ABSTRACT
The aim of this research was to study the tableting properties of Solenostemon rotundifolius starch (SRS) and modified forms for use as pharmaceutical excipient by wet granulation method of tablet production in paracetamol formulation. The physicochemical properties of native and modified starches were investigated and compared with Maize starch B.P. (MZS). Properties of granules and tablets formulated with various experimental starches and gelatin (GLT) tested as binders and disintegrants at varying concentrations of 2.5-12.5%w/w were also investigated. In order to characterize the mode of deformation of the experimental starches the compaction studies were carried out using Heckel plots and the tensile strength evaluated. The dry and wet weights of starch extracted by standard method of extraction were 9.02%w/w and 18.37%w/w respectively. Pregelatinisation produced 96.23%w/w with water (PGSW) and 57.45%w/w when precipitated with ethanol (PGSA). The pregelatinised starches exhibited better flow properties and swelling capacity than MZS and SRS. Granule properties such as angle of repose, Hausner’s ratio and Carr’s index revealed that increase in concentration of materials tested as binder and disintegrant led to improvement in flow characteristics. Tablet properties which included friability, crushing strength and disintegration time showed that an increase in binder concentration in the tablet led to a decrease in friability and an increase in crushing strength and disintegration time while increase in disintegrant concentration produced the opposite effect. The drug release for all the batches both as binder and disintegrant were below - 9 - 50%. 500 mg compacts of experimental starches made using a hydraulic press at various tableting pressures (56.6-169.9MNm-2 ) and investigated for deformation characteristics and tensile strength had the ranking order for mean yield pressure, PY as PGSA>MZS>GLT>SRS>PGSW; total plastic deformation, DA, as SRS
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CHAPTER ONE
INTRODUCTION
1.1
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