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Enhancing tablet disintegration characteristics of a highly water-soluble high-drug-loading formulation by granulation process

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The aim of this investigation was to enhance the disintegration and dissolution characteristics of a highly water-soluble tablet matrix by modifying the manufacturing process. For a high drug loading (70% w/w) API formulated with a high-shear wet granulation (HSWG) process, a prolonged disintegration time, coupled with a substantial dependency on tablet hardness, was observed. Maintaining the formulation composition mostly constant, a fluid-bed granulation (FBG) process was explored as an alternative granulation method using a 2(4−1) fractional factorial design with two center points. Ten FBG batches were produced with variations in disintegrant amount, spray rate, inlet temperature (T), and atomization air pressure. The resultant final blend particle size was significantly influenced by spray rate (p = .0009), inlet T (p = .0062), atomization air pressure (p = .0134), and the interaction effect between inlet T and spray rate (p = .0241). Compactibility of the final blend was significantly affected by disintegrant amount (p < .0001), atomization air pressure (p = .0013), and spray rate (p = .05). It was observed that the fluid-bed batches exhibited significantly lower disintegration times than the HSWG batches, with mercury intrusion porosimetry data revealing that this was attributed to the higher internal pore structure of tablets manufactured using the FBG batches.
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