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sodium (Ac-Di-Sol), polyplasdone R-XL and sodium starch glycolate (SSG). The formulated tablets were evaluated for crushing strength, friability, thickness, diameter, weight variation, drug content, wetting time, water absorption ratio,
disintegration time, and percentage of drug release. All formulations showed satisfactory result. Among them formulation F3 containing 3% of Ac-Di-Sol exhibited complete release within 12 minutes and disintegration time was within 10 seconds. Dissolution data was compared with innovator for similarity factor (f2) exhibited an acceptable value >50 (82). Accelerated stability study indicated no significant difference in assay and crushing strength. Hence, three production validation scale batches were designed based on lab scale best batch (F3) and charged for stability. All parameters were within the limit of acceptance. There was no chemical interaction between the drug and excipients during FT-IR study;
considered in the present investigation.
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