Evaluation And Compaction Studies On Binding Properties Of Enzymes Hydrolyzed Cassava Starch Using Chloroquine Tablet Formulation

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ABSTRACT

Microcrystalline starch (MCS) was produced from Native cassava starch (NCS) using enzymatic hydrolysis method with α – amylase as the enzyme. After the hydrolysis, the percentage yield of MCS was found to be 85 % w/w.

The physicochemical characterization for NCS and MCS was conducted using various standard methods. Examples of the tests carried out are; flow rate, angle of repose, mean particle size, moisture content, Carr’s index, Hausner ratio, ash content, swelling power, pH, ash content, bulk and tapped densities, etc. the mean particle size was found to be less than 12 µm for both starches.

Angle of repose and flow rate were used to determine thee flow properties of the materials while Carr’s index and Hausner ratio were used to evaluate starch compressibility. The results obtained showed that NCS have poor flow properties compare to MCS.

Compaction studies were carried out using Heckel and Kawakita plots to characterize the mode of deformation of the materials. The Kawakita plots indicate that a linear relationship exists hence both materials consolidate mainly by plastic deformation.

Chloroquine tablets were formulated by wet granulation method and direct compression using MCS.PVP, MS and NCS as binders at different concentrations of 2.5 %w/v, 5 % w/w, 7.5 %w/w and 10 %w/w. the tablet characteristics obtained was evaluated in comparison to that of PVP. This is a standard.

The mechanical properties of crushing strength and friability for MCS were comparable to those of PVP. The crushing strength increased with increase in binder concentration while friability decreases, the disintegration time also increases with increase in binder concentration. The disintegration and dissolution profile was much faster for MCS tablets when compared to that of PVP.

Using the direct compression method, crushing strength increases with increase in  binary mixture of MCC and the friability increases with increase in the proportion of MCS. The DT was above 60 min., the tablet continued to swell, absorbing more water without disintegrating for the period of the research.

MCS and NCS are starches that could be used as pharmaceutical excipients using wet granulation method to produce the tablets. 

