Formulation, Evaluation and Optimization of Metformin Hydrochloride Tablet IP 500mg

INTRODUCTION:Oral drug delivery is the fastest and more preferred route for the drug administration is also the largest and oldest segment of the total drug delivery market. Various types of drug delivery systems are available to get better therapeutic action of drug, out of which immediate release drug delivery system is gaining more importance because of their wide advantages over others like ease of administration , convenience and noninvasiveness.(1) Metformin was discovered in 1922.Study in humans began in 1950s by French physician Jean Sterne. It was introduced in France in 1957 and the United States in 1995.It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. Metformin is believed to be the most widely used medication for diabetes which is taken by mouth (2) .Metformin hydrochloride (MH) is an oral hypoglycemic drug that has been used for the management of the noninsulin- dependent diabetes mellitus. It is taken in tablets of 500 and 850mg, with low and the incomplete absorption by the gastrointestinal tract, the usual dose being 2g/day and the maximum dose 3g/day.AIM OF STUDY:Development and evaluation of Metformine hydrochloride IP 500mg tablets by using nine optimized formulations.OBJECTIVE OF STUDY:Carrying out literature survey of the drug molecules , Formulation of the tablets using different trails, Analyzing the trial samples, Optimizing the final formula SUMMARY AND CONCLUSION:The present study was aimed at developing, evaluating and optimization of the oral hypoglycaemic drug Metformin Totally 9 formulations are prepared by using different ratios of Metformin ,Starch ,Gelatin ,Talc ,Methyl paraben sodium, Propyl paraben sodium and Sodium starch glycolate. Each 9 formulations contain the twenty tablets. The granules are prepared separately in a Max mixer. Pre compression parameters like Bulk density, True density, Angle of repose indicate all the formulations are showing flow properties. The tablets are compressed by double rotary compression machine and tablets are evaluated for post compression parameters like weight variation, Hardness, Friability, Disintegration and Dissolution parameters. Formulations F1-F3 sodium starch glycolate is not used, in that formulations starch is used in definite proportions. F4-F6 sodium starch glycolate is used and the starch is not use in this formulations. Sodium starch glycolate and starch used in case of F7-F9. These formulations can be compared to innovator. In the formulation of F9 is more matched to the innovator (Metformin) according to the drug release profile. A good result is getting by using both sodium starch glycolate and starch. The F9 formulation contains Metformin- 500mg, starch- 90mg, Sodium Starch Glycolte-6.25mg, Talc-50.18, Methyl Paraben-1.16, Propyl Paraben- 0.66mg, Gelatin-2mg. The compressed tablets are subjected to stability studies at 400C and 75%RH, 250C and 60%RH. Samples were analyzed at regular intervals as mentioned in stability protocol. From the study, it may be concluded that formulation F9 (it contains both sodium starch glycolate and starch in suitable proportions) can be prepared as immediate release formulation compared to conventional formulation