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Three formulations, each containing 200mg drug X were manufactured using a wet granulation technique employing different compression forces of the final tablet. Formulation A was compressed using a low compression force, formulation B was compressed using a moderate compression force and formulation C was compressed using a high compression force. The three batches were analysed for dissolution and hardness as outlined in Table 1 and 2 respectively. Interpret and explain the observations noted for the three formulations and how this will impact on oral bioavailability (1000 words). Table 1: Dissolution testing Formulation A Formulation B Formulation C Amount of drug released (mg) Amount of drug released (mg) Amount of drug released (mg) Time (min) Average SD Average SD Average SD 5 10 4 50 5 80 9 10 25 8 80 8 100 12 15 45 6 100 6 150 11 20 60 12 120 5 200 4 25 85 9 140 7 200 8 30 110 7 180 10 200 9 35 140 5 200 8 200 10 40 170 4 200 12 200 6 45 200 6 200 7 200 7 Table 2: Hardness testing Resistance to crushing (N) Batch Result 1 Result 2 Result 3 Formulation A 38 42 40 Formulation B 22 26 23 Formulation C 16 13 14

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Observation:
From the above dissolution profiles of three different formulations of same drug X, manufactured by wet granulation method and by applying different compression force, it was observed that the rate of release of drug from the tablet, significantly depends on the force applied for its compression.
In Formulation A, the amount of drug was released in an linear fashion i.e. 10, 25, 45, 60, 85, 110, 140, 170 and 200 mg with respect to time i.e. 5, 10, 15, 20, 25, 30, 35, 40 and 45 minutes, which is represented in graph-1 also.
In Formulation B, first 50 mg of drug was released within 5 minutes, then 80, 100, 120, 140, 180, 200 mg at time 10, 15, 20, 25, 30, 35 minutes respectively. At 35 minutes complete drug is released from the tablet in formulation B. This indicates that the release rate of drug in Formulation B did not follow linearity. This is because...
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