Formulation and Evaluation of Tranexamic Acid Sustained Release Tablets

B. Venkateswara Reddy*, A. Divyasri
Department of Industrial Pharmacy, St.Paul’s College of Pharmacy, Turkayamjal (V), Hayathnagar (M), R.R.Dist-501510.

A B S T R A C T
The aim of the current investigation is to design oral sustained release tablets of Tranexamic acid a drug used for the treatment or prevention of menorrhagia, haemorrhage and various bleeding disorders. The tablets were prepared by the Wet granulation method using varying concentrations of sustained release polymers HPMC, cetosteryl alcohol and Ethyl cellulose. The compatibility of the polymers was ruled out by FT-IR studies and found to be compatible. Total 11 formulations were prepared. The Tranexamic acid and the powder-blends of tablets were evaluated for their physical properties like angle of repose, bulk density and compressibility index and found to be good and satisfactory. The prepared tablets were evaluated for in process and finished product quality control tests including appearance, dimensions, weight variation, hardness, friability, drug content, and in vitro drug release. The dissolution medium used was pH 6.8. phosphate buffer. All formulations showed acceptable pharmaco-technical properties and complied with in-house specifications for tested parameters. Among all the formulations (F₁-F₁₁), F₉ shows good flow properties and physicochemical characteristics of prepared tablets were found within the specification and formulation F₉ has shown better drug release over 12 hours of time and it released 98.85% of drug out of 11 formulations. The mechanism of drug release from the optimized formulation follows zero order kinetics and Peppa’s plot.
Keywords: Antifibrinolytic, Tranexamic acid, Sustained release, Wet granulation method, Zero order release.