Abstract
Purpose: To evaluate the super-disintegrant potentials of acid modified Borassus aethiopum starch (AMS) in comparison with native starch (NS) and commercial disintegrant sodium starch glycolate (SSG).
 Methods: Compatibility of AMS with paracetamol powder was evaluated using Fourier transform infrared (FTIR) spectrophotometry. Seven batches of paracetamol granules and tablets were prepared by wet granulation. AMS and NS were employed as disintegrants at concentrations of 2.43, 4.86 and 9.72 %w/w, respectively while 4.86 %w/w SSG was used as standard disintegrant. All the batches of the granules were compressed under the same compression settings. The properties of the granules as well as those of the tablets were assessed.
 Results: AMS was compatible with paracetamol powder as no noticeable interaction was observed in FTIR study. The paracetamol tablets formulated using AMS as disintegrant demonstrated satisfactory friability, weight uniformity, hardness, and superior disintegration characteristics to the formulations containing NS and SSG as disintegrant. Even at a lower concentration (2.43 %w/w), AMS possessed better disintegrant property than NS and SSG. AMS and NS had dimensionless disintegrant quantity of 1.447 and 0.005, respectively. As expected, increase in AMS concentration showed a decrease in disintegration time.
 Conclusion: AMS could be a potential low-cost super-disintegrant in formulation of paracetamol tablets.
 Keywords: Acid modified starch, Borassus aethiopum, Disintegrant, Compatibility
Highlights
Disintegrants are added to solid dosage formulations to promote the break-up of the compacted mass into smaller fragments increasing the available surface area and promoting a more rapid release of the active ingredient [1]
Fourier transform infrared (FTIR) spectrum of pure paracetamol displayed a characteristic vibrational broad peak at about 3336.68 cm−1 for O-H and that for CH3 stretching at 3151.34 cm-1
The disintegration time for tablets containing acid-modified starch (AMS) and native starch (NS) decreased as the concentration of disintegrant was increased and crushing strength varied with increase in the disintegrant concentration
Summary
Disintegrants are added to solid dosage formulations to promote the break-up of the compacted mass into smaller fragments increasing the available surface area and promoting a more rapid release of the active ingredient [1]. The physicochemical properties and microbiological quality of the Borassus aethiopum shoot acid-modified starch (AMS) were evaluated for its potential pharmaceutical applications. Pharmaceutical application of AMS as a pharmaceutical excipient has not been studied In this present study, AMS has been evaluated as super-disintegrant in paracetamol tablet formulations. Appropriate quantities of paracetamol, pregelatinised starch and test starch (intra-granular disintegrant) were loaded into a rapid mixer granulator (Lab/Betochem, Gujarat 393002, India) and mixed for 30 min. Test starch (extra-granular disintegrant) was mixed with the granules in a cage blender for 15 min before adding magnesium stearate. The post-compression studies were carried out for the seven batches of the paracetamol tablet formulations. The friability of tablets formulated with AMS and NS varied with increasing disintegrant concentration though there was significant variation (p < 0.05) compared to standard in both cases
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