Orally disintegrating pharmaceutical composition and preparation method thereof

A technology for orally disintegrating tablets and drugs, which is applied in drug combinations, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problem of low drug loading and encapsulation efficiency, poor production feasibility, and particle size of pellets or granules. major issues

Inactive Publication Date: 2014-08-20
李雪梅
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among these methods, physical and chemical methods are widely used in experimental research, but their production feasibility is relatively poor; physical methods are more feasible for large-scale production, but the pellets or granules produced by the fluidized bed method are relatively large in size and cannot be used in disintegration. It may cause a gritty feeling; the spray drying method produces a smaller particle size, although the oral disintegration tablet does not cause a gritty feel, but the drug loading and encapsulation efficiency are lower

Method used

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  • Orally disintegrating pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Weigh 10g of vortioxetine hydrobromide, 20g of gastric-soluble polyacrylic acid resin EPO, and 1g of diethyl phthalate and dissolve them in 20ml of absolute ethanol. ~600rpm water, after the precipitation is complete, suction filtration, the obtained powder is dried in a vacuum drying oven for 24 hours, taken out, and stored in a closed container in a cool place to obtain vortioxetine hydrobromide taste-masking microcapsules.

[0027] Tablet prescription:

[0028] Vortioxetine Hydrobromide Taste-Masked Microcapsules

[0029] Weigh the above-mentioned materials (except magnesium stearate) and pour them into a three-dimensional mixer for mixing, then add magnesium stearate for mixing; the mixed materials are poured into the hopper of a tablet press, and the tablet weight and pressure are adjusted to perform tablet compression. The hardness of the compressed tablet is maintained at 30-50N; the product is obtained by cold-forming double-aluminum blister packs.

Embodiment 2

[0031] Weigh 20g of vortioxetine hydrobromide, 80g of gastric-soluble polyacrylic acid resin EPO and 2g of diethyl phthalate and dissolve them in 20ml of absolute ethanol. ~600rpm water, after the precipitation is complete, suction filtration, the obtained powder is dried in a vacuum drying oven for 24 hours, taken out, and stored in a closed container in a cool place to obtain vortioxetine hydrobromide taste-masking microcapsules.

[0032] Tablet prescription:

[0033] Vortioxetine Hydrobromide Taste-Masked Microcapsules

[0034] Weigh the above-mentioned materials (except magnesium stearate) and pour them into a three-dimensional mixer for mixing, then add magnesium stearate for mixing; the mixed materials are poured into the hopper of a tablet press, and the tablet weight and pressure are adjusted to perform tablet compression. The hardness of the compressed tablet is maintained at 30-50N; the product is obtained by cold-forming double-aluminum blister packs.

Embodiment 3

[0036] Weigh 20g of vortioxetine hydrobromide, 80g of gastric-soluble polyacrylic acid resin EPO and 2g of diethyl phthalate and dissolve them in 20ml of absolute ethanol. ~600rpm water, after the precipitation is complete, suction filtration, the obtained powder is dried in a vacuum drying oven for 24 hours, taken out, and stored in a closed container in a cool place to obtain vortioxetine hydrobromide taste-masking microcapsules.

[0037] Tablet prescription:

[0038] Vortioxetine Hydrobromide Taste-Masked Microcapsules

[0039] Weigh the above materials (except magnesium stearate) into a three-dimensional mixer and mix for 30 minutes, then add magnesium stearate and mix for 1 to 2 minutes; pour the mixed materials into the hopper of the tablet machine, adjust the tablet weight and pressure, Tablet compression is carried out so that the hardness of the compressed tablet is maintained at 30-50N; double aluminum blisters are cold-formed and packaged.

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Abstract

The invention relates to an orally disintegrating pharmaceutical composition and a preparation method thereof and belongs to the field of pharmaceutical preparations. Considering the characteristic of bitter taste of hydrobromic acid vortioxetine, the invention provides a method for preparing orally disintegrating tablets which are small in particle size and can cover the bitter taste. The method is realized by mainly adopting the technical scheme, namely the composition is prepared by granulating or directly tabletting pharmaceutical microcapsules, 20-80 weight percent of filling agent, 5-10 weight percent of disintegrating agent, 0.5-2 percent of flavoring agent and 1-2 percent of lubricating agent. The orally disintegrating tablets do not have a grit feeling, sweetening agents such as saccharin sodium salt and Aspartame are not needed to be added into a subsequent tablet prescription, or the flavor of the tablets can be increased by adding a small amount of sweetening agent or essence and flavor according to market requirements, and the medicine content and encapsulation efficiency can meet the industrial large-scale production requirements.

Description

technical field [0001] The invention relates to an orally disintegrating pharmaceutical composition and a preparation method thereof, in particular to a taste-masking orally disintegrating pharmaceutical composition and a preparation method thereof through a technical method. Background technique [0002] In today's society, with the increasingly tense pace of life and various pressures, the number of patients with depression is astonishing. The pathogenesis of depression is mainly due to the low content of central norepinephrine (NE), 5-hydroxytryptamine (5-HT) and dopamine (DA) in the body and the decline of their receptor function. The functions of monoamine neurotransmitters in the brain are relatively complex, among which 5-HT seems to play a basic role in controlling sensory responses, NE is mainly related to insomnia and inattention, and DA controls more running and cognitive functions. These neurotransmitters have complex interactions, and together affect the human ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/495A61P25/24
Inventor 不公告发明人
Owner 李雪梅
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