COMPARATIVE ANALYSIS OF THE PHYSICOCHEMICAL AND RELEASE PROPERTIES OF AMOXICILLIN TRIHYDRATE TABLETS FORMULATED WITH DIFFERENT TYPES OF BINDERS

ABSTRACT

The aim of this research is to compare the physicochemical and release properties of amoxicillin trihydrate tablets 500mg using different binder (Peptin powder B.P, Microcrystalline cellulose and Corn starch mucilage at different concentration of 5%, 7.5%, 10% and 12.5%) to evaluate the hardness, thickness, tensile strength, weight uniformity, friability, disintegration time, dissolution rate/absorbance, moisture content and FTIR . It was revealed from the result of the study that the angle of repose varied from 30.2 ±2.96 to 27.2 ±1.2. This shows that the granules had good flow property as they were below 30o which indicates the granules is free flowing. The bulk density was found to be in the range of 0.56 ±0.05 to 0.54 ±0.056. As the granule size increases, bulk density decreases. The tapped density range from 0.65 ±0.06 to 0.65 ±0.06 while compressibility index was between 17.41 ±12.6 to 8.92 ±3.61. This was less than 10% indicated in the British Pharmacopeia from excellent flow character. This indicates that the granules had excellent flow character. The Housners ratio ranged from 0.825 ±0.09 to 0.92 ±0.035 for the different batches. The batches within 1.00 – 1.11 range had excellent flow character while the batches within the range of 0.83-0.825 had good flow character but not as the other batches. The physiochemical evaluations of the amoxicillin granules showed good flow character. All the sample passes friability test with range of 1.0 above except for two sample (corn starch mucilage 5%w/w and 5% microcrystalline cellulose that fall below 1.0%). Uniformity in tablet diameter depends on diameter of the punch use for the compression process the standard deviation permitted is ±5% of the mean diameter (British Pharmacopoeia). To this regard all the tablet passed the test by corresponding to stated standard with the range of 0.57g-0.58g. The standard binder efficiency is <30% to achieve good granule friability, however, the results for all sample shows below 30% this indicate good binding potential in pharmaceutical formulations. For hardness test, they was an increase in values as the concentration increases with the range (CSM 3.96 – 5.5, PTN 2.67 to 4.0 and MCC 3.9 to 4.9) kg respectively. Tensile strength of all the samples possess greater than 1.7 MPa with the range (CSM 4.2-4.8, PTN 2.8-4.2 and MCC 4.1-5.1)N/mm2. Disintegration time, most of the sample where dissolved upon exposure to fluids ranges between 1.3-8.6 min with most of the sample within the standard range of disintegration time. For moisture contents, the standard moisture content of drug according to the USP monograph specification limit is not more than 7%. The result on all samples shown that the range is within the specified value. The results of dissolution studies indicated that the formulations CSM (5%, 7.5%, 10% and 12.5%) PTN (5%, 7.5%, 10% and 12.5%) and MCC (5%, 7.5%, 10% and 12.5%), were successful and exhibited drug release pattern according to Pharmacopeia standard of <60min drug release profile and the drug release was found to be better. The above study demonstrated that optimized concentrations of binders and excipients ratios could be successfully employed for formulating amoxicillin trihydrate 500mg tablet. Hence it can be concluded that the above formulation of the amoxicillin trihydrate tablet shows a better drug release, disintegration time and friability on all the samples.

Keywords: Cornstarch mucilage, pectin B.P, microcrystalline cellulose, amoxicillin tryhidrate, tablet and granules.

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