Orally disintegrating tablet of Rasagiline or medicine salts thereof and preparation method thereof

Abstract

The invention belongs to the technical field of medicines and relates to an orally disintegrating tablet of Rasagiline or medicine salts thereof and a preparation method thereof. The orally disintegrating tablet comprises the following components in percentage by weight: 0.25-2 percent of Rasagiline or medicine salts thereof, 85-91 percent of spray drying mannitol, 3-10 percent of disintegrant, 0.5-2 percent of flow agent, 0.5-2 percent of lubricant, 0-2 percent of sweetener and 0-2 percent of flavoring agent. The raw materials and the auxiliary materials are uniformly mixed to obtain uniform fine powder which is directly squashed to form tablets. The orally disintegrating tablet of the Rasagiline or the medicine salts thereof has enough hardness, can satisfy the requirements of production, packaging, storage and transportation and also has good taste and shorter disintegration time.

Description

technical field [0001] The invention relates to an orally disintegrating tablet of rasagiline or a medicinal salt thereof for treating Parkinson's disease and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Tablets that disintegrate (or dissolve) rapidly in the oral cavity are uniformly defined as "orally disintegrating tablets" by the National Center for Drug Evaluation. The orally disintegrating tablet can disintegrate in the oral cavity without water. When taking it, put this product on the tongue without taking it with water. This product will disintegrate on its own and be swallowed into the stomach with saliva. [0003] The preparation techniques of orally disintegrating tablets are mainly divided into two categories: freeze-drying and tableting. Freeze-dried orally disintegrating tablets are generally prepared by vacuum freeze-drying and using soluble excipients. Its disintegration speed exceeds that of orally...

AI Technical Summary

Problems solved by technology

[0010] The above prescriptions all use microcrystalline cellulose or low-substituted hydroxypropyl cellulose, and the application of such excipients causes discomfort in the mouth after disintegration

Moreover, the orally disintegrating tablet is prepared by encapsulation technology, the production process is cumbersome and the yield is low

[0011] Chinese patent CN108098685A (application number 200580046326.7) provides a preparation method for preparing rasagiline or its medicinal salt orally disintegrating tablets, but the sodium stearyl fumarate used in this method is not yet approved by the State Food and Drug Administration Document number; at the same time, the sorbitol used in this patent has high hygroscopicity, which is not conducive to the preservation of orally disintegrating tablets, and sorbitol has greater eye irritation, and protection needs to be strengthened during production, which limits its use in the actual pharmaceutical industry Applications

According to the "Draft Guidelines and Discussion on Orally Disintegrating Tablets Issued by FDA" published by the Center for Drug Evaluation of the State Food and Drug Administration on May 8, 2007, the quality control points of China's orally disintegrating tablets require The disintegration time in water at 37°C should be less than 1 minute, and the method described in Chinese patent CN108098685A (application number 200580046326.7) is difficult to meet this requirement

[0012] To sum up, although the above contents all disclose the preparation method and application of orally disintegrating tablets, there are no products and methods suitable for actual use and operation in my country for rasagiline or its medicinal salt orally disintegrating tablets. Preparation method, while the preparation method disclosed in the above-mentioned Chinese patent CN108098685A also has deficiencies

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