Orally disintegrating tablet suitable for infants and children and preparation method thereof

Abstract

The invention relates to an oseltamivir orally disintegrating tablet which is used for treating the flu of infants and children. The oseltamivir orally disintegrating tablet is prepared from the following ingredients in percentages by weight: 10-40% of taste masking micropill, 20-80% of filling agent, 1-6% of binding agent, 2-10% of disintegrating agent, 0-5% of corrigent and 0.5-2.5% of lubricating agent, wherein the taste masking micropill comprises a medicine containing pill core and a coating layer, the medicine in the medicine containing pill core is oseltamivir or a pharmaceutically acceptable salt of the oseltamivir, which accounts for 10-40% of the total weight of the micropill, the material of the coating layer is polyacrylic resin IV, which accounts for 1-50% of the total weight of the micropill, and the particle size of the micropill is 0.10-0.50mm.

Description

technical field [0001] The invention relates to a preparation method of pharmaceutical preparations in the field of pharmacy, in particular to an orally disintegrating tablet suitable for infants and children with oseltamivir as the main ingredient and a preparation method thereof. technical background [0002] As a newly developed neuraminidase inhibitor, Oseltamivir is widely used in clinical practice. Its chemical name is (3R,4R,5S)-4-acetamide-5-amino-3(1- Ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester, the structural formula is as follows: [0003] [0004] Oseltamivir can act on the surface glycoprotein of influenza virus-neuraminidase (NA), thereby inhibiting virus replication and spread in the respiratory tract. It is a highly selective inhibitor of influenza virus NA. Oseltamivir was launched in Switzerland in 1999. After the listing, a large number of clinical practices have confirmed that oseltamivir has the advantages of being effective against inf...

AI Technical Summary

Problems solved by technology

However, orally disintegrating tablets often have the following disadvantages: problems with the taste of the drug, such as gritty feeling; packaging and transportation problems caused by too low hardness

Therefore, many researchers use encapsulation techniques such as physical and chemical methods to prepare drug-containing microcapsules, physical methods such as fluidized bed coating to prepare microcapsules or granules, and spray-drying methods to prepare drug-containing microcapsules and microspheres to obtain bitter drugs. Among these methods, physical and chemical methods are widely used in experimental research, but they cannot completely encapsulate drugs, and can still produce certain bad tastes, and the production feasibility is poor; physical methods are more feasible for large-scale production, but The particle size produced by fluidized bed is larger; the particle size produced by spray drying method is smaller, but the drug loading and encapsulation efficiency are lower

Oseltamivir common capsules and other dosage forms that are now on the market have specifications of 30mg, 45mg and 70mg. However, the commonly used dosage in pediatrics is calculated according to the weight of the child. The dosage is also 3mg / kg (see Table 1); in this way, when giving medicine to children, the dosage form on the market often needs to be divided into several parts, which will not only cause drug pollution, but also cannot accurately guarantee the dosage, and separate may affect the effect of the drug

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