENVISAGED

4 EXPERIMENTAL WORK

“CONTENTS OF PROJECT”

INTRODUCTION1. Extended Release Tablet – These are the tablets which release the medicament for prolonged period of time , These are the type of Novel Drug Delivery System.

2. Antidepressant Drugs – These are the drugs used in treatment of CNS Depression, Like : Guilt, Nervousness, Suicidal Tendency, Insomnia, Anorexia and Loss of pleasure.

LITERATURE SURVEY ADVANTAGES OF EXTENDED RELEASE DRUG DELIVERY SYSTEM

The frequency of drug administration is reduced, so patient compliance can be improved.The blood level oscillation characteristics of multiple dosing of conventional dosage form is reduced.Total amount of drug administered can be reduced.better control of drug absorption. The safety margin of high potency drug can be increased.

LIMITATIONS OF EXTENDED RELEASE DRUG DELIVERY SYSTEM

Administration of Extended release medication produce toxic effects. The physician has less flexibility in adjusting dosage regimen. Extended release forms are designed for some special cases. Extended release drug delivery system is very costly. Low physical stability of dosage form. Insoluble, erodible material cannot be readily processed to form tablet easily.

“Schematic drawing of plasma concentration-versus-time profiles following administration of three

immediate-release dosage forms versus one single sustainrelease dosage form.”

MATRIX SYSTEM

Matrix System used in extent release dosage form to controll the release of medicaments in desire manner.

TYPE OF MATRIX SYSTEM

Hydrophobic Polymers:

Digestible base (fatty compounds) : Glycerides , Glyceryltristearate, Fatty alcohols,Fatty acids, Waxes : carnauba waxNondigestible base (insoluble plastics) : Methylacrylate , Methylmethacrylate,Polyvinyl chloride, Polyethylene, Ethyl cellulose

Hydrophilic polymers:

Hydroxypropyl methyl cellulose, Sodium alginate, Xanthan gum, Polyethyleneoxide, Carbopols.

ADVANTAGES OF MATRIX SYSTEM

Easy to manufacture, Versatile, effective, low cost.Can be made to release high molecular weight compounds.Since the drug is dispersed in the matrix system, accidental leakage of the total drug component is likely to occur, although occasionally, cracking of the matrix material can cause unwanted release.DISADVANTAGES OF MATRIX SYSTEM

The remaining matrix must be removed after the drug has been released. The drug release rates vary with the square root of time. Release ratecontinuously diminishes due to an increase in diffusional resistance and/or adecrease in effective area at the diffusion front However, a substantial sustained effect can be produced through the use of very slow release rates, which in many applications are indistinguishable from zero-order One of the least complicated approaches to the manufacture of extended release dosage form involves the direct compression of blend of drug, retardant material, and additives to form a tablet in which drug is embedded in a matrix core of retardant. Alternatively, retardant drug blend may be granulated prior to compression.

LITERATURE REVIEW

Deore et al : prepare oral sustained release matrix tablets of a highly water soluble drug, tramadol hydrochloride, and evaluate the effect of concentration of the hydrophobic polymer content and method of preparation on drug release.Swati Jagdale et al : illustrated the effect of wax concentration on the release profile ofDiclofenac sodium & Theophylline sustained release fatty matrix tablet using meltgranulation technique.Uhumwangho et al : illustrated the effect of melt granulation on the release profiles of the drug particles and Effect of incorporation of hydrophobic agents on the drug release profiles of the melt granules.

Di Colo et al : formulated Metformin hydrochloride as a hydrophobic matrix sustainedrelease tablet employing wax materials and the sustained release behavior of the fabricated tablet was investigated.Shende M. A. et al : investigate the sustained release behavior of the wax matrix tablets. Matrices were prepared by melt granulation technique using carnauba wax as a release retardant.

Uhumwangho et al and Okor et al : carried out the study to investigate the releaseprofile of matrix (non-disintegrating) granules consisting of paracetamol (drug) andacrylatemethacrylate copolymer, a matrix forming material.Shende M. A. et al : investigate the sustained release behavior of the wax matrix tablets. Matrices were prepared by melt granulation technique using carnauba wax as a release retardant.

Wadher et al. : designed to develop the oral sustained release Metformin hydrochloridetablet formulation using lipophilic waxes viz. hydrogenated castor oil, stearic acid andglyceryl monostearate either alone or their combinations.Nitin Sharma et al : developed the once a day dose of dexromethorphan HBr with nonswellable waxy polymer Compritol888 by dry granulation method.Rakesh patel et al : prepared sustained release matrix tablet of Theophylline. Differentgrades of Hydroxypropyl methyl cellulose were evaluated for gel forming properties.Yorinobu Yonezawa et al : worked on Generalization of the release process through the wax matrix layer was examined by use of a reservoir device tablet.