METHOTREXATE FAST DISINTEGRATING TABLET AS A DOSAGE FORM FOR DYSPHAGIA PATIENTS
Keywords:
Fast disintegrating tablets, Dysphagia, Head and neck cancer, Methotrexate, Geriatric patientsAbstract
Objective: The objective of the present study was to develop, optimize and evaluate fast disintegrating tablet (FDT) of methotrexate (MTX) as a dosage form for dysphagia patients with a view to enhance patient compliance and safety.
Methods: FDT was prepared by direct compression technique and effect of incorporating major excipients such as Croscarmellose Sodium (CCS), Crospovidone (CP), Sodium Starch Glycolate (SSG), neusilin and magnesium stearate on various parameters were evaluated. The blends prepared were evaluated for pre and post compression evaluations. The optimized FDT was assessed for various studies such as FT-IR, Differential Scanning Calorimeter (DSC), X-Ray Diffraction (XRD), in vitro disintegration, dissolution, in vivo pharmacokinetic and stability studies.
Results: The optimized blend mixture had good flow and compressible property; hence tablets produced were of uniform weight with acceptable weight variation. The drug content assessed by HPLC was within limits indicating drug had uniformly distributed in the tablets. Tablet produced can withstand abrasion during handling, packaging and shipment as tablet had optimum hardness and least friability. There was no drug-excipient incompatibility as confirmed by FT-IR and DSC studies. Change in crystalline nature of the drug after tableting was confirmed by XRD studies. FDT prepared using CP showed quick disintegration with excellent dissolution rate profile and exhibited satisfactory stability at normal temperature. In vivo studies of FDTs (test) compared with drug solution (control) showed no statistically significant difference in pharmacokinetic parameters.
Conclusion: The study indicated that MTX FDT disintegrates rapidly in seconds and hence is a promising dosage form for dysphagia patients.
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