Abstract

DESIGN AND OPTIMIZATION OF PROCESS PARAMETERS OF ROLLER COMPACTION PROCESS FOR ROZUVASTATIN TABLETS

Vikash Jakhmola*, Sujeet Kumar, Praveen Kumar Ashok, Pranshu Tangri

Abstract

Roll compaction is a unit process in the dry compaction process; a force enhances a mass procedure in which granules are ready with suitable flowability, granulation properties, chemical stability and uniformity especially for heat sensitive and moisture formulations. Throughout the roll compaction process, the active ingredient and excipients of the dry powders, example lubricants, diluents, binders and disintegrants are mixed in the blender. The mixtures of powder are then roller granulated and reduces the size to make granules. The resultant granules are blended with lubricated and compressed into a tablet form. The current work was undertaken to prepare a stable and robust dosage form by optimizing the process parameters of roll-compaction. In roller compaction powder blend is first passed through feeding sector, then densified powder go through compaction sector between two counter rotary rolls and sheets are formed. Granules are passed through a suitable sieve and oversize & undersize granules are separated. New compaction cycle is performed if the suitable ratios of oversize and undersize granules are not achieved. Then these granules are blended and extragarnular substance is blended with previous blend. Blend is then subjected to compression for tablet preparation. Sheets are evaluated for their breaking force by using Universal Force Tester® FMT 310. A sheet piece of 10 x 10 mm was placed in the test plate and the upper stamp was driven down towards the sheet with 10 mm/min of speed and breaking force is measured. The tablets made from roll compacted granules were found to be superior quality and all test revealed that evaluation parameters were under pharmacopoeial limits. To prepare a stable and robust dosage by optimizing the process parameters (roll- compaction).

Keywords: Disintegrants flowability, pharmacopoeial limits, roll- compaction.