Oral loratadine disintegrating tablet and its prepn

Abstract

The present invention relates to loratadine medicine, and is especially oral loratadine disintegrating tablet for treating allergic diseases and its preparation process. The oral loratadine disintegrating tablet consists of loratadine 11 wt%, micro crystal cellulose 56 wt%, mannitol 22 wt%, low substituted hydroxypropyl cellulose 8 wt%, and aspartame 2 wt%, except lubricant comprising magnesium stearate, polyglycol-6000 and talcum. The preparation process includes the pre-treatment of the components, mixing, pelletizing, drying, further mixing with lubricant, and tabletting. The present invention has short disintegrating time and easy taking.

Description

Technical field [0001] The invention relates to a loratadine medicament, in particular to a loratadine orally disintegrating tablet for treating allergic diseases and a preparation method thereof. Background technique [0002] Loratadine, the chemical name is: 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cycloheptyl[1,2-b]pyridine-11-ene)-1 -Ethyl piperidine carboxylate. It was developed by Schering-Plough of the United States and first went public in 1988. It is now on the market in 89 countries and sold as over-the-counter drugs in 15 countries. In recent years, the sales of loratadine in the international market have grown rapidly, and it has become the world's best-selling antihistamine. [0003] Loratadine is a new oral, potent and long-acting tricyclic antihistamine. Its pharmacological effects include: ①Long-acting, strong and specific competition for peripheral H1 receptors, blocking the effect of histamine; ②Inhibiting the immune release of inflammatory mediators; ③Anti-allergi...

AI Technical Summary

Problems solved by technology

However, it is difficult for the elderly, children and those with dysphagia to swallow ordinary tablets and capsules, especially long-term use will lead to poor compliance of patients, so that the therapeutic effect cannot be guaranteed; and syrups are inconvenient to carry

[0005] Of course, there are also people of insight who have done research on the preparation of orally disintegrating tablets of loratadine: in order to achieve the purpose of short disintegration time, researchers have used freeze-drying methods to prepare this dosage form, using this method It can achieve the purpose of disintegration time of less than 10 seconds, but the processing equipment of this type of preparation method is very expensive, and the equipment cost of the enterprise is high; in order to reduce costs, if the wet granulation of common ordinary tablets is adopted, the disintegration of the existing formula It takes a long time (<40 seconds) and cannot achieve satisfactory results, so it is in a dilemma