Abstract

FORMULATION AND PROCESS VALIDATION OF CLARITHROMYCIN LOADED IMMEDIATE RELEASE TABLETS

Ketaki S. Shinde*, Dr. R. C. Doijad, Dr. J. S. Mulla and Sachin S. Mali

ABSTRACT

The main aim of the present research work was to study concurrent process validation of immediate release tablet. If each step of production process is validated we can assure that the final product is of the best quality. Validation is best viewed as an impartment and integral part of cGMP. Validation is therefore one element of quality assurance programs associated with a particular process. Quality cannot be assured only by doing finished product testing and in-process monitoring but it should be built into the manufacturing process. So building of quality require a special attention to a few factors like selection of material, process design, control variables, in process control and finished product testing. In this study three initial batch of clarithromycin tablet with same size, method, equipment and validation criteria were taken. The critical parameters involved in dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, lubrication, and compression stages were identified and evaluated. Results obtained with this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes. It also provides documented evidence for the operation sequence of manufacturing process and to determine the critical parameters and variables in the process of manufacturing of the tablets. The output of process validation can be used to increase productivity, its consistent quality and decreasing the need for processing or market complaints.

Keywords: Clarithromycin, Process Validation, Immediate release tablets, Control Variables.