Comparative Evaluation Of The Disintegrant Properties Of Some Pre-Gelatinied Starches In The Formulation Of Paracetamol Tablets
Loading...
Date
2023-10
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Kampala International University
Abstract
This study evaluated the tableting and release characteristics of paracetamol tablets prepared with three pregelatinised starches as disintegrants. The results obtained were compared with pharmacopoeial specification. Starches currently used are largely imported into the country, despite its widespread value and ideal properties as a pharmaceutical excipient, such as being pharmacologically inert, physically and chemically stable, native starch has limitations in pharmaceutical application, hence native starch must be pregelatinised to improve its release characteristics, lowering the high cost of importing excipients and the final cost of drugs. Starches from edible Musa paradisiaca(Entaragaza), millet cereals (tansakila), and rice cereals (supper) were extracted, pregelatinised and characterized with pharmacopoeialspecifications. Their percentage yield, solubility, pH., iron content, moisture content and sulphated ash values were determined and all the pregelatinised starch characteristics were within the pharmacopoeial specification. The pregelatinised starches were used as a disintegrant at concentrations (7.5and 10% w/w) per tablet in the formulation. The granules were compressed to tablets. The tablets diameter was 12.6 ± 0.4 mm and thickness 4.4 ± 0.02 mm. The tablets’ average weight, friability hardness, disintegration time (DT) and dissolution profiles were determined. The results showed that there was no statistically significant difference in the physicochemical characteristics of the tablets whose granules were prepared with the 3 pregelatinised test starches and those prepared with the standard maize starch BP (p > 0.05). Tablet disintegration time decreased with increase in the disintegrant concentration but was more marked with tablets produced with pregelatinised rice starch. All the tablets released between 96.4 - 100% of the drug in 45 min. Although drug release was influenced by increase in disintegrant concentration, the release rate was not significantly affected by the types of pregelatinised starch under investigation. The results permit the conclusion that the three (3) pregelatinised starches could be substituted for maize starch BP as disintegrants in the preparation of paracetamol tablets when faster disintegration is desired. FTIR spectrum also revealed peaks which were characteristic and identical to paracetamolindicating no interaction between the drug and pregelatinised starches.