Evaluation of Cocoa- Butter as a Lubricant in a Paracetamol Tablet Formulation

Adeagbo, Adebolu Adewole (2015-03-18)

Thesis

This study determined the optimum concentration of cocoa-butter obtained from Theobroma cacao L. to be used as an additional lubricant in a lubricant mix. It also determined the effect of changes in concentration of combined lubricant mix on some granule and tablet properties. This was with a view to developing a co-processed lubricant that would not have a negative impact on the flow of granules prepared, crushing strength and disintegration time of tablets produced. Assessment of the granules and tablets were done using compressional characteristics, mechanical properties, and disintegration time properties. Compressional characteristics were analysed using density measurements and the compression equations of Heckel and Kawakita, the mechanical properties of the tablets were assessed using the tensile strength (T) and brittle fracture index (BFI) tests, while the disintegrant time properties were quantified by the disintegration time test and crushing strength friability disintegration time ratio (CSFR/DT). Statistical analysis was done to compare the effects of cocoa-butter treated magnesium stearate plus talc and magnesium stearate plus talc on the tablet properties using the t-test with a 5 % level of significance. Addition of cocoa-butter to magnesium stearate plus talc had no significant effect on densification of the granules during die filling and at low pressures (t = 0.56, p < 0.05). However, cocoa-butter treated magnesium stearate plus talc exhibited a relatively slower onset of plastic deformation and lower amount of deformation under compression pressure in comparison with that of magnesium stearate plus talc (t = 1.43, p < 0.05) . The tensile strength (T) values for all the compacts increased with increased lubricant concentration, while the values of BFI decreased particularly with tablets containing cocoa-butter treated magnesium stearate plus talc. The T and BFI values for tablets containing cocoa-butter treated magnesium stearate plus talc were significantly lower than those for tablets containing magnesium stearate plus talc (t = 2.18, p > 0.05). Tablets containing cocoa-butter treated magnesium stearate plus talc had significantly longer disintegration times than those containing magnesium stearate plus talc (t = 4.11, p > 0.05). The crushing – strength and disintegration times of the tablets, increased with increased lubricant concentration while their friability decreased. The values of CSFR/DT for tablets containing cocoa-butter treated magnesium stearate plus talc were significantly lower than those for tablets containing magnesium stearate plus talc (t = 3.25, p < 0.05). The work concluded that the activity of cocoa-butter treated magnesium stearate plus talc was concentration dependent and that addition of cocoa-butter to magnesium stearate plus talc reduced the tensile strength of the paracetamol tablets.

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