TABLE OF CONTENTS

Title Page

Declaration

Certification

Dedication

Acknowledgement

Abstract

Table of Contents

List of Tables

List of Figures

List of Plates

List of appendices

Abbreviations, Definations, Glossaries and symbols

1.0 INTRODUCTION

1.1 Pharmaceutical Tablets

1.2 Stability of Solid Dosage Forms

1.3 Drug release from solid dosage form

1.4  Tablet Manufacturing

1.5 Dosage compliance

1.6 Mechanical strength of tablets

1.6.1 Properties of an ideal tablet

1.6.2 Types of tablet

1.6.3 Various types of tablets

1.6.4 Oral tablets for ingestion

1.6.5 Tablets used in oral cavity

1.6.6 |Tablets administered by other routes

1.6.7 Advantages of tablets

1.6.8 Disadvantages of tablets

1.7 Pharmaceutical Excipients

1.7.1 Disintegrating agent

1.7.2 Glidant, antiadherent lubricant

1.7.3 Colouring and flavouring agents

1.7.4Fillers/Dilutes

1.7.5 Pharmacentical binders

1.8 Volume reduction in pharmaceutical powders

1.9 The Heckel equation

1.10 The Kawakita equation

1.11 Fundamental aspects of the compaction of powders

1.11.1 Bonding in tablets

1.12 Compaction

1.13 factors affecting dry release from tablets

1.13.1 Wetting

1.13.2 Water penetration

1.13.3 Disintegration

1.14  Dissolution

1.15  Interfacial reaction

1.16 Enzyme Hydrolysis

1.17 Enzyme Hydrolyzed Starch

1.19 Statement of research problem

1.20 Aims

1.21 Objectives

1.21 Scope of work

1.22 Justification for the study

2.0 LITERATURE REVIEW

2.1 Starch

2.2 Morphology

2.3 Gelatinization

2.4 Varieties and properties of starch granules

2.5 Starch modification

2.5.1Acid hydrolysis

2.5.2Cross- linking

2.5.3Stabilization

2.5.4Enzyme hydrolysis

2.5.5Progelatization

2.5.6Annealing

2.6 Recent studies on modified starches

2.7 Chloroquine phosphate tablets

2.8 Granulation

2.9 Wet granulation

2.9.1Important steps involved in the wet granulation

2.9.2Limitation of wet granulation

2.10Special wet granulation techniques

2.10.1 High shear mixture granulation

2.10.1.1Advantages

2.10.2Fluid bed granulation

2.10.3Extrusion and spheronization

2.10.3.1Advantages

2.10.4Spray drying granulation

2.10.4.1Advantages

2.11Dry granulation

2.11.1Advantages

2.11.2Disadvantages

2.12Steps in dry granulation

2.13Two main dry granulation processes

2.13.1Slugging process

2.13.1.1Factors which determine how well a material may slug

2.13.2Roller compaction

2.14Formulation for dry granulation

2.15Advancement in granulation

2.16Direct compression

2.17Manufacturing steps for direct compression

2.18Direct compression Excipients

2.18.1Merits

2.19Merits over wet granulation process

2.19.1Demerits

2.19.1.1Excipients Related

2.19.1.2Process Related

2.20Major Excipients required in direct compression

2.21Tablet compression

2.22Compressional characteristics of granules

2.23Tablet properties

2.24Tabletting machines

2.25Modifications of tableting machines

2.25Compaction simulations

2.25.2The load frame

2.26The hydraulic power pack

2.27The control unit

3.0 Material and Method

3.1 Materials

3.1.1Chemicals and reagents

3.1.2Apparatus

3.1.3Equipment

3.2 Methods

3.2.1Collection and identification of cassava tuber

3.2.1.1Extraction of cassava starch

3.2.1.2Preparation of microcrystalline starch

3.3 Physicochemical tests on the starch

3.3.1Organoleptic properties

3.3.2Test for starch

3.3.3Ash Content

3.3.4PH determination

3.3.5Solubility

3.3.6Microscopy

3.3.7Percentage moisture loss

3.3.8Bulk and tapped densities

3.3.9Moisture sorption capacity

3.3.10Particle density

3.3.11Powder porosity

3.3.12swelling power

3.3.13Hydration capacity

3.4 Compaction studies

3.5 Preparation of granules

3.6 Physicochemical tests on granules

3.6.1Bulk and tapped densities

3.7 Particle size analysis

3.8  Determination of flow rate

3.9  Determination of angle of repose

3.10           Formulation studies

3.11     Evaluation of formulated tablets

3.11.1  Uniformity of weight

3.11.2  Diameter measurement

3.11.3  Thickness and porosity

3.11.4  Crushing strength

3.11.5  Friability test

3.11.6  Density of Tablet

3.11.7  Disintegration studies

3.12     Dissolution studies

4.0RESULT

4.1      Preliminary investigation

4.2      Physiochemical properties

4.3      Microscopy

4.4      Dilution potential

4.5    Particle size analysis

4.6      Physical properties of chloroquine granules

4.7      Compaction studies of NCS and MCS

4.8      Evaluation of tablet properties

4.9      Dissolution studies

4.10  Evaluation of tableting properties of direct compression

5.0    Discussion

5.1    Preliminary Investigation

5.2    Physicochemical properties of NCS and MCS

5.3    Physicochemical properties of Granules

5.4    Evaluation of tabletting properties of tablets produced by wet  granulation

5.5    Evaluation of tabletting properties of tablets produced by wet  granulation

5.6 Compaction studies

6.0 SUMMARY AND CONCLUSION

6.1 SUMMARY

6.2 CONCLUSION

6.3 Recommendation

Reference

Appendix

INTRODUCTION

1.1 Pharmaceutical Tablets

Solid formulations are the preparation of pharmaceutical products in their dried, powdered or solid state and these include powders, capsules, granules and tablets. Dosage forms are designed to provide the drug in a suitable form for absorption from each selected route of administration.

Oral administration of drugs is considered to be the most frequently used route, simple, convenient and safe. Over 80 % of the drugs formulated to produce systemic effects in the world are produced as oral dosage forms (Rudnic and Kottke, 1999).

Oral tablet was introduced as early as 1843 by an Englishman Brockedon, who invented the first hand-operated device for compressed pills. These pills, powders, capsules which were made by hand were available for a long time before the development of the modern pharmaceutical industry and effective production methods.

 

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