Abstract:
The purpose of research was to study prospective validation of Cimetidine 400
mg tablet dosage formulation. Quality cannot be adequately assured by in-process and
finished inspections and testing but it should be built in to the manufacturing process.
These processes should be controlled in order that the finished product meets all quality
specifications. Therefore building of quality requires careful attention to a number of
factors, such as the selection of materials, product and process design, control variables,
in process control and finished product testing. Three initial process validation batches of
same size, same equipment, method, material and validation criteria was taken. In solid
dosage forms the film coating tablets was used because of the protect from light,
temperature, moisture mask of undesirable taste or odour improves the appearance,
provide tablets identity, facilitate swallowing and control and modify release of the drug.
Film coating applied as a thin polymeric film to the surface of the tablet. The critical
process parameter involved in sifting, dry mixing, preparation of granulating agent, wet
mixing, wet milling, drying, sizing, lubrication, compression stages and coating
parameter were identified and evaluated as per validation plan. Film coating of tablet
were evaluated for coating uniformity, coating process efficiency and surface roughness.
The spray rate, atomization air pressure, distance of nozzle from tablet bed, inlet air
temperature, pan differential pressure, pan speed and % solid content these affect the
final film quality of coated tablets. Therefore based on results of process validation batch
at each of the stages for the specified parameters it was summarized and concluded that
with the prospective process validation for the Cimetidine 400 mg tablet produces the
batches with no significant deviation and reported documented evidence, that process can
be effectively produce a product which complies with the present specification and
reproducible quality standards.
