Abstract

FORMULATION AND PROCESS VALIDATION OF ATORVASTATIN FILM COATED TABLET

Sunil Kumar Sinha*, Hemant Kumar Sharma

College of Pharmacy, Sri Satya Sai University of Technology and Medical Sciences, Sehore, (M.P.)

ABSTRACT

Atorvastatin is a selective competitive inhibitor of HMG CoA reductase. It reduces total cholesterol, low density lipoprotein (LDL). HMG CoA reductase catalyzes the HMG CoA to mevolanate, which is the limiting step in cholesterol biosynthesis. It also reduces the VLDL cholesterol and triglyceride. The present research work focused on formulation and concurrent process validation for Atorvastatin 20 mg tablets. The tablets were manufactured by wet granulation method. Since the dose is 20 mg, uniform distribution of the drug in the tablet is critical which can influence the content uniformity, assay and dissolution of the tablets. 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 Atorvastatin tablet with same size, method, equipment & validation criteria were taken. Various critical parameters during dry mixing, wet granulation, drying, lubrication, compression and coating stages were identified and evaluated as per validation protocol. The outcomes of the entire process indicate that process validation data provides a high degree of assurance that the manufacturing process will produce a product meeting its predetermined specification and quality attributes. It is concluded that the wet granulation method can ensure uniform distribution of Atorvastatin and the tablets can be effectively manufactured with the desired specifications & reproducible quality standards.

Keywords: Atorvastatin, Concurrent process, Wet granulation method, Critical parameters