Orally disintegrating tablets containing montelukast sodium and preparation method thereof

Abstract

The invention relates to orally disintegrating tablets, and particularly relates to orally disintegrating tablets containing montelukast sodium and a preparation method thereof. The orally disintegrating tablets containing the montelukast sodium are composed of the following components: 5% of montelukast sodium, 50-80% of a hydrophilic filling agent, 10-60% of a non-hydrophilic filling agent, 2-10% of a disintegrating agent, 0.5-1.5% of an adhesive, and 0.5-1% of a lubricant; and the orally disintegrating tablets containing the montelukast sodium are prepared by adopting a direct powder pressing technology. The montelukast sodium is an orally effective selective leukotriene receptor antagonist which is capable of specifically inhibiting cysteinyl leukotrienes receptors; and thus, the montelukast sodium can be used for treating asthma and allergic rhinitis in adults and children. At present, no orally disintegrating tablets containing the montelukast sodium is marketed in China. Orallydisintegrating tablets containing the montelukast sodium are only marketed in Japan; however, due to adoption of freeze-drying as a preparation process, the orally disintegrating tablets containing the montelukast sodium are relatively high in cost. But for the orally disintegrating tablets containing the montelukast sodium and the preparation method thereof disclosed by the invention, the orallydisintegrating tablets containing the montelukast sodium is safe to take, excellent in disintegration property, good in taste, simple in preparation processes and low in cost.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to an orally disintegrating tablet containing montelukast sodium and a preparation method thereof. Background technique [0002] Asthma has another name called bronchial asthma. Bronchial asthma is a chronic airway inflammation involving a variety of cells and cell components. This kind of inflammation is often accompanied by increased airway reactivity, leading to recurrent symptoms such as wheezing, shortness of breath, chest tightness, and / or coughing. Occurs at night and / or in the early morning. Cysteinyl leukotrienes (CysLTs) are related to the pathophysiological process of asthma and allergic rhinitis. Montelukast sodium has a high affinity and selectivity for CysLTs receptors, and it can effectively inhibit the physiological effects of LTC4, LTD4 and LTE4 binding to CysLTs receptors without any receptor agonistic activity. [0003] At present, the exist...

AI Technical Summary

Problems solved by technology

Considering that the attack duration of asthma and allergic rhinitis varies greatly among individuals, mild asthma attacks only have chest tightness, which lasts for several minutes, and severe cases have extreme dyspnea, which lasts for several weeks or longer, so Montelu Kastir sodium is prepared as a common tablet or chewable tablet that needs to be swallowed, and the patient's compliance with taking it is very poor, and it may even block the trachea, which is potentially dangerous