Study On The Preparation Technology And Quality Evalustion Of Montelukast Sodium Orally Disintegratingtablets

ObjectiveA new generation of non-steroidal anti-inflammatory drugs is montelukast sodium, which in clinical terms has been confirmed that the treatment of certain childhood asthma. Although better efficacy of montelukast sodium, but its stability is poor, see the light easily decomposed and chewable tablets and marketed for children of poor compliance. Therefore, to reduce the variety of side effects, first consider the drug into solid dispersion, and then made orally disintegrating tablets to improve drug safety, efficacy and patient compliance.MethodsMontelukast sodium as a model drugis prepared orally disintegrating tablets in this issue, and includes four chapters:The first chapter is to establish a series of test methods that used in this study, such as HPLC(HPLC) determination of dissolution, content and related substances, the result above analysis method is accurate, reliable, convenient and fast, meet the analytical requirements.The second chapter was preparation of montelukast sodium solid dispersions by solvent- spray drying, formulation and process optimization through single factor test and orthogonal design, and solid dispersions were identified using the dissolution method. Solid dispersion can increase the stability of the drug, but the store should be low and moisture, prevent aging.The third chapter was preparation of orally disintegrating tablets using wet granulation. Kind and amount of the preferred fillers, disintegrants, lubricants and flavoring agents was used single factor test and orthogonal test. ODT optimized process for the preparation of good taste.The fourth chapter was optimized for quality evaluation of the prescription orally disintegrating tablets of montelukast sodium, by influencing factors, acceleration and long-term stability tests counterparts disintegrating tablets preliminary investigation.ResultsThrough a series of preliminary experiments and relevant literature, the final preparation obtained orally disintegrating tablets of montelukast sodium,taste, hardness, disintegration, eatl. which adhere to the relevant quality standards.ConclusionAccording to the results of stability tests and accelerated tests, obtained montelukast orally disintegrating tablet preparation process is feasible; By amplification test results of the process is more suitable for commercial production, and have certain practical significance.