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Premixed auxiliary material for preparing orally disintegrating tablet through direct compression

A technology of premixing excipients and tableting, which is applied in the field of biomedicine, can solve the problems of unsatisfactory excipient performance indicators and complicated steps, and achieve the effects of high tablet hardness, increased release rate, and improved compressibility

Active Publication Date: 2015-11-04
HUNAN ER KANG PHARMA
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  • Abstract
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AI Technical Summary

Problems solved by technology

[0004] In order to solve the problems of complicated steps for preparing pharmaceutical premixed excipients and unsatisfactory performance indicators of the obtained excipients, the present invention provides a premixed excipient, formula and preparation method for directly compressing tablets to prepare orally disintegrating tablets

Method used

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  • Premixed auxiliary material for preparing orally disintegrating tablet through direct compression
  • Premixed auxiliary material for preparing orally disintegrating tablet through direct compression

Examples

Experimental program
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Effect test

Embodiment 1-3

[0031] Table 1. Composition ratios in Examples 1-3

[0032]

[0033] According to the proportion of each component in the above table, mix each auxiliary material evenly, set the temperature from each section of the twin-screw extruder to the machine head in order of 200°C→400°C→400°C→400°C→300°C, and the screw speed is 40 r / min, the uniformly mixed material is put into the hopper, and extruded in the shape of strips from the die hole of the machine head after extrusion. The extrudate was placed in an aluminum pan, cooled at room temperature, and crushed. Pass through 80-100 mesh pharmacopoeia sieves to prepare the premixed auxiliary material compound and set aside. Mix the premixed auxiliary materials and vitamin C uniformly at a weight ratio of 4:1, and directly compress the tablet with different pressures to obtain finished vitamin C orally disintegrating tablets.

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Abstract

The invention provides a premixed auxiliary material for preparing an orally disintegrating tablet through direct compression. The auxiliary material is composed of the following auxiliary materials such as mannitol, trehalose, lactose, anhydrous sodium hydrogen phosphate, crosslinked carboxymethylcellulose sodium, microcrystalline cellulose, polacrilin potassium, polyvinylpyrrolidone and sodium stearyl fumarate. The premixed auxiliary material is obtained by re-crystallizing, grinding and screening by using a method according to respective parameters. The premixed auxiliary material is particularly suitable for dosage forms such as the orally disintegrating tablet and a buccal tablet.

Description

technical field [0001] The invention relates to a premixed auxiliary material and a preparation method thereof, belonging to the field of biomedicine, in particular to a premixed auxiliary material used for preparing orally disintegrating tablets by a direct compression method. Background technique [0002] Premixed auxiliary materials refer to the uniform mixing of two or more single auxiliary materials in a certain proportion and with a certain production process in advance to become a new auxiliary material with multi-functional or specific functions and uniform appearance. The production process Commonly used are simple blending, co-drying, hot-melt extrusion, freeze-drying or co-precipitation, etc. Premixed excipients maintain or improve the advantages of single excipients. At present, the research on premixed excipients mainly focuses on direct-compression tablet premixed excipients and film coating premixed excipients. Among them, the direct-compression tablet premix...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/32A61K9/20
Inventor 帅放文王向峰章家伟
Owner HUNAN ER KANG PHARMA
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