Abstract

SCALE UP OF SOLID ORAL DOSAGE FORM WITH COMBINATION OF THREE DIFFERENT DRUGS

Arsh Chanana*, Ajay Bilandi, Mahesh Kumar Kataria

ABSTRACT

Scale-up is generally defined as the process of increasing batch size. Scale-up of a process can also be viewed as a procedure for applying the same process to different output volumes. There is a subtle difference between these two definitions: batch size enlargement does not always translate into a size increase of the processing volume. The work was aimed on the scale up study of a solid oral dosage form with combination of three different drugs. The work was done using three trial batches in which the blending speed and stroke per min for capsules filling machine was taken as optimization parameters. The result was obtained by using the various evaluation parameters i.e. density, moisture content, average net content, weight variation, disintegration test and content uniformity of drug by HPLC. Assay was performed after blending and filling. Third batch using the 50 RPM with 100 strokes per min give higher yield than other two batches and give the less standard deviation. Thus these parameters were optimized and show the reproducibility.

Keywords: Scale Up, Technology Transfer, Combination Dosage From, Capsules Formulation.