Development and Evaluation of a New Combined Dosage form for Migraine

Abstract

This thesis deals with the studies carried out by the writer in this laboratory for the past four years on the development and evaluation of a multicomponent drug dosage form for migraine. The first chapter deals with a brief account on migraine, classification by International Headache Society, pathophysiology, theories and drugs used in migraine. A brief account of the stages of drug development, short comings of drug development, the need and advantages of fixed dose combinational dosage forms have been discussed. The evaluation of drug dosage form by using newlinehigh performance liquid chromatography, in vitro studies, stability studies and bioavailability studies have also been discussed. The review of literature on analytical and bioavailability studies carried out for naproxen sodium, sumatriptan succinate and fixed dose combinational forms containing naproxen sodium and sumatriptan succinate are also presented. The scope and objectives of the present investigation. In particular the need and merits of developing a fixed dose combinational form for migraine treatment were described. The various stages of development of a fixed dose combinational forms by preformulation, formulation studies and evaluation of the same by estimation of drugs by well developed and validated HPLC method, in vitro studies to understand the release profile, stabilities studies by evaluating the drugs physical and chemical parameters and bioavailability studies to confirm the release in human volunteers are explained. The materials and methods used and the experimental procedures adopted. It describes in detail the procedure adopted for the optimization of the fixed dosage combination form by preformulation and formulation studies. The development of HPLC method and finalized chromatographic conditions for the separation of the drug in fixed dose combinational forms and validation of the developed method, its in vitro release behaviors, stability studies and bioavailability studies are explained. newline