FORMULATION AND CHARACTERIZATION OF METHOTREXATE CONTROL RELEASE TABLETS

The present study was aimed at the formulation and evaluation of Methotrexate controlled release matrix tablets using suitable hydrophilic polymers to achieve sustained drug release and improve therapeutic efficacy. Methotrexate is an antimetabolite and antifolate drug widely used in the treatment of various cancers and autoimmune disorders. Controlled release dosage forms can reduce dosing frequency, maintain therapeutic drug concentrations, and enhance patient compliance.Methotrexate matrix tablets were prepared by the direct compression method using Sodium Alginate and Guar Gum as release-retarding polymers. The powder blends exhibited good flow properties suitable for tablet compression.The prepared tablets were evaluated for weight variation, thickness, hardness, friability, and drug content. All formulations showed acceptable physicochemical properties and complied with pharmacopeial specifications. In vitro dissolution studies demonstrated sustained drug release from the matrix tablets over a period of 8 hours. Among the four formulations, F3 exhibited the most desirable performance with satisfactory tablet characteristics, high drug content (98.83%), and maximum cumulative drug release (98.36%).Stability studies of the optimized formulation (F3) carried out under different storage conditions showed no significant changes in physicochemical properties or drug content, indicating good stability of the formulation.The results of the present investigation demonstrate that Methotrexate controlled release matrix tablets can be successfully formulated using suitable polymers, and formulation F3 was found to be the optimized formulation for providing sustained drug release with acceptable stability and tablet characteristics. Keywords: Methotrexate, FTIR Studies, Polymers, Direct compression technique, In vitro drug release studies